Possible serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis; serious hypersensitivity reactions (eg, anaphylaxis, angioedema). Discontinue use at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Patients w/ history of GI perforations, ulcers & bleeding. May increase risk of thrombotic events (especially MI & stroke). Carefully consider patients w/ significant risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking). Not a substitute for aspirin for CV prophylaxis. Further increased risk of GI adverse effects when used concomitantly w/ acetylsalicylic acid. Fluid retention. Patients w/ a history of cardiac failure, left ventricular dysfunction, or HTN & in those w/ pre-existing oedema from any other reason. Monitor BP w/in 2 wks after initiation of treatment & periodically thereafter. Patients w/ renal, hepatic or cardiac dysfunction. Patients w/ dehydration; rehydrate patients prior to therapy. May mask fever & other signs of inflammation or infection. Co-administration w/ warfarin or other oral anticoagulants. Contains lactose. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Patients who experience dizziness, vertigo or somnolence should refrain from driving or operating machinery. Possible renal papillary necrosis & other renal injury in long-term use. Consider monitoring of renal function in patients w/ pre-existing significantly impaired renal function, uncompensated heart failure or cirrhosis. Discontinue use if signs of hepatic insufficiency occur or if persistently abnormal liver function tests are detected. Not recommended in women attempting to conceive. Elderly; patients >65 yr have higher risk of GI perforations, ulcers & bleeding.
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