estradiol and norgestimate

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Pronunciation: ES tra DYE ol and nor JES ti mate

Brand: Prefest

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

Do not use estradiol and norgestimate if you are pregnant.

You should not take this medicine if you have any of the following conditions: liver disease, a recent stroke or heart attack, unusual vaginal bleeding, a history of breast or uterine cancer, if you have ever had a blood clot, or if you may be pregnant.

Smoking can increase your risk of blood clots, stroke, or heart attack while taking estradiol and norgestimate, especially if you are older than 35.

Estradiol and norgestimate should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

What is estradiol and norgestimate?

Estradiol is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

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

Estradiol and norgestimate is a combination medicine used to treat symptoms of menopause such as hot flashes and vaginal dryness, burning, and irritation. This medicine is used in women who have not had the uterus removed (hysterectomy).

Estradiol and norgestimate is also used to prevent postmenopausal osteoporosis.

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

What should I discuss with my healthcare provider before taking estradiol and norgestimate?

Smoking can increase your risk of blood clots, stroke, or heart attack while taking estradiol and norgestimate, especially if you are older than 35 years of age. Your risk increases the more you smoke. You should not take this medicine if you smoke and are older than 35 years of age.

This medicine can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking estradiol and norgestimate.

You should not take this medicine if you are allergic to estradiol or norgestimate, or if you have:

  • liver disease;
  • abnormal vaginal bleeding that has not been checked by a doctor;
  • a history of hormone-related cancer such as breast or uterine cancer;
  • a recent history of heart attack or stroke;
  • if you have ever had a blood clot (especially in your lung or your lower body); or
  • if you are pregnant.

To make sure estradiol and norgestimate is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure;
  • high cholesterol or triglycerides;
  • risk factors for coronary artery disease (such as diabetes, smoking, being overweight, or a family history of coronary artery disease);
  • asthma;
  • kidney disease;
  • epilepsy or other seizure disorder;
  • migraines;
  • lupus;
  • gallbladder disease;
  • endometriosis;
  • a thyroid disorder;
  • a history of jaundice caused by pregnancy or birth control pills;
  • high levels of calcium in your blood; or
  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Estradiol and norgestimate should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot. Ask your doctor about your individual risk.

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not use estradiol and norgestimate if you are pregnant or may become pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are taking this medicine.

Estradiol and norgestimate can pass into breast milk and may harm a nursing baby. Estrogens may also slow breast milk production. You should not breast-feed while you are taking this medication.

How should I take estradiol and norgestimate?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using this medicine.

Estradiol and norgestimate usually comes in a pack of pills that are different colors. In most cases you will take a pill of one color for 3 days in a row, and then take a pill of the other color for the next 3 days in a row. This cycle is then repeated throughout your treatment.

Each time you start a new pack, start with the first tablet in the first row of pills. Your medicine may come with stickers to mark your weekday schedule on the pack.

Be sure to have a new pack of this medicine ready to start on the day after you have finished an entire pill pack.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using estradiol and norgestimate. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estradiol and norgestimate.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss 2 doses in a row, take the next tablet in order and keep taking only one pill per day. Call your doctor if you miss more than 2 doses of this medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose can cause nausea, vomiting, or vaginal bleeding.

What should I avoid while taking estradiol and norgestimate?

Do not smoke while taking this medicine, especially if you are older than 35 years of age.

What are the possible side effects of estradiol and norgestimate?

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:

  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs;
  • swelling or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • unusual vaginal bleeding (especially if you are past menopause);
  • a lump in your breast;
  • fluid retention (swelling, rapid weight gain); or
  • high levels of calcium in your blood --numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes.

Common side effects may include:

  • nausea, vomiting, stomach pain, bloating;
  • headache;
  • breast pain;
  • loss of scalp hair;
  • vaginal itching or discharge; or
  • irregular vaginal bleeding or spotting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect estradiol and norgestimate?

Other drugs may interact with estradiol and norgestimate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about estradiol and norgestimate.

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.

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