ARRESTIN-SP 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 children, and during pregnancy and lactation.

ARRESTIN-SP 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.

Aceclofenac (in ARRESTIN-SP) 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 ARRESTIN-SP) in children is not adequate. In those receiving long-term ARRESTIN-SP, periodical monitoring of renal and hepatic functions and blood counts is necessary.

Aceclofenac (in ARRESTIN-SP) 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. Since serratiopeptidase may increase the action of anticoagulative drugs, these must be coadministered with caution with ARRESTIN-SP.

The most common side effects are hypersensitivity reactions, gastric pain, flatulence, nausea, vomiting, diarrhea and dyspepsia with ARRESTIN-SP. Rarely peptic ulcer and gastrointestinal bleeding, taste perversion, malaise, change in appetite and weight, edema, palpitations, flushing, purpura and eye disorders are possible due to aceclofenac (in ARRESTIN-SP). Neurological reactions due to aceclofenac (in ARRESTIN-SP) include headache, drowsiness, insomnia, irritability and mood disturbances.

Aceclofenac and paracetamol (in ARRESTIN-SP) can rarely cause hepatitis, renal dysfunction and blood dyscrasias.

Aceclofenac (in ARRESTIN-SP) could interact with oral thrombolytics, diuretics, cyclosporine, tacrolimus, phenytoin, digoxin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole, sulfaphenazole, methotrexate, lithium, and highly protein-bound drugs. Serratiopeptidase (in ARRESTIN-SP) can increase the action of anticoagulant drugs).