ARRESTIN-P is contraindicated in patients with hypersensitivity to any of the ingredients, in those known to have bronchospasm or acute rhinitis or urticaria with aspirin or similar agents, presence of active or suspected peptic ulcer, gastrointestinal or other active bleeding, bleeding disorders, severe heart or kidney or liver failure. It is not advocated in small children below 18 months of age, and during the last trimester of pregnancy.

ARRESTIN-P should be administered with caution in patients with acid-peptic disease, inflammatory bowel disease, impaired renal or liver functions, blood dyscrasias, SLE, porphyria, hematopoietic and coagulation disorders, and in patients with hypersensitivity to aspirin or other NSAIDs.

ARRESTIN-P is to be advocated with due caution in those on diuretics, or otherwise at risk of hypovolemia. It should be used in pregnant women and nursing mothers only if absolutely required. Data on safety and efficacy of aceclofenac in children is not adequate. In those receiving long-term ARRESTIN-P, periodical monitoring of renal and hepatic functions and blood counts is necessary.

Aceclofenac (in ARRESTIN-P) should be coadministered with caution along with oral thrombolytics, diuretics, cyclosporine, tacrolimus, phenytoin, digoxin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole, sulfaphenazole, methotrexate, lithium, and highly protein-bound drugs.

The most common side effects are gastric pain, flatulence, nausea, vomiting, diarrhea and dyspepsia; rarely peptic ulcer and gastrointestinal bleeding occur. Infrequently, hypersensitivity reactions, skin reactions, taste perversion, malaise, change in appetite and weight, edema, palpitations, flushing, purpura and eye disorders are possible due to aceclofenac (in ARRESTIN-P). Neurological reactions possible include headache, drowsiness, insomnia, irritability and mood disturbances. ARRESTIN-P can rarely cause hepatitis, renal dysfunction and blood dyscrasias on account of its aceclofenac content.

Side effects of paracetamol (in ARRESTIN-P) are rare, and usually mild. Skin rashes and other hypersensitivity reactions could occur, and, on rare occasions, paracetamol could cause hemato-logical changes.

Aceclofenac (in ARRESTIN-P) could interact with oral thrombolytics, diuretics, cyclosporine, tacrolimus, phenytoin, digoxin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole,sulfaphenazole, methotrexate, lithium, and Highly protein-bound drugs.