Acenol Plus
ACENOL PLUS
Aceclofenac and Paracetamol Caplets
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QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Aceclofenac SP: 100 mg
Paracetamol SP: 500 mg
Excipients: Q.S.
Colour: Erythrosine and brilliant Blue
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PHARMACEUTICAL DOSAGE FORM
Tablet.
For oral administration. -
CLINICAL PARTICULARS
Therapeutic indications
ACENOL PLUS is indicated for relief from severe pain and inflammation in Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis, Low back pain, Dental pain, Gynaecological pain, painful & Inflammatory conditions of ear, nose & throat.
Posology and method of administration
ACENOL PLUS tablets are supplied for oral administration in adults.
The maximum recommended dose of ACENOL PLUS is two tablets daily, taken as one tablet in the morning and one in the evening.
Contraindications
'Patients sensitive to Aceclofenac, Paracetamol or to any of the excipients of the product. 'Patients in whom aspirin or other NSAIDs, precipitate attacks of bronchospasm. acute rhinitis or urticaria Of patients hypersensitive to these drugs.
Special warnings and precautions for use
ACENOL PLUS may cause dizziness. Driving or operating machinery is to be avoided.
Individuals receiving long-term treatment should be regularly monitored for renal function tests, liver function tests and blood counts. Caution should be exercised in patients with mild to moderate impairment of cardiac, hepatic or renal function
Interaction with other medicinal products and other forms of interaction
Aceclofenac may increase the plasma concentrations of Lithium, Digoxin and Methotrexate. It may increase the activity of Anticoagulants, inhibit the activity of diuretics, enhance cyclosporine nehrotoxicity and precipitate convulsions when co-administered with Quinolone antibiotics.
Pregnancy and Lactation
The drug is not recommended for pregnant women
Undesirable effects
The majority of side effects are related to gastrointestinal system, most frequent being dyspepsia, abdominal pain and rise in hepatic enzymes. Other rare side-effects include dizziness, constipation, vomiting, ulcerative stomatitis, rash, dermatitis, headache, insomnia.
Overdose
Over dosage may cause nausea, vomiting, hepatic failure and acute renal failure.
Treatment, if required, includes gastric lavage, activated charcoal and other symptomatic measures as per medical advice.
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PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Aceclofenac
Aceclofenac relieves pain and inflammation through a variety of mechanisms and in addition exerts stimulatory effects on cartilage matrix synthesis.Paracetamol
Analgesic - the mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS).Antipyretic - paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss.
Pharmacokinetic properties
Aceclofenac
Aceclofenac is well absorbed from gastrointestinal tract and peak plasma concentrations (Cmax) are reached 1-3 hours after an oral dose.The drug is more than 99% bound to plasma proteins and the volume of distribution (Vd) is approximately 25 liters. The drug is eliminated primarily through renal excretion with 70-80% of administered dose found in urine as glucoronides and rest being excreted in faeces. The plasma elimination half life of Aceclofenac is approximately 4 hours.
Paracetamol
Paracetamol is readily absorbed from the gastro intestinal tract after oral administration. Paracetamol is .distributed into most body tissues. It crosses the placenta and is present in breast milk.Paracetamol is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5 is excreted as unchanged paracetamol.
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PHARMACEUTICAL PARTICULARS
Special precaution for storage
Do not store above 25?C.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.