A fixed-dose combination (FDC) analgesic, anti-inflammatory, and anti-edema agent. Aceclofenac is a potent NSAID with preferential COX-2 inhibition, Paracetamol is a centrally-acting analgesic and antipyretic, and Serratiopeptidase is a proteolytic enzyme with fibrinolytic, anti-inflammatory, and anti-edemic properties. This combination provides synergistic relief from pain, inflammation, and swelling, commonly used for acute musculoskeletal conditions in India.
Adult: One tablet (Aceclofenac 100mg + Paracetamol 325mg + Serratiopeptidase 15mg) twice daily, after meals.
Note: Swallow whole with a full glass of water. Take after food or with milk to minimize gastric irritation. Do not crush, chew, or break the tablet (especially if enteric-coated). Maintain adequate hydration.
Aceclofenac inhibits cyclooxygenase (COX) enzymes, preferentially COX-2, reducing prostaglandin synthesis at sites of inflammation, providing analgesic and anti-inflammatory effects. Paracetamol's exact mechanism is unclear but involves central inhibition of prostaglandin synthesis and modulation of serotonergic and cannabinoid pathways, providing analgesia and antipyresis with minimal peripheral anti-inflammatory action. Serratiopeptidase is a proteolytic enzyme that breaks down insoluble fibrin, exudates, and dead tissue, facilitating drainage, reducing swelling, and enhancing tissue permeability to improve antibiotic and NSAID penetration.
Pregnancy: Category C (first and second trimester). Avoid in third trimester (Category D) due to risk of premature closure of ductus arteriosus, oligohydramnios, and prolonged labor. Use only if potential benefit justifies potential fetal risk.
Driving: May cause dizziness, drowsiness, or blurred vision in some individuals. Patients should not drive or operate machinery until they know how the medicine affects them.
| Warfarin/Acenoocumarol | Increased risk of bleeding due to aceclofenac's antiplatelet effect and protein binding displacement. | Major |
| Aspirin, Clopidogrel | Increased risk of GI bleeding. Pharmacodynamic synergy. | Major |
| Lithium | Aceclofenac can decrease renal clearance of lithium, leading to toxicity. | Major |
| Methotrexate | NSAIDs can reduce renal excretion of methotrexate, increasing its toxicity. | Major |
| Diuretics (Furosemide, Thiazides) | Reduced diuretic and antihypertensive efficacy; increased risk of nephrotoxicity. | Moderate |
| ACE Inhibitors (Ramipril) / ARBs (Losartan) | Reduced antihypertensive effect; increased risk of renal impairment. | Moderate |
| Corticosteroids (Prednisolone) | Markedly increased risk of GI ulceration and bleeding. | Major |
| Antacids | May reduce absorption of aceclofenac. Separate administration by 2 hours. | Minor |
| Cholestyramine | Reduces absorption of paracetamol. | Moderate |
| Alcohol (Chronic use) | Potentiates risk of paracetamol hepatotoxicity and aceclofenac GI bleeding. | Major |
| Other NSAIDs (Ibuprofen, Diclofenac) | Increased risk of adverse effects without therapeutic benefit. Avoid combination. | Major |
| Antibiotics (Quinolones) | Increased risk of CNS stimulation and seizures. | Moderate |
Same composition (Aceclofenac (100mg) + Paracetamol (325mg) + Serratiopeptidase (15mg)), different brands: