Prempro®(conjugated estrogens/medroxyprogesterone)

Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia.Using estrogens with progestins may increase your chances of getting:• heart attacks• strokes• breast cancer• blood clotsUsing estrogens with progestins may increase your chances of getting dementia, based on a study of women 65 years of age or older.You and your healthcare provider should talk regularly about whether you still need treatment with PREMPRO.

PREMPRO is a prescription medicine that contains two kinds of hormones: estrogens and a progestin.PREMPRO is used in women after menopause to:• reduce moderate to severe hot flashes (vasomotor symptoms)• treat moderate to severe vaginal dryness, itching, and burning (symptoms of vulvar and vaginal atrophy)• help reduce your chances of getting osteoporosis (thin, weak bones)PREMPRO should not be used to prevent heart disease, stroke, or dementia.

• have unusual vaginal bleeding that has not been evaluated by your healthcare provider• currently have or have had certain cancers, including breast cancer or cancer of the uterus• have or have had blood clots (in your legs, lungs, or eyes)• have or have had a stroke or heart attack• have liver problems• have a bleeding disorder• have had an allergic reaction to PREMPRO or any of its ingredients• think you may be pregnant

• have any unusual vaginal bleeding• have asthma (wheezing)• have epilepsy (seizures)• have diabetes• have migraine headaches• have heart problems or kidney problems• have liver problems or thyroid problems• have high blood pressure• have high cholesterol or triglycerides• are going to have surgery or will be on bed rest• are breastfeedingTell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Take PREMPRO exactly as your healthcare provider tells you to take it.• Take one tablet daily at the same time each day.• PREMPRO may be taken with or without food.• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time.• Talk to your healthcare provider regularly (every 3 to 6 months) about whether you still need treatment with PREMPRO.

PREMPRO may increase your chances of getting:• Cancer of the uterus• Stroke• Blood clots• Heart attack• Dementia (especially in women 65 years of age and older)• Breast cancer• Gallbladder diseaseCall your healthcare provider right away if you get:• new breast lumps• unusual vaginal bleeding• changes in vision or speech• sudden new severe headaches• severe pains in your chest or legs with or without shortness of breath, weakness and fatigueThe most common side effects of PREMPRO include:• headache• breast pain or tenderness• nausea and vomiting• stomach/abdominal pain• mood changesThese are not all the possible side effects of PREMPRO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Talk with your healthcare provider regularly about whether you should continue taking PREMPRO.• If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you.• See your healthcare provider right away if you get vaginal bleeding while taking PREMPRO.• Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you something else.• If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.Do not take PREMPRO for conditions for which it was not prescribed. Do not give PREMPRO to other people, even if they have the same symptoms you have. It may harm them.This Medication Guide summarizes the most important information about PREMPRO. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about PREMPRO that is written for health professionals.

• Store PREMPRO at room temperature between 68°F to 77°F (20°C to 25°C).• Keep PREMPRO and all medicines out of the reach of children.

Active ingredients: conjugated estrogens and medroxyprogesterone acetateInactive ingredients: calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, hypromellose, lactose monohydrate, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide