IMPORTANT NOTE The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

TITLE RALOXIFENE - ORAL

HOW TO PRONOUNCE (ra-LOX-ih-feen)

COMMON BRAND NAMES Evista

USES Raloxifene is used to prevent and treat bone loss (osteoporosis) in women after menopause. Maintaining strong bones by slowing bone loss helps to reduce the risk of fractures. This drug is different from hormones (including estrogens and progestins). It works by acting like estrogen (as a selective estrogen receptor modulator or SERM) in some parts of the body. Raloxifene helps to preserve bone mass, but it does not affect the breast and uterus like estrogen or relieve symptoms of menopause such as hot flashes. This medication is not recommended for use in women before menopause. It should not be used in children.

HOW TO TAKE Take this medication by mouth usually once a day, with or without food, or as directed by your doctor. Use this medication regularly to get the most benefit from it. Remember to use it at the same time each day. Be sure to include adequate amounts of calcium and vitamin D in your diet. Consult your doctor or pharmacist to see if you need to take calcium/vitamin D supplements. This medication comes with a patient information leaflet. Read it carefully. Ask your doctor or pharmacist any questions you may have.

SIDE EFFECTS Hot flashes, sweating, or leg cramps may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly. Raloxifene may infrequently cause serious blood clots to form in the legs, lungs, or eyes. Tell your doctor immediately if any of these unlikely but serious side effects occur: leg swelling/pain, trouble breathing, chest pain, vision changes. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS Before taking raloxifene, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active or past history of blood clots (e.g., deep venous thrombosis, pulmonary embolism, retinal vein thrombosis). Lack of movement may increase the risk for blood clots. Your doctor will instruct you to stop taking this medication at least 3 days before surgery or during long periods of inactivity (e.g., bedrest). Do not start taking raloxifene until you are routinely and actively moving again. During long periods of travel, walk or move periodically to keep the blood flowing through your body. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, congestive heart failure, cancer, high blood cholesterol levels, history of high blood fat (triglyceride) levels due to estrogen treatment. This medication must not be used during pregnancy because it may cause fetal harm. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is not known whether this drug passes into breast milk. Breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS This drug should not be used with the following medication because very serious interactions may occur: cholestyramine (or other anion-exchange resins). If you are currently using this medication, tell your doctor or pharmacist before starting raloxifene. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: diazepam, diazoxide, estrogens, lidocaine, warfarin. This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE If overdose is suspected, contact your local poison control center or emergency room immediately.

NOTES Do not share this medication with others. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, breast and pelvic examination, and PAP test (for vaginal cancer) at least once a year. You should also have periodic mammograms as determined by your doctor. Follow your doctor's instructions for examining your own breasts. Report any unusual vaginal bleeding, breast pain, or lumps immediately. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, eating well-balanced meals that contain adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Consult your doctor about lifestyle changes that might benefit you. Laboratory and/or medical tests (bone density tests, x-rays, height measurement, blood mineral levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE Store the US product at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Store the Canadian product at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.