Serious hypersensitivity (eg, anaphylaxis & angioedema) & skin (eg, exfoliative dermatitis, SJS & TEN) reactions. Discontinue treatment at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity; if signs of hepatic insufficiency occur, or if persistent abnormal LFTs (3x ULN) are detected; if GI, CV, renal or hepatic deterioration occurs during treatment. Not a substitute for ASA for CV thromboembolic disease prophylaxis. Risk of thrombotic events (MI & stroke). Upper GI complications (perforations, ulcers or bleedings); fluid retention, edema & HTN; new onset or recurrent CHF; elevated ALT &/or AST (≥3x ULN). Increased risk of skin reactions in patients w/ history of any drug allergy. May mask fever & other signs of inflammation. Patients w/ risk factors for CV events (eg, HTN, hyperlipidaemia, DM & smoking); dehydration; pre-existing oedema; at risk of developing GI complication w/ NSAIDs or w/ prior history of GI disease eg, ulceration & GI bleeding; history of cardiac failure, left ventricular dysfunction, or HTN. Re-evaluate periodically the need for symptomatic relief & response to therapy, especially in patients w/ OA. Control HTN before treatment. Monitor renal function in patients w/ pre-existing significantly impaired renal function, uncompensated heart failure or cirrhosis; BP w/in 2 wk after initiation of treatment & periodically thereafter; any patient w/ symptoms &/or signs suggesting liver dysfunction or w/ abnormal LFT. Rehydrate patients prior to starting therapy. Increased risk of GI adverse effects (GI ulceration or other GI complications) w/ concomitant ASA (even at low dose). Concomitant use w/ other NSAIDs; warfarin or other oral anticoagulants. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Moderate hepatic dysfunction (Child-Pugh score 7-9). Not recommended in women attempting to conceive. Discontinue use during pregnancy. Not to breastfeed during treatment. Elderly.