Learn more about usage, cautions, and possible side effects .
Chemical Name: NORELGESTROMIN (nor-el-JES-troe-min) and ETHINYL ESTRADIOL (ETH-i-nil ES-tra-DYE-ol)
This medicine is an estrogen/progestin combination used to prevent pregnancy. It may also be used for other conditions as determined by your doctor.
WARNING: Cigarette smoking while using this medicine increases the risk of serious heart problems. The risk increases with age (older than 35 years) and with heavy smoking (15 or more cigarettes per day). Patients who use this medicine are strongly advised not to smoke. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking aprepitant, azole antifungals (eg, itraconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, troglitazone, beta-blockers (eg, atenolol), selegiline, theophyllines (eg, aminophylline), troleandomycin, or lamotrigine. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including high blood pressure; high cholesterol, triglycerides, or calcium levels; pancreatitis; gallbladder problems; obesity; breast nodules; fibrocystic disease of the breast; abnormal breast x-ray or mammogram; endometriosis or endometrial carcinomas; uterine fibroids; irregular or scanty menstrual periods; diabetes; headaches; migraine headaches; epilepsy; or allergies. Tell your doctor if you have a history of mental depression. Tell your doctor if you are taking an antibiotic, having surgery, or if you are a heavy smoker (15 or more cigarettes per day), especially if you are older than 35 years. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have blood clots in the legs, lungs, or eyes or have a history of other blood clotting problems; known or suspected breast cancer or cancer of the uterus, cervix, or vagina; cancer that is estrogen-dependent; unusual vaginal bleeding from an unknown cause; a liver tumor, liver cancer, or active liver disease; severe high blood pressure; blood vessel problems caused by diabetes; certain heart valve problems; the blood disease porphyria; headaches with neurological symptoms; are pregnant or suspect you may be pregnant; have recently given birth; or are breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of blood vessel problems of the heart or brain; heart attack; chest pain; stroke; breast cancer; or yellowing of the eyes or skin during pregnancy or previous hormonal birth control use. USE OF THIS MEDICINE IS NOT RECOMMENDED if you will be on bed rest for a long period following surgery. This medicine should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
Follow the directions for using this medicine provided by your doctor. AN EXTRA PATIENT LEAFLET is available with this medicine. Talk to your pharmacist if you have questions about this information. One patch is usually applied to the skin and worn for 1 week and then replaced. Follow the dosing schedule carefully. DO NOT OPEN THE SEALED POUCH containing the patch until ready to use. Open the pouch and remove the patch from the protective liner. Apply to an area of clean, dry skin on the lower stomach area below the belly button. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the patch lifts, press down to reapply. Wear only 1 patch at any one time. DO NOT PLACE THE PATCH on the breast. Make sure the application site is not oily, damaged, or irritated. Avoid applying to the waistline because tight clothing may rub the patch off. Do not put the patch on areas where sitting may loosen it. Do not apply to a site that is exposed to sunlight or where the skin is red, irritated, or cut. Do not use creams, oils, powder, or makeup on your skin where you will put a patch or near a patch you are using as it may cause the patch to become loose. Contact with water while bathing, showering, or swimming will not affect the patch. WHEN IT IS TIME TO CHANGE THE PATCH, remove it slowly, fold in half (with the sticky sides together), and throw it away out of the reach of children and away from pets. Do not flush patches down the toilet. APPLY A NEW PATCH to a different area to prevent skin irritation. Use a different site when replacing the patch and do not repeat the same site for at least 1 week. If the area around the patch becomes red, itchy, or irritated, remove that patch. Apply a new patch at a different site until your next scheduled patch change. If the irritation continues or becomes worse, notify your doctor promptly. IF THE PATCH HAS BECOME LOOSE or has fallen off for less than 1 day, try to reapply it or apply a new patch immediately. No other contraceptive measures are necessary. If the patch has become loose or has fallen off for more than 1 day or if you are not sure how long it has been off, apply a new patch to begin a new cycle. In this case, you may not be adequately protected from pregnancy. You must use an additional form of birth control (eg, diaphragm, male condoms, spermicide) until the patch has been in place for 7 days in a row. DO NOT EAT grapefruit or drink grapefruit juice while you use this medicine. STORE THIS MEDICINE at 77 degrees F (25 degrees C) in the original sealed pouch. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom IF YOU FORGET TO CHANGE YOUR PATCH on the scheduled day, follow the directions in the additional patient leaflet that comes with this medicine. You may need to use a backup form of birth control (eg, condoms). If you forget to change your patch on the scheduled day and you are not sure what to do, use an extra form of birth control (eg, condoms) and check with your doctor or pharmacist.
DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine. LAB TESTS will be required to monitor therapy. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a Pap test, at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. KEEP ALL DOCTOR AND LAB APPOINTMENTS. THIS MEDICINE MAY CAUSE DIZZINESS. This effect may be worse if you take it with alcohol or certain medicines. Use this medicine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. LIMIT alcoholic beverages. THIS MEDICINE MAY CAUSE dark skin patches on your face (melasma). Avoid the sun, sunlamps, or tanning booths until you know how you react to this medicine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. THIS MEDICINE MAY INCREASE the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke (especially in women older than 35 years). SOME ANTIBIOTICS may decrease this medicine's effectiveness. If you take an antibiotic while you are using this medicine, talk with your doctor or pharmacist. You may need to use an additional form of birth control (eg, condoms) while you take the antibiotic. Discuss any questions or concerns with your doctor. FOLLOW YOUR DOCTOR'S INSTRUCTIONS for examining your breasts, and report any lumps immediately. IF YOU WILL BE HAVING SURGERY or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are using this medicine. THIS MEDICINE MAY INCREASE the risk of breast and endometrial cancer. THIS MEDICINE DOES NOT STOP THE SPREAD OF HIV and other sexually transmitted diseases (STDs). Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN: DO NOT USE THIS MEDICINE IF YOU ARE PREGNANT. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. THIS MEDICINE MAY BE FOUND IN BREAST MILK. IF YOU ARE OR WILL BE BREAST-FEEDING while you use this medicine, check with your doctor. Discuss any possible risks to your baby. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
SIDE EFFECTS that may occur while taking this medicine include breast tenderness or enlargement; headache; menstrual cramps; nausea; stomach pain, cramps, or bloating; vaginal spotting or breakthrough bleeding; or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience breast lumps; breast pain; calf pain, swelling, or tenderness; changes in vision or speech (eg, loss of vision); chest pain; coughing of blood; fainting; mental/mood changes (eg, depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe or persistent vaginal bleeding; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, discomfort, itching, or odor; weakness or numbness of an arm or leg; or yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; or vomiting.
NONPRESCRIPTION THERAPY TO HELP PREVENT bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details. THIS MEDICINE MAY interfere with certain lab tests. Be sure your doctor and lab personnel know you are using this medicine. IF YOU WEAR CONTACT LENSES and you develop problems with them, contact your doctor. DO NOT TRY TO REAPPLY A PATCH IF it is no longer sticky, if it has become stuck to itself or another surface, if it has other material stuck to it, or if it has previously come loose or fallen off. Do not use any tapes or wraps to keep the patch in place. If you cannot reapply a patch, apply a new patch immediately. After removing the used patch, fold over with the sticky side together. Discard the patch out of reach of children and pets. DO NOT FLUSH PATCHES down the toilet. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of reach of children and pets. IF USING THIS MEDICINE FOR AN EXTEDED PERIOD OF TIME, obtain refills before your supply runs out.
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