Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/supplementalPatientMaterial
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Medication Guide:<br/>Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions: Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about:<br/>What is the most important information I should know about antidepressant medicines, depression, and other serious mental illnesses, and suicidal thoughts or actions?:<br/>Call a healthcare provider right away if you or your family member has any of the following symptoms especially if they are new, worse, or worry you::<br/>What else do I need to know about antidepressant medicines?: This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.
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Medication guide: NOLVADEX' (Nole-vah-dex) Tablets Generic name: tamoxifen (ta-MOX-I-fen) Written for women who use NOLVADEX to lower their high chance of getting breast cancer or who have ductal carcinoma in situ (DCIS) People taking NOLVADEX to treat breast cancer have different benefits and different decisions to make than high-risk women or women with ductal carcinoma in situ (DCIS) taking NOLVADEX to reduce the chance of getting breast cancer. If you already have breast cancer, talk with your doctor about how the benefits of treating breast cancer with NOLVADEX compare to the risks that are described in this document. Why should I read this Medication Guide? This guide has information to help you decide whether to use NOLVADEX to lower your chance of getting breast cancer. You and your doctor should talk about whether the possible benefit of NOLVADEX in lowering your high chance of getting breast cancer is greater than its possible risks. Your doctor has a special computer program or hand-held calculator to tell if you are in the high-risk group. If you have DCIS and have been treated with surgery and radiation therapy, your doctor may prescribe NOLVADEX to decrease your chance of getting invasive (spreading) breast cancer. Read this guide carefully before you start NOLVADEX. It is important to read the information you get each time you get more medicine. There may be something new. This guide does not tell you everything about NOLVADEX and does not take the place of talking with your doctor. Only you and your doctor can determine if NOLVADEX is right for you. What is the most important information I should know about using NOLVADEX to reduce the chance of getting breast cancer? NOLVADEX is a prescription medicine that is like estrogen (female hormone) in some ways and different in other ways. In the breast, NOLVADEX can block estrogen's effects. Because it does this, NOLVADEX may block the growth of breast cancers that need estrogen to grow (cancers that are estrogen- or progesterone-receptor positive). NOLVADEX can lower the chance of getting breast cancer in women with a higher than normal chance of getting breast cancer in the next five years (high-risk women) and women with DCIS. Because high-risk women don't have cancer yet, it is important to think carefully about whether the possible benefit of NOLVADEX in lowering the chance of getting breast cancer is greater than its possible risks. This Medication Guide reviews the risks and benefits of using NOLVADEX to reduce the chance of getting breast cancer in high-risk women and women with DCIS. This guide does not discuss the special benefits and decisions for people who already have breast cancer. Why do women and men use NOLVADEX? NOLVADEX has more than one use. NOLVADEX is used: to lower the chance of getting breast cancer in women with a higher than normal chance of getting breast cancer in the next 5 years (high-risk women) to lower the chance of getting invasive (spreading) breast cancer in women who had surgery and radiation for ductal carcinoma in situ (DCIS). DCIS means the cancer is only inside the milk ducts. to treat breast cancer in women after they have finished early treatment. Early treatment can include surgery, radiation, and chemotherapy. NOLVADEX may keep the cancer from spreading to others parts of the body. It may also reduce the woman's chance of getting a new breast cancer. in women and men, to treat breast cancer that has spread to other parts of the body (metastatic breast cancer). This guide talks only about using NOLVADEX to lower the chance of getting breast cancer (#1 and #2 above). What are the benefits of NOLVADEX to lower the chance of getting breast cancer in high-risk women and in women treated for DCIS? A large US study looked at high-risk women and compared the ones who took NOLVADEX for 5 years with others who took a pill without NOLVADEX (placebo). High-risk women were defined as women who have a 1.7% or greater chance of getting breast cancer in the next 5 years, based on a special computer program. In this study: Out of every 1,000 high-risk women who took a placebo, each year about 7 got breast cancer. Out of every 1,000 high-risk women who took NOLVADEX, each year about 4 got breast cancer. The study showed that on average, high-risk women who took NOLVADEX lowered their chances of getting breast cancer by 44%, from 7 in 1,000 to 4 in 1,000. Another US study looked at women with DCIS and compared those who took NOLVADEX for 5 years with others who took a placebo. In this study: Out of every 1,000 women with DCIS who took placebo, each year about 17 got breast cancer. Out of every 1,000 women with DCIS who took NOLVADEX, each year about 10 got breast cancer. The study showed that on average, women with DCIS who took NOLVADEX lowered their chances of getting invasive (spreading) breast cancer by 43%, from 17 in 1,000 to 10 in 1,000. These studies do not mean that taking NOLVADEX will lower your personal chance of getting breast cancer. We do not know what the benefits will be for any one woman who takes NOLVADEX to reduce her chance of getting breast cancer. What are the risks of NOLVADEX? In the studies described under���What are the benefits of NOLVADEX?���, the high-risk women who took NOLVADEX got certain side effects at a higher rate than those who took a placebo. Some of these side effects can cause death. In one study, in women who still had their uterus Out of every 1,000 women who took a placebo, each year 1 got endometrial cancer (cancer of the lining of the uterus) and none got uterine sarcoma (cancer of the body of the uterus). Out of every 1,000 women who took NOLVADEX, each year 2 got endometrial cancer and fewer than 1 got uterine sarcoma. These results show that, on average, in high-risk women who still had their uterus, NOLVADEX doubled the chance of getting endometrial cancer from 1 in 1,000 to 2 in 1,000, and it increased the chance of getting uterine sarcoma. This does not mean that taking NOLVADEX will double your personal chance of getting endometrial cancer or increase your chance of getting uterine sarcoma. We do not know what this risk will be for any one woman. The risk is different for women who no longer have their uterus. For all women in this study, taking NOLVADEX increased the risk of having a blood clot in their lungs or veins, or of having a stroke. In some cases, women died from these effects. NOLVADEX increased the risk of getting cataracts (clouding of the lens of the eye) or needing cataract surgery. (See���What are the possible side effects of NOLVADEX?���for more details about side effects.) What don't we know about taking NOLVADEX to reduce the chance of getting breast cancer? We don't know if NOLVADEX lowers the chance of getting breast cancer in women who have abnormal breast cancer genes (BRCA1 and BRCA2) if taking NOLVADEX for 5 years reduces the number of breast cancers a woman will get in her lifetime or if it only delays some breast cancers if NOLVADEX helps a woman live longer the effects of taking NOLVADEX with hormone replacement therapy (HRT), birth control pills, or androgens (male hormones) the benefits of taking NOLVADEX if you are less than 35 years old Studies are being done to learn more about the long-term benefits and risks of using NOLVADEX to reduce the chance of getting breast cancer. What are the possible side effects of NOLVADEX? The most common side effect of NOLVADEX is hot flashes. This is not a sign of a serious problem. The next most common side effect is vaginal discharge. If the discharge is bloody, it could be a sign of a serious problem. [See���Changes in the lining (endometrium) or body of your uterus���below.] Less common but serious side effects of NOLVADEX are listed below. These can occur at any time. Call your doctor right away if you have any signs of side effects listed below: Changes in the lining (endometrium) or body of your uterus. These changes may mean serious problems are starting, including cancer of the uterus. The signs of changes in the uterus are: - Vaginal bleeding or bloody discharge that could be a rusty or brown color. You should call your doctor even if only a small amount of bleeding occurs. - Change in your monthly bleeding, such as in the amount or timing of bleeding or increased clotting. -Pain or pressure in your pelvis (below your belly button). Blood clots in your veins or lungs. These can cause serious problems, including death. You may get clots up to 2-3 months after you stop taking NOLVADEX. The signs of blood clots are: - sudden chest pain, shortness of breath, coughing up blood -pain, tenderness, or swelling in one or both of your legs Stroke. Stroke can cause serious medical problems, including death. The signs of stroke are: -sudden weakness, tingling, or numbness in your face, arm or leg, especially on one side of your body -sudden confusion, trouble speaking or understanding - sudden trouble seeing in one or both eyes - sudden trouble walking, dizziness, loss of balance or coordination - sudden severe headache with no known cause Cataracts or increased chance of needing cataract surgery. The sign of these problems is slow blurring of your vision. Liver problems, including jaundice. The signs of liver problems include lack of appetite and yellowing of your skin or whites of your eyes. These are not all the possible side effects of NOLVADEX. For a complete list, ask your doctor or pharmacist. Who should not take NOLVADEX? Do not take NOLVADEX for any reason if you Are pregnant or plan to become pregnant while taking NOLVADEX or during the 2 months after you stop taking NOLVADEX. NOLVADEX may harm your unborn baby. It takes about 2 months to clear NOLVADEX from your body. To be sure you are not pregnant, you can start taking NOLVADEX while you are having your menstrual period. Or, you can take a pregnancy test to be sure you are not pregnant before you begin. Are breast feeding. We do not know if NOLVADEX can pass through your milk and harm your baby. Have had an allergic reaction to NOLVADEX or tamoxifen (the other name for NOLVADEX), or to any of its inactive ingredients. If you get pregnant while taking NOLVADEX, stop taking it right away and contact your doctor. NOLVADEX may harm your unborn baby. Do not take NOLVADEX to lower your chance of getting breast cancer if You ever had a blood clot that needed medical treatment. You are taking medicines to thin your blood, like warfarin, (also called Coumadin'*). Your ability to move around is limited for most of your waking hours. You are at risk for blood clots. Your doctor can tell you if you are at high risk for blood clots. You do not have a higher than normal chance of getting breast cancer. Your doctor can tell you if you are a high-risk woman. How should I take NOLVADEX? Swallow the tablet(s) whole, with water or another non-alcoholic liquid. You can take NOLVADEX with or without food. Take your medicine every day. It may be easier to remember if you take it at the same time each day. If you forget a dose, take it when you remember, then take the next dose as usual. If it is almost time for your next dose or you remember at your next dose, do not take extra tablets to make up the missed dose. Take NOLVADEX for 5 years, unless your doctor tells you otherwise. What should I avoid while taking NOLVADEX? Do not become pregnant while taking NOLVADEX or for 2 months after you stop. NOLVADEX can stop hormonal birth control methods from working. Hormonal methods include birth control pills, patches, injections, rings and implants. Therefore, while taking NOLVADEX, use birth control methods that don't use hormones, such as condoms, diaphragms with spermicide, or plain IUD's.If you get pregnant, stop taking NOLVADEX right away and call your doctor. Do not breast feed. We do not know if NOLVADEX can pass through your milk and if it can harm the baby. What should I do while taking NOLVADEX? Have regular gynecology check-ups (���female exams���), breast exams and mammograms. Your doctor will tell you how often. These will check for signs of breast cancer and cancer of the endometrium (lining of the uterus). Because NOLVADEX does not prevent all breast cancers, and you may get other types of cancers, you need these exams to find any cancers as early as possible. Because NOLVADEX can cause serious side effects, pay close attention to your body. Signs you should look for are listed in���What are the possible side effects of NOLVADEX?��� Tell all of the doctors that you see that you are taking NOLVADEX. Tell your doctor right away if you have any new breast lumps. General information about the safe and effective use of NOLVADEX Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Your doctor has prescribed NOLVADEX only for you. Do not give it to other people, even if they have a similar condition, because it may harm them. Do not use it for a condition for which it was not prescribed. This Medication Guide is a summary of information about NOLVADEX for women who use NOLVADEX tolower their high chance of getting breast cancer or who have DCIS. If you want more information about NOLVADEX, ask your doctor or pharmacist. They can give you information about NOLVADEX that is written for health professionals. For more information about NOLVADEX or breast cancer, please visit www.NOLVADEX.com or call 1-800-236-9933. Ingredients: tamoxifen citrate, carboxymethylcellulose calcium, magnesium stearate, mannitol and starch. *Coumadin' is a registered trademark of Bristol-Myers Squibb Pharmaceuticals. All other trademarks are the property of the AstraZeneca group This Medication Guide has been approved by the US Food and Drug Administration Manufactured by: AstraZeneca Pharmaceuticals LP Wilmington, Delaware 19850-5437 eSTAR# 240479 Printed in USA��2003,2004,2005 2006AstraZeneca Rev. 03���06
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USE ONLY ON THE FACE Read this leaflet carefully before you start to use your medicine. Read the information you get every time you get more medicine. There may be new information about the drug. This leaflet does not take the place of talks with your doctor. It is important for you to talk with your doctor about how to use Tretinoin Cream, USP (Emollient) for thebest results and how to reduce side effects.<br/>What is the Most Important Information about Tretinoin Cream, USP (Emollient)?: Tretinoin Cream, USP (Emollient) is a serious medicine. Do not use Tretinoin Cream, USP (Emollient) if you are pregnant or attempting to become pregnant. If you become pregnant while using Tretinoin Cream, USP (Emollient), please contact your doctor immediately. Avoid sunlight and other medicines that may increase your sensitivity to sunlight (See���Who should not use Tretinoin Cream, USP (Emollient)?���). Tretinoin Cream, USP (Emollient) does not remove wrinkles or repair sun-damaged skin. (See���What is Tretinoin Cream, USP (Emollient)?���for more details.) Tretinoin Cream, USP (Emollient) 0.05% has not been tested in people over age 50 or in people with medium or dark skin color. (See���Who should not use Tretinoin Cream, USP (Emollient)?���).<br/>What is Tretinoin Cream, USP (Emollient) 0.05%?: Tretinoin Cream, USP (Emollient) 0.05% is a prescription medicine that may reduce fine facial wrinkles, facial mottled hyperpigmentation, and facial skin roughness. It is for patients who are also using a skin care and sunlight avoidance program. Tretinoin Cream, USP (Emollient) does not remove wrinkles or repair sun-damaged skin. Tretinoin Cream, USP (Emollient) does not work for everyone who uses it. It may work better for some patients than for others. Tretinoin Cream, USP (Emollient) should be used only under the guidance of your doctor as part of a skin care and sunlight avoidance program. This program should include avoiding sunlight as much as possible, using clothing to protect you from sunlight, using sunscreens with a minimum SPF of 15, and using face creams that add moisture to the skin. When you use Tretinoin Cream, USP (Emollient), you will not see improvement right away. Generally, you may notice some effects in 3 to 4 months. If Tretinoin Cream, USP (Emollient) treatment is stopped, the improvement may gradually disappear. The use of Tretinoin Cream, USP (Emollient) 0.05% in patients for more than 48 weeks has not been studied. Therefore, it is not known if Tretinoin Cream, USP (Emollient) 0.05% is safe or works if used longer than 48 weeks. Tretinoin Cream, USP (Emollient) 0.05% has not been shown to work or be safe in people over age 50, in people with medium to dark skin color, or in people with visible actinic keratoses or in people with a history of skin cancer.<br/>Who should not use Tretinoin Cream, USP (Emollient)?: Do not use Tretinoin Cream, USP (Emollient) if: Tretinoin Cream, USP (Emollient) can cause increased skin irritation and increased chance of sunburn. Tell your doctor if you have any skin condition. Tretinoin Cream, USP (Emollient) may not be right for you. Because Tretinoin Cream, USP (Emollient) may make your skin more likely to burn from sunlight, tell your doctor if you are using other medicines that increase sensitivity to sunlight. You should not use Tretinoin Cream, USP (Emollient) with such medicines. These include, but are not limited to: If you are taking any prescription or non-prescription medicines, check with your doctor to make sure you can use Tretinoin Cream, USP (Emollient) with them. We do not know if Tretinoin Cream, USP (Emollient) is passed to infants through breast milk. Therefore, tell your doctor if you are breast feeding.<br/>How should I use Tretinoin Cream, USP (Emollient)?: Use Tretinoin Cream, USP (Emollient) as part of a total skin care and sunlight avoidance program. Follow your doctor's instructions on how to use Tretinoin Cream, USP (Emollient). Tretinoin Cream, USP (Emollient) is usually applied to the face once a day in the evening, following the 3 steps listed below: Be especially careful when applying Tretinoin Cream, USP (Emollient) to avoid your eyes, ears, nostrils, angles of the nose, and mouth. Tretinoin Cream, USP (Emollient) may cause severe redness, itching, burning, stinging, and peeling if used on these areas. Using too much Tretinoin Cream, USP (Emollient) may increase discomfort and skin redness and peeling. You may use cosmetics one hour after applying Tretinoin Cream, USP (Emollient). If you do, be sure to clean your face before applying Tretinoin Cream, USP (Emollient) again. Skin moisturizers should be used at least every morning to protect the treated areas from dryness. Use sunscreen and wear protective clothing to protect the treated areas from sunlight. If you sunburn easily, or if you spend a lot of time exposed to sunlight, be especially careful to protect your skin.<br/>What should I avoid while using Tretinoin Cream, USP (Emollient)?: Tretinoin Cream, USP (Emollient) can make your treated skin more sensitive to sunlight. Therefore, keep out of the sunlight as much as possible and do not use sunlamps. Avoid as much as possible products that can increase skin irritation, such as:<br/>What are the possible side effects of Tretinoin Cream, USP (Emollient)?: You may feel brief warmth or stinging on your skin after you use Tretinoin Cream, USP (Emollient). Most patients report peeling, dry skin, burning, stinging, itching, and redness. These are usually mild to moderate and occur early in treatment. Contact your doctor if the side effects are a problem.<br/>General advice about prescription medicines: Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Only use Tretinoin Cream, USP (Emollient) to treat the condition that your doctor has prescribed it for. Do not give Tretinoin Cream, USP (Emollient) to other people. It may harm them. This leaflet summarizes the most important information about Tretinoin Cream, USP (Emollient). If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Tretinoin Cream, USP (Emollient) that is written for health professionals. SPEAR DERMATOLOGY PRODUCTSRandolph, New Jersey 07869
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Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.):<br/>What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?: NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: NSAID medicines should never be used right before or after a heart surgery called a���coronary artery bypass graft (CABG).��� NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: The chance of a person getting an ulcer or bleeding increases with:<br/>What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?: NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:<br/>Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?: Do not take an NSAID medicine: Tell your healthcare provider:<br/>What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?: Serious side effects include: Other side effects include: Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.<br/>Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): *Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC label warns that long term continuous use may increase the risk of heart attack or stroke. This Medication Guide has been approved by the U.S. Food and Drug Administration.
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Medication Guide: 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
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Medication Guide: 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
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SPL Patient Package Insert:
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Medication Guide:<br/>Antidepressant Medicines,
Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions: Read the Medication Guide
that comes with you or your family member's antidepressant medicine.
This Medication Guide is only about the risk of suicidal thoughts and actions with
antidepressant medicines. Talk to your, or your family
member's healthcare provider about:<br/>What is the most important
information I should know about antidepressant medicines, depression and other
serious mental illnesses, and suicidal thoughts or actions?:<br/>Call a healthcare provider
right away if you or your family member has any of the following symptoms,
especially if they are new, worse, or worry you::<br/>What else do I need to know
about antidepressant medicines?: This Medication Guide
has been approved by the U.S. Food and Drug Administration for all
antidepressants.
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SPL Patient Package Insert:<br/>Finasteride is for use by men only.:<br/>Why your doctor has prescribed finasteride:<br/>What is BPH?:<br/>Treatment options for BPH: There are two main treatment options to reduce the risk of serious problems due to BPH:<br/>What finasteride does:<br/>How to take finasteride:
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What is metformin?:<br/>Who should not take metformin?: Tell your doctor if you are pregnant or plan to become pregnant. Metformin may not be right for you. Talk with your doctor about your choices. You should also discuss your choices with your doctor if you are nursing a child.<br/>Can metformin hydrochloride tablets be used in children?: Metformin hydrochloride tablets have been shown to effectively lower glucose levels in children (ages 10 to 16 years) with type 2 diabetes. Metformin hydrochloride tablets have not been studied in children younger than 10 years old. Metformin hydrochloride tablets have not been studied in combination with other oral glucose-control medicines or insulin in children. If you have any questions about the use of metformin hydrochloride tablets in children, talk with your doctor or other healthcare provider.<br/>How should I take metformin hydrochloride tablets?:<br/>What should I avoid while taking metformin hydrochloride tablets?: Do not drink a lot of alcoholic drinks while taking metformin. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis.<br/>What are the side effects of metformin?:
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Medication GuideAntidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions: Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about:<br/>Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you::<br/>What else do I need to know about antidepressant medicines?: This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. CARACO PHARMACEUTICAL LABORATORIES, LTD.DETROIT, MI 48202 C.S. No.: 5221T05
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INSTRUCTIONS FOR USE: Please follow these instructions carefully when using
TIMOPTIC. Use TIMOPTIC as prescribed by your doctor. WARNING: Keep out of reach of children. If you have any questions about the use of TIMOPTIC, please
consult your doctor. Issued September 2005 9391006 Manuf. for:MERCK&CO., Inc., Whitehouse Station, NJ 08889, USA By: Laboratories Merck Sharp&Dohme-Chibret 63963 Clermont-Ferrand Cedex 9, France
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PATIENT INFORMATIONMETFORMIN HYDROCHLORIDE TABLETS, USP: Read this information carefully before you start taking this medicine and each time you refill your prescription. There may be new information. This information does not take the place of your doctor's advice. Ask your doctor or pharmacist if you do not understand some of this information or if you want to know more about this medicine.<br/>What is Metformin?: Metformin is used to treat type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus. People with type 2 diabetes are not able to make enough insulin or respond normally to the insulin their bodies make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level. High blood sugar can be lowered by diet and exercise, by a number of medicines taken by mouth, and by insulin shots. Before you take metformin, try to control your diabetes by exercise and weight loss. While you take your diabetes medicine, continue to exercise and follow the diet advised for your diabetes. No matter what your recommended diabetes management plan is, studies have shown that maintaining good blood sugar control can prevent or delay complications of diabetes, such as blindness. Metformin helps control your blood sugar in a number of ways. These include helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb. Metformin does not cause your body to make more insulin. Because of this, when taken alone, they rarely cause hypoglycemia (low blood sugar), and usually do not cause weight gain. However, when they are taken with a sulfonylurea, hypoglycemia is more likely to occur, as is weight gain.<br/>Who should not take metformin?: Some conditions increase your chance of getting lactic acidosis, or cause other problems if you take metformin. Most of the conditions listed below can increase your chance of getting lactic acidosis. Do not take metformin if you: Tell your doctor if you are pregnant or plan to become pregnant. Metformin may not be right for you. Talk with your doctor about your choices. You should also discuss your choices with your doctor if you are nursing a child.<br/>Can metformin hydrochloride tablets, USP be used in children?: Metformin hydrochloride tablets, USP has been shown to effectively lower glucose levels in children (ages 10 to 16 years) with type 2 diabetes. Metformin hydrochloride tablets, USP have not been studied in children younger than 10 years old. Metformin hydrochloride tablets, USP have not been studied in combination with other oral glucose-control medicines in children. If you have any questions about the use of metformin hydrochloride tablets, USP in children, talk with your doctor or healthcare provider.<br/>How should I take metformin hydrochloride tablets, USP?: Your doctor will tell you how much medicine to take and when to take it. You will probably start out with a low dose of the medicine. Your doctor may slowly increase your dose until your blood sugar is better controlled. You should take metformin with meals. Your doctor may have you take other medicines along with metformin to control your blood sugar. These medicines may include insulin shots. Taking metformin hydrochloride tablets, USP with insulin may help you better control your blood sugar while
reducing the insulin dose. Continue your excercise and diet program and test your blood sugar regularly while taking metformin. Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally. There is no evidence that metformin causes harm to the liver or kidneys. Tell your doctor if you<br/>What should I avoid while taking metformin hydrochloride tablets, USP?: Do not drink a lot of alcoholic drinks while taking metformin. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis.<br/>What are the side effects of metformin?:<br/>General advice about prescription medicines: If you have questions or problems, talk with your doctor or other healthcare provider. You can ask your doctor or pharmacist for the information about metformin that is written for health care professionals. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use metformin for a condition for which it was not prescribed. Do not share your medicine with other people. CARACO PHARMACEUTICAL LABORATORIES, LTD. Manufactured by: C.S. No: 5249T10Caraco Pharmaceutical Laboratories, Ltd.1150 Elijah McCoy Drive,Detroit, MI 48202
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Medication GuideAntidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions: Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about:<br/>What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?: Call the health care provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:<br/>What else do I need to know about antidepressant medicines?: ���Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.��� This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. CARACO PHARMACEUTICAL LABORATORIES, LTD.
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SPL Patient Package Insert: Since there are many brand names for these medicines, check with your doctor or pharmacist if you have any questions.
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DETAILED PATIENT LABELING: This product (like all oral contraceptives)
is intended to prevent pregnancy. It does not protect against HIV infection
(AIDS) and other sexually transmitted diseases. PLEASE NOTE: This
labeling is revised from time to time as important new medical information
becomes available. Therefore, please review this labeling carefully. The
following oral contraceptive product contains a combination of a progestogen
and estrogen, the two kinds of female hormones: ORTHO-CEPT (desogestrel and ethinyl estradiol)
Tablets Each light orange tablet contains
0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each green tablet contains
inert ingredients. INTRODUCTION Any woman who considers using oral contraceptives
(the birth control pill or the pill) should understand the benefits and risks
of using this form of birth control. This patient labeling will give you much
of the information you will need to make this decision and will also help
you determine if you are at risk of developing any of the serious side effects
of the pill. It will tell you how to use the pill properly so that it will
be aseffective as possible. However, this labeling is not a replacement for
a careful discussion between you and your healthcare professional. You should
discuss the information provided in this labeling with him or her, both when
you first start taking the pill and during your revisits. You should also
follow your healthcare professional's advice with regard to regular check-ups
while you are on the pill. EFFECTIVENESS
OF ORAL CONTRACEPTIVES Oral contraceptives
or "birth control pills" or "the pill" are used to prevent pregnancy and are
more effective than most other non-surgical methods of birth control. When
they are taken correctly without missing any pills, the chance of becoming
pregnant is approximately 1% (1 pregnancy per 100 women per year of use).
Typical failure rates, including women who do not always take the pills exactly
as directed, are approximately 5% per year. The chance of becoming pregnant
increases with each missed pill during a menstrual cycle. WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES Cigarette smoking increases the
risk of serious cardiovascular side effects from oral contraceptive use. This
risk increases with age and with heavy smoking (15 or more cigarettes per
day) and is quite marked in women over 35 years of age. Women who use oral
contraceptives are strongly advised not to smoke. Some women should not use the pill. For example, you should
not take the pill if you have any of the following conditions: Tell your healthcare professional if you have ever had any
of these conditions. Your healthcare professional can recommend another method
of birth control. OTHER
CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES Tell
your healthcare professional if you have or have had: Women with any of these conditions should be checked often
by their healthcare professional if they choose to use oral contraceptives. Also,
be sure to inform your healthcare professional if you smoke or are on any
medications. RISKS OF
TAKING ORAL CONTRACEPTIVES 1.
Risk of Developing Blood Clots Blood clots
and blockage of blood vessels are one of the most serious side effects of
taking oral contraceptives and can cause death or serious disability. In particular,
a clot in the legs can cause thrombophlebitis and a clot that travels to the
lungs can cause a sudden blocking of the vessel carrying blood to the lungs.
The risks of these side effects may be greater with desogestrel-containing
oral contraceptives, such as ORTHO-CEPT, than with certain other low-dose
pills. Rarely, clots occur in the blood vessels of the eye and may cause blindness,
double vision, or impaired vision. If you take oral
contraceptives and need elective surgery, need to stay in bed for a prolonged
illness or injury or have recently delivered a baby, you may be at risk of
developing blood clots. You should consult your healthcare professional about
stopping oral contraceptives three to four weeks before surgery and not taking
oral contraceptives for two weeks after surgery or during bed rest. You should
also not take oral contraceptives soon after delivery of a baby. It is advisable
to wait for at least four weeks after delivery if you are not breast feeding.
If you are breast feeding, you should wait until you have weaned your child
before using the pill. (See also the section on Breast Feeding in General Precautions.) The
risk of circulatory disease in oral contraceptive users may be higher in users
of high dose pills. The risk of venous thromboembolic disease associated with
oral contraceptives does not increase with length of use and disappears after
pill use is stopped. The risk of abnormal blood clotting increases with age
in both users and nonusers of oral contraceptives, but the increased risk
from the oral contraceptive appears to be present at all ages. For women aged
20 to 44 it is estimated that about 1 in 2,000 using oral contraceptives will
be hospitalized each year because of abnormal clotting. Among nonusers in
the same age group, about 1 in 20,000 would be hospitalized each year. For
oral contraceptive users in general, it has been estimated that in women between
the ages of 15 and 34 the risk of death due to a circulatory disorder is about
1 in 12,000 per year, whereas for nonusers the rate is about 1 in 50,000 per
year. In the age group 35 to 44, the risk is estimated to be about 1 in 2,500
per year for oral contraceptive users and about 1 in 10,000 per year for nonusers. 2. Heart Attacks and Strokes Oral
contraceptives may increase the tendency to develop strokes (stoppage or rupture
of blood vessels in the brain) and angina pectoris and heart attacks (blockage
of blood vessels in the heart). Any of these conditions can cause death or
serious disability. Smoking greatly increases the possibility
of suffering heart attacks and strokes. Furthermore, smoking and the use of
oral contraceptives greatly increase the chances of developing and dying of
heart disease. 3. Gallbladder
Disease Oral contraceptive users probably
have a greater risk than nonusers of having gallbladder disease, although
this risk may be related to pills containing high doses of estrogens. 4. Liver Tumors In rare cases,
oral contraceptives can cause benign but dangerous liver tumors. These benign
liver tumors can rupture and cause fatal internal bleeding. In addition, some
studies report an increased risk of developing liver cancer. However, liver
cancers are rare. 5. Cancer
of the Reproductive Organs and Breasts Various
studies give conflicting reports on the relationship between breast cancer
and oral contraceptive use. Oral contraceptive use may slightly increase your
chance of having breast cancer diagnosed, particularly after using hormonal
contraceptives at a younger age. After you stop using hormonal contraceptives,
the chances of having breast cancer diagnosed begin to go back down. You should
have regular breast examinations by a healthcare professional and examine
your own breasts monthly. Tell your healthcare professional if you have a
family history of breast cancer or if you have had breast nodules or an abnormal
mammogram. Womenwho currently have or have had breast cancer should not use
oral contraceptives because breast cancer is usually a hormone-sensitive tumor. Some
studies have found an increase in the incidence of cancer of the cervix in
women who use oral contraceptives. However, this finding may be related to
factors other than the use of oral contraceptives. There is insufficient evidence
to rule out the possibility that pills may cause such cancers. ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY All methods of birth control and pregnancy
are associated with a risk of developing certain diseases which may lead to
disability or death. An estimate of the number of deaths associated with different
methods of birth control and pregnancy has been calculated and is shown in
the following In the above table, the risk of death from any birth control
method is less than the risk of childbirth, except for oral contraceptive
users over the age of 35 who smoke and pill users over the age of 40 even
if they do not smoke. It can be seen in the table that for women aged 15 to
39, the risk of death was highest with pregnancy (7-26 deaths per 100,000
women, depending on age). Among pill users who do not smoke, the risk of death
is always lower than that associated with pregnancy for any age group, although
over the age of 40, the risk increases to 32deaths per 100,000 women, compared
to 28 associated with pregnancy at that age. However, for pill users who smoke
and are over the age of 35, the estimated number of deaths exceeds those for
other methods of birth control. If a woman is over the age of 40 and smokes,
her estimated risk of death is four times higher (117/100,000 women) than
the estimated risk associated with pregnancy (28/100,000 women) in that age
group. The suggestion that women over 40 who do not
smoke should not take oral contraceptives is based on information from older,
higher-dose pills. An Advisory Committee of the FDA discussed this issue in
1989 and recommended that the benefits of low-dose oral contraceptive use
by healthy, non-smoking women over 40 years of age may outweigh the possible
risks. Older women, as all women, who take oral contraceptives, should take
an oral contraceptive which contains the least amount of estrogen and progestogen
that is compatible with the individual patient needs. WARNING SIGNALS If any of
these adverse effects occur while you are taking oral contraceptives, call
your healthcare professional immediately: SIDE EFFECTS OF ORAL CONTRACEPTIVES 1. Vaginal Bleeding Irregular vaginal bleeding or spotting may
occur while you are taking the pills. Irregular bleeding may vary from slight
staining between menstrual periods to breakthrough bleeding which is a flow
much like a regular period. Irregular bleeding occurs most often during the
first few months of oral contraceptive use, but may also occur after you have
been taking the pill for some time. Such bleeding may be temporary and usually
does not indicate any serious problems. It is important to continue taking
your pills on schedule. If the bleeding occurs in more than one cycle or lasts
for more than a few days, talk to your healthcare professional. 2. Contact Lenses If you
wear contact lenses and notice a change in vision or an inability to wear
your lenses, contact your healthcare professional. 3. Fluid Retention Oral contraceptives
may cause edema (fluid retention) with swelling of the fingers or ankles and
may raise your blood pressure. If you experience fluid retention, contact
your healthcare professional. 4.
Melasma A spotty darkening of the skin is
possible, particularly of the face, which may persist. 5. Other Side Effects Other
side effects may include nausea and vomiting, change in appetite, headache,
nervousness, depression, dizziness, loss of scalp hair, rash, vaginal infections
and allergic reactions. If any of these side effects
bother you, call your healthcare professional. GENERAL PRECAUTIONS 1. Missed Periods and Use of Oral Contraceptives Before or
During Early Pregnancy There may be times
when you may not menstruate regularly after you have completed taking a cycle
of pills. If you have taken your pills regularly and miss one menstrual period,
continue taking your pills for the next cycle but be sure to inform your healthcare
professional before doing so. If you have not taken the pills daily as instructed
and missed a menstrual period, you may be pregnant. If you missed two consecutive
menstrual periods, you may be pregnant. Check with your healthcare professional
immediately to determine whether you are pregnant. Stop taking oral contraceptives
if pregnancy is confirmed. There is no conclusive evidence
that oral contraceptive use is associated with an increase in birth defects,
when taken inadvertently during early pregnancy. Previously, a few studies
had reported that oral contraceptives might be associated with birth defects,
but these findings have not been seen in more recent studies. Nevertheless,
oral contraceptives should not be used during pregnancy. You should check
with your healthcare professional about risks to your unborn child of any
medication taken during pregnancy. 2. While Breast Feeding If
you are breast feeding, consult your healthcare professional before starting
oral contraceptives. Some of the drug will be passed on to the child in the
milk. A few adverse effects on the child have been reported, including yellowing
of the skin (jaundice) and breast enlargement. In addition, oral contraceptives
may decrease the amount and quality of your milk. If possible, do not use
oral contraceptives while breast feeding. You should use another method of
contraception since breast feeding provides only partial protection from becoming
pregnant and this partial protection decreases significantlyas you breast
feed for longer periods of time. You should consider starting oral contraceptives
only after you have weaned your child completely. 3. Laboratory Tests If you
are scheduled for any laboratory tests, tell your healthcare professional
you are taking birth control pills. Certain blood tests may be affected by
birth control pills. 4. Drug
Interactions Certain drugs may interact with
birth control pills to make them less effective in preventing pregnancy or
cause an increase in breakthrough bleeding. Such drugs include rifampin; drugs
used for epilepsy such as barbiturates (for example, phenobarbital); topiramate
(TOPAMAX), carbamazepine (Tegretol is one
brand of this drug), phenytoin (Dilantin is one brand of
this drug); phenylbutazone (Butazolidin is one brand); certain
drugs used in the treatment of HIV or AIDS; and possibly certain antibiotics.
Medicine for pulmonary hypertension, such as bosentan (Tracleer).Pregnancies and breakthrough bleeding have been reported by women who used
some form of the herbal supplement St. John's Wort while using combined hormonal
contraceptives. Hormonal contraceptives may interact with lamotrigine (LAMICTAL),
an anticonvulsant used for epilepsy. This may increase the risk of seizures
so your healthcare professional may need to adjust the dose of lamotrigine.
You may need to use additional contraception when you take other products
which can make oral contraceptives less effective. Be sure to tell your healthcare
professional if you are taking or start taking any medications while taking
birth control pills. 5. Sexually
transmitted diseases This
product (like all oral contraceptives) is intended to prevent pregnancy. It
does not protect against transmission of HIV (AIDS) and other sexually transmitted
diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis
B, and syphilis. HOW
TO TAKE THE PILL BEFORE YOU
START TAKING YOUR PILLS: BEFORE
YOU START TAKING YOUR PILLS You have a choice of which day to start taking your first
pack of pills. ORTHO-CEPT is available in the DIALPAK Tablet
Dispenser which is preset for a Sunday Start. Day 1 Start is also provided.
Decide with your healthcare professional which is the best day for you. Pick
a time of day which will be easy to remember. DAY 1 START: SUNDAY START: If you MISS 1 light
orange "active" pill: If you MISS 2 light
orange "active" pills in a row in WEEK 1 OR WEEK
2 of your pack: If you MISS 2 light
orange "active" pills in a row in THE 3RD WEEK: If you MISS 3 OR MORE light
orange "active" pills in a row (during the first 3 weeks): A REMINDER: If
you forget any of the 7 green "reminder" pills in Week 4: THROW
AWAY the pills you missed.Keep taking 1 pill each day until the pack
is empty.You do not need a back-up method. FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS
YOU HAVE MISSED: Use a BACK-UP METHOD anytime
you have sex.KEEP TAKING ONE LIGHT ORANGE "ACTIVE"
PILL EACH DAY until you can reach your healthcare professional PREGNANCY DUE TO PILL FAILURE When
taken correctly without missing any pills, oral contraceptives are highly
effective; however the typical failure rate of large numbers of pill users
is 5% per year when women who miss pills are included. If failure does occur,
the risk to the fetus is minimal. PREGNANCY
AFTER STOPPING THE PILL There may be some
delay in becoming pregnant after you stop using oral contraceptives, especially
if you had irregular menstrual cycles before you used oral contraceptives.
It may be advisable to postpone conception until you begin menstruating regularly
once you have stopped taking the pill and desire pregnancy. There
does not appear to be any increase in birth defects in newborn babies when
pregnancy occurs soon after stopping the pill. OVERDOSAGE Serious ill effects
have not been reported following ingestion of large doses of oral contraceptives
by young children. Overdosage may cause nausea and withdrawal bleeding in
females. In case of overdosage, contact your healthcare professional. OTHER INFORMATION Your healthcare
professional will take a medical and family history before prescribing oral
contraceptives and will examine you. The physical examination may be delayed
to another time if you request it and the healthcare professional believes
that it is a good medical practice to postpone it. You should be reexamined
at least once a year. Be sure to inform your healthcare professional if there
is a family history of any of the conditions listed previously in this leaflet.
Be sure to keep all appointments with your healthcare professional because
this is a time to determine if there are early signs of side effects of oral
contraceptive use. Do not use the drug for any condition
other than the one for which it was prescribed. This drug has been prescribed
specifically for you; do not give it to others who may want birth control
pills. HEALTH BENEFITS
FROM ORAL CONTRACEPTIVES In addition to preventing
pregnancy, use of combination oral contraceptives may provide certain benefits.
They are: If you want more information about birth control pills,
ask your healthcare professional or pharmacist. They have a more technical
leaflet called the Professional Labeling, which you may wish to read. The
professional labeling is also published in a book entitled Physicians'
Desk Reference, available in many book stores and public libraries. STORAGE:
Store at 25��C (77��F); excursions permitted to 15��- 30��C
(59��- 86��F).
|
| dailymed-drugs:2465 |
DETAILED PATIENT LABELING: This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.<br/>INTRODUCTION: Any woman who considers using oral contraceptives (���birth control pills���or���the pill���) should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and also will help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your health care provider. You should discussthe information provided in this leaflet with him or her, both when you first start taking the pill and during your regular visits. You also should follow the advice of your health care provider with regard to regular checkups while you are on the pill.<br/>EFFECTIVENESS OF ORAL CONTRACEPTIVES: Oral contraceptives are used to prevent pregnancy and are more effective than other non-surgical methods of birth control. When they are taken correctly, without missing any pills, the chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use). Typical failure rates are actually 3% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle. In comparison, typical failure rates for other nonsurgical methods of birth control during the first year are as follows:<br/>WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES: Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You also should not use the pill if you have any of the following conditions: Tell your health care provider if you have ever had any of these conditions. Your health care provider can recommend a safer method of birth control.<br/>OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES: Tell your health care provider if you have or have had: Women with any of these conditions should be checked often by their health care provider if they choose to use oral contraceptives. Also, be sure to inform your doctor or health care provider if you smoke or are on any medications.<br/>RISKS OF TAKING ORAL CONTRACEPTIVES: 1. Risk of developing blood clots Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives. In particular, a clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision. If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery if you are not breast feeding. If you are breast feeding, you should wait until you have weaned your child before using the pill . 2. Heart attacks and strokes Oral contraceptives may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or temporary or permanent disability. Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increase the chances of developing and dying of heart disease. 3. Gallbladder disease Oral contraceptive users may have a greater risk than non-users of having gallbladder disease, although this risk may be related to pills containing high doses of estrogen. 4. Liver tumors In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with the pill and liver cancers in 2 studies in which a few women who developedthese very rare cancers were found to have used oral contraceptives for long periods. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer. 5. Cancer of the breast and reproductive organs There is, at present, no confirmed evidence that oral contraceptives increase the risk of cancer of the reproductive organs in human studies. Several studies have found no overall increase in the risk of developing breast cancer. However, women who use oral contraceptives and have a strong family history of breast cancer or who have breast nodules or abnormal mammograms should be followed closely by their doctors. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.<br/>ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY: All methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table: In the above table, the risk of death from any birth control method is less than the risk of child-birth except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen from the table that for women aged 15 to 39 the risk of death is highest with pregnancy (7���26 deaths per 100,000 women, depending on age). Among pill users who do not smoke the risk of death is always lower than that associated with pregnancy for any age group, although over the age of 40 the risk increases to 32 deaths per 100,000 women compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35 the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is 4 times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group. The suggestion that women over 40 who don't smoke should not take oral contraceptives is based on information from older high-dose pills and on less selective use of pills than is practiced today. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral contraceptive use by healthy, non-smoking women over 40 years of age may outweigh the possible risks. However, all women, especially older women, are cautioned to use the lowest dose pill that is effective.<br/>WARNING SIGNALS: If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately:<br/>SIDE EFFECTS OF ORAL CONTRACEPTIVES: 1.Vaginal bleeding Irregular vaginal bleeding or spotting may occur while you are taking the pill. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problem. It is important to continue taking your pills on schedule. If the bleeding occurs in more than 1 cycle or lasts for more than a few days, talk to your doctor or health care provider. 2. Contact lenses If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or health care provider. 3. Fluid retention Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your doctor or health care provider. 4. Melasma (Mask of Pregnancy) A spotty darkening of the skin is possible, particularly of the face. 5. Other side effects Other side effects may include change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash and vaginal infections. If any of these side effects occur, contact your doctor or health care provider.<br/>GENERAL PRECAUTIONS: 1. Missed periods and use of oral contraceptives before or during early pregnancy At times you may not menstruate regularly after you have completed taking a cycle of pills. If you have taken your pills regularly and miss 1 menstrual period, continue taking your pills for the next cycle but be sure to inform your health care provider before doing so. If you have not taken the pills daily as instructed and miss 1 menstrual period, or if you miss 2 consecutive menstrual periods, you may be pregnant. Check with your health care provider immediately to determine whether you are pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use another method of birth control. There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects but these studies have not been confirmed. Nevertheless, oral contraceptives or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy. 2. While breast feeding If you are breast feeding, consult your doctor before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, oral contraceptives may decrease the amount and quality of your milk. If possible, do not use oral contraceptives and use another method of contraception while breast feeding. You should consider starting oral contraceptives only after you have weaned your child completely. 3. Laboratory tests If you are scheduled for any laboratory tests, tell your doctor you are taking birth control pills. Certain blood tests may be affected by birth control pills. 4. Drug interactions Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin; drugs used for epilepsy such as barbiturates (for example phenobarbital) and phenytoin (Dilantin is one brand of this drug); phenylbutazone (Butazolidin is one brand of this drug) and possibly certain antibiotics. You may need to use additional contraception when you take drugs which can make oral contraceptives less effective. 5. This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.<br/>HOW TO TAKE THE PILL: BEFORE YOU START TAKING YOUR PILLS: 1. BE SURE TO READ THESE DIRECTIONS: Before you start taking your pills. Anytime you are not sure what to do. 2. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. 3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF PILLS. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your doctor or clinic. 4. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. 5. IF YOU HAVE VOMITING OR DIARRHEA, for any reason, or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well. Use a back-up method (such as condoms, foam, or sponge) until you check with your doctor or clinic. 6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control. 7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or clinic. 1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day. 2. LOOK AT YOUR PILL PACK: The pill pack has 21���active���white (with hormones) pills to take for 3 weeks, followed by 1 week of reminder peach pills (without hormones). 3. ALSO FIND: Active Pill Color: WhiteReminder Pill Color: Peach 4. BE SURE YOU HAVE READY AT ALL TIMES: ANOTHER KIND OF BIRTH CONTROL (such as condoms, foam, or sponge) to use as a back-up in case you miss pills. AN EXTRA, FULL PILL PACK. * For use of day labels, see WHEN TO START THE FIRST PACK OF PILLS below. You have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember. DAY 1 START: SUNDAY START: Start the next pack on the day after your last���reminder���pill. Do not wait any days between packs. If you MISS 1 white���active���pill: If you MISS 2 white���active���pills in a row in WEEK 1 OR WEEK 2 of your pack: If you MISS 2 white���active���pills in a row in THE 3rd WEEK: If you MISS 3 OR MORE white���active���pills in a row (during the first 3 weeks): __________________________________________________________________ REMINDER: If you forget any of the 7 peach���reminder���pills in Week 4: THROW AWAY the pills you missed. Keep taking 1 pill each day until the pack is empty. You do not need a back-up method. FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED: Use a BACK-UP METHOD anytime you have sex. KEEP TAKING ONE���ACTIVE���PILL EACH DAY until you can reach your doctor or clinic. 6. Missed periods, spotting or light bleeding At times, you may not have a period after you have completed a pack of pills. If you miss 1 period but you have taken the pills exactly as you were supposed to, continue as usual into the next cycle. If you have not taken the pills correctly, and have missed a period, you may be pregnant and you should stop taking the pill until your doctor or clinic determines whether or not you are pregnant. Until you can talk to your doctor or clinic, use an appropriate back-up birth control method. If you miss 2 consecutive periods, you should stop taking the pill until it is determined that you are not pregnant. Even if spotting or light bleeding should occur, continue taking the pill according to the schedule. Should spotting or light bleeding persist, you should notify your doctor or clinic. 7. Stopping the pill before surgery or prolonged bed rest If you are scheduled for surgery or you need to stay in bed for a long period of time you should tell your doctor that you are on the pill. You should stop taking the pill four weeks before your operation to avoid an increased risk of blood clots. Talk to your doctor about when you may start taking the pill again. 8. Starting the pill after pregnancy After you have a baby it is advisable to wait 4���6 weeks before starting to take the pill. Talk to your doctor about when you may start taking the pill after pregnancy. 9. Pregnancy due to pill failure When the pill is taken correctly, the expected pregnancy rate is approximately 1% (i.e., 1 pregnancy per 100 women per year). If pregnancy occurs while taking the pill, there is little risk to the fetus. The typical failure rate of large numbers of pill users is less than 3% when women who have missed pills are included. If you become pregnant, you should discuss your pregnancy with your doctor. 10. Pregnancy after stopping the pill There may be some delay in becoming pregnant after you stop taking the pill, especially if you had irregular periods before you started using the pill. Your doctor may recommend that you delay becoming pregnant until you have had one or more regular periods. There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill. 11. Overdosage There are no reports of serious illness or side effects in young children who have swallowed a large number of pills. In adults, overdosage may cause nausea and/or bleeding in females. In case of overdosage, contact your doctor, clinic or pharmacist. 12. Other information Your doctor or clinic will take a medical and family history and will examine you before prescribing the pill. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be re-examined at least once a year. Be sure to inform your doctor or clinic if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your doctor or clinic because this is a time to determine if there are early signs of side effects from using the pill. Do not use the pill for any condition other than the one for which it was prescribed. The pill has been prescribed specifically for you, do not give it to others who may want birth control pills. If you want more information about birth control pills, ask your doctor or clinic. They have a more technical leaflet called PHYSICIAN LABELING which you might want to read. NON-CONTRACEPTIVE HEALTH BENEFITS In addition to preventing pregnancy, use of oral contraceptives may provide certain non-contraceptive health benefits: Store at controlled room temperature 15��C to 25��C (59��F to 77��F). Keep this and all medications out of the reach of children. BRIEF SUMMARY PATIENT PACKAGE INSERT This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Oral contraceptives, also known as���birth control pills���or���the pill,���are taken to prevent pregnancy and, when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. For most women, oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take oral contraceptives considerably increases the chances of pregnancy. For the majority of women, oral contraceptives can be taken safely, but there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you: You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding. Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first 3 months of use. The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill: The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or health care provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anti-convulsants and some antibiotics, may decrease oral contraceptive effectiveness. Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use. Taking the pill provides some important non-contraceptive health benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections and fewer cancers of the ovary and the lining of the uterus. Be sure to discuss any medical condition you may have with your health care provider. Your health care provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be re-examined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information which you should read and discuss with your health care provider. HOW TO TAKE THE PILL See full text of HOW TO TAKE THE PILL which is printed in full in the DETAILED PATIENT LABELING. Keep this and all medications out of the reach of children. Address medical inquiries to:Watson Pharma, Inc.Medical CommunicationsP.O. Box 1953Morristown, NJ 07962-1953800-272-5525 Manufactured for: WATSON PHARMA, INC.A subsidiary of Watson Pharmaceuticals, Inc.Corona, CA 92880 USA Manufactured by: Patheon Inc.Mississauga, Ontario L5N 7K9 CANADA IN-5186/S Low-Ogestrel(Norgestrel and Ethinyl Estradiol Tablets USP,0.3 mg/0.03 mg)
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| dailymed-drugs:2475 |
Meloxicam Tablets<br/>Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): (See the end of this Medication Guide for a list of prescription NSAID medicines). ________________________________________________________________________ What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: NSAID medicines should never be used right before or after a heart surgery called a���coronary artery bypass graft (CABG).��� NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: ________________________________________________________________________ What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): NSAID medicines that need a prescription All registered trademarks in this document are the property of their respective owners. Address medical inquiries to:Watson Pharma, Inc.Medical CommunicationsP.O. Box 1953Morristown, NJ 07962-1953800-272-5525 Manufactured for: Watson Laboratories Inc.Corona, CA 92880 USA Manufactured by: Cipla Ltd.Kurkumbh, INDIA Revised: August 2006 This Medication Guide has been approved by the US Food and Drug Administration
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MEDICATION GUIDE: Bupropion Hydrochloride Extended-Release Tablets (XL)Rx Only Read this Medication Guide carefully before you start using bupropion hydrochloride extended-release tablets (XL) and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about bupropion hydrochloride extended-release tablets (XL), ask your doctor or pharmacist. IMPORTANT: Be sure to read the section of this Medication Guide beginning with���What is the most important information I should know about bupropion hydrochloride extended-release tablets (XL)?���It contains important information about this medication. It immediately follows the next section called���Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions.��� Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about: What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: What else do I need to know about antidepressant medicines? What is the most important information I should know about bupropion hydrochloride extended-release tablets (XL)? There is a chance of having a seizure (convulsion, fit) with bupropion hydrochloride extended-release tablets (XL), especially in people: The chance of having seizures increases with higher doses of bupropion hydrochloride extended-release tablets (XL). For more information, see the sections���Who should not take bupropion hydrochloride extended-release tablets (XL)?���and���What should I tell my doctor before using bupropion hydrochloride extended-release tablets (XL)?���Tell your doctor about all of your medical conditions and all the medicines you take. Do not take any other medicines while you are using bupropion hydrochloride extended-release tablets (XL) unless your doctor has said it is okay to take them. If you have a seizure while taking bupropion hydrochloride extended-release tablets (XL), stop taking the tablets and call your doctor right away. Do not take bupropion hydrochloride extended-release tablets (XL) again if you have a seizure. What is important information I should know and share with my family about taking antidepressants? Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, not being able to sleep, or other unusual changes in behavior. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your doctor. For additional information see section above entitled���About Using Antidepressants in Children and Teenagers.���Bupropion hydrochloride extended-release tablets (XL) have not been studied in children under the age of 18 and are not approved for use in children and teenagers. What are bupropion hydrochloride extended-release tablets (XL)? Bupropion hydrochloride extended-release tablets (XL) are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.<br/>Who should not take bupropion hydrochloride extended-release tablets (XL)?: Do not take bupropion hydrochloride extended-release tablets (XL) if you:<br/>What should I tell my doctor before using bupropion hydrochloride extended-release tablets (XL)?: Tell your doctor about your medical conditions. Tell your doctor if you: How should I take bupropion hydrochloride extended-release tablets (XL)? What should I avoid while taking bupropion hydrochloride extended-release tablets (XL)? What are possible side effects of bupropion hydrochloride extended-release tablets (XL)? Common side effects reported in studies of major depressive disorder include weight loss, loss of appetite, dry mouth, skin rash, sweating, ringing in the ears, shakiness, stomach pain, agitation, anxiety, dizziness, trouble sleeping, muscle pain, nausea, fast heartbeat, sore throat, and urinating more often. If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime. Tell your doctor right away about any side effects that bother you. These are not all the side effects of bupropion hydrochloride extended-release tablets (XL). For a complete list, ask your doctor or pharmacist. How should I store bupropion hydrochloride extended-release tablets (XL)? General Information about bupropion hydrochloride extended-release tablets (XL) This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (XL). For more information, talk with your doctor. You can ask your doctor or pharmacist for information about bupropion hydrochloride extended-release tablets (XL) that is written for health professionals. What are the ingredients in bupropion hydrochloride extended-release tablets (XL)? Active ingredient: bupropion hydrochloride.Inactive ingredients: colloidal silicon dioxide, ethylcellulose, hydroxypropyl cellulose, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, hydrochloric acid and triethyl citrate. The tablets are printed with edible black ink. The following are registered trademarks of their respective manufacturers: Prozac/Eli Lilly and Company; Zoloft/Pfizer Pharmaceuticals; Luvox/Solvay Pharmaceuticals, Inc.; Anafranil/Mallinckrodt Inc.; Nardil/Warner Lambert Company; Parnate/GlaxoSmithKline; Marplan/Oxford Pharmaceutical Services, Inc.; Zyban/GlaxoSmithKline; Wellbutrin/GlaxoSmithKline; Wellbutrin SR/GlaxoSmithKline. This Medication Guide has been approved by the U.S. Food and Drug Administration. Watson Laboratories, Inc.Corona, CA 92880 USA Revised: May 2007
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DETAILED PATIENT LABELING: This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.<br/>INTRODUCTION: You should not use Necon 1/50, which contains higher doses of estrogen than other oral contraceptives, unless specifically recommended by your health care provider. Any woman who considers using oral contraceptives (���birth control pills���or���the pill���) should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and also will help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your health care provider. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your regular visits. You also should follow the advice of your health care provider with regard to regular checkups while you are on the pill.<br/>EFFECTIVENESS OF ORAL CONTRACEPTIVES: Oral contraceptives are used to prevent pregnancy and are more effective than other non-surgical methods of birth control. When they are taken correctly, without missing any pills, the chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use). Typical failure rates are actually 3% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle. In comparison, typical failure rates for other nonsurgical methods of birth control during the first year are as follows: _______________________________________________________________________________<br/>WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES: Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You also should not use the pill if you have any of the following conditions: Tell your health care provider if you have ever had any of these conditions. Your health care provider can recommend a safer method of birth control.<br/>OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES: Tell your health care provider if you have or have had: Women with any of these conditions should be checked often by their health care provider if they choose to use oral contraceptives. Also, be sure to inform your doctor or health care provider if you smoke or are on any medications.<br/>RISKS OF TAKING ORAL CONTRACEPTIVES: 1. Risk of developing blood clots Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives. In particular, a clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision. If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery if you are not breast feeding.If you are breast feeding, you should wait until you have weaned your child before using the pill . 2. Heart attacks and strokes Oral contraceptives may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or temporary or permanent disability. Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increase the chances of developing and dying of heart disease. 3. Gallbladder disease Oral contraceptive users may have a greater risk than non-users of having gallbladder disease, although this risk may be related to pills containing high doses of estrogen. 4. Liver tumors In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with the pill and liver cancers in 2 studies in which a few women who developed these very rare cancers were found to have used oral contraceptives for long periods. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer. 5. Cancer of the breast and reproductive organs There is, at present, no confirmed evidence that oral contraceptives increase the risk of cancer of the reproductive organs in human studies. Several studies have found no overall increase in the risk of developing breast cancer. However, women who use oral contraceptives and have a strong family history of breast cancer or who have breast nodules or abnormal mammograms should be followed closely by their doctors. Some studies have reported an increase in the riskof developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.<br/>ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY: All methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table: In the above table, the risk of death from any birth control method is less than the risk of childbirth except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen from the table that for women aged 15 to 39 the risk of death is highest with pregnancy (7���26 deaths per 100,000 women, depending on age). Among pill users who do not smoke the risk of death is always lower than that associated with pregnancy for any age group, although over the age of 40 the risk increases to 32 deaths per 100,000 women compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35 the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is 4 times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group. The suggestion that women over 40 who don't smoke should not take oral contraceptives is based on information from older high-dose pills and on less selective use of pills than is practiced today. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral contraceptive use by healthy, non-smoking women over 40 years of age may outweigh the possible risks. However, all women, especially older women, are cautioned to use the lowest dose pill that is effective.<br/>WARNING SIGNALS: If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately:<br/>SIDE EFFECTS OF ORAL CONTRACEPTIVES: 1. Vaginal bleeding Irregular vaginal bleeding or spotting may occur while you are taking the pill. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problem. It is important to continue taking your pills on schedule. If the bleeding occurs in more than 1 cycle or lasts for more than a few days, talk to your doctor or health care provider. 2. Contact lenses If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or health care provider. 3. Fluid retention Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your doctor or health care provider. 4. Melasma (Mask of Pregnancy) A spotty darkening of the skin is possible, particularly of the face. 5. Other side effects Other side effects may include change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections. If any of these side effects occur, contact your doctor or health care provider.<br/>GENERAL PRECAUTIONS: 1. Missed periods and use of oral contraceptives before or during early pregnancy At times you may not menstruate regularly after you have completed taking a cycle of pills. If you have taken your pills regularly and miss 1 menstrual period, continue taking your pills for the next cycle but be sure to inform your health care provider before doing so. If you have not taken the pills daily as instructed and miss 1 menstrual period, or if you miss 2 consecutive menstrual periods, you may be pregnant. Check with your health care provider immediately to determine whether you are pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use another method of birth control. There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects but these studies have not been confirmed. Nevertheless, oral contraceptives or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy.<br/>2. While breast feeding: If you are breast feeding, consult your doctor before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, oral contraceptives may decrease the amount and quality of your milk. If possible, do not use oral contraceptives anduse another method of contraception while breast feeding. You should consider starting oral contraceptives only after you have weaned your child completely. 3. Laboratory tests If you are scheduled for any laboratory tests, tell your doctor you are taking birth control pills. Certain blood tests may be affected by birth control pills. 4. Drug interactions Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin; drugs used for epilepsy such as barbiturates (for example phenobarbital) and phenytoin (Dilantin is one brand of this drug); phenylbutazone (Butazolidin is one brand of this drug) and possibly certain antibiotics. You may need to use additional contraception when you take drugs which can make oral contraceptives less effective. 5. This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.<br/>HOW TO TAKE THE PILL: BEFORE YOU START TAKING YOUR PILLS: * For use of day labels, seeWHEN TO START THE FIRST PACK OF PILLS below. You have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember. DAY 1 START: SUNDAY START: 1. Take the first���active���white pill of the first pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day. 2. Use another method of birth control as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). Condoms, foam, or the sponge are good back-up methods of birth control. If you MISS 1 white���active���pill: If you MISS 2 white���active���pills in a row in WEEK 1 OR WEEK 2 of your pack: If you MISS 2 white���active���pills in a row in THE 3rd WEEK: If you MISS 3 OR MORE white���active���pills in a row (during the first 3 weeks): _______________________________________________________________________________REMINDER: If you forget any of the 7 orange���reminder���pills in Week 4: THROW AWAY the pills you missed. Keep taking 1 pill each day until the pack is empty. You do not need a back-up method._______________________________________________________________________________ FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED: Use a BACK-UP METHOD anytime you have sex. KEEP TAKING ONE���ACTIVE���PILL EACH DAY until you can reach your doctor or clinic. 6. Missed periods, spotting or light bleeding At times, you may not have a period after you have completed a pack of pills. If you miss 1 period but you have taken the pills exactly as you were supposed to, continue as usual into the next cycle. If you have not taken the pills correctly, and have missed a period, you may be pregnant and you should stop taking the pill until your doctor or clinic determines whether or not you are pregnant. Until you can talk to your doctor or clinic, use an appropriate back-up birth control method. If you miss 2 consecutive periods, you should stop taking the pill until it is determined that you are not pregnant. Even if spotting or light bleeding should occur, continue taking the pill according to the schedule. Should spotting or light bleeding persist, you should notify your doctor or clinic. 7. Stopping the pill before surgery or prolonged bed rest If you are scheduled for surgery or you need to stay in bed for a long period of time you should tell your doctor that you are on the pill. You should stop taking the pill four weeks before your operation to avoid an increased risk of blood clots. Talk to your doctor about when you may start taking the pill again. 8. Starting the pill after pregnancy After you have a baby it is advisable to wait 4���6 weeks before starting to take the pill. Talk to your doctor about when you may start taking the pill after pregnancy. 9. Pregnancy due to pill failure When the pill is taken correctly, the expected pregnancy rate is approximately 1% (i.e., 1 pregnancy per 100 women per year). If pregnancy occurs while taking the pill, there is little risk to the fetus. The typical failure rate of large numbers of pill users is less than 3% when women who have missed pills are included. If you become pregnant, you should discuss your pregnancy with your doctor. 10. Pregnancy after stopping the pill There may be some delay in becoming pregnant after you stop taking the pill, especially if you had irregular periods before you started using the pill. Your doctor may recommend that you delay becoming pregnant until you have had one or more regular periods. There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill. 11. Overdosage There are no reports of serious illness or side effects in young children who have swallowed a large number of pills. In adults, overdosage may cause nausea and/or bleeding in females. In case of overdosage, contact your doctor, clinic or pharmacist. 12. Other information Your doctor or clinic will take a medical and family history and will examine you before prescribing the pill. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be re-examined at least once a year. Be sure to inform your doctor or clinic if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your doctor or clinic because this is a time to determine if there are early signs of side effects from using the pill. Do not use the pill for any condition other than the one for which it was prescribed. The pill has been prescribed specifically for you, do not give it to others who may want birth control pills. If you want more information about birth control pills, ask your doctor or clinic. They have a more technical leaflet called PHYSICIAN LABELING which you might want to read.<br/>NON-CONTRACEPTIVE HEALTH BENEFITS: In addition to preventing pregnancy, use of oral contraceptives may provide certain non-contraceptive health benefits: Store at controlled room temperature 15 - 25��C (59 -77��F). Keep this and all medication out of the reach of children.<br/>BRIEF SUMMARY PATIENT PACKAGE INSERT: This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Oral contraceptives, also known as���birth control pills���or���the pill,���are taken to prevent pregnancy and, when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. For most women, oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take oral contraceptives considerably increases the chances of pregnancy. For the majority of women, oral contraceptives can be taken safely, but there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you: You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding. Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first 3 months of use. The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill: The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or health care provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anti-convulsants and some antibiotics, may decrease oral contraceptive effectiveness. Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use. Taking the pill provides some important non-contraceptive health benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections and fewer cancers of the ovary and the lining of the uterus. Be sure to discuss any medical condition you may have with your health care provider. Your health care provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be re-examined at leastonce a year while taking oral contraceptives. The detailed patient information leaflet gives you further information which you should read and discuss with your health care provider. HOW TO TAKE THE PILL See full text of HOW TO TAKE THE PILL which is printed in full in the Detailed Patient Labeling. Address medical inquiries to:Watson Pharma, Inc.Medical CommunicationsP.O. Box 1953Morristown, NJ 07962-1953800-272-5525 Distributed by: WATSON PHARMA, INC.A subsidiary of Watson Pharmaceuticals, Inc.Corona, CA 92880 USA Manufactured by: Patheon, Inc.Mississauga, Ontario L5N 7K9CANADA Revised: June 2007 IN-5377/SS0607 Necon1/50(Norethindrone and MestranolTablets USP, 1 mg/0.05 mg)
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Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
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| dailymed-drugs:2631 |
PATIENT INFORMATION Estropipate Tablets USP Read this PATIENT INFORMATION before you start taking estropipate tablets and read what you get each time you refill estropipate tablets. There may be new information. This information does not take the place of talking to your health care provider about your medical condition or your treatment. What is estropipate? Estropipate is a medicine that contains estrogen hormones. What is estropipate used for? Estropipate is used during and after menopause to: Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use estropipate tablets only to prevent osteoporosis from menopause, talk with your health care provider about whether a different treatment or medicine without estrogens might be better for you. You and your health care provider should talk regularly about whether youshould continue with estropipate tablets. Weight-bearing exercise, like walking or running, and taking calcium and vitamin D supplements may also lower your chances of getting postmenopausal osteoporosis. It is important to talk about exercise and supplements with your health care provider before starting them. Estropipate is also used to: treat certain conditions in women before menopause if their ovaries do not make enough estrogen naturally. Who should not take estropipate tablets? Do not start taking estropipate tablets if you: Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or had cancer, talk with your health care provider about whether you should take estropipate tablets. See the end of this leaflet for a list of ingredients in estropipate tablets. These are some of the warning signs of serious side effects: Call your health care provider right away if you get any of these warning signs, or any other unusual symptom that concerns you. Common side effects include: These are not all the possible side effects of estropipate tablets. For more information, ask your health care provider or pharmacist. What can I do to lower my chances of getting a serious side effect with estropipate tablets? Talk with your health care provider regularly about whether you should continue taking estropipate tablets. If you have a uterus, talk to your health care provider about whether the addition of a progestin is right for you. See your health care provider right away if you get vaginal bleeding while taking estropipate tablets. Have a breast exam and mammogram (breast X-ray) every year unless your health care provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast examinations more often.If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your health care provider for ways to lower your chances for getting heart disease. General information about safe and effective use of estropipate Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take estropipate for conditions for which it was not prescribed. Do not give estropipate tablets to other people, even if they have the same symptoms you have. It may harm them. Keep estropipate tablets out of the reach of children. This leaflet provides a summary of the most important information about estropipate tablets. If you would like more information, talk with your health care provider or pharmacist. You can ask for information about estropipate tablets that is written for health professionals. You can get more information by calling the toll free number 1-800-272-5525. What are the ingredients in estropipate tablets? Estropipate tablets contain estropipate as the active ingredient. Estropipate tablets also contain: lactose NF, magnesium stearate NF, piperazine USP, pregelatinized starch NF, talc USP, and coloring agents: 0.75 mg���D&C Yellow #10; 1.5 mg���FD&C Yellow #6; 3 mg���FD&C Blue #2; 6 mg���FD&C Blue #2 and D&C Yellow #10. Watson Laboratories, Inc.Corona, CA 92880 USA 12270-4Revised April 2006
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| dailymed-drugs:2660 |
BRIEF SUMMARY PATIENT PACKAGE INSERT: This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Oral contraceptives, also known as���birth-control pills���or���the pill���, are taken to prevent pregnancy, and when taken correctly, have a failure rate of less than 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. For most women oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy. For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability or death. The risks associated with taking oral contraceptives increase significantly if you: You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding. Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use. The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill: The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, may decrease oral contraceptive effectiveness. Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that pills may cause such cancers. Taking the pill provides some important non-contraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus. Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is appropriate to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient information booklet gives you further information which you should read and discuss with your healthcare provider. This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. INSTRUCTIONS TO PATIENTSHOW TO TAKE THE PILL BEFORE YOU START TAKING YOUR PILLS: You have a choice for which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember. DAY 1 START: SUNDAY START: If you MISS 1 (white)���active���pill: If you MISS 2 (white)���active���pills in a row in WEEK 1 OR WEEK 2 of your pack: If you MISS 2 (white)���active���pills in a row in THE 3rd WEEK: If you MISS 3 OR MORE (white)���active���pills in a row (during the first 3 weeks). ______________________________________________________________________________A REMINDER FOR THOSE ON 28-DAY PACKS:If you forget any of the 7 (peach)���reminder���pills in Week 4:THROW AWAY the pills you missed.Keep taking one pill each day until the pack is empty. You do not need a back-up method.______________________________________________________________________________ FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED:Use a BACK-UP METHOD anytime you have sex.KEEP TAKING ONE ACTIVE PILL EACH DAY until you can reach your doctor or clinic.______________________________________________________________________________ DETAILED PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy.It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.<br/>INTRODUCTION: Any woman who considers using oral contraceptives (the���birth-control pill���or���the���pill���) should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your healthcare provider. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your revisits. You should also follow your healthcare provider's advice with regard to regular check-up while you are on the pill.<br/>EFFECTIVENESS OF ORAL CONTRACEPTIVES: Oral contraceptives or���birth-control pills���or���the pill���are used to prevent pregnancy and are more effective than other nonsurgical methods of birth control. When they are taken correctly, the chance of becoming pregnant is less than 1.0% when used perfectly, without missing any pills. Typical failure rates are less than 3.0% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle. In comparison, typical failure rates for other nonsurgical methods of birth control during the first year of use are as follows:<br/>WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES: Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You should also not use the pill if you have had any of the following conditions: Tell your healthcare provider if you have ever had any of these conditions. Your healthcare provider can recommend another method of birth control.<br/>OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES: Tell your healthcare provider if you or any family member has ever had: Women with any of these conditions should be checked often by their healthcare provider if they choose to use oral contraceptives. Also, be sure to inform your doctor or healthcare provider if you smoke or are on any medications.<br/>RISKS OF TAKING ORAL CONTRACEPTIVES: 1. RISK OF DEVELOPING BLOOD CLOTS Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives and can be fatal. In particular, a clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can cause sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision. If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby or a mid-trimester pregnancy termination. It is advisable to wait for at least four weeks after delivery if you are not breast-feeding. If you are breast-feeding, you should wait until you have weaned your child before using the pill. 2. HEART ATTACKS AND STROKES Oral contraceptives may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or serious disability. Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increase the chances of developing and dying of heart disease. 3. GALLBLADDER DISEASE Oral contraceptive users probably have a greater risk than nonusers of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens. 4. LIVER TUMORS ln rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. ln addition, a possible but not definite association has been found with the pill and liver cancers in two studies, in which a few women who developed these very rare cancers were found to have used oral contraceptives for long periods. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer. 5. CANCER OF THE REPRODUCTIVE ORGANS There is, at present, no confirmed evidence that oral contraceptives increase the risk of cancer of the reproductive organs in human studies. Several studies have found no overall increase in the risk of developing breast cancer. However, women who use oral contraceptives and have a strong family history of breast cancer or who have breast nodules or abnormal mammograms should be closely followed by their doctors. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives. In the above table, the risk of death from any birth-control method is less than the risk of childbirth, except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7-26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death was always lower than that associated with pregnancy for any age group, except for those women over the age of 40, when the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35, the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is four times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group. The suggestion that women over 40 who do not smoke should not take oral contraceptives is based on information from older high-dose pills and on less-selective use of pills than is practiced today. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral contraceptive use by healthy, non-smoking women over 40 years of age may outweigh the possible risks. However, all women, especially older women, are cautioned to use the lowest-dose pill that is effective.<br/>WARNING SIGNALS: If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately:<br/>SIDE EFFECTS OF ORAL CONTRACEPTIVES: 1. VAGINAL BLEEDING Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding, which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk to your doctor or healthcare provider. 2. CONTACT LENSES If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or healthcare provider. 3. FLUID RETENTION Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your doctor or healthcare provider. 4. MELASMA A spotty darkening of the skin is possible, particularly of the face. 5. OTHER SIDE EFFECTS Other side effects may include change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections. If any of these side effects bother you, call your doctor or healthcare provider.<br/>GENERAL PRECAUTIONS: 1. Missed periods and use of oral contraceptives before or during early pregnancy. There may be times when you may not menstruate regularly after you have completed taking a cycle of pills. If you have taken your pills regularly and miss one menstrual period, continue taking your pills for the next cycle but be sure to inform your healthcare provider before doing so. If you have not taken the pills daily as instructed and missed a menstrual period, or if you missed two consecutive menstrual periods, you may be pregnant. Check with your healthcare provider immediately to determine whether you are pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use another method of contraception. There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these studies have not been confirmed. Nevertheless, oral contraceptives or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor. You should check with your doctor about risks to your unborn child of any medication taken during pregnancy. 2. While Breast-Feeding If you are breast-feeding, consult your doctor before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, oral contraceptives may decrease the amount and quality of your milk. If possible, do not use oral contraceptives while breast-feeding. You should use another method of contraception since breast-feeding provides only partial protection from becoming pregnant, and this partial protection decreases significantly as you breast-feed for longer periods of time. You should consider starting oral contraceptives only after you have weaned your child completely. 3. Laboratory Tests If you are scheduled for any laboratory tests, tell your doctor you are taking birth-control pills. Certain blood tests may be affected by birth-control pills. 4. Drug Interactions Certain drugs may interact with birth-control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin, drugs used for epilepsy such as barbiturates (for example, phenobarbital) and phenytoin (Dilantin is one brand of this drug), phenylbutazone (Butazolidin is one brand) and possibly certain antibiotics. You may need to use an additional method of contraception during any cycle in which you take drugs that can make oral contraceptives less effective. 5. Sexually transmitted diseases This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. HOW TO TAKE THE PILL BEFORE YOU START TAKING YOUR PILLS: You have a choice for which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember. DAY 1 START: SUNDAY START: If you MISS 1 (white)���active���pill: If you MISS 2 (white)���active���pills in a row in WEEK 1 OR WEEK 2 of your pack: If you MISS 2 (white)���active���pills in a row in THE 3rd WEEK: If you MISS 3 OR MORE (white)���active���pills in a row (during the first 3 weeks). ______________________________________________________________________________ A REMINDER FOR THOSE ON 28-DAY PACKS:If you forget any of the 7 (peach)���reminder���pills in Week 4:THROW AWAY the pills you missed.Keep taking one pill each day until the pack is empty.You do not need a back-up method.______________________________________________________________________________ FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED:Use a BACK-UP METHOD anytime you have sex.KEEP TAKING ONE ACTIVE PILL EACH DAY until you can reach your doctor or clinic.______________________________________________________________________________<br/>PREGNANCY DUE TO PILL FAILURE: The incidence of pill failure resulting in pregnancy is approximately less than 1.0% if taken every day as directed, but more typical failure rates are less than 3.0%. If failure does occur, the risk to the fetus is minimal.<br/>PREGNANCY AFTER STOPPING THE PILL: There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraception. It may be advisable to postpone contraception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy. There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill.<br/>OVERDOSAGE: Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your healthcare provider or pharmacist.<br/>OTHER INFORMATION: Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is appropriate to postpone it. You should be reexamined at least once a year. Be sure to inform your healthcare provider if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your healthcare provider,because this is a time to determine if there are early signs of side effects of oral contraceptive use. Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth-control pills.<br/>HEALTH BENEFITS FROM ORAL CONTRACEPTIVES: In addition to preventing pregnancy, use of oral contraceptives may provide certain benefits. They are: If you want more information about birth-control pills, ask your doctor or pharmacist. They have a more technical leaflet called the Physician Prescribing Information which you may wish to read. Address medical inquiries to:Watson Pharma, Inc.Medical Communications P.O. Box 1953Morristown, NJ 07962-1953800-272-5525 Manufactured for: WATSON PHARMA, INC.A subsidiary of Watson Pharmaceuticals, Inc.Corona, CA 92880 USA Manufactured by: Patheon, Inc.Mississauga, Ontario L5N 7K9 CANADA Issued: July 2006 IN-5318/S
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| dailymed-drugs:2677 |
Medication GuideAntidepressant Medicines, Depression and other Serious Mental Illnesses,and Suicidal Thoughts or Actions: Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about: What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: What else do I need to know about antidepressant medicines? This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. Revised: August 2007
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| dailymed-drugs:2762 |
Medication GuideAntidepressant Medicines, Depression and other Serious Mental Illnesses,and Suicidal Thoughts or Actions: Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about: What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: What else do I need to know about antidepressant medicines? This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. Revised: August 2007
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| dailymed-drugs:3038 |
Medication GuideAntidepressant Medicines, Depression and other Serious Mental Illnesses,and Suicidal Thoughts or Actions: Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about: What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: What else do I need to know about antidepressant medicines? This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. Revised: August 2007
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| dailymed-drugs:2701 |
MEDICATION GUIDE: DESOXYN(Pronounced D��-s��ks-��n)(methamphetamine hydrochloride tablets, USP) Read the Medication Guide that comes with DESOXYN before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your or your child's doctor about your or your child's treatment with DESOXYN. What is DESOXYN? DESOXYN is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder; (ADHD). DESOXYN may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. DESOXYN should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. DESOXYN is also used short-term, along with a low calorie diet, for weight loss in obese patients who have not been able to lose weight on other therapies. Who should not take DESOXYN? DESOXYN should not be taken if you or your child: DESOXYN is not recommended for use in children less than 6 years old in the treatment of ADHD. DESOXYN may not be right for you or your child. Before starting DESOXYN tell your or your child's doctor about all health conditions (or a family history of) including: Tell your or your child's doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding. Can DESOXYN be taken with other medicines? Tell your or your child's doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. DESOXYN and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking DESOXYN. Your or your child's doctor will decide whether DESOXYN can be taken with other medicines. Especially tell your or your child's doctor if you or your child takes: Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist. Do not start any new medicine while taking DESOXYN without talking to your or your child's doctor first. How should DESOXYN be taken? What are possible side effects of DESOXYN? See���What is the most important information I should know about DESOXYN?���for information on reported heart and mental problems. Other serious side effects include: Common side effects include:���fast heart beat���decreased appetite���tremors���headache���trouble sleeping���dizziness���stomach upset���weight loss���dry mouth DESOXYN may affect your or your child's ability to drive or do other dangerous activities. Talk to your or your child's doctor if you or your child has side effects that are bothersome or do not go away. This is not a complete list of possible side effects. Ask your or your child's doctor or pharmacist for more information. How should I store DESOXYN? General information about DESOXYN Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DESOXYN for a condition for which it was not prescribed. Do not give DESOXYN to other people, even if they have the same condition. It may harm them and it is against the law. This Medication Guide summarizes the most important information about DESOXYN. If you would like more information, talk with your or your child's doctor. You can ask your or your child's doctor or pharmacist for information about DESOXYN that was written for healthcare professionals. For more information about DESOXYN, contact OVATION Pharmaceuticals at 1-888-514-5204 or visit www.ovationpharma.com. What are the ingredients in DESOXYN? Active Ingredient: methamphetamine hydrochloride Inactive Ingredients: Corn starch, lactose, sodium paraminobenzoate, stearic acid and talc This Medication Guide has been approved by the U.S. Food and Drug Administration. OVATION Pharmaceuticals. Inc.Deerfied, IL 60015 ' Trademark of Ovation Pharmaceuticals, Inc. Issued: May 2007715102-1
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| dailymed-drugs:2705 |
Medication Guide About Using Antidepressants in Children and Teenagers: What is the most important information I should know if my child is being prescribed an antidepressant? Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant: 1. There is a Risk of Suicidal Thoughts or Actions Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Antidepressants increase suicidal thoughts and actions in some children and teenagers. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal. A large study combined the results of 24 different studies of children and teenagers with depression or other illnesses. In these studies, patients took either a placebo (sugar pill) or an antidepressant for 1 to 4 months. No one committed suicide in these studies, but some patients became suicidal. On sugar pills, 2 out of every 100 became suicidal. On the antidepressants, 4 outof every 100 patients became suicidal. For some children and teenagers, the risks of suicidal actions may be especially high. These include patients with If any of these are present, make sure you tell your healthcare provider before your child takes an antidepressant. 2. How to Try to Prevent Suicidal Thoughts and Actions To try to prevent suicidal thoughts and actions in your child, pay close attention to changes in her or his moods or actions, especially if the changes occur suddenly. Other important people in your child's life can help by paying attention as well (e.g., your child, brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3, on what to watch for. Whenever an antidepressant is started or its dose is changed, pay close attention to your child. After starting an antidepressant, your child should generally see his or her healthcare provider: You should call your child's healthcare provider between visits if needed. 3. You Should Watch for Certain Signs If Your Child is Taking an Antidepressant Contact your child's healthcare provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child's teacher: Never let your child stop taking an antidepressant without first talking to his or her healthcare provider. Stopping an antidepressant suddenly can cause other symptoms. 4. There are Benefits and Risks When Using Antidepressants Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your healthcare provider, not just the use of antidepressants. Other side effects can occur with antidepressants (see section below). Of all the antidepressants, only fluoxetine (Prozac)* has been FDA approved to treat pediatric depression. For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac)*, sertraline (Zoloft)*, fluvoxamine, and clomipramine (Anafranil)*. Your healthcare provider may suggest other antidepressants based on the past experience of your child or other family members. Is this all I need to know if my child is being prescribed an antidepressant? No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your healthcare provider or pharmacist where to find more information. *Prozac is a registered trademark of Eli Lilly and Company *Zoloft is a registered trademark of Pfizer Inc. *Anafranil is a registered trademark of Mallinckrodt Inc. This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. Valeant Pharmaceuticals International3300 Hyland Ave., Costa Mesa, CA 92626 U.S.A. 3380597EX02 Rev. September 05
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| dailymed-drugs:2745 |
DiastatAcuDial���(diazepam rectal gel) ADMINISTRATION AND DISPOSAL INSTRUCTIONS IMPORTANT Read first before using To the caregiver using Diastat Please do not give Diastat until: To the caregiver using Diastat AcuDial Please do not give Diastat AcuDial���until Please do not administer DIASTAT until you feel comfortable with how to use DIASTAT. The doctor will tell you exactly when to use DIASTAT correctly and safely you will help bring seizures under control. Be sure to discuss every aspect of your role with the doctor. If you are not comfortable, then discuss you role with the doctor again. To help the person with seizures: To know what responses to expect: If you have any question or feel unsure about using the treatment, CALL THE DOCTOR before using DIASTAT. When to treat. Based on the doctor's directions and prescription ________________________________________________________ ________________________________________________________ Special considerations. DIASTAT should be used with caution: Discuss beforehand with the doctor any additional steps you may need to take if there is leakage of DIASTAT or a bowel movement. Patient's DIASTAT dosageis: __________mg Patient's resting breathing rate_________ Patient's current weight____________ Confirm current weight is still the same as when DIASTAT was prescribed____________ Check expiration data and always remove cap before using. Be sure seal pin is removed with the cap. TREATMENT 1------------------------------------------------------------------------------------------------------------ Important things to tell the doctor. Things to do after treatment with DIASTAT. Stay with the person for 4 hours and make notes on the following: TREATMENT 2 ------------------------------------------------------------------------------------------------------------ Important things to tell the doctor Things to do after treatment with DIASTAT. Stay with the person for 4 hours and make notes on the following: HOW TO ADMINISTER AND DISPOSAL
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| dailymed-drugs:2783 |
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: NSAID medicines should never be used right before or after a heart surgery called a���coronary artery bypass graft (CABG).��� NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Serious side effects include: Other side effects include: Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) NSAID medicines that need a prescription This Medication Guide has been approved by the U.S. Food and Drug Administration. Watson Laboratories, Inc.Corona, CA 92880Effective Date: July 2007
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| dailymed-drugs:2838 |
Patient Package Insert: PATIENT INFORMATION ABOUT FINASTERIDE TABLETS, USP 5 mg 8570-01(fin-AS-tur-eyed) Finasteride is for use by men only. Please read this leaflet before you start taking finasteride. Also, read it each time you renew your prescription, just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss finasteride when you start taking your medication and at regular checkups. Why your doctor has prescribed finasteride Your doctor has prescribed finasteride because you have a medical condition called benign prostatic hyperplasia or BPH. This occurs only in men. What is BPH? BPH is an enlargement of the prostate gland. After age 50, most men develop enlarged prostates. The prostate is located below the bladder. As the prostate enlarges, it may slowly restrict the flow of urine. This can lead to symptoms such as: In some men, BPH can lead to serious problems, including urinary tract infections, as well as the need for surgery. Treatment options for BPH There are three main treatment options for symptoms of BPH: There are two main treatment options to reduce the risk of serious problems due to BPH: What finasteride does Finasteride lowers levels of a key hormone called DHT (dihydrotestosterone), which is a major cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland in most men. This can lead to gradual improvement in urine flow and symptoms over the next several months. Finasteride will help reduce the risk of the need for surgery. However, since each case of BPH is different, you should know that: What you need to know while taking finasteride How to take finasteride Follow your doctor's advice about how to take finasteride. You must take it every day. You may take it with or between meals. To avoid forgetting to take finasteride, it may be helpful to take it at the same time every day. Do not share finasteride with anyone else; it was prescribed only for you. Keep finasteride and all medicines out of the reach of children. FOR MORE INFORMATION ABOUT���finasteride' AND BPH, TALK WITH YOUR DOCTOR. IN ADDITION, TALK TO YOUR PHARMACIST OR OTHER HEALTH CARE PROVIDER. Manufactured by:INTAS PHARMACEUTICALS LTD.Plot No. 457, 458Sarkhej-Bavla HighwayMatoda-382 210Gujarat, India Distributed by:Actavis Totowa LLC990 Riverview Drive Totowa,NJ 07512 USA 8570-01 01/07
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| dailymed-drugs:2959 |
BRIEF SUMMARY PATIENT PACKAGE INSERT This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Oral contraceptives, also known as���birth control pills���or���the pill,���are taken to prevent pregnancy, and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. For most women, oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy. For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you: Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding. Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, headache, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use. The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill: The symptoms associated with these serious side effects are discussed in the detailed patient labeling given to you with your supply of pills. Notify your doctor or clinic if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness. There is conflict among studies regarding breast cancer and oral contraceptive use. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use. The majority of studies have found no overall increase in the risk of developing breast cancer. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives. There is insufficient evidence to rule out the possibility that pills may cause such cancers. Taking the pill provides some important non-contraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus. Be sure to discuss any medical condition you may have with your doctor or clinic. Your doctor or clinic will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your doctor or clinic. This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.<br/>DETAILED PATIENT LABELING: This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. PLEASE NOTE: This labeling is revised from time to time as important new medical information becomes available. Therefore, please review this labeling carefully. The following oral contraceptive product contains a combination of a progestogen and estrogen, the two kinds of female hormones: RECLIPSENTablets Each white tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each green tablet contains inert ingredients. INTRODUCTION Any woman who considers using oral contraceptives (the birth control pill or the pill) should understand the benefits and risks of using this form of birth control. This patient labeling will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this labeling is not a replacement for a careful discussion between you and your doctor or clinic. You should discuss the information provided in this labeling with him or her, both when you first start taking the pill and during your revisits. You should also follow your doctor's or clinic's advice with regard to regular check-ups while you are on the pill. EFFECTIVENESS OF ORAL CONTRACEPTIVES Oral contraceptives or���birth control pills���or���the pill���are used to prevent pregnancy and are more effective than other non-surgical methods of birth control. When they are taken correctly, the chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use) when used perfectly, without missing any pills. Typical failure rates are actually 3% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle. In comparison, typical failure rates for other non-surgical methods of birth control during the first year of use are as follows: Implant:<1% Injection:<1% IUD: 1 to 2% Diaphragm with spermicides: 20% Spermicides alone: 26% Vaginal sponge: 20 to 40% Female sterilization:<1% Male sterilization:<1% Cervical Cap with spermicides: 20 to 40% Condom alone (male): 14% Condom alone (female): 21% Periodic abstinence: 25% Withdrawal: 19% No methods: 85% WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You should also not use the pill if you have any of the following conditions: Tell your doctor or clinic if you have ever had any of these conditions. Your doctor or clinic can recommend another method of birth control. OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES Tell your doctor or clinic if you have or have had: Women with any of these conditions should be checked often by their doctor or clinic if they choose to use oral contraceptives. Also, be sure to inform your doctor or clinic if you smoke or are on any medications. RISKS OF TAKING ORAL CONTRACEPTIVES 1. Risk of developing blood clots Blood clots and blockage of blood vessels are one of the most serious side effects of taking oral contraceptives and can cause death or serious disability. In particular, a clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs. The risks of these side effects may be greater with desogestrel-containing oral contraceptives, such as RECLIPSEN, than with other low-dose pills. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision. If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor or clinic about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery if you are not breast feeding or four weeks after a second trimester abortion. If you are breast feeding, you should wait until you have weaned your child before using the pill.(See also the section on Breast Feeding in General Precautions.) The risk of circulatory disease in oral contraceptive users may be higher in users of high dose pills. The risk of venous thromboembolic disease associated with oral contraceptives does not increase with length of use and disappears after pill use is stopped. The risk of abnormal blood clotting increases with age in both users and nonusers of oral contraceptives, but the increased risk from the oral contraceptive appearsto be present at all ages. For women aged 20 to 44 it is estimated that about 1 in 2,000 using oral contraceptives will be hospitalized each year because of abnormal clotting. Among nonusers in the same age group, about 1 in 20,000 would be hospitalized each year. For oral contraceptive users in general, it has been estimated that in women between the ages of 15 and 34 the risk of death due to a circulatory disorder is about 1 in 12,000 per year, whereas for nonusers the rate is about 1 in 50,000 per year.In the age group 35 to 44, the risk is estimated to be about 1 in 2,500 per year for oral contraceptive users and about 1 in 10,000 per year for nonusers. 2. Heart attacks and strokes Oral contraceptives may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or serious disability. Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increase the chances of developing and dying of heart disease. 3. Gallbladder disease Oral contraceptive users probably have a greater risk than nonusers of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens. 4. Liver tumors In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer. However, liver cancers are rare. 5. Cancer of the reproductive organs and breasts There is conflict among studies regarding breast cancer and oral contraceptive use. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use. The majority of studies have found no overall increase in the risk of developing breast cancer. A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years. This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives. There is insufficient evidence to rule out the possibility that pills may cause such cancers. ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY All methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table. In the above table, the risk of death from any birth control method is less than the risk of childbirth, except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7-26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death is always lower than that associated with pregnancy for any age group, although over the age of 40, the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35, the estimated number of deaths exceed those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is four times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group. The suggestion that women over 40 who do not smoke should not take oral contraceptives is based on information from older, higher-dose pills. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of low-dose oral contraceptive use by healthy, non-smoking women over 40 years of age may outweigh the possible risks. WARNING SIGNALS If any of these adverse effects occur while you are taking oral contraceptives, call your doctor or clinic immediately: SIDE EFFECTS OF ORAL CONTRACEPTIVES 1. Vaginal bleeding Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk to your doctor or clinic. 2. Contact lenses If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or clinic. 3. Fluid retention Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your doctor or clinic. 4. Melasma A spotty darkening of the skin is possible, particularly of the face, which may persist. 5. Other side effects Other side effects may include nausea and vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections. If any of these side effects bother you, call your doctor or clinic.<br/>GENERAL PRECAUTIONS: 1. Missed periods and use of oral contraceptives before or during early pregnancy There may be times when you may not menstruate regularly after you have completed taking a cycle of pills. If you have taken your pills regularly and miss one menstrual period, continue taking your pills for the next cycle but be sure to inform your doctor or clinic before doing so. If you have not taken the pills daily as instructed andmissed a menstrual period, you may be pregnant. If you missed two consecutive menstrual periods, you may be pregnant. Check with your doctor or clinic immediately to determine whether you are pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use another method of contraception. There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects, when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these findings have not been seen in more recent studies. Nevertheless, oral contraceptives or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor or clinic. You should check with your doctor or clinic about risks to your unborn child of any medication taken during pregnancy. 2. While breast feeding If you are breast feeding, consult your doctor or clinic before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, oral contraceptives may decrease the amount and quality of your milk. If possible, do not use oral contraceptives while breast feeding. You should use another method of contraception since breast feeding provides only partial protection from becoming pregnant and this partial protection decreases significantly as you breast feed for longer periods of time. You should consider starting oral contraceptives only after you have weaned your child completely. 3. Laboratory tests If you are scheduled for any laboratory tests, tell your doctor or clinic you are taking birth control pills. Certain blood tests may be affected by birth control pills. 4. Drug interactions Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin, drugs used for epilepsy such as barbiturates (for example, phenobarbital), anticonvulsants such as carbamazepine, phenytoin, phenylbutazone, and possibly certain antibiotics. You may need to use additional contraception when you take drugs which can make oral contraceptives less effective. 5. Sexually transmitted diseases This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. HOW TO TAKE THE PILL BEFORE YOU START TAKING YOUR PILLS: 1. BE SURE TO READ THESE DIRECTIONS: Before you start taking your pills. Anytime you are not sure what to do. 2. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. 3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF PILLS. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your doctor or clinic. 4. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. 5. IF YOU HAVE VOMITING OR DIARRHEA, for any reason, or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well. Use a back-up method (such as condoms, foam, or sponge) until you check with your doctor or clinic. 6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control. 7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or clinic. 1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day. 2. LOOK AT YOUR PILL PACK TO SEE IF IT HAS 28 PILLS: The 28-pill pack has 21���active���white pills (with hormones) to take for 3 weeks, followed by 1 week of���reminder���green pills (without hormones). 3. ALSO FIND: CHECK PICTURE OF PILL PACK AND ADDITIONAL INSTRUCTIONS FOR USING THIS PACKAGE IN THE INSTRUCTIONS FOR USE SECTION BELOW. 4. BE SURE YOU HAVE READY AT ALL TIMES: ANOTHER KIND OF BIRTH CONTROL (such as condoms, foam, or sponge) to use as a back-up method in case you miss pills. AN EXTRA, FULL PILL PACK. You have a choice of which day to start taking your first pack of pills. RECLIPSEN���Tablets are available in a 28 day tablet dispenser pre-printed for a Sunday Start. Day 1 Start is also provided. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember. DAY 1 START: SUNDAY START: 1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY. Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often. 2. WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS: Start the next pack on the day after your last���reminder���pill. Do not wait any days between packs. If you MISS 1 white���active���pill: 1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day. 2. You do not need to use a back-up birth control method if you have sex. If you MISS 2 white���active���pills in a row in WEEK 1 OR WEEK 2 of your pack: 1. Take 2 pills on the day you remember and 2 pills the next day. 2. Then take 1 pill a day until you finish the pack. 3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days. If you MISS 2 white���active���pills in a row in THE 3RD WEEK: 1. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day. If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. 2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant. 3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days. If you MISS 3 OR MORE white���active���pills in a row (during the first 3 weeks): 1. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day. If you area Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. 2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant. 3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.________________________________________________________________________A REMINDER FOR THOSE ON 28-DAY PACKS: If you forget any of the 7 green���reminder���pills in Week 4: THROW AWAY the pills you missed. Keep taking 1 pill each day until the pack is empty. You do not need a back-up method.______________________________________________________________________ FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED: Use a BACK-UP METHOD anytime you have sex. KEEP TAKING ONE���ACTIVE���PILL EACH DAY until you can reach your doctor or clinic.___________________________________________________________________ PREGNANCY DUE TO PILL FAILURE The incidence of pill failure resulting in pregnancy is approximately one percent (i.e., one pregnancy per 100 women per year) if taken every day as directed, but more typical failure rates are about 3%. If failure does occur, the risk to the fetus is minimal. PREGNANCY AFTER STOPPING THE PILL There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy. There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill. OVERDOSAGE Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your doctor, clinic or pharmacist. OTHER INFORMATION Your doctor or clinic will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be re-examined at least once a year. Be sure to inform your doctor or clinic if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your doctor or clinic because this is a time to determine if there are early signs of side effects of oral contraceptive use. Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control pills. HEALTH BENEFITS FROM ORAL CONTRACEPTIVES In addition to preventing pregnancy, use of combination oral contraceptives may provide certain benefits. They are: ________________________________________________________________________INSTRUCTIONS FOR USE Tablet Dispenser - 28's If you want more information about birth control pills, ask your doctor, clinic or pharmacist. They have a more technical leaflet called the Professional Labeling, which you may wish to read. Watson Laboratories, Inc.Corona, CA 92880 USA
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| dailymed-drugs:2985 |
Patient Package Insert: PHARMACIST���DETACH HEREAND GIVE PATIENT INFORMATION SHEET TO PATIENT PATIENT INFORMATION ABOUT DOXAZOSIN MESYLATE For Benign Prostatic Hyperplasia (BPH) Revised���October 2003 Read this leaflet: ���before you start taking doxazosin mesylate ���each time you get a new prescription. You and your doctor should discuss this treatment and your BPH symptoms before you start taking doxazosin mesylate and at your regular checkups. This leaflet does NOT take the place of discussions with your doctor. Doxazosin mesylate is used to treat both benign prostatic hyperplasia (BPH) and high blood pressure (hypertension). This leaflet describes doxazosin mesylate as treatment for BPH (although you may be taking doxazosin mesylate for both your BPH and high blood pressure). What is BPH? BPH is an enlargement of the prostate gland. This gland surrounds the tube that drains the urine from the bladder. The symptoms of BPH can be caused by a tensing of the enlarged muscle in the prostate gland which blocks the passage of urine. This can lead to such symptoms as: Treatment Options for BPH The four main treatment options for BPH are:<br/>What Doxazosin Mesylate Does: Doxazosin mesylate works on a specific type of muscle found in the prostate, causing it to relax. This in turn decreases the pressure within the prostate, thus improving the flow of urine and your symptoms. Other lmportant Facts How To Take Doxazosin Mesylate and What You Should Know While Taking Doxazosin Mesylate for BPH Doxazosin Mesylate Can Cause a Sudden Drop in Blood Pressure After the VERY FlRST DOSE. You may feel dizzy, faint or���light-headed,���especially after you stand up from a lying or sitting position. This is more likely to occur after you've taken the first few doses or if you increase your dose, but can occur at any time while you are taking the drug. It can also occur if you stop taking the drug and then restart treatment. If you feel very dizzy, faint or���light-headed���you should contact your doctor. Your doctor will discuss with you how often you need to visit and how often your blood pressure should be checked. Your blood pressure should be checked when you start taking doxazosin mesylate even if you do not have high blood pressure (hypertension). Your doctor will discuss with you the details of how blood pressure is measured. Blood Pressure Measurement: Whatever equipment is used, it is usual for your blood pressure to be measured in the following way: measure your blood pressure after lying quietly on your back for five minutes. Then, after standing for two minutes measure your blood pressure again. Your doctor will discuss with you what other times duringthe day your blood pressure should be taken, such as two to six hours after a dose, before bedtime or after waking up in the morning. Note that moderate to high-intensity exercise can, over a period of time, lower your average blood pressure. You can take doxazosin mesylate either in the morning or at bedtime and it will be equally effective. If you take doxazosin mesylate at bedtime but need to get up from bed to go to the bathroom, get up slowly and cautiously until you are sure how the medication affects you. It is important to get up slowly from a chair or bed at any time until you learn how you react to doxazosin mesylate. You should not drive or do any hazardous tasks until you are used to the effects of the medication. If you begin to feel dizzy, sit or lie down until you feel better. FOR MORE lNFORMATION ABOUT DOXAZOSIN MESYLATE AND BPH TALK WlTH YOUR DOCTOR, NURSE, PHARMAClST OR OTHER HEALTH CARE PROVIDER. Manufactured by:PUREPAC PHARMACEUTICAL CO.Elizabeth, NJ 07207 USA Revised���October 2003
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Medication GuideAntidepressant Medicines, Depression and other Serious Mental Illnesses,and Suicidal Thoughts or Actions: Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about: What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: What else do I need to know about antidepressant medicines? This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. Revised: September 2007
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Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: NSAID medicines should never be used right before or after a heart surgery called a���coronary artery bypass graft (CABG).��� NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) NSAID medicines that need a prescription This Medication Guide has been approved by the U.S. Food and Drug Administration.
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Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: NSAID medicines should never be used right before or after a heart surgery called a���coronary artery bypass graft (CABG).��� NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: ___________________________________________________________________________ What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are use to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) This Medication Guide has been approved by the U.S. Food and Drug Administration.
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ALERT: Find out about medicines
that should NOT be taken with INVIRASE. Please also read
the section MEDICINES YOU SHOULD NOT TAKE WITH INVIRASE. Please read this product information carefully before
you start taking INVIRASE and each time you renew your prescription.
There may be new information. Reading this information can help you
take this medicine correctly. However, it is not a substitute for
your doctor's advice about the safety and benefits of INVIRASE. You
should talk to your doctor about INVIRASE as part of your long-term
treatment plan for HIV before you start taking your medication and
ask any questions you may have at regular checkups. Remember, you
should remain under a doctor's care when using INVIRASE and should
not change or stop your therapy without talking to your doctor first. What is INVIRASE? How does INVIRASE work? INVIRASE fights HIV as it grows inside cells by blocking
an enzyme (protease) that HIV needs to reproduce. Who should
not take INVIRASE? Anyone
who has had a severe allergic reaction to INVIRASE or any of the ingredients
in the capsule or tablet should not take it. The use of INVIRASE in
patients under 16 years of age, over 65 years of age, or patients
with severe liver problems has not been fully investigated. How should INVIRASE/Norvir' (ritonavir) be taken? What results have been seen with INVIRASE? INVIRASE with ritonavir has been shown to reduce the amount
of virus in the blood ("viral load") and increase CD(T)
cells when taken with other HIV therapy. What are the side effects
of INVIRASE? People treated
with INVIRASE in combination with Norvir may have side effects. The
majority of these have been described as mild. In clinical studies
of patients who received saquinavir in combination with Norvir and
other HIV drugs the side effects seen most often were: body fat change
(5.4%), nausea (10.8%), vomiting (7.4%), diarrhea (8.1%), stomach
pain (6.1%), tiredness (6.1%), and pneumonia (5.4%). Diabetes (new onset or worsening) and increased blood sugar levels
have been reported with the use of protease inhibitors. In addition,
increased bleeding in patients with hemophilia has also been associated
with these drugs. When saquinavir is taken with
ritonavir, some patients may experience large increases in triglyceride
and lipid levels. The long-term chance of getting complications such
as heart attack and stroke due to increases in triglyceride and cholesterol
levels caused by protease inhibitors is not known at this time. Changes in body fat have been seen in some patients taking
anti-HIV medications. These changes may include increased amount of
fat in the upper back and neck ("buffalo hump"), breasts, and around
the trunk. Loss of fat from the legs and arms may also happen. The
cause and long-term health effects of these conditions are not known
at this time. These are not the only side effects
that can occur with INVIRASE. Your doctor can discuss with you a more
complete list of side effects and laboratory abnormalities that may
accompany this medication. If any side effects
or unusual symptoms do occur, contact your doctor immediately. Do
not stop or decrease your dose on your own. Lowering the dose may
make INVIRASE less effective in fighting HIV. Are there
other medications that I should not take with INVIRASE/Norvir (ritonavir)? There are some drugs that should
not be taken with INVIRASE. Before starting therapy with INVIRASE;
be sure to tell your doctor all of the medicines���prescription
medications, as well as over-the- counter drugs and nutritional supplements���that
you are now taking or plan to take. INVIRASE causes increased
blood levels of these compounds. This can lead to serious or life-threatening
reactions such as irregular heartbeat or prolonged sedation. Taking INVIRASE with St. John's wort (hypericum perforatum),
an herbal product sold as a dietary supplement, or products containing
St. John's wort is not recommended. Talk with your doctor if you are
taking or are planning to take St. John's wort. Taking St. John's
wort may decrease INVIRASE levels and lead to increased viral load
and possible resistance to INVIRASE or cross-resistance to other antiretroviral
drugs. No data are available for the coadministration
of INVIRASE and Norvir with garlic capsules. Garlic capsules should
not be used while taking saquinavir due to the potential for garlic
capsules to decrease the amount of saquinavir in the blood. Your doctor may want to change your medicine if you are
taking rifampin (known as Rifadin', Rifamate, Rifater or Rimactane) or Mycobutin (rifabutin); these drugs substantially reduce the level
of INVIRASE in the blood. Rifampin, in combination with INVIRASE and
ritonavir, may also cause severe liver problems. Caution should be exercised when taking INVIRASE with digoxin. Your
doctor may want to decrease the dose of digoxin and monitor the levels
of digoxin in your blood. The following drugs
increase blood levels of INVIRASE: Norvir (ritonavir), Viracept (nelfinavir), Rescriptor (delavirdine), Nizoral (ketoconazole), Crixivan (indinavir), Biaxin(clarithromycin) and omeprazole. Talk to your
doctor if you are taking lipid (cholesterol) lowering drugs and Viagra (sildenafil citrate), Levitra (vardenafil),
and Cialis (tadalafil). Does INVIRASE cure HIV/AIDS? INVIRASE does not cure AIDS, and
it does not prevent you from getting other illnesses that result from
advanced HIV infection. In addition, INVIRASE has not been shown to
reduce the risk that you may transmit HIV to others through sexual
contact or infected blood. You must continue to follow all of your
doctor's recommendations for managing your illness. What else
should I discuss with my doctor? Inform your doctor: How is INVIRASE supplied? INVIRASE is available as light brown and green capsules in a 200-mg
strength. INVIRASE comes in bottles of 270 capsules. INVIRASE is also available as light orange to greyish- or brownish-orange
tablets in a 500-mg strength. INVIRASE comes in bottles of 120 tablets. How should I store INVIRASE? INVIRASE capsules and tablets should be stored at room temperature.
The bottles should be kept tightly closed. INVIRASE
has been prescribed specifically for you, and only for a particular
condition. Do not use it for anything else. Do not give it to anyone
else. If you think you have taken more than your prescribed dose,
seek medical attention. Keep this medication and all other medications out of the reach of
children. Do not keep medicine that is out of date or that
you no longer need. Be sure that if you throw any medicine away, it
is out of the reach of children. This provides
only a brief summary of product information about INVIRASE. If you
have any questions about INVIRASE or HIV, talk to your doctor. FORTOVASE and Versed are registered
trademarks of Hoffmann-La Roche Inc. Norvir, Rhythmol, and Biaxin
are registered trademarks of Abbott Laboratories. Halcion, Mycobutin
and Rescriptor are registered trademarks of Pharmacia&Upjohn
Co. Hismanal, Propulsid and Nizoral are registered trademarks of Janssen
Pharmaceutica Inc. Seldane, Rifadin, Rifamate and Rifater are registered
trademarks of Hoechst Marion Roussel. Rimactane and Cafergot are registered
trademarks of Novartis Pharmaceuticals Corporation. Viracept is a
registered trademark of Agouron Pharmaceuticals Inc. Crixivan is a
registered trademark of Merck&Co., Inc. Viagra is a registered
trademark of Pfizer, Inc. Levitra is a registered trademark of Bayer
Pharmaceuticals Corp. Cialis is a registered trademark of Eli Lilly
and Company. Tambocor is a registered trademark of 3M. Pacerone is
a registered trademark of Upsher-Smith. If you have any questions about INVIRASE, call
toll free at 1-800-910-4687. 27899381 10085697 Revised: July 2007 Copyright��1999-2007 by Roche Laboratories Inc.
All rights reserved.
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Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): (See the end of this Medication Guide for a list of prescription NSAID medicines).<br/>What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?: NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: NSAID medicines should never be used right before or after a heart surgery called a���coronary artery bypass graft (CABG).��� NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used:<br/>What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?: NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:<br/>Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?: Do not take an NSAID medicine: Tell your healthcare provider:<br/>What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?: Serious side effects include: Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.<br/>Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)::<br/>NSAID medicines that need a prescription: All registered trademarks in this document are the property of their respective owners. * Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually use for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This Medication Guide has been approved by the US Food and Drug Administration. Manufactured by:Caraco Pharmaceutical Laboratories, Ltd.1150 Elijah McCoy DriveDetroit, MI 48202
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SPL Medguide: Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: NSAID medicines should never be used right before or after a heart surgery called a���coronary artery bypass graft (CABG).��� The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines. Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days. NSAID medicines that need a prescription Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Medication GuideAntidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions: Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about:<br/>What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?:<br/>3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?: Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:<br/>What else do I need to know about antidepressant medicines?: This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. CARACO PHARMACEUTICAL LABORATORIES, LTD.DETROIT, MI 48202
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Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): (See the end of this Medication Guide for a list of prescription NSAID medicines.)<br/>What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?: NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: NSAID medicines should never be used right before or after a heart surgery called a���coronary artery bypass graft (CABG).��� NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: NSAID medicines should only be used:<br/>What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?: NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:<br/>Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?: Do not take an NSAID medicine: Tell your healthcare provider:<br/>What are the possible side effects of Non-Steroidal Anti-inflammatory Drugs (NSAIDs)?: Serious side effects include: Other side effects include: Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.<br/>Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): NSAID medicines that need a prescription *Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC label warns that long term continuous use may increase the risk of heart attack or stroke. All registered trademarks in this document are the property of their respective owners. This Medication Guide has been approved by the U.S. Food and Drug Administration.
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MEDICATION GUIDE: SYMBICORT' 80/4.5(budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol SYMBICORT'160/4.5 (budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol Read the Medication Guide that comes with SYMBICORT' before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about SYMBICORT? What is SYMBICORT? SYMBICORT combines an inhaled corticosteroid medicine, budesonide (the same medicine found in PULMICORT TURBUHALER), and a long-acting beta-agonist medicine (LABA), formoterol (the same medicine found in FORADIL AEROLIZER). SYMBICORT is used long-term, twice a day, everyday to control symptoms of asthma, and prevent symptoms such as wheezing in patients 12 years of age and older. SYMBICORT contains formoterol (the same medicine found in FORADIL AEROLIZER). Because LABA medicines such as formoterol may increase the chance of death from asthma problems, SYMBICORT is not for patients with asthma who: What should I tell my healthcare provider before using SYMBICORT? Tell your healthcare provider about all of your health conditions, including if you: Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. SYMBICORT and certain other medicines may interact with each other. This may cause serious side effects. Know all the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine. How do I use SYMBICORT? See the step-by-step instructions for using SYMBICORT at the end of this Medication Guide. Do not use SYMBICORT unless your healthcare provider has taught you and you understand everything. Ask your healthcare provider or pharmacist if you have any questions. What are the possible side effects with SYMBICORT? SYMBICORT contains formoterol. In patients with asthma, LABA medicines such as formoterol may increase the chance of death from asthma problems. See���What is the most important information I should know about SYMBICORT?��� Other possible side effects with SYMBICORT include: Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the side effects with SYMBICORT. Ask your healthcare provider or pharmacist for more information. How do I store SYMBICORT? General Information about SYMBICORT Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide. Do not use SYMBICORT for a condition for which it was not prescribed. Do not give your SYMBICORT to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about SYMBICORT. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about SYMBICORT that was written for healthcare professionals. You can also contact the company that makes SYMBICORT (toll free) at 1-800-236-9933 or visit our website at www.symbicort-us.com. HOW TO USE SYMBICORT Follow the instructions below for using SYMBICORT. You will breathe-in (inhale) the medicine. If you have any questions, ask your doctor or pharmacist. PREPARING YOUR INHALER FOR USE Do not spray the medicine in your eyes during priming or use. WAYS TO HOLD THE INHALER FOR USE OR USING YOUR SYMBICORT INHALER 5. SHAKE THE INHALER WELL for 5 seconds. Remove the mouthpiece cover. Check the mouthpiece for foreign objects. 6. Breathe out fully (exhale). Raise the inhaler up to your mouth. Place the white mouthpiece fully into your mouth and close your lips around it. Make sure that the inhaler is upright and that the opening of the mouthpiece is pointing towards the back of your throat (see Figure 4). 7. While breathing in deeply and slowly through your mouth, press down firmly and fully on the grey top of the inhaler to release the medicine (see Figures 2 and 3). 8. Continue to breathe in and hold your breath for about 10 seconds, or for as long as is comfortable. Before breathing out, release your finger from the grey top and remove the inhaler from your mouth while keeping the inhaler upright. 9. Shake the inhaler again for 5 seconds and repeat steps 6 through 8. AFTER USING YOUR SYMBICORT INHALER 10. Replace the mouthpiece cover after use. 11. After you finish taking this medicine (2 puffs), rinse your mouth with water. Spit out the water. Do not swallow it. 12. Use the enclosed dose tracker card to track the number of puffs you have taken by marking off or punching through each of your morning and evening doses. OTHER IMPORTANT INFORMATION ABOUT YOUR SYMBICORT INHALER It is very important that you keep track of the number of inhalations (puffs) you have taken from your SYMBICORT inhaler. Discard SYMBICORT after you have used the number of inhalations on the product label and box. Your inhaler may not feel empty, but you will not get the right amount of medicine if you keep using it. SYMBICORT should also be discarded within 3 months after it is taken out of its foil pouch. HOW TO CLEAN YOUR SYMBICORT INHALER Clean the white mouthpiece of the inhaler every 7 days. To clean the mouthpiece: SYMBICORT and PULMICORT TURBUHALER are trademarks of the AstraZeneca group of companies. ADVAIR DISKUS, ADVAIR HFA, SEREVENT and DISKUS are trademarks of GlaxoSmithKline. FORADIL AEROLIZER is a trademark of Novartis Pharmaceuticals Corporation. ��AstraZeneca 2006 Manufactured for AstraZeneca LP, Wilmington, DE 19850 By: AstraZeneca Dunkerque Production, Dunkerque, France Product of France This Medication Guide has been approved by the U.S. Food and Drug Administration 31154���00 Rev. 07/06
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Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAIDmedicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:with longer use of NSAID medicines NSAID medicines should never be used right before or after a heart surgery called a���coronary artery bypass graft (CABG).��� NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAIDs)? Do not take an NSAID medicine: Tell your healthcare provider: What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) NSAID medicines that need a prescription This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured for: Par Pharmaceutical, Inc. , Spring Valley, NY 10977 By: Ivax Pharmaceuticals, Inc. Miami, Florida 33137
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