Frequently Asked Questions

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Ask your healthcare provider about ANGELIQ

Ask your healthcare provider about ANGELIQ

Use this guide to start the discussion with your healthcare provider today.

About ANGELIQ® (drospirenone/estradiol) tablets

About menopause and hormone therapy (HT)

 

About ANGELIQ (drospirenone/estradiol) tablets

Q: What is ANGELIQ?

A: ANGELIQ is a medicine that contains two kinds of hormones, estrogen and progestin. It’s available in two doses, ANGELIQ (0.25 mg drsp®/0.5 mg E2) tablets and ANGELIQ (0.5 mg drsp/1.0 mg E2) tablets.

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Q: What is ANGELIQ (0.25 mg drsp/0.5 mg E2) used for?

A: ANGELIQ (0.25 mg drsp/0.5 mg E2) tablets are used after menopause in women who have a uterus to:

  • Reduce moderate to severe hot flashes

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Q: What is ANGELIQ (0.5 mg drsp/1.0 mg E2) used for?

A: ANGELIQ (0.5 mg drsp/1.0 mg E2) tablets are 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 (0.5 mg drsp/1.0 mg E2) tablets only to treat dryness, itching and burning in and around the vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

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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, such as cancer of the breast or uterus; had a stroke or heart attack in the past year
  • 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
  • Have been diagnosed with a bleeding disorder
  • Are allergic to ANGELIQ or any of its ingredients
  • Are pregnant or plan to become pregnant

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Q: How should I take ANGELIQ?

A: Take one ANGELIQ tablet at the same time every day.

  • Take ANGELIQ tablets whole. Do not break, crush, dissolve, or chew ANGELIQ tablets before swallowing. If you cannot swallow ANGELIQ tablets whole, tell your healthcare provider. You may need a different medicine
  • If you miss a dose of ANGELIQ, take it as soon as possible
  • If more than 24 hours have passed since you missed a dose of ANGELIQ, you should not take the missed dose
  • Estrogens should be used at the lowest dose possible and 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

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Q: What are the serious side effects or complications with ANGELIQ?

A: ANGELIQ may increase the risk of heart attack; stroke; blood clots; dementia; cancer of the breast, ovary, or lining of the uterus (womb); high blood pressure; high blood sugar; gallbladder disease; liver problems; or enlargement of benign tumors of the uterus (fibroids).

In addition, ANGELIQ contains drospirenone which may increase the potassium level in your blood. Do not take ANGELIQ if you have kidney, liver or adrenal disease because these conditions may also increase the potassium level in your blood. Tell your healthcare provider about all the medicines you take because some other medicines may increase potassium. In some situations, your healthcare provider may recommend testing your blood for potassium level.

Call your healthcare provider right away if you have:

  • New breast lumps; changes in vision or speech; sudden new severe headaches; severe pain in your chest or legs with or without shortness of breath, weakness and fatigue; vaginal bleeding while taking ANGELIQ

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 more common side effects of ANGELIQ?

A: The most common side effects were stomach and abdominal pain, vaginal bleeding or spotting, breast pain/discomfort, headache, vaginal yeast infection, nausea, diarrhea, and fluid retention.

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Q: Does the drospirenone (drsp) in ANGELIQ increase potassium?

A: Drospirenone may increase potassium 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.

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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. Learn more about menopause from these resources.

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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. Learn more about when and how menopause happens from these resources.

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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. Learn more from these resources.

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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. Learn more about menopause symptoms from these resources.

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Q: What is hormone therapy?

A: Hormone therapy (HT) 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. Using estrogen alone may increase your chance of getting cancer of the uterus (womb). If you do not have a uterus, you should not use a progestin. Learn more about HT from these resources.

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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.

Have a pelvic exam, 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 the blood), diabetes, are overweight, or if you use tobacco, you may have a greater chance of getting heart disease. Ask your healthcare provider for ways to lower your risk.

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Q: How long should I take hormone therapy?

A: Hormone therapy (HT) should be used only as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with ANGELIQ. Learn more about HT.

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Call your healthcare provider right away if you have:

What are the most common side effects in ANGELIQ clinical trials?

The most common side effects were stomach and abdominal pain, vaginal bleeding or spotting, breast pain/discomfort, headache, vaginal yeast infection, nausea, diarrhea, and fluid retention.


IMPORTANT SAFETY INFORMATION

What is ANGELIQ® used for?

ANGELIQ (0.25 mg drsp/0.5 mg estradiol E2) tablets and ANGELIQ (0.5 mg drsp/1.0 mg E2) tablets are used after menopause in women who have a uterus to reduce moderate to severe hot flashes.

In addition, ANGELIQ (0.5 mg drsp/1.0 mg E2) is used after menopause in women who have a uterus to treat moderate to severe dryness, itching, and burning in or around the vagina. If you use ANGELIQ (0.5 mg drsp/1.0 mg E2) only to treat dryness, itching, and burning in or around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

What is the most important information I should know about ANGELIQ (combination of estrogen and progestin hormones)?

  • Do not use estrogens with progestins, or estrogen-alone, to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function)
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestins, or estrogen-alone, may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • Using estrogen-alone may increase your chance of getting strokes, blood clots or cancer of the uterus (womb)
  • You and your healthcare provider should talk regularly about whether you still need treatment with ANGELIQ

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, such as cancer of the breast or uterus; 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; have been diagnosed with a bleeding disorder; are allergic to ANGELIQ or any of its ingredients; or are pregnant or plan to become pregnant.

What are the most serious risks of taking ANGELIQ?

ANGELIQ may increase the risk of heart attack; stroke; blood clots; dementia; cancer of the breast, ovary, or lining of the uterus (womb); high blood pressure; high blood sugar; gallbladder disease; liver problems; or enlargement of benign tumors of the uterus (fibroids).

In addition, ANGELIQ contains drospirenone which may increase the potassium level in your blood. Do not take ANGELIQ if you have kidney, liver or adrenal disease because these conditions may also increase the potassium level in your blood. Tell your healthcare provider about all the medicines you take because some other medicines may increase potassium. In some situations, your healthcare provider may recommend testing your blood for potassium level.

Call your healthcare provider right away if you have:

  • New breast lumps; changes in vision or speech; sudden new severe headaches; severe pain in your chest or legs with or without shortness of breath, weakness and fatigue; vaginal bleeding while taking ANGELIQ

What are the most common side effects in ANGELIQ clinical trials?

The most common side effects were stomach and abdominal pain, vaginal bleeding or spotting, breast pain/discomfort, headache, vaginal yeast infection, nausea, diarrhea, and fluid retention.

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.