This preparation is indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.

It is a combination product containing Diclofenac Sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and Misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E1 analog. The mechanism of action of Diclofenac Sodium, like other NSAIDs, is mainly related to inhibition of prostaglandin synthetase, leading to reduced prostaglandin synthesis. NSAIDs inhibit prostaglandin production, and a reduction of prostaglandins in the gastric and duodenal mucosa may decrease bicarbonate and mucus secretion, contributing to mucosal damage and ulcer formation. Misoprostol increases bicarbonate and mucus production in the gastrointestinal tract and helps protect the gastric and duodenal mucosa, thereby preventing ulcer formation.

Osteoarthritis: The recommended dosage for maximal GI mucosal protection is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.

Rheumatoid arthritis: The recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid or qid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.

Aspirin: Concomitant administration with aspirin is not recommended because Diclofenac Sodium is displaced from its binding sites by aspirin, resulting in lower plasma concentrations, peak plasma levels, and AUC values.

Digoxin: Elevated digoxin levels have been reported in patients receiving digoxin and Diclofenac Sodium together.

Antihypertensives: NSAIDs may reduce the activity of antihypertensive drugs, including ACE inhibitors.

Warfarin: The combined use of NSAIDs and warfarin increases the risk of gastrointestinal bleeding due to synergistic effects.

Oral hypoglycaemics: Diclofenac Sodium does not alter glucose metabolism in healthy individuals but may modify the response to insulin or oral hypoglycaemic agents in diabetic patients.

Antacids: Antacids reduce the bioavailability of Misoprostol and may delay the absorption of Diclofenac Sodium.

Diuretics: NSAIDs may inhibit diuretic activity. Concomitant use with potassium-sparing diuretics may increase serum potassium levels.

This combination is contraindicated in patients hypersensitive to Diclofenac, Misoprostol, or other prostaglandins. It is also contraindicated in patients who have experienced asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs.

The most common side effects are abdominal pain, diarrhea, and other gastrointestinal symptoms. These usually occur early in therapy and are self-limiting within 2–7 days. Rare cases of severe diarrhea leading to dehydration have been reported with Misoprostol.

Due to the abortifacient property of Misoprostol, this combination is contraindicated during pregnancy. Diclofenac Sodium is excreted in breast milk; therefore, it is not recommended during breastfeeding.

Patients with inflammatory bowel disease or those at risk of dehydration should be closely monitored during therapy.

Paediatric use: Safety and effectiveness in paediatric patients have not been established.

Geriatric use: Elderly patients may be more sensitive to adverse effects, although no major differences in safety or efficacy have been observed compared to younger patients.

Misoprostol: Convulsions, sedation, tremor, dyspnoea, diarrhea, abdominal pain, fever, palpitations, hypotension, and bradycardia. Management is supportive.

Diclofenac: Lethargy, drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression, anaphylactoid reactions, and coma (rare).

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs).

Store in a cool, dry place below 25°C. Protect from light.