A fixed-dose combination (FDC) analgesic, anti-inflammatory, and centrally-acting muscle relaxant. Thiocolchicoside is a semi-synthetic derivative of colchicoside with GABA-agonist and glycine-mimetic activity. Aceclofenac is a potent NSAID of the phenylacetic acid class. Paracetamol is a centrally-acting analgesic and antipyretic. This combination provides synergistic action for acute painful musculoskeletal conditions by targeting pain, inflammation, and muscle spasm simultaneously.
Adult: One tablet (Thiocolchicoside 4mg + Aceclofenac 100mg + Paracetamol 325mg) twice daily, after meals. Maximum duration: 7-10 days unless supervised by a physician.
Note: Take with or immediately after food with a full glass of water to minimize gastric irritation. Do not crush or chew. Swallow whole. Maintain adequate hydration. Do not take for more than the prescribed duration.
The combination exerts a multi-modal action. Thiocolchicoside acts as a competitive antagonist at spinal and supraspinal GABA-A receptor sites and as a glycine receptor agonist, leading to hyperpolarization of motor neurons and reduced muscle tone. Aceclofenac inhibits cyclooxygenase (COX) enzymes, preferentially COX-2, reducing prostaglandin synthesis (PGE2, PGF2α) at the site of inflammation. Paracetamol's exact mechanism is debated but involves central inhibition of prostaglandin synthesis, activation of descending serotonergic pathways, and possible interaction with the endocannabinoid and TRPV1 systems.
Pregnancy: Category C (Aceclofenac/Thiocolchicoside) and Category B (Paracetamol). Avoid in first and second trimesters unless potential benefit justifies risk. ABSOLUTELY CONTRANDICATED in third trimester (risk of premature closure of ductus arteriosus, oligohydramnios, prolonged labor).
Driving: Thiocolchicoside can cause dizziness, drowsiness, and blurred vision. Patients should be cautioned against driving or operating machinery until their response is known.
| Warfarin/Acenocoumarol | Increased risk of bleeding due to aceclofenac's antiplatelet effect and protein binding displacement | Major |
| Methotrexate | Reduced renal clearance of methotrexate, increasing toxicity risk | Major |
| Lithium | NSAIDs decrease renal lithium clearance, leading to lithium 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 |
| Other NSAIDs (Aspirin, Ibuprofen) | Increased risk of GI toxicity without added benefit | Major |
| Antiplatelets (Clopidogrel, Aspirin) | Increased risk of GI bleeding | Moderate |
| SSRIs (Fluoxetine, Sertraline) | Increased risk of upper GI bleeding | Moderate |
| Anticonvulsants (Phenobarbital, Carbamazepine) | Increased metabolism of paracetamol to toxic NAPQI, raising hepatotoxicity risk | Moderate |
| Alcohol (Chronic use) | Increased risk of hepatotoxicity (paracetamol) and GI bleeding (aceclofenac) | Major |
| CYP2C9 Inhibitors (Fluconazole, Amiodarone) | Increased aceclofenac plasma levels, risk of toxicity | Moderate |
| CYP3A4 Inhibitors (Ketoconazole, Clarithromycin) | Increased thiocolchicoside levels, risk of CNS side effects | Moderate |
Same composition (Thiocolchicoside (4mg) + Aceclofenac (100mg) + Paracetamol (325mg)), different brands: