Raloxifene is used to treat osteoporosis in postmenopausal women.

Raloxifene is not for use in men.

Raloxifene may also be used for purposes not listed in this medication guide.

raloxifene may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take raloxifene if you have ever had this type of blood clot.

Raloxifene can also increase your risk of a stroke, which can be fatal. This risk is highest if you have certain risk factors (such as smoking, having heart problems or high blood pressure, or if you have ever had a heart attack or a stroke).

Although this medicine is for use only in postmenopausal women, you should not take raloxifene if you are pregnant or breastfeeding.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

If you need major surgery or will be on long-term bed rest, you will need to stop taking raloxifene at least 3 days ahead of time. You may not be able to restart the medicine until you are active again. Tell any doctor or surgeon who treats you that you take raloxifene.

Raloxifene is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin D supplements. Follow your doctor's instructions very closely.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Osteoporosis:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

Usual Adult Dose for Prevention of Osteoporosis:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

Usual Adult Dose for Prevention of Breast Cancer:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

This medicine may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take raloxifene if you have ever had this type of blood clot.

This medicine is for use only in women who can no longer get pregnant. Raloxifene can harm an unborn baby. Do not use if you are pregnant or may become pregnant.

Do not breastfeed while taking raloxifene.

Raloxifene can increase your risk of a stroke, which can be fatal. Tell your doctor if you have ever had:

• heart problems, irregular heartbeats;

• a heart attack or stroke, including "mini-stroke";

• high blood pressure;

• cancer; or

• if you smoke.

Tell your doctor if you have ever had:

• a blood clot;

• high triglycerides caused by using estrogen;

• liver or kidney disease;

• endometriosis;

• abnormal vaginal bleeding; or

• if you have not gone through menopause.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

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.

If you take calcium supplements, do not take more than your doctor has prescribed. Taking more calcium than recommended will not provide extra protection for your bones, and may cause serious side effects including kidney stones.

Avoid sitting still for long periods of time during travel while you are taking raloxifene.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Raloxifene may cause serious side effects. Stop using raloxifene and call your doctor at once if you have:

• swelling, tenderness, or other changes in your breasts;

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), slurred speech, vision problems;

• signs of a blood clot in the lung--chest pain, trouble breathing, coughing up blood; or

• signs of a blood clot deep in the body--swelling, warmth, or redness in an arm or leg.

Common side effects of raloxifene may include:

• hot flashes;

• leg cramps;

• swelling in your hands, feet, or ankles;

• joint pain;

• flu symptoms; or

• increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• cholestyramine;

• warfarin (Coumadin, Jantoven); or

• birth control pills or hormone replacement therapy.

This list is not complete. Other drugs may affect raloxifene, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.