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

Diclofenac sodium/misoprostol tablets are 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. Diclofenac sodium/misoprostol tablets contain diclofenac, an arthritis medication. Diclofenac sodium/misoprostol tablets also contain 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 diclofenac sodium/misoprostol tablets if you are pregnant (see boxed CONTRAINDICATIONS AND WARNINGS). Diclofenac sodium/misoprostol tablets contain 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 (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 diclofenac sodium/misoprostol tablets, stop taking diclofenac sodium/misoprostol tablets 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 diclofenac sodium/misoprostol tablets and consult your doctor immediately.

Diclofenac sodium/misoprostol tablets are not recommended for nursing mothers.

Diclofenac sodium/misoprostol tablets, 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). Diclofenac sodium/misoprostol tablets 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). 

Diclofenac sodium/misoprostol tablets, 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.

Diclofenac sodium/misoprostol tablets 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 diclofenac sodium/misoprostol tablets with meals and by avoiding the use of antacids containing magnesium (if needed, use one containing aluminum or calcium instead). 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 diclofenac sodium/misoprostol tablets. If you have prolonged difficulty (more than 7 days), or if you have severe diarrhea, cramping, and/or nausea, call your doctor.

Diclofenac sodium/misoprostol tablets 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.) 

Diclofenac sodium/misoprostol tablets, 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 diclofenac sodium/misoprostol tablets only according to the directions given by your doctor. Changes in dose should be made only with your doctor's approval.

Do not give diclofenac sodium/misoprostol tablets 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 diclofenac sodium/misoprostol tablets. See your doctor if you have questions.

Keep out of reach of children.

This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.