WHAT IS Norethindrone/Norethindrone acetate TABLETS?

NORETHINDRONE is an oral contraceptive. The product contains a female hormone known as a progestin. It is used to prevent pregnancy. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

WHERE SHOULD I KEEP Norethindrone/Norethindrone acetate?

Keep out of the reach of children.

HOW SHOULD I USE Norethindrone/Norethindrone acetate?

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

Contact your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine has been used in female children who have started having menstrual periods.

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

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

Note: This medicine is only for you. Do not share this medicine with others.

WHAT IF I MISS A DOSE?

Try not to miss a dose. Every time you miss a dose or take a dose late your chance of pregnancy increases. When 1 pill is missed (even if only 3 hours late), take the missed pill as soon as possible and continue taking a pill each day at the regular time (use a back up method of birth control for the next 48 hours). If more than 1 dose is missed, use an additional birth control method for the rest of your pill pack until menses occurs. Contact your health care professional if more than 1 dose has been missed.

WHAT SHOULD I WATCH FOR WHILE USING Norethindrone/Norethindrone acetate?

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.

Use an additional method of birth control during the first cycle that you take these tablets.

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.

This medicine does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.

WHAT MAY INTERACT WITH Norethindrone/Norethindrone acetate?

Do not take this medicine with any of the following:

• bosentan
• amprenavir or fosamprenavir

This medicine may also interact with the following:

• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin/Fulvicin, and possibly penicillins or tetracyclines
• carbamazepine/Tegretol
• topiramate/Topamax
• aprepitant
• St. John's wort
• modafinil
• felbamate
• phenytoin/Dilantin
• ritonavir/Norvir or other medicines for HIV infection or AIDS
• barbiturate medicines, such as phenobarbital
• oxcarbazepine/Trileptal

This list may not describe all possible interactions. Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

WHAT SIDE EFFECTS MAY I NOTICE FROM Norethindrone/Norethindrone acetate?

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

• severe headache
• sudden shortness of breath
• vision or speech problems
• yellowing of skin or eyes
• pain in the abdomen, chest, groin or leg
• unusually weak or tired
• breast tenderness or discharge
• skin rash, itching, or hives

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

• fluid retention and swelling
• headache
• irritability
• weight gain or loss
• change in menstrual flow
• facial hair growth
• changes in sexual desire
• nausea

This list may not describe all possible side effects.

WHAT SHOULD I TELL MY HEALTH CARE PROVIDERS BEFORE I TAKE Norethindrone/Norethindrone acetate?

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

• pregnant or trying to get pregnant
• seizures
• an unusual or allergic reaction to norethindrone , other medicines, foods, dyes, or preservatives
• breast, cervical, or vaginal cancer
• migraine
• mental depression
• heart disease
• blood vessel disease or blood clots
• stroke
• breast-feeding
• vaginal bleeding
• liver disease
• kidney disease
• diabetes

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.