• Chemical Composition

    Paracetamol 500 mg - Diclofenac sodum 50 mg (as enteric coated granules)

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Mechanism Of Action Paracetamol is a clinically proven analgesic/antipyretic. Paracetamol produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating centre. Diclofenac has potent anti-inflammatory analgesic and antipyretic actions. The mechanism of these actions is inhibition of the enzyme, cyclo-oxygenase in the pathway of prostaglandin (PG) synthesis. PGs are known to be associated with inflammation. Diclofenac is available as the sodium or potassium salt. The former is enteric-coated to ensure optimum bioavailability, but this leads to some delay in the onset of action. The potassium salt is absorbed rapidly and action sets in much earlier.
INDICATIONS ٍEXTRAGESIC is used for the management of primary dysmenorrhoea, mild to moderate pain relief, non-articular rheumatoid conditions, rheumatoid or osteo-arthritis, cervical spondylosis, dental conditions, and pain and fever associated with inflammation.
CONTRAINDICATIONS -Hypersensitivity to any of the ingredients. -Paracetamol should not be used in patients with severe liver disease. -Diclfenac should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Side EFFECTS Nausea, vomiting, epigastric discomfort, skin rash, peptic ulcer, fluid retention, oedema, impairment of hepatic function rarely.
WARNINGS If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take any pain relievers/fever reducers. Extragesic should be used with caution in patients with symptoms or history of gastrointestinal diseases, impaired hepatic, or renal functions. ٍEXTRAGESIC may cause stomach bleeding or liver and renal damage. ٍEXTRAGESIC should be used with caution in patients with fluid retention, hypertension, or heart failure
DRUG INTERACTIONS An excessive intake of alcohol may increase the damage to the liver when taken with paracetamol. Cholestyramine may reduce the absorption of paracetamol from the gut. Paracetamol may increase the effects of warfarin and other anti-coagulant medicines. Furthermore, the effects of warfarin and NSAIDs on GI bleeding are synergistic. Blood levels of hydantoines, lithium and digoxin increased, when used concomitantly with ٍEXTRAGESIC, leading to enhanced efficacy and possible toxicity. Diclofenac Sodium inhibits diuretics but efficacy of Sodium sparing diuretics enhanced. Moreover, when used with cyclosporine the nephrotoxicity of both agents increases.
Pregnancy And lactations ٍEXTRAGESIC is contraindicated in late pregnancy, as with other NSAIDs, diclofenac should be avoided because it may cause premature closure of the ductus arteriosus. ٍEXTRAGESIC should be used with caution during breast feeding
Dosage And Administration For the treatment of pain or primary dysmenorrhea the recommended dosage is one tablet t.i.d. For the relief of osteoarthritis the recommended dosage is one tablet b.i.d. or t.i.d. For the relief of rheumatoid arthritis the recommended dosage is one tablet t.i.d. or q.i.d.
Storage Conditions “Store below 30 C” “Keep out of reach of children”