ethinyl estradiol/norelgestromin patch-topical (cont.)
SIDE EFFECTS: Nausea, vomiting, headache, redness or itching at the patch application site, dizziness, breast tenderness, vaginal discomfort/irritation, or stomach cramping/bloating may occur. If any of these effects persist or worsen, notify your doctor. Promptly tell your doctor if any of these side effects occur: dark patches on the skin (melasma), change in appetite, weight changes (gain or loss), problem wearing contact lenses. Tell your doctor immediately if any of these serious side effects occur: unusual vaginal discharge, changes in vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged or complete stoppage of bleeding), swelling, severe headache, mental/mood changes. Tell your doctor immediately if any of these unlikely but serious side effects occur: pain in the groin or lower legs, trouble breathing, rash, chest pain, stomach pain, vision or eye problems. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes or skin, dark urine, one-sided weakness, numbness in the arms/legs, lumps in the breast. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: This medication is not recommended for use if you have the following medical conditions: blood circulation problems (e.g., history of blood clots in the legs or groin), history of heart disease or stroke, 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), liver problems, history of yellowing eyes and skin (jaundice) during pregnancy or while using birth control pills, cancer (especially endometrial or breast cancer), undiagnosed abnormal vaginal bleeding, currently pregnant, heavy tobacco use (if 35 years old or greater). Tell your doctor your medical history, especially of: high cholesterol or triglyceride (fat) levels, depression, high blood pressure, gallbladder problems, thyroid problems, any allergies. Do not smoke cigarettes. Hormonal birth control (e.g., pills, injections, devices) products combined with smoking cigarettes significantly increase your risk for strokes, blood clots, high blood pressure, and heart attacks; especially in women older than 35 years of age. Ask your doctor or pharmacist or consult the patient information leaflet that comes with this product for more details. 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. The drugs in this patch may cause blotchy, dark areas on your skin (melasma) and sunlight may intensify this effect. If this occurs, avoid prolonged sun exposure, use a sunscreen, and wear protective clothing when outdoors. If you are near-sighted or wear contact lenses, you may develop vision problems or may have problems wearing your contact lenses. Contact your eye doctor if these problems occur. This medication device must not be used in pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. The medication from this patch passes into breast milk and may have undesirable effects on the 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.
- Hormonal Methods of Birth Control - Read about hormonal birth control methods, such as oral contraceptives, the patch, birth control injection, and vaginal ring. The hormones used in hormonal birth control are estrogen and/or progesterone.
- Pregnancy Planning - The goals of pregnancy planning are to create a healthy environment for the fetus and to prevent birth defects and other pregnancy related problems.
- Birth Control - There are a number of different methods of birth control to include: barrier methods, IUDs, hormonal methods, natural methods, and surgical sterilization. No birth control method, except abstinence, is considered to be 100% effective.
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