Raloxifene (By mouth)

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

Introduction

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

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• Never share your medicine with anyone.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use 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 away from children and 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.