Norethindrone Acetate Oral tablet

What is this medicine?

NORETHINDRONE ACETATE (nor eth IN drone AS e tate) is a female hormone. This medicine is used to treat endometriosis, uterine bleeding caused by abnormal hormone levels, and secondary amenorrhea. Secondary amenorrhea is when a woman stops getting menstrual periods due to low levels of certain female hormones.

How should I use this medicine?

Take this medicine by mouth with a glass of water. You may take this medicine with or without food. Follow the directions on the prescription label. Take this medicine at the same time each day. Do not take your medicine more often than directed.

A patient information sheet will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• breast tenderness or discharge

• pain in the abdomen, chest, groin or leg

• severe headache

• skin rash, itching, or hives

• sudden shortness of breath

• unusually weak or tired

• vision or speech problems

• yellowing of skin or eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in sexual desire

• change in menstrual flow

• facial hair growth

• fluid retention and swelling

• headache

• irritability

• nausea

• weight gain or loss

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• amprenavir or fosamprenavir

• bosentan

This medicine may also interact with the following medications:

• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines

• aprepitant

• barbiturate medicines, such as phenobarbital

• carbamazepine

• felbamate

• modafinil

• oxcarbazepine

• phenytoin

• ritonavir or other medicines for HIV infection or AIDS

• St. John's wort

• topiramate

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood vessel disease or blood clots

• breast, cervical, or vaginal cancer

• diabetes

• heart disease

• kidney disease

• liver disease

• mental depression

• migraine

• seizures

• stroke

• vaginal bleeding

• an unusual or allergic reaction to norethindrone, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine.

If you have any reason to think you are pregnant, stop taking this medicine right away and contact your doctor or health care professional.

If you are taking this medicine for hormone related problems, it may take several cycles of use to see improvement in your condition.