Do not use estrogens, with or without progestins, to prevent heart disease,
heart attacks, strokes or dementia (decline in brain function). Using estrogens,
with or without progestins, may increase your chance of getting dementia, based
on a study of women 65 years of age or older.
Using estrogens with progestins may increase your chances of getting heart attacks,
strokes, breast cancer, or blood clots.
You and your healthcare provider should talk regularly about whether you still need
treatment with PREMPRO.
PREMPRO should not be used if you have unusual vaginal bleeding; have or had cancer;
had a stroke or heart attack; have or had blood clots or liver problems; have a
bleeding disorder; are allergic to any of its 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 is used after menopause to reduce moderate to severe hot flashes; to treat
moderate to severe dryness, itching, and burning, in and around the vagina; and
to help reduce the chances of getting osteoporosis (thin weak bones).
If you are using or are considering using PREMPRO only to treat symptoms of vaginal
dryness, consider topical therapies first. If you are using or are considering using
PREMPRO only to prevent osteoporosis due to menopause, talk with your health care
professional about whether a different treatment or medicine without estrogens might
be better for you. PREMPRO should be used at the lowest effective dose and for the
shortest duration consistent with your treatment goals and risks.
Please see Full Prescribing Information including Boxed Warning and Patient Information.