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Brand Names: Prefest

Generic Name: estradiol and norgestimate (Pronunciation: ess tra DYE all and nor JESS tih mate)

• What is estradiol and norgestimate (Prefest)?
• What are the possible side effects of estradiol and norgestimate (Prefest)?
• What is the most important information I should know about estradiol and norgestimate (Prefest)?
• What should I discuss with my healthcare provider before taking estradiol and norgestimate (Prefest)?
• How should I take estradiol and norgestimate (Prefest)?
• What happens if I miss a dose (Prefest)?
• What happens if I overdose (Prefest)?
• What should I avoid while taking estradiol and norgestimate
• What other drugs will affect estradiol and norgestimate (Prefest)?
• Where can I get more information?

What is estradiol and norgestimate (Prefest)?

Estradiol is a female sex hormone that is involved in the development and maintenance of the female reproductive system.

Norgestimate is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Estradiol and norgestimate is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.

Estradiol and norgestimate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of estradiol and norgestimate (Prefest)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• pain or swelling in your lower leg;
• abnormal vaginal bleeding;
• pain, swelling, or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes); or
• a lump in your breast.

Less serious side effects may include:

• nausea, vomiting, loss of appetite;
• swollen breasts;
• swelling of your hands or feet;
• problems with wearing contact lenses;
• acne or skin color changes;
• migraine headaches or dizziness;
• vaginal pain, dryness, itching, or discharge;
• swelling of your ankles or feet;
• depression;
• enlargement of uterine fibroids; or
• changes in your menstrual periods, break-through bleeding.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about estradiol and norgestimate (Prefest)?

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estradiol and norgestimate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol and norgestimate may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol and norgestimate.

Long-term estradiol and norgestimate treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol and norgestimate long-term. Your doctor should check your progress on a regular basis to determine whether you should continue this treatment.