ORTHO MICRONOR® Tablets

Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn starch, D&C Green No. 5 , D&C Yellow No. 10, lactose, magnesium stearate, and povidone.

1. Indications
   Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
2. Efficacy
   If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.

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.

ORTHO MICRONOR®Tablets have not been studied for and are not indicated for use in emergency contraception.

To achieve maximum contraceptive effectiveness, ORTHO MICRONOR® must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no in terruption between pill packs. See Detailed Patient Labeling for detailed instruction.

ORTHO MICRONOR® (0.35 mg norethindrone) Tablets are available in a DIALPAK® Tablet Dispenser

(NDC 0062-1411-16) containing 28 lime green, round, flat faced, beveled edge tablets, imprinted “ORTHO 0.35” on both sides.

STORAGE: Store at 25°C

Keep out of reach of children.

REFERENCE

McCann M, and Potter L. Progestin-Only Oral Contraceptives: A Comprehensive Review. Contraception, 50:60 (Suppl. 1), December 1994.

Truitt ST, Fraser A, Gallo ME, Lopez LM, Grimes DA and Schulz KF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation (Review). The Cochrane Collaboration. 2007, Issue 3.

Halderman, LD and Nelson AL. Impact of early postpartum administration of progestin-only hormonal contraceptives compared with nonhormonal contraceptives on short-term breast-feeding patterns. Am J Obstet Gynecol.; 186 (6):1250-1258.

Ostrea EM, Mantaring III JB, Silvestre MA. Drugs that affect the fetus and newborn infant via the placenta or breast milk. Pediatr Clin N Am; 51(2004): 539-579.

Cooke ID, Back DJ, Shroff NE: Norethisterone concentration in breast milk and infant and maternal plasma during ethynodiol diactetate administration. Contraception 1985; 31:611-21.

ORTHO-McNEIL, PHARMACEUTICAL, INC., Raritan, New Jersey 08869. REVISED June, 2008. FDA rev date: 6/20/2008

Adverse reactions reported with the use of POPs include:

• Menstrual irregularity is the most frequently reported side effect.
• Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely.
• Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies.
• Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.

The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics.

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.
• Thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG).

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

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

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. Healthcare 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.

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.

Irregular Genital Bleeding

Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.

Carcinoma of the Breast and Reproductive Organs

Some epidemiological studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increases the risk.

A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years.

This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.

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 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 is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.

Hepatic Neoplasia

Benign hepatic adenomas are associated with combined oral contraceptive 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 have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare in the U.S. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.

General

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

Physical Examination and Follow up

It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the healthcare professional.

Carbohydrate and Lipid Metabolism

Some 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, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.

Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL₃, LDL, or VLDL.

Carcinogenesis

See WARNINGS section.

Pregnancy

Many 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.

Nursing Mothers

In general, no adverse effects have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma.

Pediatric Use

Safety and efficacy of ORTHO MICRONOR® Tablets have 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 for users 16 years and older. Use of this product before menarche is not indicated.

Fertility Following Discontinuation

The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.

Headache

The onset or exacerbation of migraine or development of severe headache with focal neurological symptoms which is recurrent or persistent requires discontinuation of progestin-only contraceptives and evaluation of the cause.

Information for the Patient

1. See “Detailed Patient Labeling” for detailed information.
2. Counseling issues

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

1. The necessity of taking pills at the same time every day, including throughout all bleeding episodes.
2. The need to use a backup method such as condoms and spermicides for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late.
3. The potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities.
4. The need to inform the healthcare professional of prolonged episodes of bleeding, amenorrhea or severe abdominal pain.
5. 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.

There have been no reports of serious ill effects from overdosage, including ingestion by children.

Progestin-only oral contraceptives (POPs) 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

Mode of Action

ORTHO MICRONOR® progestin-only oral contraceptives 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.

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 serum progestin levels and a shorter elimination half-life than concomitant administration with estrogens.

ORTHO MICRONOR®
(norethindrone) 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.

DESCRIPTION

ORTHO MICRONOR® Tablets

Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn starch, D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, and povidone.

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 healthcare 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?

About 1 in 200 POP users will get pregnant in the first year if they all take POPs perfectly (that is, on time, every day). About 1 in 20 “typical” POP users (including women who are late taking pills or miss pills) gets pregnant in the first year of use. Table 2 will help you compare the efficacy of different methods.

Table 2: 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.

POPs can prevent pregnancy in different ways including:

• They make the cervical mucus at the entrance to the womb (the uterus) too thick for the sperm to get through to the egg.
• They prevent ovulation (release of the egg from the ovary) in about half of the cycles.
• They also affect other hormones, the fallopian tubes and the lining of the uterus.

YOU SHOULD NOT TAKE POPs

• If there is any chance you may be pregnant. If you have breast cancer.
• If you have bleeding between your periods that has not been diagnosed.
• If you are taking certain drugs for epilepsy (seizures) or for TB. (See “Using POPs with Other Medicines” below.)
• If you are hypersensitive, or allergic, to any component of this product.
• If you have liver tumors, either b enign or cancerous.
• If you have acute liver disease.

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 healthcare 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 in women who use combined oral contraceptives that contain both estrogen and a progestin have reported an increase in the risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. There is insufficient data to determine whether the use of POPs similarly increases this risk.

A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years. This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives and there is insufficient data to determine whether the use of POPs increases the risk of developing cancer of the cervix.

Liver Tumors

In rare cases, combined oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer among women who use combined oral contraceptives. However, liver cancers are rare. There is insufficient data to determine whether POPs increase the risk of liver tumors.

Diabetic Women

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

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 or herpes.

SIDE EFFECTS Irregular Bleeding:

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

Other Side Effects:

Less common side effects include headaches, tender breasts, nausea and dizziness. Weight gain, acne and extra hair on your face and body have been reported, but are rare.

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

USING POPs WITH OTHER MEDICINES

Before taking a POP, inform your healthcare professional of any other medication, including over-the-counter medicine, that you may be taking.

These medicines can make POPs less effective:

Medicines for seizures such as:

• Phenytoin (Dilantin®)
• Carbamazepine (Tegretol)
• Phenobarbital

Medicine for TB:

• Rifampin (Rifampicin)

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

HOW TO TAKE POPs

IMPORTANT POINTS TO REMEMBER

• POPs must be taken at the same time every day, so choose a time and then take the pill at that same time every day. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant.
• Start the next pack the day after the last pack is finished. There is no break between packs. Always have your next pack of pills ready.
• You may have some menstrual spotting between periods. Do not stop taking your pills if this happens.
• If you vomit soon after taking a pill, use a backup method (such as a condom and/or a spermicide) for 48 hours.
• If you want to stop taking POPs, you can do so at any time, but, if you remain sexually active and don't wish to egnant, be certain to use another birth control method.
• If you are not sure about how to take POPs, ask your healthcare professional.

STARTING POPs

• It's the first day of your menstrual period.best to take your first POP on
• If you decide to take your first POP on another day, use a backup method (such as a condom and/or a spermicide) every time you have sex during the next 48 hours.
• If you have had a miscarriage or an abortion, you can start POPs the ne xt day.

IF YOU ARE LATE OR MISS TAKING YOUR POPs

• If you are more than 3 hours late or you miss one or more POPs:
  1. TAKE a missed pill as soon as you remember that you missed it,
  2. THEN go back to taking POPs at your regular time,
  3. BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.
• If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your healthcare professional.

IF YOU ARE BREASTFEEDING

• If you are fully breastfeeding (not giving your baby any food or formula), you may start your pills 6 weeks after delivery.
• If you are partially breastfeeding (giving your baby some food or formula), you should start taking pills by 3 weeks after delivery.

IF YOU ARE SWITCHING PILLS

• If you are switching from the combined pills to POPs, take the first POP the day after you finish the last active combined pill. Do not take any of the 7 inactive pills from the combined pill pack. You should know that many women have irregular periods after switching to POPs, but this is normal and to be expected.
• If you are switching from POPs to the combined pills, take the first active combined pill on the first day of your period, even if your POPs pack is not finished.
• If you switch to another brand of PO Ps, start the new brand anytime.
• If you are breastfeeding, you can switch to another method of birth control at any time, except do not switch to the combined pills until you stop breastfeeding or at least until 6 months after delivery.

PREGNANCY WHILE ON THE PILL

If you think you are pregnant, contact your healthcare professional. Even though research has shown that POPs do not cause harm to the unborn baby, it is always best not to take any drugs or medicines that you don't need when you are pregnant.

You should get a pregnancy test:

• If your period is late and you took one or more pills late or missed taking them and had sex without a backup method.
• Anytime it has been more than 45 days since the beginning of your last period.

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

If you are breastfeeding, POPs should not affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported.

OVERDOSE

No serious problems have been reported when many pills were taken by accident, even by a small child, so there is usually no reason to treat an overdose.

OTHER QUESTIONS OR CONCERNS

If you have any questions or concerns, check with your healthcare professional. You can also ask for the more detailed “Professional Labeling” written for doctors and other healthcare professionals.

HOW TO STORE YOUR POPs

Store at 25°C

Keep out of reach of children.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

NORETHINDRONE (CONTRACEPTIVE) - ORAL

(nor-ETH-in-drone)

COMMON BRAND NAME(S): Micronor, Nor-Q-D

USES: This medication is used to prevent pregnancy. It is often referred to as the "mini-pill" because it does not contain any estrogen. Norethindrone (a form of progestin) is a hormone that prevents pregnancy by changing the womb and cervical mucus to make it more difficult for an egg to meet sperm (fertilization) or for the fertilized egg to attach to the wall of the womb (implantation). Regular use of the "mini-pill" prevents the release of an egg (ovulation) in about half of the women who use it.

While the "mini-pill" is more effective than certain other methods of birth control (e.g., condoms, cervical cap, diaphragm), it is less effective than estrogen/progestin birth control because it does not consistently prevent ovulation. It is usually used by women who cannot take estrogen. For the most effective benefit, it is very important to take this medication exactly as prescribed.

Using this medication does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Norethindrone may also be used to help decrease pain and blood loss from a certain menstrual condition (heavy/painful periods due to endometriosis) and to help make your periods more regular.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on when to take your pills and what to do if you miss a dose. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. For this medication to be effective, you must take it at the same time each day. Pick a time of day that is easy for you to remember, and take your pill at the same time each day. Missing a pill, taking it more than 3 hours late, or starting a new pack late will increase your risk of becoming pregnant. If you miss a pill or take this medication 3 or more hours later than usual, use a backup method of birth control (e.g., condom, spermicide) every time you have sex for the next 2 days.

Taking this medication after your evening meal or at bedtime may help if you have any stomach upset or nausea with the medication. You may choose to take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart. Ask your doctor or pharmacist if you have any questions.

Continue taking one tablet every day. After taking the last tablet in your old pack, start a new pack the next day. There is no break between packs, and you do not take any "reminder" tablets (tablets without medication). Your periods may be early or late, shorter or longer, heavier or lighter than normal. You may also have some spotting between periods. Do not stop taking your pills if this happens.

If you vomit within 4 hours after taking this medication or have diarrhea, use a back-up method of birth control (e.g., condoms, spermicide) every time you have sex for the next 2 days.

If you continue to have regular menstrual periods while on this medication, you may be ovulating. This medication might still prevent pregnancy even if you are ovulating. Consult your doctor for more information, and ask about your risk of pregnancy and the possible use of other forms of birth control.

If this is the first time you are using this medication and you are not switching from another form of hormonal birth control (e.g., patch, other birth control pills), take the first pill in the pack on the first day of your period. Use an additional form of birth control for the first 2 days if you are instructed to start this medication on any other day.

Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (e.g., patch, other birth control pills) to this product. If any of this information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

SIDE EFFECTS: Nausea, vomiting, stomach cramping/bloating, dizziness, headache, tiredness, breast tenderness, decrease in breast size, acne, oily scalp, hair loss, weight gain, and vaginal infections may occur. If any of these effects persist or worsen, notify your doctor promptly. Your periods may be early or late, shorter or longer, heavier or lighter than normal. You may also have some spotting between periods, especially during the first several months of use. If bleeding is prolonged (more than 8 days) or unusually heavy, contact your doctor. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these infrequent but serious side effects occur: depression, unwanted facial/body hair, swelling of the ankles/feet.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal/pelvic pain, lumps in the breast, unusual tiredness, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to norethindrone; or to other progestins (e.g., norgestrel); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: abnormal breast exam, breast cancer, liver problems (e.g., liver tumor, active liver disease), current or suspected pregnancy, unexplained vaginal bleeding.

Before you take this medication, tell your doctor your entire medical history, including family medical history, especially of: stroke or other blood clots (e.g., in the legs, eyes, lungs), high blood pressure, low levels of "good" cholesterol (HDL), diabetes, heart disease (e.g., heart attack, chest pain), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, migraine headaches, obesity, long period of sitting or lying down (e.g., immobility such as being bedridden).

Smoking cigarettes/using tobacco while using hormonal birth control (pill/patch/ring) increases your risk of heart problems and stroke. Do not smoke. The risk of heart problems increases with age (especially in women over 35) and with frequent smoking (15 or more cigarettes a day).

Before having surgery, including dental surgery, tell your doctor or dentist that you are using this medication.

Norethindrone should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately.

This drug passes into breast milk and may have undesirable effect on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: nevirapine, sodium tetradecyl sulfate.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.

Before taking this medication, tell your doctor of all prescription and nonprescription medications you may use, especially of: acitretin, drugs that speed up the movement of the gut (e.g., metoclopramide), isotretinoin, troleandomycin.

Certain drugs can decrease the effectiveness of birth control by decreasing the amount of birth control hormones in your system. This can result in pregnancy. These drugs include: aprepitant, bexarotene, bosentan, dapsone, felbamate, griseofulvin, certain HIV protease inhibitors (e.g., amprenavir, indinavir, nelfinavir, ritonavir, zidovudine), modafinil, phenylbutazone, rifamycins (e.g., rifampin), many seizure medications (e.g., barbiturates, carbamazepine, phenytoin, topiramate), St. John's wort. Consult your doctor or pharmacist for details, and ask if you should use additional reliable birth control methods while taking any of the drugs listed above.

This medication can affect the results of certain lab tests (e.g., sex-hormone-binding globulin, thyroid). Make sure laboratory personnel and all your doctors know you use this medication.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe nausea, vomiting. Females may experience sudden/unusual vaginal bleeding.

NOTES: Do not share this medication with others.

Keep all laboratory and medical appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (pap smear). Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.

MISSED DOSE: Read the package information for advice on missed/late doses. You may need to use back-up birth control (e.g., condoms or spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.

If you often forget to take the pill as directed, contact your doctor to discuss switching to another form of birth control.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from moisture and light. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medication away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.