BONADOL Tablet / Caplet Ref.[115615] Active ingredients: Paracetamol

Posology

Adults including the elderly and children over 16 years

One to two tablets every 4-6 hours as required, to a maximum of 8 tablets daily in divided doses.

Children 10-15 years

One tablet every 4-6 hours as necessary to a maximum of 4 doses in 24 hours.

Children under 10 years

Not recommended for children under 10 years of age. Alternative presentations of paracetamol are recommended for paediatric usage in order to obtain suitable doses of less than 500 mg.

Method of Administration

For oral administration.

Liver damage is possible in adults who have taken 10g or more of Paracetamol. Ingestion of 5g or more of Paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

A, Is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John’s Wort or other drugs than induce liver enzymes.

Or

B, Regularly consumes ethanol in excess of recommended amounts.

Or

C, Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV, starvation, cachexia.

Symptoms

Symptoms of Paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisioning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention.

Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote decines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

3 years.

Do not store above 25°C. Store in the original package.

Primary packaging: The primary packs are blister pack (composed of printed Aluminium foil and Transparent PVC foil or the primary packs are Bulk pack (composed of 1000cc plastic container and 1000cc polyethylene nylon).

Secondary packaging: A light orange and white inner carton containing ten blister packs of ten caplets each. or A labeled 1000cc plastic jar containing 1000 caplets held in sealed 1000cc “BOND” polythene bag.

No special requirements.

Any unused product or waste materials should be disposed of in accordance with local requirements.