When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to ethinyl estradiol or norgestrel, or if you are pregnant. Do not use this medicine if you have liver disease or liver cancer, breast cancer, cancer of the uterus, a blood vessel disorder, heart disease, high blood pressure that is not controlled, or a history of blood clots, heart attacks, or strokes. Do not use this medicine if you have unusual vaginal bleeding, or certain types of headaches. Do not use this medicine if you have ever had jaundice (yellow eyes or skin) caused by pregnancy or birth control pills, or if you are having a surgery that requires bedrest for a long time.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Carefully follow your doctor's instructions about when to start taking your medicine. You may begin taking the pills on the first day of your menstrual period, or on the Sunday after your period begins.
• You may need to use a second form of birth control when you first start using this medicine. Talk with your doctor about this. Some other forms of birth control include condoms, diaphragms, or contraceptive foams and jellies.
• Take your pill at the same time every day. Birth control pills work best when there is no more than 24 hours between doses. It is very important that you take this medicine on time every day.
• Keep your pills in the container you receive from the pharmacy. Take the pills in the order they appear in the container.

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

• Make sure your doctor knows if you are using acetaminophen (Tylenol®), ascorbic acid (Vitamin C), cyclosporine (Gengraf®, Neoral®, Sandimmune®), modafinil (Provigil®), morphine (Astramorph PF®, Duramorph®), phenylbutazone (Butazolidin®), salicylic acid, St. John's wort, or theophylline (Theo-Dur®).
• Tell your doctor if you are also using certain antibiotics (such as ampicillin, griseofulvin, rifabutin, rifampin, penicillin, tetracycline, troleandomycin, Grifulvin V®, Mycobutin®, Omnipen®, Rifadin®, Rimactane®, Sumycin®, Tao®), medicine for seizures (such as carbamazepine, felbamate, oxcarbazepine, phenobarbital, phenytoin, primidone, temazepam, topiramate, Dilantin®, Felbatol®, Mysoline®, Restoril®, Solfoton®, Tegretol®, Topamax®, Trileptal®), or steroid medicine (such as dexamethasone, prednisolone, Decadron®, Delta-Cortef®).
• Make sure you doctor knows if you are also using medicine to treat HIV or AIDS (such as indinavir, ritonavir, Crixivan®, Norvir®), medicine to treat a fungus infection (such as fluconazole, itraconazole, ketoconazole, Diflucan®, Nizoral®, Sporanox®), or medicine to lower cholesterol (such as atorvastatin, clofibric acid, Lipitor®).

Warnings While Using This Medicine:

• Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have high blood pressure, high cholesterol or triglycerides (fat) in your blood, diabetes, breast lumps, a family history of breast cancer, migraine headaches, a history of depression, gallbladder disease, heart disease, kidney disease, or irregular monthly periods.
• If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over 35 years old, if you have diabetes, high blood pressure, high cholesterol in the blood, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
• This medicine may also increase your risk of certain types of cancer. Talk to your doctor if you have concerns about this risk.
• This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor.
• You might have some light bleeding or spotting when you first start using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding lasts more than a few days in a row, call your doctor.
• If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
• If you wear contact lenses and you have vision problems or eye discomfort, check with your eye doctor.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

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
• Breast changes or lumps.
• Chest pain, shortness of breath, or coughing up blood.
• Dark-colored urine or pale stools.
• Decrease in how much or how often you urinate.
• Heavy vaginal bleeding.
• Irregular, late, or missed menstrual periods.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Rapid weight gain.
• Sudden and severe stomach pain, nausea, vomiting, and lightheadedness.
• Sudden or severe headache, problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Yellowing of your skin or the whites of your eyes.

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

• Acne, mild skin rash, or darkened skin on your face.
• Breast tenderness, pain, swelling, or discharge.
• Changes in appetite.
• Contact lens discomfort, or changes in vision.
• Hair loss or increased hair growth in areas other than the head.
• Mild headache or dizziness.
• Mild nausea, vomiting, diarrhea, stomach cramps, or bloated feeling.
• Mood changes, depression, nervousness, or trouble sleeping.
• Problems having sex.
• Vaginal spotting or light bleeding, itching, or discharge.
• Weight changes.

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