Medications and Drugs

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Brand Names: Arthrotec

Generic Name: diclofenac and misoprostol (Pronunciation: dye KLOE fen ak and mye so PROST ole)

• What is diclofenac and misoprostol (Arthrotec)?
• What are the possible side effects of diclofenac and misoprostol (Arthrotec)?
• What is the most important information I should know about diclofenac and misoprostol (Arthrotec)?
• What should I discuss with my healthcare provider before taking diclofenac and misoprostol (Arthrotec)?
• How should I take diclofenac and misoprostol (Arthrotec)?
• What happens if I miss a dose (Arthrotec)?
• What happens if I overdose (Arthrotec)?
• What should I avoid while taking diclofenac and misoprostol (Arthrotec)?
• What other drugs will affect diclofenac and misoprostol (Arthrotec)?
• Where can I get more information?

What is diclofenac and misoprostol (Arthrotec)?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs.

The combination of diclofenac and misoprostol is used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.

Diclofenac and misoprostol may also be used for purposes not listed in this medication guide.

Arthrotec 50 mg

round, white, imprinted with SEARLE 1411, AAAA 50

Arthrotec 75 mg

round, white, imprinted with SEARLE 1421, AAAA 75

What are the possible side effects of diclofenac and misoprostol (Arthrotec)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using diclofenac and misoprostol and call your doctor at once if you have a serious side effect such as:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• swelling or rapid weight gain;
• urinating less than usual or not at all;
• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
• bruising, severe tingling, numbness, pain, muscle weakness;
• neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or
• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

• mild stomach pain, nausea, diarrhea, bloating, gas;
• dizziness, drowsiness, headache;
• blurred vision, ringing in your ears; or
• unusual vaginal bleeding.

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.

What is the most important information I should know about diclofenac and misoprostol (Arthrotec)?

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use diclofenac and misoprostol just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking diclofenac and misoprostol, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol. It may increase your risk of stomach bleeding caused by diclofenac.

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