Uses

This medication is used to treat women with abnormal bleeding from the uterus. It is also used to treat women who have stopped having menstrual periods for several months (amenorrhea) but who are not pregnant or going through menopause. In addition, this medication is used to treat a condition (endometriosis) in which tissue that normally lines the inside of the uterus is found outside the uterus in the abdomen/pelvic area, causing painful/irregular periods. Norethindrone is a type of hormone (progestin). It is like the hormone progesterone that your body makes naturally. This medication works by stopping the normal growth of the uterus lining during the menstrual cycle and signaling hormone changes in the uterus to restore normal menstrual periods.

This medication must not be used to test for pregnancy.

Progestins are not effective in preventing miscarriages.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using this drug and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as prescribed by your doctor. You may take it with food or after a meal to prevent stomach upset. Follow the dosing schedule carefully. Ask your doctor if you have any questions. The dosage is based on your medical condition and response to treatment.

For the treatment of stopped menstrual periods and abnormal bleeding from the uterus, take this drug as directed by your doctor, usually once daily for 5 to 10 days during the second half of the planned menstrual cycle. Withdrawal bleeding usually occurs within 3 to 7 days after you stop taking the medication.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Nausea, vomiting, headache, dizziness, mood swings, trouble sleeping, weight gain/loss, acne, breast swelling/tenderness, change in sexual interest, unwanted hair growth, or hair loss may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including:

• changes in vaginal bleeding (such as spotting, breakthrough bleeding, changes in menstrual flow, no menstrual bleeding)
• change in vaginal discharge
• depression
• swelling of the hands/feet
• frequent/burning/painful urination
• yellowing eyes/skin
• dark patches on the skin or face (melasma)

This medication, especially if used along with an estrogen product, may rarely cause very serious (possibly fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs, blindness). Get medical help right away if you have:

• chest/jaw/left arm pain
• weakness on one side of the body
• trouble speaking
• sudden vision changes (such as blurred/double vision, loss of vision, bulging eyes)
• confusion
• sudden severe headache
• severe dizziness
• fainting
• trouble breathing
• coughing up blood
• pain/redness/swelling/weakness of the arms/legs
• calf pain/swelling that is warm to the touch

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking norethindrone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• vaginal bleeding of unknown cause
• bleeding in the brain
• a loss of pregnancy with some tissue remaining in the uterus ("missed abortion")
• family medical history (especially breast lumps/cancer or blood clots)
• obesity
• heart disease (such as heart attacks, coronary artery disease, heart failure)
• high blood pressure
• cancer (especially endometrial or breast cancer)
• blood clots
• lupus
• seizures
• migraine headaches
• asthma
• liver disease
• kidney problems
• high blood levels of cholesterol/fats
• depression
• diabetes
• strokes
• smoking

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of norethindrone from your body, which may affect how norethindrone works. Examples include azole antifungals (such as itraconazole), rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe nausea and vomiting.

Notes

Do not share this medication with others.

Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam, pelvic exam, Pap smear) should be done while you are taking this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.