IMPORTANT SAFETY INFORMATION

Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using PREMARIN. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

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 estrogen-alone may increase your chances of getting strokes or blood clots. 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 PREMARIN.

PREMARIN 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 general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.

In a clinical trial, the most commonly reported (≥5%) side effects that occurred more frequently with PREMARIN than with placebo were vaginitis due to yeast or other causes, vaginal bleeding, painful menstruation, and leg cramps.

INDICATIONS

PREMARIN 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 PREMARIN only to treat symptoms of vaginal dryness, consider topical therapies first. If you are using or are considering using PREMARIN 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. PREMARIN 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.

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