Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Each OVRETTE tablet contains 0.075 mg of norgestrel ( dl  -13-beta-ethyl-17-alpha-ethinyl- 17-beta-hydroxygon-4-en-3- one). The inactive ingredients present are cellulose, FD&C Yellow 5, lactose, magnesium stearate, and polacrilin potassium.

Each OVRETTE tablet contains 0.075 mg of a single active steroid ingredient, norgestrel, a totally synthetic progestogen. The available data suggest that the d  (-)enantiomeric form of norgestrel is the biologically active portion. This form amounts to 0.0375 mg per OVRETTE tablet.

The primary mechanism through which OVRETTE prevents conception is not known, but progestogen-only contraceptives are known to alter the cervical mucus, exert a progestational effect on the endometrium, interfering with implantation, and, in some patients, suppress ovulation.

See LO/OVRAL®.

CONTRAINDICATIONS

See LO/OVRAL.

See LO/OVRAL.

PRECAUTIONS

See LO/OVRAL.

INFORMATION FOR THE PATIENT

See LO/OVRAL.

DRUG INTERACTIONS

See LO/OVRAL.

CARCINOGENESIS

See LO/OVRAL.

PREGNANCY

See LO/OVRAL.

NURSING MOTHERS

See LO/OVRAL.

ADVERSE REACTIONS

See LO/OVRAL.

OVERDOSAGE

See LO/OVRAL.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, OVRETTE must be taken exactly as directed and at intervals not exceeding 24 hours.

OVRETTE is administered on a continuous daily dosage regimen starting on the first day of menstruation, i.e., one tablet each day, every day of the year.

Tablets should be taken at the same time each day and continued daily, without interruption, whether bleeding occurs or not. The patient should be advised that, if prolonged bleeding occurs, she should consult her physician. In the nonlactating mother, OVRETTE may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see " Contraindications ," " ," and " Precautions " concerning thromboembolic disease). It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.

The risk of pregnancy increases with each tablet missed. If the patient misses one tablet, she should be instructed to take it as soon as she remembers and to also take her next tablet at the regular time. If she misses two tablets, she should take one of the missed tablets as soon as she remembers, as well as taking her regular tablet for that day at the proper time. Furthermore, she should use a method of nonhormonal contraception in addition to taking OVRETTE until fourteen tablets have been taken. If more than 2 tablets have been missed, OVRETTE should be discontinued immediately and a method of nonhormonal contraception should be used until menses has appeared or pregnancy has been excluded. If menses does not appear within 45 days from the last period, a method of nonhormonal contraception should be substituted until the start of the next menstrual period or an appropriate diagnostic procedure is performed to rule out pregnancy.

HOW SUPPLIED

OVRETTE® Tablets (0.075 mg norgestrel) are available in packages of 6 PILPAK® dispensers with 28 tablets each as follows: NDC 0008-0062-01, yellow, round tablet marked "WYETH" and "62".

Store at room temperature, approx. 25°C (77°F).

References available upon request.

Brief Summary Patient Package Insert: See LO/OVRAL

DETAILED PATIENT LABELING: See LO/OVRAL.

HOW TO TAKE THE PILL

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphillis.

1. General Instructions
   You must take your pill every day according to the instructions. Oral contraceptives are most effective if taken no more than 24 hours apart. Take your pill at the same time every day so that you are less likely to forget to take it. You will then maintain an effective dose of the oral contraceptive in your body.
   If your doctor has scheduled you for surgery, or you need prolonged bed rest, he or she may suggest that you stop taking the pill four weeks before surgery to avoid an increased risk of blood clots. It is also advisable not to start oral contraceptives sooner than four weeks after delivery of a baby or a midtrimester pregnancy termination.
   Ovrette is administered on a continuous daily dosage schedule, one tablet each day, every day of the year. Take the first tablet on the first day of your menstrual period. Tablets should be taken at the same time every day, without interruption, whether bleeding occurs or not. If bleeding is prolonged (more than 8 days) or unusually heavy, you should contact your doctor.
   SPOTTING OR BREAKTHROUGH BLEEDING
   Spotting is slight staining between menstrual periods which may not even require a pad. Breakthrough bleeding is a flow much like a regular period, requiring sanitary protection. Spotting is more common than breakthrough bleeding, and both occur more often in the first few cycles than in later cycles. These types of bleeding are usually temporary and without significance. It is important to continue taking your pills on schedule. If the bleeding persists for more than a few days, consult your doctor.
2. If you forget to take your pill
   The risk of pregnancy increases with each tablet missed. Therefore, it is very important that you take one tablet daily as directed. If you miss one tablet, take it as soon as you remember and also take your next tablet at the regular time. If you miss two tablets, take one of the missed tablets as soon as you remember, as well as your regular tablet for that day at the proper time. Furthermore, you should use another method of birth control in addition to taking Ovrette until you have taken fourteen days (2 weeks) of medication.
   If more than two tablets have been missed, Ovrette should be discontinued immediately and another method of birth control used until the start of your next menstrual period. Then you may resume taking Ovrette.
   At times there may be no menstrual period after a cycle of pills. Therefore, if you miss one menstrual period but have taken the pills exactly as you were supposed to, continue as usual into the next cycle. If you have not taken the pills correctly and miss a menstrual period, or if it is 45 days or more from the start of your last menstrual period, you may be pregnant and should stop taking oral contraceptives until your doctor determines whether or not you are pregnant. Until you can get to your doctor, use another form of non-hormonal contraception. If two consecutive menstrual periods are missed, you should stop taking pills until it is determined by a physician whether you are pregnant.
3. Pregnancy due to pill failure
   The incidence of pill failure resulting in pregnancy is approximately less than 1.0% if taken every day as directed, but more typical failure rates are less than 3.0%. If failure does occur, the risk to the fetus is minimal.
4. Risks to the fetus
   If you do become pregnant while using oral contraceptives, the risk to the fetus is small, on the order of no more than one per thousand. You should, however, discuss the risks to the developing child with your doctor.
5. Pregnancy after stopping the pill
   There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy.
   There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill.
6. Overdosage
   Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your health-care provider or pharmacist.
7. Other information
   Your health-care provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health-care provider believes that it is appropriate to postpone it. You should be reexamined at least once a year. Be sure to inform your health-care provider if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your health-care provider, because this is a time to determine if there are early signs of side effects of oral-contraceptive use.
   Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control pills.

HEALTH BENEFITS FROM ORAL CONTRACEPTIVES

In addition to preventing pregnancy, use of oral contraceptives may provide certain benefits.

They are:

• Menstrual cycles may become more regular.
• Blood flow during menstruation may be lighter, and less iron may be lost. Therefore, anemia due to iron deficiency is less likely to occur.
• Pain or other symptoms during menstruation may be encountered less frequently.
• Ovarian cysts may occur less frequently.
• Ectopic (tubal) pregnancy may occur less frequently.
• Noncancerous cysts or lumps in the breast may occur less frequently.
• Acute pelvic inflammatory disease may occur less frequently.
• Oral-contraceptive use may provide some protection against developing two forms of cancer: cancer of the ovaries and cancer of the lining of the uterus.

If you want more information about birth-control pills, ask you doctor or pharmacist. They have a more technical leaflet called the Professional Labeling which you may wish to read.

Manufactured by:

Wyeth Laboratories

A Wyeth-Ayerst Company

Philadelphia, PA 19101

CI 4271-2  Revised August 14, 1996