Norethindrone Oral tablet

What is this medicine?

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.

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

How should I use this medicine?

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 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

This list may not describe all possible interactions. Give your health care provider 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 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.

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 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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.