When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to ethinyl estradiol or ethynodiol diacetate. You should not use this medicine if you are pregnant or if you have liver disease, heart disease such as myocardial infarction, a blood vessel disorder or if you have unusual vaginal bleeding that has not been checked by a doctor. Do not use if you have breast cancer, liver cancer, ovarian cancer, or cancer of the uterus. You should not use this medicine if you have ever had a stroke, heart attack, problems with blood clots, or jaundice caused by pregnancy or birth control pills.

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.
• Start taking this medicine on the first Sunday after your menstrual period. If your period starts on a Sunday, start taking this medicine on that day. Then continue taking one pill each day in the order they appear in the package.
• 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 schedule every day.

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 rifampin (Rifadin®, Rifamate®), troglitazone, phenylbutazone (Butazolidine®), medicine for seizures such as phenytoin (Depakote®, Dilantin®). Tell your doctor if you use antibiotics such as ampicillin, griseofulvin, or tetracycline (such as doxycycline, minocycline, Minocin®, or Vibramycin®).
• There are many other drugs that can interact with this medicine. Make sure your doctor knows about all other medicines you are using.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are breast feeding or if you have recently been pregnant. Tell your doctor if you have breast lumps or a family history of breast cancer.
• Make sure your doctor knows if you have blood clotting problems, heart disease, high blood pressure, or high cholesterol or triglycerides in your blood.
• Make sure your doctor knows if you have diabetes, depression, kidney disease, liver disease, a history of migraine headaches, seizures, or tuberculosis (TB).
• Make sure your doctor knows about all the other medical problems you have before taking this pills.
• This medicine can cause serious side effects such as heart attack or stroke. You are much more likely to have these side effects if you smoke cigarettes, are overweight, are over 35 years of age, or have certain health problems.
• 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 seven days in a row, call your doctor.
• Make sure your doctor knows if you have vomiting or diarrhea while using this pills, you may need to use another kind of birth control for a few days.
• 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.
• 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.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Call your doctor for a pregnancy test if your menstrual period does not start while taking this pills.

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 lump, breast tenderness or any swelling or discharge.
• Chest pain, shortness of breath, or coughing up of blood.
• Dark-colored urine or pale stools.
• Heavy vaginal bleeding.
• Missed or late menstrual periods.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Severe pain in lower leg (calf).
• Spotting for more than 7 consecutive days while taking the active pills.
• Sudden 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 or mild skin rash.
• Depression.
• Itching or white discharge from your vagina.
• Loss of hair.
• Mild nausea, vomiting, loss of appetite, or pain in your stomach.
• Pain or discharge from your breasts.
• Rapid weight gain or loss.
• Trouble sleeping.
• Problems with wearing contact lenses.

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