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|Norethindrone Tablets

Norethindrone

Norethindrone is used for:

Preventing pregnancy. It may also be used for other conditions as determined by your doctor.

Norethindrone is a progestin hormone. It works by suppressing ovulation, thickening cervical mucus to prevent sperm penetration, and altering the lining of the uterus.

Do NOT use Norethindrone if:

• you are allergic to any ingredient in Norethindrone
• you have vaginal bleeding of unknown cause, or if you have a history of blood clots, bleeding in the brain (eg, stroke), liver problems, liver tumors, known or suspected breast cancer, or genital cancer
• you are pregnant or may be pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Norethindrone:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have diabetes, seizures (eg, epilepsy), migraines, asthma, heart problems, kidney problems, or a history of depression
• if you have a history of ectopic pregnancy (pregnancy outside the uterus)

Some MEDICINES MAY INTERACT with Norethindrone. Tell your health care provider if you are taking any of the following medicines:

• Acitretin, aprepitant, azole antifungals (eg, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), phenylbutazone, rifampin, St. John"s wort, tetracyclines (eg, doxycycline), or troglitazone because they may decrease Norethindrone"s effectiveness. Talk with your doctor about using alternate contraception (birth control) if you are taking any of these medicines.
• Beta-adrenergic blockers (eg, metoprolol), corticosteroids (eg, prednisone), theophylline, or troleandomycin because the risk of their side effects may be increased by Norethindrone
• Lamotrigine because its effectiveness may be decreased by Norethindrone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Norethindrone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Norethindrone:

Use Norethindrone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Norethindrone. Talk to your pharmacist if you have questions about this information.
• Take Norethindrone by mouth with or without food.
• Begin taking Norethindrone on the first day of your menstrual period. If you begin taking Norethindrone on a different day, use a backup method of birth control (eg, condoms, spermicides) for the next 48 hours.
• Take Norethindrone at the same time every day, with doses not more than 24 hours apart.
• Start the next pack the day after the last pack is finished. There is no break between packs. Be sure to call in your refills ahead of time so that your next pack will be ready.
• If you take Norethindrone more than 3 hours late, or if you vomit soon after taking Norethindrone, use a backup method of birth control (eg, condoms, spermicides) for the next 48 hours.
• If you miss a dose of Norethindrone, take it as soon as possible and then return to your regular dosing schedule. If you are unsure what to do about a missed dose, contact your doctor or other health care provider.

Ask your health care provider any questions you may have about how to use Norethindrone.

Important safety information:

• Norethindrone may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Norethindrone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Norethindrone may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
• Norethindrone does not stop the spread of HIV or sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.
• If you are taking a medicine that may decrease the effectiveness of Norethindrone, talk with your doctor about using an alternate form of birth control.
• If you are switching from one form of hormonal birth control to another form, talk to your doctor about how to start taking the new form of birth control.
• Norethindrone may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to this medicine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Diabetes patients - Norethindrone may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Check with your doctor about having an annual physical exam while you are using Norethindrone.
• Norethindrone should not be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Norethindrone if you are pregnant. If you think you may be pregnant, contact your doctor right away. Norethindrone is found in breast milk. If you are or will be breast-feeding while you use Norethindrone, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Norethindrone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast tenderness; changes in menstrual flow, including breakthrough bleeding or spotting; dizziness; headache; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); absent or late menstrual period; chest pain; dark urine; depression; increased facial hair; lower abdominal pain; lumps in the breast or under the armpits; migraine headache; partial or complete loss of vision or changes in vision; shortness of breath; slurred speech; stomach pain; sudden loss of coordination; sudden or severe headache; swelling of fingers or ankles; tenderness, pain, or swelling of the calf; weakness, numbness, or pain in the arms or legs; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Norethindrone at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Norethindrone out of the reach of children and away from pets.

General information:

• If you have any questions about Norethindrone, please talk with your doctor, pharmacist, or other health care provider.
• Norethindrone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Norethindrone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.