GENERIC NAME: ORAL CONTRACEPTIVES
WARNING: Smoking cigarettes while using this medication increases your chance of having heart problems. Do not smoke while using this medication. The risk of heart problems increases with age (especially in women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater).
USES: This medication is used to prevent pregnancy or to regulate your menstrual cycle. Certain brands of birth control pills may be used for treating acne or as a "morning after" pill for emergency contraception. Consult your doctor or pharmacist. Use of this medication does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea).
HOW TO USE: Take this medication with food or immediately after a meal to prevent stomach upset. Try to take this medication at the same time each day. This may help you to remember to take it. Learn proper use of your particular brand of medication. Follow your dosing schedule carefully. Be sure to ask your doctor or pharmacist if you have any questions. Use a supplemental form of birth control during the first week of taking this medication since it takes a while to be effective. Follow your doctor's directions exactly if this drug is being used as a "morning after" pill.
SIDE EFFECTS: This medication may cause dizziness, headache, lightheadedness, stomach upset, bloating, or nausea. If these effects persist or worsen, contact your doctor. Notify your doctor if you experience: severe depression, groin or calf pain, sudden severe headache, chest pain, shortness of breath, lumps in the breast, weakness or tingling in the arms or legs, yellowing of the eyes or skin. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before you take this medication, tell your doctor your entire medical history, including family medical history, especially: asthma, high blood pressure, kidney disease, liver disease, heart disease, stroke, history of jaundice (yellowing skin/eyes) or high blood pressure during pregnancy, excessive weight gain or fluid retention during menstrual cycle, blood clots, heart attack, seizures, migraine headaches, breast cancer, high blood level of cholesterol or lipids (fats), diabetes, depression. Depending on strength, this drug may cause a patchy, darkening of the skin on the face (melasma). Higher strengths are more likely to cause melasma. Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing. It may take a long time for you to become pregnant after you stop taking birth control pills. Consult your doctor. Do not smoke cigarettes. Birth-control pills slightly increase your risk of strokes, blood clots, high blood pressure, heart attacks, gallbladder disease, vision problems, and liver tumors. Cigarette smoking (especially 15 or more cigarettes daily) and age (women older than 35/smokers or 40/nonsmokers years of age) further increase the risk of stroke, blood clots, high blood pressure and heart attacks. Ask your pharmacist or doctor for a copy of the patient labeling which explains these risks in more detail. Consult your doctor for any questions, including possible use in nonsmokers over 40 years of age. If you are near-sighted or wear contact lenses, you may develop vision problems. Also, your tolerance of the lenses may decrease. Contact your eye doctor if these problems occur. If you will be having surgery, be confined to a chair or bed for a long period of time (e.g., a long plane flight), or have recently delivered a baby, notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking this drug. This drug must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication passes into breast milk. This may affect milk production and may have harmful effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Certain drugs can decrease the effectiveness of combination-type birth control pills by decreasing the amount of birth control pill hormones in your system (impaired enterohepatic recirculation or hepatic induction). This can result in pregnancy. Consult your doctor or pharmacist for details. Drugs that may cause this effect include: many antibiotics (e.g., cephalosporins, chloramphenicol, macrolides, penicillins, tetracyclines, sulfas), aprepitant, bexarotene, bosentan, dapsone, griseofulvin, certain HIV protease inhibitors (e.g., amprenavir, nelfinavir, ritonavir), modafinil, nevirapine, rifamycins (e.g., rifampin), many seizure medications (e.g., barbiturates, carbamazepine, phenytoin, primidone, topiramate), St. John's wort. Ask your doctor if you should use additional reliable birth control methods while taking any of the drugs mentioned above while also taking birth control pills. Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal medications you may use, especially of: thyroid hormone drugs, certain benzodiazepines (e.g., diazepam, chlordiazepoxide), prednisone-like drugs, certain antidepressants (e.g., tricyclics), beta-blockers (e.g., metoprolol), "blood thinners" (anticoagulants such as warfarin), insulin. This product can affect the results of certain lab tests (e.g., thyroid). Inform all laboratory personnel that you use this drug. Birth control pills may significantly intensify the effects of alcohol. Consult your doctor or pharmacist about this. Do not start or stop any medicine without doctor or pharmacist approval.
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OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include nausea and vomiting. Females may experience vaginal bleeding.
NOTES: Do not share this medication with others. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination that includes blood pressure measurements and breast/pelvic examinations at regular intervals (e.g., once a year) or as directed by your doctor. Follow your doctor's instructions on how to examine your own breasts and report any lumps immediately. You should also be regularly screened for cervical cancer (e.g., Pap test). Consult your doctor for more details. A manufacturer's fact sheet about this drug should be dispensed with each prescription. Read the information carefully. Ask your doctor or pharmacist any questions you may have.
MISSED DOSE: Missed dose advice differs and depends on the brand used, and the number of doses missed. Refer to the product package information for advice on missed doses. Ask your doctor or pharmacist if you have any questions.
STORAGE: Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.