INFORMATION FOR PATIENTS

Read this leaflet before taking ARTHROTEC (diclofenac sodium 50 or 75 mg/misoprostol 200 mcg) and each time your prescription is renewed, because the leaflet may be changed.

ARTHROTEC is being prescribed by your doctor for treatment of your arthritis symptoms while at the same time providing protection from the development of stomach and intestinal ulcers due to the arthritis medication. ARTHROTEC contains diclofenac, an arthritis medication. ARTHROTEC also contains misoprostol to decrease the chance of getting stomach and intestinal ulcers that sometimes develop with NSAID medications. Serious side effects are still possible, however, and you should report to your physician any signs or symptoms of gastrointestinal ulceration or bleeding, skin rash, weight gain or swelling. If signs of liver toxicity occur (nausea, fatigue, lethargy, itching, jaundice, right upper quadrant tenderness, and "flu-like" symptoms) you should stop therapy and seek immediate medical attention.

Do not take ARTHROTEC if you are pregnant and do not become pregnant while taking this medication. ARTHROTEC can cause miscarriage, often associated with potentially dangerous bleeding. Such miscarriages may result in hospitalization, surgery, infertility or death.

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If you become pregnant during ARTHROTEC therapy, stop taking ARTHROTEC and contact your doctor immediately. Remember that even if you are using a means of birth control, it is still possible to become pregnant. Should this occur, stop taking ARTHROTEC and consult your physician immediately.

ARTHROTEC may cause diarrhea, abdominal pain, upset stomach and/or nausea in some people. In most cases these problems develop during the first few weeks of therapy and stop after about a week with continued treatment. You can minimize possible diarrhea by making sure you take ARTHROTEC with meals and by avoiding the use of antacids containing magnesium (if needed, use one containing aluminum or calcium instead). ARTHROTEC tablets should be swallowed whole, and not chewed, crushed or dissolved.

Because these side effects are usually mild to moderate and usually go away in a matter of days, most patients can continue to take ARTHROTEC. If you have prolonged difficulty (more than 7 days), or if you have severe diarrhea, cramping and/or nausea, call your doctor.

Take ARTHROTEC only according to the directions given by your doctor. Changes in dose should be made only with your doctor's approval.

Do not give ARTHROTEC to anyone else. It has been prescribed for your specific condition, may not be the correct treatment for another person, and could be dangerous for another person, especially a woman who may be, or could become, pregnant.

This information sheet does not cover all possible side effects of ARTHROTEC. See your doctor if you have questions.

ARTHROTEC is available only as a unit-of-use package that includes a leaflet containing patient information. The patient should read the leaflet before taking ARTHROTEC and each time the prescription is renewed because the leaflet may have been revised. Keep ARTHROTEC out of the reach of children.