Norgestrel

Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

Description

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.

Clinical Pharmacology

1. Mode of Action
   Progestin-only oral contraceptives such as OVRETTE prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.
2. Pharmacokinetics
   Serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state progestin levels and a shorter elimination half-life than concomitant administration with estrogens.

Indications and Usage

1. Indications
   Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
2. Efficacy
   Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods except sterilization, the IUD, and the NORPLANT System, depends upon the reliability with which they are used correctly. Consistent use of these methods can result in lower failure rates.

Table 1: Percentage Of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year United States   % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method (1) Typical Use 1 (2) Perfect Use 2 (3) (4) Chance 4 85 85   Spermicides 5 26 6 40 Periodic abstinence 25   63   Calendar   9     Ovulation Method   3     Sympto-Thermal 6   2     Post-Ovulation   1   Cap 7         Parous Women 40 26 42   Nulliparous Women 20 9 56 Sponge         Parous Women 40 20 42   Nulliparous Women 20 9 56 Diaphragm 7 20 6 56 Withdrawal 19 4   Condom 8         Female (Reality) 21 5 56   Male 14 3 61 Pill 5   71   Progestin only   0.5     Combined   0.1   IUD         Progesterone T 2.0 1.5 81   Copper T380A 0.8 0.6 78   LNg 20 0.1 0.1 81 Depo-Provera 0.3 0.3 70 Levonorgestrel Implants (Norplant) 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 9 Source: Trussell J, Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

Contraindications

Progestin-only oral contraceptives should not be used by women who currently have the following conditions:

• Known or suspected pregnancy
• Known or suspected carcinoma of the breast
• Undiagnosed abnormal genital bleeding
• Hypersensitivity to any component of this product
• Benign or malignant liver tumors
• Acute liver disease

Warnings

Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.

OVRETTE does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combination oral contraceptives (COCs). The health-care professional is referred to the prescribing information of COCs for a discussion of those risks. The relationship between progestin-only oral contraceptives and these risks is not fully defined. The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.

1. Ectopic Pregnancy
   The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Health-care professionals should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives.
2. Delayed Follicular Atresia/Ovarian Cysts
   If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention.
3. Irregular Genital Bleeding
   Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy, pregnancy, or other conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated. If one menstrual period is missed and the progestin-only oral contraceptive has not been taken according to directions, or if two consecutive periods are missed, tablet-taking should be discontinued and a nonhormonal back-up method of contraception should be used until the possibility of pregnancy is excluded.
4. Carcinoma of the Breast and Reproductive Organs
   Some epidemiological studies of oral contraceptive users have reported a slightly increased risk of having breast cancer diagnosed in women who were currently using combination oral contraceptives (COCs). The increased risk gradually disappeared within 10 years after stopping use of combination oral contraceptives. Breast cancers diagnosed in ever-users tend to be less clinically advanced than the cancers diagnosed in never-users. These studies have predominantly involved COCs and there are insufficient data to determine whether the use of progestin-only oral contraceptives similarly increases the risk. However, women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined.
   Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia or invasive cervical cancer in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
   There are insufficient data to determine whether the use of progestin-only oral contraceptives increases the risk of developing cervical intraepithelial neoplasia.
5. Hepatic Neoplasia/Liver Disease
   Benign hepatic adenomas are associated with COC use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.
   Studies from Britain and the US have shown an increased risk of developing hepatocellular carcinoma in COC-users. However, these cancers are rare. There are insufficient data to determine whether progestin-only oral contraceptives increase the risk of developing hepatic neoplasia.
   Women with a history of oral contraceptive related cholestasis or women with cholestasis during pregnancy are more likely to have this condition with oral contraceptive use. If these women receive a progestin-only oral contraceptive they should be carefully monitored and, if the condition recurs, progestin-only oral contraceptive use should be discontinued.
6. Thromboembolic Disorders and Other Vascular Problems
   An increased risk of venous and arterial thrombotic and thromboembolic events have been found to be associated with the use of COCs. These events include superficial venous thrombosis, deep-vein thrombosis, pulmonary embolism, retinal vascular thrombosis, myocardial infarction, and cerebrovascular events (thrombotic and hemorrhagic strokes). There are insufficient data to determine whether the use of progestin-only contraceptives increases the risk of developing thrombotic disease and/or other vascular problems. However, there have been reports of some of these conditions coincident with the use of progestin-only oral contraceptives; therefore, the possibility of thrombosis should be considered.
   Care should be used when prescribing progestin-only oral contraceptives to women predisposed to thromboembolic disorders (eg, a history of thromboembolic events, thrombophilia, cardiovascular disease; women who are obese or experience prolonged immobilization).

Precautions

1. General

Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

2. Physical Examination and Follow Up

A complete personal and family medical history and physical examination is appropriate for all women, including women using oral contraceptives. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. Such examinations should be repeated periodically during the use of progestin-only oral contraceptives.

3. Carbohydrate and Lipid Effects

Some progestin-only oral contraceptive users may experience slight deterioration in glucose tolerance with increases in plasma insulin, but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, diabetic women should be carefully observed while taking progestin-only oral contraceptives.

Lipid metabolism is occasionally affected in that HDL, HDL ₂ , and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL ₃ , LDL, or VLDL.

4. Drug Interactions

The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants, phenytoin, carbamazepine; barbiturates; the antituberculosis drug rifampin; protease inhibitors; and herbal preparations containing St. John's Wort (hypericum perforatum). This could result in unintended pregnancy or breakthrough bleeding. There are anecdotal reports of reduced efficacy of combination oral contraceptives when used concomitantly with broad-spectrum antibiotics. No significant interaction has been found with progestin-only oral contraceptives and broad-spectrum antibiotics.

During concomitant use of OVRETTE and substances that may affect its efficacy, it is recommended that a nonhormonal back-up method of contraception be used in addition to the regular intake of OVRETTE. Use of a nonhormonal back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes. It may take several weeks until enzyme induction has subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance. For women receiving long-term therapy with hepatic enzyme inducers, another method of contraception should be considered.

Substances that reduce gastrointestinal transit time may affect contraceptive efficacy.

The product information of concomitant medications/substances should be consulted to identify potential interactions.

5. Interactions with Laboratory Tests

The following endocrine tests may be affected by progestin-only oral contraceptive use:

• Sex hormone-binding globulin (SHBG) concentrations may be decreased.
• Total thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG). However, free thyroxine level should remain unchanged.

6. Carcinogenesis

See WARNINGS section.

7. Pregnancy

Many epidemiological studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use. Epidemiological studies also do not suggest a teratogenic effect of oral contraceptives when taken inadvertently during early pregnancy. (See CONTRAINDICATIONS .)

8. Nursing Mothers

Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma. No adverse effects have been found on breastfeeding performance. Very rarely, adverse effects in the infant/child have been reported, including jaundice.

9. Fertility Following Discontinuation

The limited available data do not indicate a significant delay in the return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.

10. Migraine/Headache

The onset or exacerbation of migraine, or development of headache with a new pattern that is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause.

Women with migraine (particularly migraine with aura) who take progestin-only oral contraceptives may be at increased risk of stroke.

11. Gastrointestinal

Diarrhea and/or vomiting may reduce hormone absorption.

12. Pediatric Use

Safety and efficacy of OVRETTE has been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and users 16 and older. Use of this product before menarche is not indicated.

13. FD&C Yellow No. 5

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. (See CONTRAINDICATIONS .)

14. Geriatric Use

This product has not been studied in women over 65 years of age and is not indicated in this population.

INFORMATION FOR THE PATIENT

1. See PATIENT LABELING for detailed information.
2. Counseling issues

The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives:

• The necessity of taking pills at the same time every day, including throughout all bleeding episodes.
• The need to use a nonhormonal back-up method of contraception (such as condoms and/or spermicides) for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late.
• The potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities.
• The need to inform the clinician of prolonged episodes of bleeding, amenorrhea or severe abdominal pain.
• The importance of using a barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting STDs/HIV.

Adverse Reactions

An increased risk of the following adverse reactions has been reported with the use of progestin-only oral contraceptives (see WARNINGS section for additional information):

Ectopic pregnancy

Delayed follicular atresia/ovarian cysts

Menstrual irregularity, changes in menstrual flow; breakthrough bleeding/spotting; amenorrhea, prolonged bleeding

The following adverse reactions also have been reported with the use of progestin-only oral contraceptives:

Abdominal pain, cramps, distention

Acne

Alopecia

Anaphylactic/anaphylactoid reactions, including urticaria, throat tightness, and facial edema

Appetite increase or decrease

AST, ALT, bilirubin increase

Blood pressure increase

Breast pain, enlargement, secretion, and tenderness

Chloasma/melasma that may persist

Cholestasis

Dizziness

Edema

Fatigue

Galactorrhea

Glucose intolerance

HDL decrease

Hirsutism

Leg cramps/pain

Libido decrease

Migraine/headache

Mood disturbances, including depression

Myocardial infarction

Nausea

Nervousness

Rash

Stroke

Vaginal discharge

Vomiting

Weight change (increase or decrease)

See WARNINGS section for discussion of:

Carcinoma of the breast and reproductive organs

Hepatic neoplasia

Arterial and venous thromboembolic events

Overdosage

Symptoms of oral contraceptive overdosage may include nausea, vomiting, breast tenderness, dizziness, somnolence (drowsiness/fatigue), and withdrawal bleeding in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

Dosage and Administration

To achieve maximum contraceptive effectiveness, OVRETTE must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See PATIENT LABELING for detailed instructions.

If one menstrual period is missed and the progestin-only oral contraceptive has not been taken according to directions, or if two consecutive periods are missed, tablet-taking should be discontinued and a nonhormonal back-up method of contraception should be used until the possibility of pregnancy is excluded.

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" on one side and "62" on reverse side.

STORAGE

Store at controlled room temperature 20° to 25°C (68° to 77°F).

References available upon request.

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.

DETAILED PATIENT LABELING

OVRETTE (norgestrel) TABLETS

This product (like all oral contraceptives) is used to prevent pregnancy. It does not protect against HIV infection (AIDS) or other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

DESCRIPTION

Each OVRETTE tablet contains 0.075 mg of norgestrel. The inactive ingredients present are cellulose, FD&C Yellow 5, lactose, magnesium stearate, and polacrilin potassium.

INTRODUCTION

This leaflet is about birth control pills that contain one hormone, a progestin. Please read this leaflet before you begin to take your pills. It is meant to be used along with talking with your health-care professional.

Progestin-only pills are often called "POPs" or "the minipill." POPs have less progestin than the combined birth control pill (or "the pill") which contains both an estrogen and a progestin.

HOW EFFECTIVE ARE POPs?

POPs or "birth-control pills" or "the pill" are used to prevent pregnancy and are more effective than other nonsurgical methods of birth control. When they are taken correctly, without missing any pills the chance of becoming pregnant is approximately 1.0% per year. Average failure rates are approximately 5% per year when women who miss pills are included. The chance of becoming pregnant increases with each missed pill during the menstrual cycle.

In comparison, average failure rates for other methods of birth control during the first year of use are as follows:

HOW DO POPs WORK?

POPs can prevent pregnancy in different ways including:

YOU SHOULD NOT TAKE POPs

RISKS OF TAKING POPs

Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.

Warning:   If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your health-care professional immediately.

Ectopic Pregnancy

An ectopic pregnancy is a pregnancy outside the womb. Because POPs protect against pregnancy, the chance of having a pregnancy outside the womb is very low. If you do get pregnant while taking POPs, you have a slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods.

Ovarian Cysts

These cysts are small sacs of fluid in the ovary. They are more common among POP-users than among users of most other birth control methods. They usually disappear without treatment and rarely cause problems.

Cancer of the Reproductive Organs and Breasts

Some studies reported a slightly increased risk of the diagnosis of breast cancer in women who were currently using oral contraceptives, which contained both estrogen and progestin. The risk gradually disappeared within 10 years after stopping use of the combination oral contraceptive. There is not enough information to determine whether the use of POPs increases this risk in a similar way.

Some studies have found an increase in the incidence of cancer or precancerous lesions of the cervix in women who use combination oral contraceptives (COCs). However, this finding may be related to factors other than the use of oral contraceptives and there is not enough information to determine whether the use of POPs increases the risk of developing cancer of the cervix.

Liver Tumors or Diseases

In rare cases, use of COCs has been associated with non-cancerous but dangerous liver tumors. These non-cancerous liver tumors can rupture and cause fatal internal bleeding. In addition, a possible association has been found with COCs and liver cancer in studies in which a few women who developed these very rare cancers were found to have used COCs for long periods of time. There is not enough information to determine if POPs increase the risk of liver tumors. Talk with your health-care professional if you have or have had liver problems.

Headache/Migraine

If you develop or have worsening of migraine or develop headache with a new pattern that is recurrent, persistent, or severe, you should discontinue taking oral contraceptives and see your health-care professional for an evaluation of the cause.

Women with migraine (particularly migraine with aura) who take POPs may be at increased risk of stroke.

Abnormal Blood Clotting

Changes in the blood clotting system have been reported in users of COCs. These changes allow the blood to clot more easily, possibly allowing clots to form in the bloodstream. If blood clots do form in the bloodstream, they can cause serious problems by cutting off the blood supply to vital organs. These problems may include a stroke (if the clot is in a blood vessel of the brain), a heart attack (if the clot is in a blood vessel of the heart), a pulmonary embolus (if the clot forms in the legs or pelvis, then breaks off and travels to the lungs), retinal thrombosis (if the clot is in a blood vessel of the eye) or other problems. Any of these conditions may cause death or serious long term disability.

There is not enough information to determine whether the use of POPs is associated with the development of blood clots, blockage of blood vessels, heart attack, and stroke. However, there have been reports of some of these conditions with the use of POPs. Therefore, the possibility of blood clots should be considered.

Diabetic Women

Diabetic women taking POPs do not generally require changes in the amount of insulin they are taking. However, your health-care professional may monitor you more closely under these conditions.

FD&C Yellow No. 5 (tartrazine)

Ovrette contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin sensitivity.

SEXUALLY TRANSMITTED DISEASES (STDs)

Warning:  POPs DO NOT PROTECT AGAINST GETTING OR GIVING SOMEONE HIV (AIDS) OR ANY OTHER STD SUCH AS CHLAMYDIA, GONORRHEA, GENITAL WARTS, HERPES, HEPATITIS B, AND SYPHILIS.

SIDE EFFECTS

An increased risk of the following side effects (see RISKS OF TAKING POPs for additional information) has been associated with the use of POPs:

Irregular bleeding - The most common side effect of POPs is a change in menstrual bleeding. Your periods may be either early or late, shorter or longer, heavier or lighter and/or you may have some spotting between periods. Taking pills late or missing pills can also result in some spotting or bleeding.

Ectopic pregnancy (pregnancy outside of the uterus)

Ovarian cysts

Other Side Effects:

Abdominal pain, cramps, bloating

Acne

Allergic/hypersensitivity reactions, including hives, rash, throat tightness, and facial swelling

Appetite increase or decrease

Blood pressure increase

Blood sugar increase

Breast pain, enlargement, secretion, and tenderness

Changes in liver function tests (AST, ALT, bilirubin increase)

Darkening areas of skin, especially on the face that may persist

Dizziness

Excessive hair growth on the face and body

Fatigue

Fluid retention

Hair loss

HDL decrease

Headache/migraine

Heart attack

Jaundice

Leg cramps/pain

Milky breast discharge

Mood disturbances, including depression

Nausea

Nervousness

Rash

Sex drive decrease

Stroke

Vaginal discharge

Vomiting

Weight changes (increase or decrease)

See also RISKS OF TAKING POPs for information on:

Abnormal blood clotting

Cancer of the reproductive organs and breast

Liver tumors

If you are concerned about any of these side effects, check with your health-care professional.

USING POPs WITH OTHER MEDICINES

Before taking a POP, inform your health-care professional if you are taking medicines for seizures (epilepsy), tuberculosis (TB), HIV/AIDS, or any other medication, including over-the-counter medicine and herbal products.

These medicines can make POPs less effective:

Medicines for seizures such as:

Medicine for TB:

Herbal Preparations such as:

HIV/AIDS drugs such as:

Before you begin taking any new medicines, be sure your health-care professional knows you are taking a progestin-only birth control pill.

HOW TO TAKE POPs

CHANGING FROM ANOTHER TYPE OF PROGESTIN-ONLY METHOD (IMPLANT, INJECTION)

Tablet-taking should start on the day of an implant removal or, if using an injection, the day the next injection would be due. In addition, a nonhormonal back-up method of birth control should be used for the first 48 hours.

PREGNANCY WHILE ON THE PILL

If you become pregnant or think you might be pregnant contact your health-care professional. You should stop taking POPs if pregnancy is confirmed. Even though POPs have not been shown to cause harm to the unborn baby, it is always best to avoid taking any drugs or medicines that you do not need when you are pregnant.

You should get a pregnancy test:

WILL POPs AFFECT YOUR ABILITY TO GET PREGNANT LATER?

If you want to become pregnant, simply stop taking POPs. POPs will not delay your ability to get pregnant.

BREASTFEEDING

POPs have not been shown to affect breastfeeding performance. As with other medications taken while breastfeeding, small amounts of Ovrette can pass into the breast milk. Very rarely, adverse effects in the infant/child have been reported, including jaundice.

OVERDOSE

Overdosage may cause nausea, vomiting, breast tenderness, dizziness, somnolence (fatigue/drowsiness), and withdrawal bleeding in females. In case of overdosage, contact your health-care professional or pharmacist.

OTHER QUESTIONS OR CONCERNS

If you have any questions or concerns, check with your health-care professional. You can also ask for the more detailed "Professional Labeling" written for health-care professionals.

HOW TO STORE OVRETTE

Store at controlled room temperature, 20° to 25°C (68° to 77°F).

Wyeth

  Wyeth Pharmaceuticals Inc.

  Philadelphia, PA 19101

W10454C003

             ET02

     Rev 10/03