What is the most important information I should know about PREMPRO and PREMPHASE (combinations of estrogens and a progestin)?

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

If you use or are considering PREMPRO only to treat your menopausal changes in or around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

If you use or are considering PREMPRO only to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens would be better for you.

Do not take PREMPRO if you have unusual vaginal bleeding; currently have or have had cancer of the breast or uterus; had a stroke or heart attack; currently have or have had blood clots; currently have or have had liver problems; have had a bleeding disorder; are allergic to PREMPRO or any of their ingredients; or think you may be pregnant.

In a clinical trial, the most common side effects (>5%) that occurred with PREMPRO were vaginal bleeding, vaginitis due to yeast or other causes, painful menstruation, breast enlargement, breast pain, and leg cramps.

PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) is a prescription treatment used after menopause. PREMPRO is used after menopause to reduce moderate to severe hot flashes, to treat menopausal changes in and around the vagina, and to help reduce your chances of getting osteoporosis (thin, weak bones).

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Please see full Prescribing Information, including boxed warning and Patient Information.

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