Premarin®(conjugated estrogens)

Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking 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 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.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.You and your healthcare provider should talk regularly about whether you still need treatment with PREMARIN.

PREMARIN is a prescription medicine that contains a mixture of estrogen hormones.PREMARIN 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)PREMARIN is also used to treat certain conditions in younger women with low estrogen levels due to hypogonadism, removal of the ovaries (castration), or primary ovarian failure.

• 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 PREMARIN 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 PREMARIN exactly as your healthcare provider tells you to take it.• Take one tablet daily at the same time each day.• PREMARIN 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.

PREMARIN may increase your chances of getting:• Cancer of the uterus• Stroke• Blood clots• Heart attack• Dementia• 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 PREMARIN include:• headaches• breast pain or tenderness• irregular vaginal bleeding or spotting• stomach/abdominal cramps or bloating• nausea and vomiting• hair lossThese are not all the possible side effects of PREMARIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Active ingredients: conjugated estrogens (a mixture of sodium estrone sulfate and sodium equilin sulfate)Inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide. Each tablet strength also contains various colorants.