| *Clinical significance is unknown.
IMPORTANT SAFETY INFORMATION
Estrogens with progestins should not be used to prevent heart disease, heart attacks, strokes, or dementia. Using estrogens with progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years and older. You and your healthcare professional should talk regularly about whether you still need treatment with PROMETRIUM® Capsules.[1]
Do not take PROMETRIUM® Capsules if you are allergic to peanuts or any of the ingredients in PROMETRIUM®, have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, or think you may be pregnant.[1]
PATIENTS WHO ARE ALLERGIC TO PEANUTS SHOULD NOT USE PROMETRIUM® CAPSULES.[1]
The most common adverse events reported at a rate greater than placebo in a clinical trial by postmenopausal women receiving conjugated estrogens 0.625 mg daily plus cyclic PROMETRIUM® 200 mg capsules were: headache, breast tenderness, depression, dizziness, abdominal bloating, chest pain, and diarrhea.[1]
The most common adverse events reported at a rate greater than placebo in a clinical trial by postmenopausal women receiving PROMETRIUM® 400 mg capsules were: dizziness, abdominal pain, headache, breast pain, musculoskeletal pain, and viral infection.[1]
You are encouraged to report suspected adverse reactions. Please contact Solvay Pharmaceuticals, Inc. at 1-800-241-1643 or the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
Please click here for PROMETRIUM® Patient Information.
References:
1. PROMETRIUM® [package insert]. Marietta, Ga: Solvay Pharmaceuticals, Inc.; 2009. 2. Role of progestogen in hormone therapy for postmenopausal women: position statement of the North American Menopause Society. Menopause. 2003;10:113-132. |
