Raloxifene (ral-OX-i-feen)

Treats and prevents osteoporosis (weak or thin bones) in women who are past menopause. Also helps decrease the risk of breast cancer in women who are past menopause and who have osteoporosis or a high risk of getting breast cancer.

Brand Name(s):

Evista, Raloxifene AvPak

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• You may take this medicine with or without food.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Never share your medicine with anyone.

If a dose is missed:

• Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using a blood thinner (Coumadin®), cholestyramine (Questran®), diazepam (Valium®), diazoxide (Proglycem®), lidocaine (Lidoderm®), estrogen (hormone replacement therapy or HRT), or medicine to lower cholesterol (such as Baycol®, Lescol®, Lipitor®, Mevacor®, Pravachol®, or Zocor®).

Warnings While Using This Medicine:

• Although it is unlikely that a postmenopausal woman might become pregnant, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you have congestive heart failure, cancer, liver disease, kidney disease, high cholesterol or triglycerides in your blood, or a history of breast cancer. Also tell your doctor if you have a history of stroke, transient ischemic attacks (TIA), heart rhythm problems, or high blood pressure.
• Raloxifene may increase your risk of having blood clots, especially during the first 4 months that you are using the medicine. Avoid sitting for long periods of time (such as during a long car trip); get up and walk around often.
• Raloxifene does not act like an estrogen to stimulate the uterus or breast. If you have vaginal bleeding, breast pain, or breast enlargement while you are using this medicine, check with your doctor right away.
• If you will be inactive for several days (such as recovering from surgery), talk with your doctor. You may need to stop taking this medicine for awhile.
• You can help this medicine work better by eating a balanced diet, exercising regularly, and avoiding cigarettes and alcohol. Make sure you get enough calcium and vitamin D every day, through either food or supplements. Talk with your doctor about specific ways you can improve your situation.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, or painful urination.
• Chest pain, shortness of breath, or coughing up blood.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain, redness, or swelling in your leg, especially the lower leg (calf).
• Sudden or severe headache, problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Unusual vaginal pain, bleeding, or discharge.

If you notice these less serious side effects, talk with your doctor:

• Depression or trouble sleeping.
• Hot flashes.
• Leg cramps.
• Muscle or joint pain.
• Nausea, vomiting, diarrhea, or upset stomach.
• Skin rash.
• Weight gain.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088