ACF-Plus Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Aceclofenac 100 mg, paracetamol 500 mg

Indications/Uses

Relief from pain & inflammation associated w/ ankylosing spondylitis, OA & RA.

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Dosage/Direction for Use

2 tab daily.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Hypersensitivity to aceclofenac & paracetamol, aspirin or other NSAIDs. Precipitate attacks of bronchospasm, acute rhinitis or urticaria. Active or suspected peptic ulcer or GI bleeding or bleeding disorders; severe heart failure, HTN, hepatic or renal insufficiency. Pregnancy (3rd trimester).

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Special Precautions

Regularly monitor for renal function tests, LFT & blood count if receiving long term treatment. Hepatic porphyria, coagulation disorder, history of peptic ulcer, ulcerative colitis, Crohn's disease cerebrovascular bleeding. Mild to moderate cardiac impairment. Patients on diuretic therapy or otherwise at risk of hypovolemia. May cause dizziness; avoid driving or operating machinery. Mild to moderate impairment of hepatic or renal function. Pregnancy & lactation. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Aceclofenac: Hypersensitivity, leukocytoclastic vasculitis, type III hypersensitivity reaction; anaphylaxis. Paracetamol: Haematological reactions including thrombocytopenia, leukopenia, pancytopenia, neutropenia, & agranulocytosis; skin rashes & other hypersensitivity reactions (occasionally).

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Drug Interactions

Aceclofenac: May increase plasma conc of lithium & digoxin. Increased nephrotoxicity w/ diuretics. Monitor serum K when used w/ K-sparing diuretics. May enhance activity of anticoagulants. May increase plasma MTX levels leading to toxicity w/in 2-4 hr of MTX administration. Risk of convulsions w/ quinolones. Paracetamol: Reduced absorption of cholestyramine (w/in 1 hr). Accelerated absorption w/ metoclopramide. Increased risk of liver damage in chronic alcoholics. Increased risk of toxicity w/ high dose, long-term use of barbiturates, carbamazepine, hydantoins, INH, rifampicin & sulfinpyrazone.

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Storage

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Description

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Action

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MIMS Class

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

ATC Classification

N02BE51 - paracetamol, combinations excl. psycholeptics ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

Regulatory Classification

Presentation/Packing

Form

ACF-Plus FC tab

Packing/Price

100's

ACF-Plus

aceclofenac + paracetamol

Manufacturer:

Mediwin

Distributor:

Phil Asia Pharma

Marketer:

Ambica