Learn more about usage, cautions, and possible side effects .
Chemical Name: NORETHINDRONE (nor-eth-IN-drone) ACETATE and ETHINYL ESTRADIOL (ETH-in-il ess-tra-DYE-ole) and IRON
This medicine is progesterone and estrogen combination contraceptive pill used to prevent pregnancy. It may also be used to treat other conditions as determined by your doctor.
WARNING: Smoking cigarettes while using this medicine increases your chance of having heart problems. Do not smoke while using this medicine. The risk of heart problems increases with age (in women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater). Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. If an accidental overdose does occur, seek immediate medical attention or call a poison control center. 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. DO NOT TAKE THIS MEDICINE if you are also taking nevirapine, rifampin, or St. John's wort. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking beta-blockers (such as carvedilol or metoprolol), clofibrate medicines (such as fenofibrate), corticosteroids (such as prednisolone), cyclosporine, lamotrigine, penicillamine, pioglitazone, theophylline, thyroid hormones (such as levothyroxine), tizanidine, troleandomycin, or medicine for seizures. AN ADDITIONAL METHOD OF BIRTH CONTROL MAY BE NEEDED if you are taking azole antifungals (such as ketoconazole), aprepitant, barbiturates (such as butalbital or phenobarbital), carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (such as ritonavir or tipranavir), hydantoins (such as phenytoin), modafinil, penicillin antibiotics (such as ampicillin or amoxicillin), rifampin, tetracycline antibiotics (such as doxycycline or tetracycline), topiramate, or troglitazone. Inform your doctor of any other medical conditions, including diabetes, chronic headaches, high cholesterol, a history of depression, a history of a heart attack, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have undiagnosed abnormal vaginal bleeding, blood vessel problems from diabetes, a history of cancer (such as breast, endometrial, or liver), estrogen-dependent growths, heart or liver problems, severe high blood pressure, history of jaundice while pregnant or while using birth control pills, pulmonary embolism, blood clots, stroke, cerebrovascular disease, or smoking. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
Follow the directions for using this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TALK WITH YOUR DOCTOR about how you should start to take your first pack of this medicine. IF YOU BEGIN TO TAKE THIS MEDICINE on the Sunday after your period starts, ask your doctor if you need an extra form of birth control for the first 7 days of your pack. IF YOU ARE SWITCHING FROM ANOTHER BIRTH CONTROL PILL to this medicine, start this medicine on the same day that you would have started a new pack of your previous birth control pills. Talk with your doctor if you have any questions about how to switch from another form of hormonal birth control to this medicine. THIS MEDICINE MAY BE TAKEN ON AN EMPTY STOMACH OR WITH FOOD. STORE THIS MEDICINE at 77 degrees F (25 degrees C), away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. IF YOU ARE USING A 28 DAY PACK, start the first pill from the new pack the very next day after taking the last pill from the previous pack. IF YOU ARE USING A 21 DAY PACK, wait 7 days after taking the last pill from the previous pack before you start the first pill from the new pack. TAKE THIS MEDICINE ON A REGULAR SCHEDULE at the same time of the day. Do not skip doses even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseous. If you have these side effects and they do not go away, check with your doctor. IF YOU MISS ONE DOSE OF THIS MEDICINE, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup form of birth control if you only miss 1 pill. If you miss more than 1 dose, read the extra patient leaflet that comes with this medicine or contact your doctor for instructions. YOU MUST USE A BACKUP FORM of birth control if you miss more than 1 dose. If you are not sure how to handle missed doses, use an extra form of birth control (eg, condoms) until you talk with your doctor. If you have any questions, contact your doctor, nurse, or pharmacist.
DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a PAP test (for vaginal cancer), at least once a year. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. This medicine may affect certain lab test results. Make sure laboratory personnel and your doctors know you use this medicine. If you will be having surgery or will be confined to a chair or bed for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks beforehand. Special precautions may need to be taken in these circumstances while you are taking this medicine. IF YOU MISS YOUR PERIOD during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant. BLEEDING OR SPOTTING may occur while taking this medicine. DO NOT STOP taking this medicine if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor. SMOKING CIGARETTES while using this medicine may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels. DO NOT SMOKE OR USE OTHER TOBACCO PRODUCTS while using this medicine. TAKING CERTAIN ANTIBIOTICS or anticonvulsants while you are using this medicine may decrease the effectiveness of this medicine. To prevent pregnancy, use an additional form of birth control until your next period. If you have any questions, contact your doctor, nurse, or pharmacist. YOU SHOULD USUALLY NOT TAKE THIS MEDICINE within 4 weeks after giving birth or otherwise ending a pregnancy. Discuss any questions or concerns with your doctor. IF YOU WEAR CONTACT LENSES and you develop problems with them, contact your doctor. THIS MEDICINE MAY CAUSE dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths. USE OF THIS MEDICINE WILL NOT PREVENT the spread of sexually transmitted diseases (STDs). DO NOT USE THIS MEDICINE if you are pregnant. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while you are taking this medicine. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
SIDE EFFECTS that may occur while you are taking this medicine include breast tenderness or enlargement; changes in appetite or weight; dizziness; headache; mild hair loss; nausea; nervousness; spotting or breakthrough bleeding; stomach cramps or bloating; or vomiting. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience change in the amount of urine produced; difficulty wearing contact lenses; persistent or recurrent vaginal bleeding; persistent or recurring headache or dizziness; swelling of fingers, hands, legs, or ankles; vaginal discomfort or irritation; or unusual vaginal discharge. CONTACT YOUR DOCTOR IMMEDIATELY if you experience a missed menstrual period; breast lump or discharge; calf/leg pain or swelling; chest pain; confusion; coughing up blood; dark urine; fainting; heavy vaginal bleeding; mental or mood changes (such as depression); migraines; numbness of an arm or leg; one-sided weakness; pale stools; severe stomach pain; severe dizziness; slurred speech; sudden severe headache or vomiting; sudden shortness of breath; unusual tiredness or weakness; vision changes (such as loss of vision); or yellowing of the skin or eyes (with or without fever). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. 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 of overdose may include persistent or severe nausea or vomiting or unexplained vaginal bleeding.
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 the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
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