Raloxifene

IMPORTANT WARNING:

Taking raloxifene may increase the risk that you will develop a blood clot in your legs or lungs. Tell your doctor if you have or have ever had a blood clot in your legs, lungs, or eyes. Your doctor will probably tell you not to take raloxifene. Stop taking raloxifene and call your doctor immediately if you experience any of the following symptoms: leg pain; feeling of warmth in the lower leg; swelling of the hands, feet, ankles, or lower legs; sudden chest pain; shortness of breath; coughing up blood; or sudden changes in vision, such as loss of vision or blurred vision.

Remaining still for a long time may increase the chance that you will develop a blood clot. Your doctor will probably tell you to stop taking raloxifene at least three days before a scheduled surgery and not to take the medication if you require an extended period of bed rest for any reason. If you will be having surgery, be sure to tell your doctor that you are taking raloxifene. If you travel while you are taking raloxifene, avoid remaining still (such as sitting in an airplane or car) for long periods of time during your trip.

If you have coronary artery disease (hardening of the arteries that lead to the heart that may cause chest pain or heart attacks) or if you are at high risk of developing coronary artery disease, taking raloxifene may increase the chance that you will have a serious or fatal stroke. Tell your doctor if you have ever had a stroke or mini-stroke, if you smoke, and if you have or have ever had high blood pressure or an irregular heartbeat.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with raloxifene and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Raloxifene is used to prevent and treat osteoporosis (condition in which the bones become thin and weak and break easily) in postmenopausal (women who have experienced a change of life; end of menstrual periods) women. Raloxifene is also used to decrease the risk of developing invasive breast cancer (breast cancer that has spread outside of the milk ducts or lobules into the surrounding breast tissue) in postmenopausal women who are at high risk of developing this type of cancer or who have osteoporosis. Raloxifene cannot be used to treat invasive breast cancer or to prevent invasive breast cancer from coming back in women who have already had the condition. Raloxifene also cannot be used to decrease the risk of developing noninvasive breast cancer. Raloxifene should not be used in women who have not yet experienced menopause. Raloxifene is in a class of medications called selective estrogen receptor modulators (SERMs). Raloxifene prevents and treats osteoporosis by mimicking the effects of estrogen (a female hormone produced by the body) to increase the density (thickness) of bone. Raloxifene decreases the risk of developing invasive breast cancer by blocking the effects of estrogen on breast tissue. This may stop the development of tumors that need estrogen to grow.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Raloxifene comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take raloxifene at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take raloxifene exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take raloxifene even if you feel well. Do not stop taking raloxifene without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking raloxifene,

• tell your doctor and pharmacist if you are allergic to raloxifene, any other medications, or any of the ingredients in raloxifene tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven), cholestyramine (Prevalite), colestipol (Colestid), diazepam (Valium), diazoxide (Proglycem), medications that contain estrogen such as hormone replacement therapy (ERT or HRT), and lidocaine (Akten, Lidoderm, Xylocaine). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have any type of cancer and if you have or have ever had breast lumps or breast cancer; heart failure; kidney disease; or liver disease. If you have ever taken estrogen, tell your doctor if your triglycerides increased during your treatment.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Do not become pregnant while taking raloxifene. If you become pregnant while taking raloxifene, call your doctor immediately. Raloxifene may harm the fetus.

• you should know that raloxifene has not been found to cause spotting or menstrual-like bleeding nor to increase the risk of cancer of the lining of the uterus. Tell your doctor if you develop vaginal bleeding or spotting. Your doctor will need to examine you or order tests to find the cause of the bleeding.

• you should know that although raloxifene decreases the chance that you will develop invasive breast cancer, there is still a risk that you will develop this condition. You will still need regularly scheduled breast exams and mammograms before you start taking raloxifene and during your treatment with raloxifene. Call your doctor if you notice tenderness, enlargement, lumps, or any other changes in your breasts.

• if you are taking raloxifene to treat osteoporosis, talk to your doctor about other things you can do to prevent osteoporosis from developing or worsening. Your doctor will probably tell you to avoid smoking and drinking large amounts of alcohol and to follow a regular program of weight-bearing exercise.

What SPECIAL DIETARY instructions should I follow?

You should eat and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are taking raloxifene. Your doctor will tell you which foods and drinks are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods or if you have a condition that makes it difficult for your body to absorb the nutrients that you eat, tell your doctor. In that case, your doctor can prescribe or recommend a supplement.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Raloxifene may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• hot flashes (more common in the first 6 months of raloxifene therapy)
• leg cramps
• swelling of the hands, feet, ankles, or lower legs
• flu-like syndrome
• joint pain
• sweating
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of the symptoms mentioned in the IMPORTANT WARNING section, call your doctor immediately.

Raloxifene may cause other side effects. Call your doctor if you experience any unusual symptoms while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• leg cramps
• dizziness
• loss of coordination
• vomiting
• rash
• diarrhea
• tremor
• flushing

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.