When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to norethindrone or mestranol, or if you are pregnant. You should not use this medicine if you have heart disease, angina (chest pain), a blood vessel disorder, problems with your heart valves, or uncontrolled high blood pressure. You should not use this medicine if you have diabetes, liver disease, unusual vaginal bleeding, or headaches. You should not use this medicine if you have breast cancer, liver cancer, or cancer of the uterus. You should not use this medicine if you have ever had a stroke, problems with blood clots, or jaundice caused by pregnancy or birth control pills. You should not use this medicine during pregnancy.

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.
• This medicine comes in a Dialpak® tablet dispenser set up for Sunday start. The instructions in package are revised from time to time as important new medical information becomes available. Therefore you should read the label that comes along with medicine carefully every time you get a new supply of this medicine.
• The pill pack has 21 yellow "active" pills to take for 3 weeks followed by 1 week of green "reminder" pills.
• Start taking this medicine on the first Sunday after your menstrual period starts. 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 one pill at the same time every day until the pack is empty. You will need to use a another method of birth control such as condoms or spermicide for the first seven days.
• Start the next pack on the day after your last green "reminder" pill. Do not wait any days between packs. 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 everyday.

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 medicine for seizures such as carbamazepine (Tegretol®), felbamate, oxcarbazepine, phenylbutazone (Butazolidine®), phenytoin (Dilantin®), or topiramate (Topamax®). Tell your doctor if you are using medicine to treat infection such as ampicillin, griseofulvin, itraconazole, ketoconazole, or tetracyclines (doxycycline, minocycline, Minocin®, or Vibramycin®).
• Make sure your doctor knows if you are using medicine to lower cholesterol or triglycerides such as atorvastatin, or medicines to treat HIV or AIDS (such as Agenerase®, Crixivan®, Invirase®, Norvir®, or Viracept®).
• There are many medicines that 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 pregnant or breast feeding. Make sure your doctor knows if you have breast lumps or a family history of breast cancer.
• Make sure your doctor knows if you have heart disease, high blood pressure, blood clotting problems, or high cholesterol or triglycerides in your blood.
• Make sure your doctor knows if you have liver disease, kidney disease, diabetes, a history of migraine headaches, seizures, or depression.
• 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 40 years of age, or have certain health problems. Talk to your doctor about these risks.
• You might have some light bleeding or spotting when you first start using this medicine. This is normal and should not last long. 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 these pills, you might need to use another kind of birth control for a few days. Ask your doctor, nurse, or other health caregiver.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• 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 such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, or syphilis. If this is a concern for you, talk with your doctor.
• You may need to stop using this medicine for a few weeks before and after having surgery, or if you will be on bed-rest or otherwise inactive.
• Make sure to tell your doctor about all other medical problems you have, before taking this medicine.
• Call your doctor for a pregnancy test if your menstrual period does not start while taking this medicine.

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.
• Chest pain or coughing up blood.
• Dark-colored urine or pale stools.
• Heavy vaginal bleeding.
• Lightheadedness or fainting.
• Missed or late menstrual periods.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Severe nausea, vomiting, loss of appetite, or pain in your upper stomach.
• 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:

• Darkening of your skin.
• Itching or white discharge from your vagina.
• Loss of hair.
• Mild nausea or vomiting.
• Pain in your breasts.
• Rapid weight gain.
• Trouble sleeping.
• Trouble 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