Raloxifene Hydrochloride Oral tablet

RALOXIFENE (ral OX i feen) prevents and treats osteoporosis after menopause. It works by making your bones stronger and less likely to break (fracture). It may also be used to lower the risk of breast cancer in people with osteoporosis or who are at high risk of breast cancer after menopause. It works by blocking the hormone estrogen in breast tissue, which prevents breast cancer cells from spreading or growing.

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. The tablets can be taken with or without food. Take your doses at regular intervals. Do not take your medication more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Vaginal bleeding after menopause, pelvic pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Hot flashes
• Joint pain
• Muscle pain or cramps
• Sweating
• Swelling of the ankles, hands, or feet

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

They need to know if you have any of these conditions:

• Blood clots
• Cancer
• Heart disease or recent heart attack
• High cholesterol or triglycerides
• History of stroke
• Kidney disease
• Liver disease
• Premenopausal
• Tobacco use
• An unusual or allergic reaction to raloxifene, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

• Cholestyramine
• Estrogen or progestin hormones
• Warfarin

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Visit your care team for regular checks on your progress. Do not stop taking this medication except on the advice of your care team.

If you are taking this medication to reduce your risk of getting breast cancer, you should know that this medication does not prevent all types of breast cancer. Talk to your care team if you have questions.

This medication does not prevent hot flashes. It may cause hot flashes in some patients at the start of therapy.

You should make sure that you get enough calcium and vitamin D while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

Exercise may help to prevent bone loss. Discuss your exercise needs with your care team.

This medication can rarely cause blood clots. If you are going to have surgery, tell your care team that you are taking this medication. This medication should be stopped at least 3 days before surgery. After surgery, it should be restarted only after you are walking again. It should not be restarted while you still need long periods of bed rest.

You should not smoke while taking this medication. Smoking may increase your risk of blood clots or stroke.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.