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

ARTHROTEC (diclofenac sodium, misoprostol) 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 (diclofenac sodium, misoprostol) contains diclofenac, an arthritis medication. ARTHROTEC (diclofenac sodium, misoprostol) 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 doctor 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.

If signs of an anaphylactic reaction occur (e.g., difficulty breathing, swelling of the face or throat), you should stop therapy and seek immediate medical attention (see WARNINGS).

Do not take ARTHROTEC if you are pregnant (see boxed CONTRAINDICATIONS AND WARNINGS). ARTHROTEC (diclofenac sodium, misoprostol) contains diclofenac sodium and misoprostol. Misoprostol can cause abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. It is also important to avoid pregnancy while taking this medication and for at least one month or through one menstrual cycle after you stop taking it. Misoprostol has been reported to cause the uterus to rupture (a tear) when given after the eighth week of pregnancy. Rupture (tearing) of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death.

If you become pregnant during therapy with ARTHROTEC (diclofenac sodium, misoprostol) , stop taking ARTHROTEC (diclofenac sodium, misoprostol) 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 (diclofenac sodium, misoprostol) and consult your doctor immediately. ARTHROTEC (diclofenac sodium, misoprostol) is not recommended for nursing mothers.

ARTHROTEC (diclofenac sodium, misoprostol) , like other NSAIDs, may cause an increased risk of heart attack or stroke, which can lead to death. This risk may increase with duration of use. If you have heart disease or risk factors for heart disease, you may be at greater risk (see boxed CONTRAINDICATIONS AND WARNINGS). ARTHROTEC (diclofenac sodium, misoprostol) should never be used for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see boxed CONTRAINDICATIONS AND WARNINGS).

Although serious CV events can occur without warning symptoms, ask for medical advice when observing signs and symptoms of chest pain, shortness of breath, weakness, or slurring of speech (see boxed CONTRAINDICATIONS AND WARNINGS).

ARTHROTEC (diclofenac sodium, misoprostol) , like other NSAIDs, may cause GI discomfort and, rarely, serious GI effects such as ulcers and bleeding, which may result in hospitalization and even death. ARTHROTEC (diclofenac sodium, misoprostol) 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 (diclofenac sodium, misoprostol) with meals and by avoiding the use of antacids containing magnesium (if needed, use one containing aluminum or calcium instead). ARTHROTEC (diclofenac sodium, misoprostol) 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 (diclofenac sodium, misoprostol) . If you have prolonged difficulty (more than 7 days), or if you have severe diarrhea, cramping, and/or nausea, call your doctor.

ARTHROTEC (diclofenac sodium, misoprostol) may also cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can lead to death. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see boxed CONTRAINDICATIONS AND WARNINGS). This risk may increase with duration of use.

Although serious GI tract ulcerations and bleeding can occur without warning symptoms, ask for medical advice when observing signs and symptoms of ulceration and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis. (See boxed CONTRAINDICATIONS AND WARNINGS.)

ARTHROTEC (diclofenac sodium, misoprostol) , like other NSAIDs, may cause serious skin side effects, such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis, which may result in hospitalization and even death.

Although serious skin reactions may occur without warning, ask for medical advice when observing signs or symptoms, such as skin rash and blisters, fever, or other signs of hypersensitivity such as itching. Stop the drug immediately at the first appearance of skin rash or any other signs of hypersensitivity and contact your physician as soon as possible.

Take ARTHROTEC (diclofenac sodium, misoprostol) 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 (diclofenac sodium, misoprostol) 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 (diclofenac sodium, misoprostol) . See your doctor if you have questions.

Keep out of reach of children.

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.

This chance increases:

• with longer use of NSAID medicines
• in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

• can happen without warning symptoms
• may cause death

The chance of a person getting an ulcer or bleeding increases with:

• taking medicines called “corticosteroids” and “anticoagulants”
• longer use
• smoking
• drinking alcohol
• older age
• having poor health

NSAID medicines should only be used:

• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

• different types of arthritis
• menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery

Tell your healthcare provider:

• about all of your medical conditions.
• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
• if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
• if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Get emergency help right away if you have any of the following symptoms:

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some of these NSAID medicines are sold in lower doses without a prescription (over –the –counter). Talk to your healthcare provider before using over –the –counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 2/9/2011
This monograph has been modified to include the generic and brand name in many instances.