Raloxifene Hydrochloride Oral tablet

What is this medicine?

RALOXIFENE (ral OX i feen) reduces the amount of calcium lost from bones. It is used to treat and prevent osteoporosis in women who have experienced menopause.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

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

• a history of blood clots
• cancer
• heart failure
• liver disease
• premenopausal
• an unusual or allergic reaction to raloxifene, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine 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 medicine more often than directed. A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

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.

What may interact with this medicine?

• ampicillin
• cholestyramine
• colestipol
• diazepam
• diazoxide
• female hormones like hormone replacement therapy
• lidocaine
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Do not stop taking this medicine except on the advice of your doctor or health care professional.

You should make sure you get enough calcium and vitamin D in your diet while you are taking this medicine. Discuss your dietary needs with your health care professional or nutritionist.

Exercise may help to prevent bone loss. Discuss your exercise needs with your doctor or health care professional.

This medicine can rarely cause blood clots. You should avoid long periods of bed rest while taking this medicine. If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine. This medicine 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 medicine. Smoking may also increase your risk of blood clots. Smoking can also decrease the effects of this medicine.

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

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• change in vision
• chest pain
• difficulty breathing
• leg pain or swelling
• skin rash, itching

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

• fluid build-up
• leg cramps
• stomach pain
• sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

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 medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.