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Chemical Name: NORETHINDRONE (nor-eth-IN-drone) and ETHINYL ESTRADIOL (ETH-in-il ess-tra-DYE-ole)
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. Women greater than 35 years of age and women who smoke 15 or more cigarettes per day are at a greater risk for heart problems. 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 azole antifungal medicines such as ketoconazole or itraconazole, acitretin, aprepitant, bosetan, barbiturates, griseofulvin, carbamazepine, topiramate, tetracycline antibiotics, hydantoins such as phenytoin, St. John's wort, or rifampin without talking with your doctor. An increased risk of pregnancy has been identified when taking these medicines with birth-control pills. Check with your doctor or pharmacist for more information. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking benzodiazepines, corticosteroids, felbamate, HIV protease inhibitors, nevirapine, modafinil, beta-blockers such as metoprolol or carvedilol, lamotrigine, pioglitazone, penicillin antibiotics, theophylline, troglitazone, troleandomycin, or medicine for seizures. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including cancer, diabetes, headaches or migraines, high triglyceride level in the blood, high blood pressure, recent surgery, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of problems with the blood vessels in the brain or heart, heart valve problems, heart attack, uncontrolled high blood pressure, abnormal or undiagnosed vaginal bleeding, certain cancers including breast cancer, serious liver problems, blood clots, certain blood disorders such as porphyria, stroke, 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 during the first 24 hours of your period, you do not need to use an extra form of birth control. If you begin to take this medicine on the Sunday after your period starts, you will need to use an extra form of birth control for 7 days after you start taking this medicine. 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. TAKE THIS MEDICINE AT THE SAME TIME EVERY DAY, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day. FOR THIS MEDICINE TO BE EFFECTIVE it must be taken every 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. 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 taking this medicine include nausea, vomiting, bleeding between menstrual periods, breast tenderness, or weight change. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience persistent or recurrent abnormal vaginal bleeding, a missed menstrual period, dizziness or fainting, swelling of fingers or ankles, headache, difficulty wearing contact lenses, mood or mental changes (such as depression), or vaginal itching or discharge. CONTACT YOUR DOCTOR IMMEDIATELY if you experience calf/leg pain or swelling, trouble breathing or shortness of breath, chest pain, one-sided weakness, slurred speech, lumps in the breast, sudden severe headache, sharp or crushing chest pain, sudden shortness of breath, yellowing skin or eyes, changes in vision, numbness of an arm or leg, or severe stomach pain. 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, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.
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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