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.

Available by presription 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.