PARACETAMOL 500 mg Tablets

COMPOSITION:

Each tablet contains:Paracetamol 500 mg

PHARMACOLOGICAL ACTION:

Paracetamol has analgesic and antipyretic effects similar to those of aspirin. However, it has no anti-inflammatory effect and does not share the antirheumatic properties of the salicylates. It is rapidly and practically completely absorbed from the gastro-intestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is about 2 hours after therapeutic doses. It is distributed into most body tissues.

INDICATIONS:

For the relief of mild to moderate pain and fever.

CONTRA-INDICATIONS:

Sensitivity to paracetamol.
Severe liver function impairment.

WARNING:
Dosage in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should only take paracetamol under medical supervision. Consult your doctor if no relief is obtained from the recommended dosage.

DOSAGE AND DIRECTIONS FOR USE:

Adults
1 to 2 tablets every 4 hours when necessary (maximum 8 tablets in 24 hours).
Children 6 - 12 years
½ to 1 tablet when necessary (maximum 4 tablets in 24 hours).
Children under 6 years
Paracetamol tablets are not recommended.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Skin rashes and other allergic reactions may occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions. In a few cases the use of paracetamol has been associated with the occurrence of thrombocytopaenia, neutropaenia, pancytopaenia, leucopaenia and agranulocytosis. The dose should be reduced in renal functional impairment.
Paracetamol should also be given with care to patients taking other drugs that affect the liver such as the barbiturates.
The absorption of paracetamol may be accelerated by metoclopramide. Excretion may be affected and plasma concentrations altered when administered with probenecid.
Prolonged excessive use may cause irreversible kidney damage.

STORAGE INSTRUCTIONS:

Store below 25°C. Protect from light and moisture. Keep out of reach of children.