Ortho Tri Cyclen Tablets

GENERIC NAME: NORGESTIMATE (nor-JES-ti-mate) and ETHINYL ESTRADIOL (ETH-in-il ess-tra-DYE-ole)

COMMON USES: 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.

HOW TO USE 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.

CAUTIONS: 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. IF YOU HAVE VOMITING OR DIARRHEA for any reason, your medicine may not work as well. 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. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. IF YOU WEAR CONTACT LENSES and you develop problems with them, contact your doctor. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. 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. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

POSSIBLE SIDE EFFECTS: 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. 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.

BEFORE USING THIS MEDICINE: 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 are at risk for developing severe blood clots or have certain heart problems (such as certain heart valve problems or certain types of irregular heartbeat); chest pain caused by angina; certain types of headaches or migraines with aura; severe or uncontrolled high blood pressure; diabetes that affects circulation; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; undiagnosed abnormal vaginal bleeding; active liver disease; or liver cancer or tumors. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of blood clotting problems, severe blood clots (such as in the lungs, legs, or eyes), certain blood vessel problems (such as bleeding in the brain, heart attack, or stroke), breast cancer, or yellowing of the eyes or skin caused by pregnancy or prior birth control use. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have had surgery and are or will be confined to a bed or a chair for an extended period of time, or if you are older than 35 years old and you smoke 15 or more cigarettes per day. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

OVERDOSE: 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.

ADDITIONAL INFORMATION: 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.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.