The use of diclofenac sodium and misoprostol delayed-release tablets in patients with hepatic porphyria should be avoided. To date, one patient has been described in whom diclofenac sodium probably triggered a clinical attack of porphyria. The postulated mechanism, demonstrated in rats, for causing such attacks by diclofenac sodium, as well as some other NSAIDs, is through stimulation of the porphyrin precursor delta-aminolevulinic acid (ALA). 

Information for patients: Women of childbearing potential using diclofenac sodium and misoprostol delayed-release tablets to treat arthritis should be told that they must not be pregnant when therapy with diclofenac sodium and misoprostol delayed-release tablets is initiated, and that they must use an effective contraception method while taking diclofenac sodium and misoprostol delayed-release tablets. See boxed CONTRAINDICATIONS AND WARNINGS. 

THE PATIENT SHOULD NOT GIVE DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS TO ANYONE ELSE. Diclofenac sodium and misoprostol delayed-release tablets have been prescribed for the patient's specific condition, may not be the correct treatment for another person, and may be dangerous to the other person if she were to become pregnant. 

SPECIAL NOTE FOR WOMEN: DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS contain diclofenac sodium and misoprostol. Misoprostol may cause abortion (sometimes incomplete), premature labor, or birth defects if given to pregnant women.

Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.

  * Diclofenac sodium and misoprostol delayed-release tablets, like other NSAIDs, may cause serious side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS, CARDIOVASCULAR EFFECTS). 
  * Diclofenac sodium and misoprostol delayed-release tablets, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulceration and bleeding, and should ask for medical advice when observing any indicative sign or symptoms, including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding and Perforation). 
  * Diclofenac sodium and misoprostol delayed-release tablets, like other NSAIDs, can cause serious skin side effects, such as exfoliative dermatitis, SJS and TEN, which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible. 
  * Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians. 
  * Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness and “flu-like” symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical attention. 
  * Patients should be informed of the signs of an anaphylactic reaction (e.g. difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS, Anaphylactic Reactions). 
  * In late pregnancy, as with other NSAIDs, diclofenac sodium and misoprostol delayed-release tablets should not be taken because it may cause premature closure of the ductus arteriosus. 
  * Diclofenac sodium and misoprostol delayed-release tablets should not be taken by nursing mothers. 
  * Concomitant use of voriconazole increases the systemic exposure to diclofenac. When concomitant voriconazole use is necessary, the total daily dose of diclofenac should not exceed the lowest recommended dose of diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg twice daily (see Drug Interactions and Dosage and Administration). 



See PATIENT INFORMATION at the end of this labeling for important information to discuss with the patient. 

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