RALOXIFENE ORAL (EVISTA) BOXED WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE * Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA. Women with active or past history of venous thromboembolism should not take EVISTA. * Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke. BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP LIVER PROBLEMS. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * This medicine can be taken with or without food, REGARDLESS of meal times. If stomach upset occurs, take with food. * Talk to your physician about weight-bearing exercises which may improve your condition. * Take calcium and vitamin D supplements, if dietary intake is inadequate, unless otherwise instructed by your physician. WARNINGS/PRECAUTIONS: TOP * This medicine is CONTRAINDICATED for use during pregnancy. CALL YOUR DOCTOR IMMEDIATELY IF PREGNANT or intend to become pregnant. * Smoking or drinking alcohol may worsen your condition. * Flushing may occur and does not disappear with continued drug use. * Avoid long periods of restricted movement, such as during travel, to reduce the risk of stroke. * It is advisable to have an annual medical evaluation and physical examination. Other Common Side Effects: TOP Hot sensation and redness of face; Joint pain; Infection; Flu-like symptoms; Skin rash; Nausea; Swelling of the extremities; Leg pain / cramps; Vomiting; Vaginal bleeding; Muscle pain; Hot flashes. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Taking this medication may cause the following mineral depletion: TOP ; ; . This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved