FAQs

About ANGELIQ^® tablets (drospirenone/estradiol)

• What is ANGELIQ?
• What is ANGELIQ used for?
• Who should not use ANGELIQ?
• How should I take ANGELIQ?
• What are the possible side effects of ANGELIQ?
• What are the serious side effects or complications with ANGELIQ?
• What can I do to lower my chances of a serious side effect with ANGELIQ?
• What are the active ingredients in ANGELIQ?

About Menopause and Hormone Therapy (HT)

• What is menopause?
• At what age can I expect to go through menopause?
• What is the difference between natural and surgical menopause?
• What are common symptoms of menopause?
• What is hormone therapy?
• What are the benefits of hormone therapy?
• What are the risks of hormone therapy?
• How long should I take hormone therapy?

About ANGELIQ

Q: What is ANGELIQ?
A: ANGELIQ is a medicine that contains two kinds of hormones, estrogen and progestin.
See: A unique combination

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Q: What is ANGELIQ used for?
A: ANGELIQ is used after menopause to:

• Reduce moderate to severe hot flashes
• Treat moderate to severe dryness, itching, and burning in or around the vagina
  • When prescribing solely for vaginal dryness, other treatments should be considered

See: About ANGELIQ

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Q: Who should not use ANGELIQ?
A: Do not use ANGELIQ if you have had your uterus removed (hysterectomy).
ANGELIQ contains a progestin to decrease the chances of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not use ANGELIQ.
Learn about a possible solution for you.
See: Is ANGELIQ right for me?

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Q: How should I take ANGELIQ?
A: Take one tablet every day. Estrogens should be used only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with ANGELIQ.
See: Using ANGELIQ

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Q: What are the possible side effects of ANGELIQ?
A: ANGELIQ is different from other hormonal medicines for menopausal symptoms because it contains drospirenone, and drospirenone may increase potassium or lower the sodium in your blood.
You should not take ANGELIQ if you have kidney, liver, or adrenal disease because these conditions may also increase the potassium in your blood. Some other medicines also increase potassium. If you regularly take another medicine that increases potassium levels, talk with your healthcare provider about whether ANGELIQ is right for you. In some situations, your healthcare provider may recommend testing your blood for potassium. For more information, please review the patient information provided on this site.

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Q: What are the serious side effects or complications with ANGELIQ?
A: ANGELIQ should be taken only for as long as your symptoms persist. Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attack, strokes, breast cancer, and blood clots. Using estrogens with or without progestins may increase your risk of dementia. It is important to consult with your healthcare provider each year about whether you should remain on hormone therapy. Adverse events most commonly observed in clinical trials were headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, and hair loss. For more information, please review the patient information provided on this site.

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Q: What can I do to lower my chances of a serious side effect with ANGELIQ?
A: Talk with your healthcare provider regularly about whether you should continue taking ANGELIQ. See your healthcare provider right away if you get vaginal bleeding while taking ANGELIQ. For more information, please review the patient Information provided on this site.

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Q: What are the active ingredients in ANGELIQ?
A: The active ingredients in ANGELIQ are drospirenone (a progestin) and estradiol. For more information, please review the patient information provided on this site.
See: A unique combination

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About Menopause and Hormone Therapy

Q: What is menopause?
A: Menopause is the end of monthly menstrual periods. Menopause is caused by the drop in body estrogen levels when the ovaries stop making estrogens. Estrogens are hormones made by a woman's ovaries.
See: About Menopause

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Q: At what age may I expect to go through menopause?
A: The ovaries normally stop making estrogens when a woman is between 45 to 55 years old.
See: About Menopause

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Q: What is the difference between natural and surgical menopause?
A: Natural menopause occurs when a woman's ovaries normally stop making estrogens. Surgical menopause is caused by a sudden drop in estrogen levels when both ovaries are removed during an operation before natural menopause takes place.
See: About Menopause

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Q: What are common symptoms of menopause?
A: When estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden 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.
See: Understanding Your Symptoms

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Q: What is hormone therapy?
A: Hormone therapy can be estrogen alone or estrogen with a progestin. Hormone therapy is used after menopause to reduce moderate to severe hot flashes, and treat moderate to severe dryness, itching, and burning around the vagina.
See: Treatment Options

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Q: What are the benefits of hormone therapy?
A: Hormone therapy is used after menopause to reduce moderate to severe hot flashes, and treat moderate to severe dryness, itching, and burning around the vagina.
See: Treatment Options

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Q: What are the risks of hormone therapy?
A: Using estrogens with or without progestins may increase your chances of heart attack, strokes, breast cancer, and blood clots. Using estrogens with or without progestins may increase your risk of dementia.
See: About Hormone Therapy

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Q: How long should I take hormone therapy?
A: Estrogens should be used at the lowest effective dose for the shortest period of time. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment.
See: About Hormone Therapy

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IMPORTANT SAFETY INFORMATION

What is ANGELIQ used for?

ANGELIQ is used after menopause to:

• Reduce moderate to severe hot flashes
• Treat moderate to severe dryness, itching, and burning in or around the vagina
  • When prescribing solely for vaginal dryness, other treatments should be considered

Who should not use ANGELIQ?

Do not use ANGELIQ if you have had your uterus removed (hysterectomy). ANGELIQ contains a progestin to decrease the chances of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not use ANGELIQ.

Do not start taking ANGELIQ if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, have kidney disease, liver disease, or disease of your adrenal glands, are allergic to ANGELIQ or any of its ingredients, or think you may be pregnant.

What are the warnings of less common but serious side effects of ANGELIQ?

Warnings of less common but serious side effects of ANGELIQ include 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, and vomiting. Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

What are common side effects of ANGELIQ?

Common side effects of ANGELIQ include headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, and hair loss.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see the full prescribing information.