Raloxifene Hydrochloride, Oral

What are other names for this medicine?

Type of medicine: selective estrogen receptor modulator (SERM)

Generic and brand names: raloxifene hydrochloride, oral; Evista

What is this medicine used for?

This medicine is taken by mouth to prevent and treat osteoporosis (loss of bone mass) in postmenopausal women (women who no longer have regular monthly periods).

This medicine is also used to lower the risk of invasive breast cancer in postmenopausal women who have osteoporosis or who are at increased risk of invasive breast cancer. It does not treat breast cancer and will not prevent all types of breast cancer.

It may be used for other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Do not take this medicine if you:

• are pregnant or could become pregnant
• have ever had an allergic reaction to this medicine
• have ever had blood clots
• have to stay in bed for a long time (more than 48 hours) for any reason. You may need to stop taking this medicine while you recover from surgery or major illness.

Tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• cancer
• heart disease or a stroke
• high cholesterol or high triglyceride levels in your blood
• liver or kidney disease
• phlebitis (inflammation of the veins in your legs)

Females of childbearing age: Do not take this medicine if you are pregnant or could become pregnant because it can seriously harm the baby. Do not breast-feed while taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine directed by your healthcare provider. Do not stop taking this medicine unless your healthcare provider approves. You may take this medicine with or without food. Take the medicine at the same time each day to help you remember to take it.

Your healthcare provider may suggest that you take calcium and vitamin D tablets to help prevent bone loss.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: leg cramps, dizziness, diarrhea, tremor, flushing, rash.

What should I watch out for?

Women who have had blood clots in the past should not take this medicine. To prevent blood clots, avoid long periods of sitting. If you are traveling, try to walk around for at least a few minutes every hour or two. Stop taking this medicine if you have to stay in bed for more than 72 hours, such as while you recover from surgery or major illness. Talk with your provider about this.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine. Your healthcare provider may want you to stop taking this medicine at least 3 days before a planned surgery.

Hot flashes are common while taking this medicine, especially during the first six months that you take it.

Your healthcare provider may recommend walking or other exercise while you are taking this medicine. Also, your healthcare provider may recommend that you do not smoke or drink alcohol because they increase your risk of osteoporosis.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Serious (report these to your healthcare provider right away): Severe leg pain or feeling of warmth in the calves, swelling of the legs, hands, or feet, shortness of breath, coughing up blood, chest pain, rash, unexplained vaginal bleeding, sudden change in vision, sudden or severe headache, sudden numbness or weakness.

Other: Hot flashes, leg cramps, headache, trouble sleeping, tiredness, nausea, diarrhea, gas, weight gain, muscle or joint pain, depression, sweating.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• cholesterol-lowering medicines such as cholestyramine (Questran) and colestipol (Colestid)
• diazepam (Valium)
• diazoxide (Proglycem)
• estrogen products such as conjugated estrogens (Premarin), esterified estrogens (Estratab, Menest), estradiol (Estraderm, FemPatch, Vivelle, Estrace), and estropipate (Ogen, Ortho-Est)
• lidocaine (Lidoderm)
• warfarin (Coumadin)

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.