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 serious side effects or complications with ANGELIQ?
• What are the possible common side effects of ANGELIQ?
• Does the drospirenone (drsp) in ANGELIQ increase potassium?
• What are the active ingredients in ANGELIQ?

About Menopause and Hormone Therapy

• 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 can I do to lower my chances of a serious side effect with ANGELIQ?
• 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: An Effective Combination

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Q: What is ANGELIQ used for?
A: ANGELIQ is used after menopause in women who have a uterus to:

• Reduce moderate to severe hot flashes
• Treat moderate to severe dryness, itching, and burning in or around the vagina

If you use ANGELIQ only to treat dryness, itching and burning in and around the vagina, talk with your healthcare provider about whether a topical vaginal product is the right choice for you.

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.

Do not start taking ANGELIQ 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 ANGELIQ
• 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
• Think you may be pregnant

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 serious side effects or complications with ANGELIQ?
A: Less common but serious side effects include the following and should be discussed with your healthcare provider to assess your personal risks:

• 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.

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Q: What are the most common side effects of ANGELIQ?
A: Common side effects of ANGELIQ include breast pain, upper respiratory infection, stomach/abdominal cramps, headache, irregular vaginal bleeding or spotting, pain in arms, legs or back, flu syndrome, bloating, accidental injury, surgery and sinus infection.

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Q: Does the drospirenone (drsp^®) in ANGELIQ increase potassium?
A: drsp^® 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 may 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.

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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: An Effective 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 and 55 years old.
See: About Menopause

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Q: What is the difference between natural and surgical menopause?
A: Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 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”
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"). Some women may also experience vaginal dryness, itching and burning. 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. Progestins decrease the chances of getting cancer of the uterus. If you do not have a uterus, you should not use a progestin.
See: Prescription Hormone Therapies

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Q: What can I do to lower my chances of a serious side effect with ANGELIQ?
A: Talk with your health care provider regularly about whether you should continue taking ANGELIQ. See your health care provider right away if you get vaginal bleeding while taking ANGELIQ.
Have a breast exam and mammogram (breast X-ray) every year unless your health care 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 the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your health care provider for ways to lower your chances of getting heart disease.
See: About Hormone Therapy

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Q: How long should I take hormone therapy?
A: Hormone therapy should be used only as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with ANGELIQ.
See: About Hormone Therapy

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IMPORTANT SAFETY INFORMATION

What is ANGELIQ used for?

ANGELIQ is used after menopause in women who have a uterus to:

• Reduce moderate to severe hot flashes
• Treat moderate to severe dryness, itching, and burning in or around the vagina.
  • If you use ANGELIQ only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

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, 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, currently have or have had certain cancers. Estrogens may increase the chances of getting cancer of the breast or uterus.

What are possible side effects of ANGELIQ?

ANGELIQ is different from other hormonal medicines for menopausal symptoms because it contains drospirenone, and drospirenone may increase the potassium or lower 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 may 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.

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

Less common but serious side effects of ANGELIQ include: breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease and ovarian cancer.

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

Warning signs 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 you 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 breast pain, upper respiratory infection, stomach/abdominal cramps, headache, irregular vaginal bleeding or spotting, pain in arms, legs or back, flu syndrome, bloating, accidental injury, surgery and sinus infection.

ANGELIQ is available by prescription only.

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 about ANGELIQ, please see the full prescribing information.