SAFETY AND SIDE EFFECTS

PREMPRO offers several dose options so you and your healthcare professional can choose the best dose to meet your individual treatment goals. It is important that you understand the benefits and risks before starting any treatment.

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

Important Safety Information
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.

INDICATIONS
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.

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; 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).

Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.

Scroll for Important Safety Information and Indication

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.

INDICATIONS
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.