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February 9, 2010
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levonorgestrel/ethinyl estradiol extended cycle (cont.)

SIDE EFFECTS: Dizziness, headache, stomach upset, bloating, nausea, vomiting, trouble sleeping, vaginal discomfort/irritation, increased vaginal discharge, or vaginal bleeding between periods may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: dark patches on the skin or face (melasma), weight changes (gain or loss), problem wearing contact lenses, depression, mental/mood changes. Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, coughing up blood, shortness of breath, groin or calf pain/swelling, one-sided weakness, vision problems/changes, slurred speech, confusion, sudden severe headache, lumps in the breast, severe stomach/abdominal pain, tingling/weakness/numbness in the arms/leg, yellowing of eyes or skin, dark urine. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, severe swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood clots (e.g., in the legs, groin, lungs), history of heart disease or stroke, heart valve disease, severe high blood pressure, diabetes (especially affecting the circulation), severe headaches, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, cancer (especially endometrial or breast cancer), undiagnosed abnormal vaginal bleeding, liver problems, currently pregnant, heavy tobacco use (if 35 years old or greater). Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, high blood level of cholesterol or triglycerides (fats), gallbladder problems, kidney problems, thyroid problems, migraine headaches, depression, recent pregnancy, smoking, obesity, any allergies (especially to hormones used in other birth control pills). You should have your period (withdrawal bleeding) when you are taking the inactive pills. If bleeding does not occur, contact your doctor immediately. Your doctor will need to check to see if you are pregnant. Bleeding or spotting between your periods may occur while taking this medication. If this bleeding continues for more than 7 days or is heavy, contact your doctor. This drug may cause a patchy, darkening of the skin on the face (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. There may be a delay in becoming pregnant after you stop taking birth control pills. Consult your doctor. 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.




Report Problems to the Food and Drug Administration

 

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.


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