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.
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.
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS HEART PROBLEMS ASSOCIATED WITH USE OF THIS MEDICINE. This risk increases with age and with heavy smoking (15 or more cigarettes per day). Women who are more than 35 years old may have a greater risk. Women who use this medicine should not smoke. 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, azole antifungals (such as ketoconazole), barbiturates (such as phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, phenylbutazone, St. John's wort, HIV protease inhibitors (such as ritonavir), hydantoins (such as phenytoin), modafinil, nevirapine, penicillins (such as ampicillin), pioglitazone, rifampin, tetracyclines (such as doxycycline), topiramate, or troglitazone. These medicines may decrease the effectiveness of the birth control pills. Ask your doctor or pharmacist for more information about additional forms of birth control. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking ACE inhibitors (such as captopril), angiotensin II receptor blockers (such as losartan), aldosterone blockers (such as eplerenone), anticoagulants (such as warfarin or heparin), atorvastatin, beta-blockers (such as metoprolol), corticosteroids (such as prednisone), cyclosporine, lamotrigine, potassium supplements, potassium-sparing diuretics (such as spironolactone), theophylline, tizanidine, troleandomycin, or nonsteroidal anti-inflammatory medicines (such as ibuprofen or naproxen). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including blood or bleeding problems, breast or uterus problems, cancer, chorea (jerky movements of the face, arms, or legs), depression, diabetes, fluid retention problems, gallbladder or pancreas problems, high blood calcium or potassium levels, irregular menstrual periods, seizures, severe headaches, high blood cholesterol or lipid levels, high blood pressure, jaundice, kidney problems, lupus, recent surgery, varicose veins, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have kidney or adrenal problems; certain blood problems (such as porphyria); endometrial, cervical, or vaginal cancer; estrogen-dependent growths; certain heart problems (such as heart valve problems or certain types of irregular heartbeat); chest pain caused by angina; certain types of severe headaches; diabetes that affects circulation; liver disease; liver tumors; uncontrolled high blood pressure; or abnormal or undiagnosed vaginal bleeding. 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 hormonal contraceptive use. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are more than 35 years old and you smoke 15 or more cigarettes per day; or if you have had surgery and will be confined to a bed or chair for an extended period of time. USE OF THIS MEDICINE IN CHILDREN who have not yet had their first menstrual period is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. 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, nausea, vomiting, or weight changes. 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. 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 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); 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; sudden 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, 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.
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.