📌 COMPOSITION

• Each capsule contains: 100 mg Diclofenac Sodium as follows:
  • Diclofenac Sodium B.P. 25 mg (in EC form)
  • Diclofenac Sodium B.P. 75 mg (in SR form)
• Each dispersible tablet of Diclosan DT contains: Diclofenac Free Acid 46.5 mg equivalent to 50 mg Diclofenac Sodium.

📌 DESCRIPTION

Diclosan (Diclofenac Sodium) is a non‑steroidal anti‑inflammatory compound with antirheumatic, analgesic, and antipyretic properties. Diclofenac Sodium acts mainly by inhibiting prostaglandin synthesis, which plays a major role in inflammation, pain and fever. Diclosan is an ideal dual‑release Diclofenac formulation containing part of the dose in enteric‑coated pellets that provide immediate action after consumption, while the rest of the dose is in the form of controlled‑release pellets that prolong the action sufficiently to prevent pain at night and early morning stiffness. The former component ensures that the drug is not released in the stomach, thus preventing gastric irritation and the ulcer‑producing tendency of the drug. Diclofenac Sodium is well absorbed after oral administration. Its peak plasma concentrations are achieved rapidly, and the plasma concentration remains above the effective level for a longer period. More than 99% of diclofenac is bound to plasma proteins. It penetrates the synovial fluid, where the concentration may persist for a long time (elimination half‑life 3-6 hours).

📌 INDICATIONS

• Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis.
• Painful syndromes of the vertebral column.
• Non‑articular rheumatism.
• Post‑traumatic and postoperative pain, inflammation and swelling.
• Painful and/or inflammatory conditions in gynaecology (e.g., primary dysmenorrhoea).

📌 DOSAGE & ADMINISTRATION

• Diclosan DRS: Should be taken with liquid, preferably with meals, as a single daily dose (one capsule) in milder cases and for long‑term therapy.
• Diclosan DT: Drop a Diclosan DT tablet into a glass of water and stir to aid dispersion before swallowing. 2-3 dispersible tablets daily.

📌 RESTRICTIONS ON USE

Contraindications

• Diclosan is contraindicated in patients with gastric or intestinal ulcer and known hypersensitivity to the active substance.
• It is also contraindicated in patients in whom urticaria, attacks of asthma or acute rhinitis are precipitated by any agent with prostaglandin synthetase‑inhibiting activity.

Precautions

• Diclosan should be taken with caution in patients suffering from impaired hepatic function and in patients with symptoms indicative of gastrointestinal disorders or a history of gastric or intestinal ulceration, as well as in patients with ulcerative colitis or Crohn's disease.
• As with other NSAIDs, hepatic function and blood count should be monitored regularly during long‑term treatment with Diclosan.
• Particular caution should be taken in patients with impaired cardiac or renal function, the elderly, and patients being treated with diuretics.

Use in Pregnancy and Lactation

Not recommended unless strictly recommended by a physician.

📌 DRUG INTERACTIONS

• Diclofenac Sodium may enhance the anticoagulant effect of coumarins.
• Concomitant therapy with cyclosporine may increase cyclosporine's nephrotoxicity.
• Diclofenac Sodium may raise plasma concentrations of lithium and digoxin when given concomitantly.
• Diclofenac Sodium may increase the blood concentration of methotrexate and its toxicity if administered less than 24 hours before or after treatment with methotrexate.
• Concomitant use of probenecid with Diclofenac Sodium increases the elimination rate of Diclofenac Sodium.
• Concomitant use of furosemide can reduce the natriuretic effect of furosemide and thiazides.

📌 ADVERSE EFFECTS

• Diclosan is well tolerated.
• The main adverse effects include: epigastric pain, nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, flatulence and anorexia.
• Rare adverse effects: gastrointestinal bleeding, gastric or intestinal ulcer.
• The drug should be discontinued if GIT bleeding occurs.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Diclosan DRS: Pack of 10 capsules and hospital packs of different sizes.
• Diclosan DT: Pack of 20 tablets and hospital packs of different sizes.