Raloxifene

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.

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 must stop taking raloxifene at least 3 days ahead of time. You may not be able to restart the medicine until you are active again. Inform any doctor or surgeon who treats you that you take raloxifene.

Raloxifene is only a part of a complete treatment program that may also include changes to your diet, 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 regularly. Self-examine your breasts for lumps every month, and have regular mammograms.

Store at room temperature away from moisture and heat.

raloxifene may increase your risk of a blood clot in your leg, lung, or 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.

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

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

Do not breastfeed while taking raloxifene.

Raloxifene can increase your risk of having a stroke, which can be deadly. Inform your doctor if you have ever had:

• heart problems or irregular heartbeats;
• a heart attack or stroke, including a "mini-stroke";
• high blood pressure;
• cancer; or
• if you smoke.

Inform your doctor if you have ever had:

• a blood clot;
• high triglycerides due to using estrogen;
• liver or kidney disease;
• endometriosis;
• abnormal vaginal bleeding; or
• if you have not gone through menopause.

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.

Usual Adult Dose for Osteoporosis:

60 mg orally per dayComments:-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 dayComments:-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 dayComments:-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.

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

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

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

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.

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.