Aceclofenac, paracetamol.
Orange coloured capsule shaped biconvex film coated tablet with break line on one side and other side plain.
Each film-coated tablet contains: Aceclofenac 100 mg, Paracetamol 500 mg.
Non-Steroidal Anti-inflammatory and Antirheumatic/Analgesic.
Pharmacology: Pharmacodynamics: Aceclofenac is well absorbed from the gastrointestinal tract, peak plasma concentrations are reached 1 to 3 hours after an oral dose.
Plasma-elimination half-life is about 4 hours. About two-thirds of a dose is excreted in the urine, mainly as hydroxy metabolites. A small amount is converted to diclofenac.
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral doses.
Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. The elimination half-life of Paracetamol varies from about 1 to 3 hours. Paracetamol is metabolised mainly in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged Paracetamol. A minor hydroxylated metabolite (N-acetyl-p-benzoquinone imine), is usually produced in very small amounts by cytochrome P450 isoenzymes (mainly CYP2E1 and CYP3A4) in the liver and kidney. It is usually detoxified by conjugation with glutathione but may accumulate after Paracetamol overdosage and cause tissue damage.
Pharmacokinetics: Absorption: Aceclofenac: Rapidly absorbed; almost 100% bioavailability; peak plasma levels reached about 1.25-3 hr after oral admin.
Distribution: Aceclofenac: >99.7% bound to plasma proteins; distributes into synovial fluid.
Paracetamol: Distributes throughout most fluids of the body.
Metabolism: Aceclofenac: Probably metabolised by CYP2C9; average plasma elimination half-life: 4-4.3 hr.
Paracetamol: Mainly metabolised hepatically; plasma elimination half-life: 1-4 hr.
Excretion: Aceclofenac: About two-thirds of the administered dose is removed in the urine, mainly as conjugated hydroxy metabolites.
Aceclofenac + Paracetamol is indicated for relief from pain and inflammation associated with ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis.
The usual dose is 2 tablets a day. Reduced dose should be used in patients with hepatic impairment.
Or as prescribed by the physician.
Overdosage may cause nausea, vomiting, pain in abdomen, dizziness, somnolence, headache, sweating, pancreatitis, hepatic failure and acute renal failure. Treatment, if required, includes gastric lavage, activated charcoal and other symptomatic measures as per medical advice.
Aceclofenac + Paracetamol is contraindicated in the following situations: Patients sensitive to Aceclofenac, Paracetamol or to any of the excipients of the product.
Patients in whom aspirin or other Non-Steroidal Anti-Inflammatory Drug, precipitate attacks of bronchospasm, acute rhinitis or urticaria or patients hypersensitive to drugs.
Patients with active or suspected peptic ulcer or gastrointestinal bleeding or bleeding disorders.
Patients with severe heart failure, hypertension, hepatic or renal insufficiency.
Third trimester of pregnancy.
The combination of Aceclofenac and Paracetamol may cause dizziness. Driving or operating machinery should be avoided. Individuals receiving long term treatment should be regularly monitored for renal function tests, liver function test and blood count. It is used with caution in hepatic porphyria, coagulation disorder, history of peptic ulcer, ulcerative colitis, Crohn's disease cerebrovascular bleeding, pregnancy and lactation. Caution should be exercised in patients with mild to moderate impairment of cardiac, hepatic or renal function and in elderly patients who are more likely to be suffering from these conditions. Caution is also required in patients on diuretic therapy or otherwise at risk of hypovolemia.
Aceclofenac + Paracetamol (ACF-PLUS) should not be taken during pregnancy (Third trimester) and lactation.
Hypersensitivity, Leukocytoclastic vasculitis, a type III hypersensitivity reaction, has been reported after therapy with aceclofenac. Anaphylaxis has also occurred. Paracetamol are rare and usually mild, although haematological reactions including thrombocytopenia, leukopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Skin rashes and other hypersensitivity reactions occur occasionally.
Seek medical attention immediately at the first sign of any adverse drug reaction.
Paracetamol: Reduced absorption of cholestyramine within 1 hr of administration. Accelerated absorption with metoclopramide.
Increased risk of liver damage in chronic alcoholics. Increased risk of toxicity with high doses or long term administration of barbiturates, carbamazepine, hydantoins, isoniazid, rifampicin and sulfinpyrazone.
Aceclofenac: May increase the plasma concentrations of lithium and digoxin. Increased nephrotoxicity with diuretics. Serum-potassium should be monitored when used with potassium-sparing diuretics. May enhance activity of anticoagulants. May increase plasma methotrexate levels leading to toxicity if administered within 2-4 hours of methotrexate administration. Risk of convulsions with quinolones. Potentially fatal.
Store at temperatures not exceeding 30°C.
N02BE51 - paracetamol, combinations excl. psycholeptics ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
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