When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to ethinyl estradiol or norgestimate, or if you are pregnant or have unusual vaginal bleeding that has not been checked by your doctor. Do not use it if you have liver disease, breast cancer, or problems with blood clots. Do not use it if you have high blood pressure, certain heart problems, or diabetes with kidney, eye, nerve, or blood vessel damage.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Each brand of birth control pills has specific directions. Read and follow the patient instructions for your prescribed brand. Talk to your doctor or pharmacist if you have any questions.
• Ask your doctor if you should use a second form of birth control for the first 7 days of your first cycle of pills.
• Take your pill at the same time every day. Birth control pills work best when there is no more than 24 hours between doses. Keep the pills in the original container. Take the pills in the order they appear in the container.
• Follow the instructions in the patient leaflet or call your doctor if you vomit or have diarrhea within 3 to 4 hours of taking this medicine.
• Missed dose: Read and carefully follow the patient instructions if you miss a dose. You may need to use a second form of birth control for several days. Ask your doctor or pharmacist if you have any questions.
• Store the medicine in the original package at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how birth control pills work. Tell your doctor if you are also using the following:
  
  • Acetaminophen, aprepitant, ascorbic acid, aspirin, atorvastatin, boceprevir, bosentan, clofibrate, colesevelam, cyclosporine, morphine, prednisolone, rifabutin, rifampicin, rosuvastatin, St John's wort, telaprevir, temazepam, theophylline, tizanidine
  • Seizure medicine, including carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenytoin, topiramate
  • Thyroid replacement medicine
  • Medicine to treat an infection, including fluconazole, itraconazole, ketoconazole, voriconazole
  • Protease inhibitor to treat HIV/AIDS

Warnings While Using This Medicine:

• Tell your doctor right away if you think you have become pregnant. If you miss 2 monthly periods in a row, call your doctor for a pregnancy test before you take any more pills.
• Tell your doctor if you are breastfeeding, or if you had a baby within 4 weeks before you start using this medicine. Tell your doctor if you have cervical cancer, diabetes, epilepsy, gallbladder problems, migraine headaches, heart or blood vessel disease, high cholesterol, or a family history of breast cancer or depression. Tell your doctor if you smoke or have a history of chloasma (skin discoloration of the face), especially during pregnancy.
• This medicine may cause the following problems:
  
  • Blood clots, which may lead to stroke or heart attack (risk is increased by cigarette smoking)
  • Possible increased risk of breast or cervical cancer
  • Liver cancer or tumors
  • Gallbladder disease
  • High blood pressure
• You might have spotting or irregular bleeding when you first start to use this medicine. You might have unplanned bleeding if you miss a dose or are late taking it. Call your doctor if you think there is a problem, such as if you have heavy bleeding.
• You may need to stop using this medicine for a few weeks before and after you have surgery because of the risk of blood clots.
• This medicine will not protect you from HIV/AIDS or other sexually transmitted diseases.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, or coughing up blood
• Nausea, unusual sweating, fainting
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Pain in your lower leg (calf)
• Unusual or unexpected vaginal bleeding or heavy bleeding
• Yellow skin or eyes
• Vision loss, double vision

If you notice these less serious side effects, talk with your doctor:

• Depression, mood changes
• Headaches
• Light spotting or bleeding between periods

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088