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PREFEST
(estradiol/norgestimate)

Read this PATIENT INFORMATION before you start taking PREFEST (estradiol, norgestimate) and read what you get each time you refill PREFEST (estradiol, norgestimate) . There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What Is PREFEST (estradiol, norgestimate) ?

PREFEST (estradiol, norgestimate) is a medicine that contains two kinds of hormones, estrogen and a progestin.

What is PREFEST (estradiol, norgestimate) used for?

PREFEST (estradiol, norgestimate) is used after menopause to:

• reduce moderate or severe hot flashes.

Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.”

When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your health care provider should talk regularly about whether you still need treatment with PREFEST (estradiol, norgestimate) .

• treat moderate to severe dryness, itching, and burning in and around the vagina.

You and your healthcare provider should talk regularly about whether you still need treatment with PREFEST (estradiol, norgestimate) to control these problems. If you use PREFEST (estradiol, norgestimate) only to treat your dryness, itching, and burning in and around your vagina, talk with your health care provider about whether a topical vaginal product would be better for you.

• help reduce your chances of getting osteoporosis (thin, weak bones).

Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use PREFEST (estradiol, norgestimate) only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you should continue with PREFEST (estradiol, norgestimate) .

Weight-bearing exercise, like walking or running, and taking calcium and vitamin D supplements may also lower your chances of getting postmenopausal osteoporosis. It is important to talk about exercise and supplements with your healthcare provider before starting them.

Who Should Not Take PREFEST (estradiol, norgestimate) ?

Do not start taking PREFEST (estradiol, norgestimate) if you:

• have unusual vaginal bleeding.
• currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or had cancer, talk with your healthcare provider about whether you should take PREFEST (estradiol, norgestimate) .
• had a stroke or heart attack in the past year.
• currently have or have had blood clots.
• currently have or have had liver problems.
• are allergic to PREFEST (estradiol, norgestimate) or any of its ingredients. See the end of this leaflet for a list of ingredients in PREFEST (estradiol, norgestimate) .
• think you may be pregnant.

Tell your healthcare provider:

• if you are breastfeeding. The hormones in PREFEST (estradiol, norgestimate) can pass into your milk.
• about all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
• about all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how PREFEST (estradiol, norgestimate) works. PREFEST (estradiol, norgestimate) may also affect how your other medicines work.
• if you are going to have surgery or will be on bed rest. You may need to stop taking estrogens.

How Should I Take PREFEST (estradiol, norgestimate) ?

• PREFEST (estradiol, norgestimate) therapy consists of taking one single pink tablet (estrogen only) each day for three days followed by one single white tablet (combination of estrogen and progestin) each day for three days. The three days of pink tablets followed by the three days of the white tablets are repeated continuously during treatment.
• If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your normal schedule. Do not take 2 doses at the same time.

Estrogens and progestins should be used at the lowest dose possible for your treatment, only as long as needed. The lowest effective dose of PREFEST (estradiol, norgestimate) has not been determined. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with PREFEST (estradiol, norgestimate) .

What are the possible side effects of estrogens?

Less common but serious side effects include:

• Breast cancer
• Cancer of the uterus
• Stroke
• Heart attack
• Blood clots
• Dementia
• Gallbladder disease
• Ovarian cancer

These are some of the warning signs of serious side effects:

• Breast lumps
• Unusual vaginal bleeding
• Dizziness and faintness
• Changes in speech
• Severe headaches
• Chest pain
• Shortness of breath
• Pains in your legs
• Changes in vision
• Vomiting

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vomiting
• Hair loss

Other side effects include:

• High blood pressure
• Liver problems
• High blood sugar
• Fluid retention
• Enlargement of benign tumors of the uterus (“fibroids”)
• Vaginal yeast infection

These are not all the possible side effects of PREFEST (estradiol, norgestimate) . For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chances of a serious side effect with PREFEST (estradiol, norgestimate) ?

Talk with your healthcare provider regularly about whether you should continue taking PREFEST (estradiol, norgestimate) . See your healthcare provider right away if you get vaginal bleeding while taking PREFEST (estradiol, norgestimate) . Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often. If you have high blood pressure, high cholesterol (fat in blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about the safe and effective use of PREFEST (estradiol, norgestimate)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take PREFEST (estradiol, norgestimate) for conditions for which it was not prescribed. Do not give PREFEST (estradiol, norgestimate) to other people, even if they have the same symptoms you have. It may harm them.

Keep PREFEST (estradiol, norgestimate) out of reach of children.

This leaflet provides a summary of the most important information about PREFEST (estradiol, norgestimate) . If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about PREFEST (estradiol, norgestimate) that is written for health professionals. You can get more information by calling the toll free number 1-800-776-3637, select option 5.

What are the ingredients in PREFEST (estradiol, norgestimate) ?

PREFEST (estradiol, norgestimate) contains two separate tablets. One tablet (pink color) contains 1.0 mg estradiol, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, ferric oxide red, and lactose monohydrate. The other tablet (white color) contains 1.0 mg estradiol, 0.09 mg norgestimate, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, and lactose monohydrate.

Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.