This medicine is a progesterone and estrogen combination birth control pill that also contains a folate. It is used to prevent pregnancy. It may also be used to treat premenstrual dysphoric disorder (PMDD) or certain forms of acne in women who are using this medicine for birth control. It is also used to increase folate levels in order to decrease the risk of certain birth defects in women who become pregnant while taking this medicine or shortly after stopping this medicine. It may also be used to treat other conditions as determined by your doctor.
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 this medicine on the Sunday after your period starts, you will need to use 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 (eg, patch, vaginal ring) to this medicine. THIS MEDICINE MAY BE TAKEN ON AN EMPTY STOMACH OR WITH FOOD. It is preferable to take it after the evening meal or at bedtime with liquid. 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. KEEP THIS MEDICINE out of the reach of children and away from pets. 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. SEVERE VOMITING OR DIARRHEA may decrease this medicine's effectiveness. Talk with your doctor about what to do if severe vomiting or diarrhea occurs while you take this medicine. If you vomit within 3 to 4 hours after you take this medicine, this should be considered a missed dose. IF YOU MISS 1 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 (eg, condoms) 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) and talk with your doctor. If you have any questions, contact your doctor, nurse, or pharmacist.
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 more 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. AN ADDITIONAL FORM OF BIRTH CONTROL may be needed if you are taking aprepitant, armodafinil, azole antifungals (eg, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, phenylbutazone, St. John's wort, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, ampicillin), pioglitazone, rifamycins (eg, rifampin), rufinamide, tetracyclines (eg, doxycycline), topiramate, or troglitazone. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking ACE inhibitors (eg, captopril), angiotensin II receptor blockers (eg, losartan), aldosterone blockers (eg, eplerenone), acetaminophen, ascorbic acid (vitamin c), anticoagulants (eg, warfarin, heparin), atorvastatin, beta-blockers (eg, metoprolol), cholestyramine, clofibric acid (clofibrate), corticosteroids (eg, prednisone), cyclosporine, lamotrigine, methotrexate, morphine, nonsteroidal anti-inflammatory medicines (eg, ibuprofen), potassium supplements, potassium-sparing diuretics (eg, spironolactone), pyrimethamine, salicylic acid, sulfasalazine, temazepam, theophylline, tizanidine, tranexamic acid, troleandomycin, thyroid hormones (eg, levothyroxine), a folate (folic acid) supplement, 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 a history of endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, abnormal vaginal bleeding, a lump in the breast, fibrocystic breast disease, diabetes or high blood sugar, gallbladder problems, migraines or severe or persistent headaches, heart problems, high blood pressure, high blood cholesterol or lipid levels, kidney or liver problems, blood or bleeding problems (eg, porphyria), mental or mood problems (eg, depression), lupus, high blood calcium or potassium levels, chorea (jerky, involuntary movements of the face, arms, or legs), varicose veins, yellowing of the eyes or skin, pancreas problems, seizures, a condition called hereditary angioedema, allergies, pregnancy, or breast-feeding. TELL YOUR DOCTOR if you smoke, are very overweight, have fluid retention or swelling problems, have certain types of anemia (eg, pernicious anemia), or if a member of your family has a history of high triglyceride levels or breast cancer. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have been through menopause; if you have kidney or adrenal problems; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; certain heart problems (eg, heart valve problems, certain types of irregular heartbeat); chest pain caused by angina; certain types of migraines or severe headaches; diabetes that affects circulation, nerves, eyes, or kidneys; liver disease; liver tumors; uncontrolled high blood pressure; or undiagnosed abnormal vaginal bleeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of blood clotting problems, severe blood clots (eg, in the lungs, legs, or eyes), certain blood vessel problems (eg, in the brain or heart, bleeding in the brain, heart attack, stroke), breast cancer, or yellowing of the eyes or skin caused by pregnancy or prior birth control use. USE OF THIS MEDICINE IN CHILDREN who have not yet had their first menstrual period is not recommended. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include bleeding or spotting between menstrual periods, breast tenderness, stomach cramps or bloating, headache, nausea, or vomiting. If they continue or are bothersome, check with 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, contact your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience migraine headache; persistent vaginal spotting; swelling of the fingers, hands, legs, or ankles; severe or persistent trouble sleeping; unusual tiredness or weakness; or vaginal odor, irritation, or discharge. CONTACT YOUR DOCTOR IMMEDIATELY if you experience a missed menstrual period; breast pain, lump, or discharge; calf or leg pain, swelling, or tenderness; change in amount of urine produced; chest pain or heaviness; confusion; coughing up blood; fainting; irregular heartbeat; left-sided jaw, neck, shoulder, or arm pain; mental or mood changes (such as depression); muscle cramps or weakness; numbness of an arm or leg; one-sided weakness; persistent, severe, or recurring headache or dizziness; severe stomach pain or tenderness; slurred speech; sudden severe vomiting; shortness of breath; symptoms of liver problems (such as yellowing of the skin or eyes, fever, dark urine, pale stools, loss of appetite); unusual or severe vaginal bleeding; or vision changes (such as sudden 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, or tongue; unusual hoarseness. 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.
If overdose is suspected contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe nausea or vomiting, or unexplained vaginal bleeding.
USE OF THIS MEDICINE WILL NOT PREVENT the spread of HIV or other sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. YOU MAY EXPERIENCE A DELAY in being able to become pregnant after stopping this medicine, especially if you had irregular periods before starting this medicine. Discuss any concerns with your doctor or pharmacist. 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. Your chance of becoming pregnant may be increased if you do not take this medicine every day as directed. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.