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 in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). 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 other 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; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and seek medical attention or call your doctor at once if you have any of these serious side effects:

• 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, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• bruising, severe tingling, numbness, pain, muscle weakness; or
• neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

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)?

Misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus if the medication is taken during pregnancy. Diclofenac can cause birth defects if it is taken during the last 3 months of pregnancy.

Do not use diclofenac and misoprostol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use diclofenac. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking diclofenac. Older adults may have an even greater risk of these serious gastrointestinal side effects.

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

Do not drink alcohol while taking diclofenac and misoprostol. Alcohol can increase the risk of stomach bleeding caused by diclofenac.