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Drug Information For:
TRIVORA TABLETS 28'S
Ingredient Name:LEVONORGESTREL (LEE-voe-nor-jess-trel) and ETHINYL ESTRADIOL (ETH-in-il ess-tra-DYE-ole)
Drug Manufacturer:WATSON LABS
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.
Before Using This Medicine:WARNING Cigarette smoking increases the risk of serious heart problems associated with use of this medicine. This risk increases with age and with heavy smoking. Women who are older than 35 years old have a greater risk. Women who are older than 35 years old and smoke should not use this medicine. 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 atorvastatin, azole antifungals (eg, ketoconazole), nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, etravirine, nevirapine), protease inhibitors (eg, boceprevir, ritonavir), rosuvastatin, acitretin, aprepitant, armodafinil, barbiturates (eg, phenobarbital), bosentan, carbamazepine, clobazam, colesevelam, felbamate, griseofulvin, hydantoins (eg, phenytoin), mifepristone, modafinil, oxcarbazepine, rifamycins (eg, rifampin), rufinamide, St. John's wort, topiramate, troglitazone, cyclosporine, prednisolone, theophylline, tizanidine, voriconazole, clofibric acid, lamotrigine, morphine, temazepam, thyroid hormones (eg, levothyroxine), or valproic acid. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, abnormal vaginal bleeding, a lump in the breast, fibrocystic breast disease, porphyria, diabetes or high blood sugar; gallbladder problems, heart problems (eg, angina), high blood pressure, high cholesterol or triglycerides, high blood calcium levels, kidney or liver problems, mental or mood problems (eg, depression), migraines or headaches, pancreas problems, seizures, allergies, pregnancy, or breast-feeding. Tell your doctor if you smoke, are very overweight, have fluid retention or swelling problems, or you will be confined to a bed or chair for an extended period of time (eg, because of surgery or a long airplane ride). TELL YOUR DOCTOR IF you have a family history of high blood triglyceride levels or if a family member has had breast cancer. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are pregnant or think you may be pregnant, or have severe blood clots (eg, in the legs, lungs, eyes); a risk of developing severe blood clots; chest pain caused by angina; certain types of headaches or migraines with aura; have abnormal vaginal bleeding of an unknown cause; uncontrolled high blood pressure; certain heart valve problems; diabetes that affects circulation; liver disease, liver tumor or cancer; or known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have ahistory of breast cancer, heart or brain blood vessel problems, heart attack, stroke, yellowing of the eyes or skin caused by pregnancy or prior birth control use, or blood clots or blood clotting problems. 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. THIS MEDICINE SHOULD NOT be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed. Contact your doctor or pharmacist if you have any questions about taking this medicine.
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. TAKE THIS MEDICINE BY MOUTH with food or without food. TALK WITH YOUR DOCTOR about how you should start to take your first pack of this medicine. TAKE THIS MEDICINE AT THE SAME time each day. TAKE THE TABLETS in the order directed on the blister pack. THIS MEDICINE MAY NOT be effective for up to 7 days after you begin taking the first cycle of pills. USE A BACK-UP METHOD of birth control for the first 7 days after you start this medicine. SEVERE VOMITING OR DIARRHEA may decrease this medicine's effectiveness. Use a back-up method of birth control until you check with your doctor. EATING GRAPEFRUIT OR DRINKING GRAPEFRUIT JUICE while you are taking this medicine may increase the amount of this medicine in your blood, which may increase your risk for side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet. IF YOU ALSO TAKE COLESEVELAM, take it 4 hours before or after you take this medicine. STORE THIS MEDICINE at room temperature. Store this medicine in the container it came in, tightly closed, away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. FOR THIS MEDICINE TO BE EFFECTIVE, it must be taken exactly as directed. DO NOT SKIP DOSES EVEN if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. 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. 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 active dose of this medicine. 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.
Cautions:DO NOT TAKE THIS MEDICINE if you are allergic to any ingredient in this product. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS. 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. THIS MEDICINE MAY INCREASE the risk of a stroke, a heart attack, blood clots, high blood pressure, or similar problems. The risk is greater if you smoke. Do not smoke or use other tobacco products while taking this medicine. IF YOU MISS MORE THAN 2 periods in a row or if you miss 1 period when you have not taken your pills correctly, contact your doctor. Also, if you have morning sickness or unusual breast tenderness, contact your doctor. You may be pregnant if any of these occur. TELL YOUR DOCTOR OR DENTIST that you take this medicine before you receive any medical or dental care, emergency care, or surgery. If possible, this medicine should be stopped at least 4 weeks before through 2 weeks after surgery or any time you might be confined to a bed or chair for a long period of time (eg, long plane flight, bedrest, lengthy illness). YOU SHOULD USUALLY NOT TAKE this medicine within 4 weeks after giving birth or after a second-trimester abortion. Talk with your doctor about how to start taking this medicine in these instances. YOU MAY EXPERIENCE A DELAY in being able to become pregnant after stopping this medicine. This effect may be greater in patients who had irregular periods before starting this medicine. Discuss any concerns with your doctor or pharmacist. THIS MEDICINE DOES NOT STOP the spread of HIV and other sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD. DO NOT SHARE needles, injection supplies, or items like toothbrushes or razors. CERTAIN ANTIBIOTICS, ANTICONVULSANTS, and other medicines may decrease the effectiveness of this medicine. Ask your pharmacist if you have questions about which medicines may decrease this medicine's effectiveness. To prevent pregnancy while taking these medicines, use an extra form of birth control (eg, condoms). You may also need to use an extra form of birth control for a period of time after you stop taking these medicines. Check with your doctor for more information. DO NOT USE THIS MEDICINE if you are pregnant. IF YOU THINK 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 thedose of your diabetes medicine.
Possible Side Effects:SIDE EFFECTS that may occur while taking this medicine include breast tenderness, headache; nausea; stomach cramps and bloating; vomiting; or weight gain. If they continue or are bothersome, check with your doctor. BLEEDING OR SPOTTING MAY OCCUR while you are taking this medicine, especially during the first 3 months. Do not stop taking this medicine if this occurs. If bleeding or spotting is persistent or if it occurs after menstrual cycles that were previously regular, 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. IF YOU WEAR CONTACT LENSES and you develop problems with them or other vision changes, contact your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience breast pain, lumps, or discharge; bulging eyes; calf or leg pain, swelling, redness, or tenderness; change in amount of urine produced; chest pain or pressure; coughing up blood; fainting; fever; mental or mood changes (eg, depression); persistent, severe, or headache or dizziness; severe stomach pain or tenderness; shortness of breath; sudden, severe nausea or vomiting; swelling of the fingers, hands, legs, or ankles; symptoms of liver problems (eg, yellowing of the skin or eyes, fever, dark urine, pale stools, loss of appetite, unusual tiredness); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); unusual or severe vaginal bleeding; unusual sweating; vaginal irritation or discharge; or vision changes (eg, vision loss, double vision). 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; swelling of the mouth, face, lips, tongue. 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.
Overdose:If overdose is suspected contact your local poison control center or emergency room immediately.
Additional Information:DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2014 Wolters Kluwer Health, Inc.