ANALGISER Tablet Ref.[28102] Active ingredients: Paracetamol

Posology

Adults

One to two Analgiser tablets every 4 to 6 hours. Dosage should not be repeated earlier than 4 hours. Not more than 8 Analgiser tablets should be administered daily (maximum 4g of paracetamol daily).

Paediatric population

Children 12 years and over

Dosage as for adults.

Children under 12 years

Half to one tablet three or four times daily at intervals of not less than four hours, up to a maximum of four tablets in 24 hours.

Children under 6 years

Not recommended.

Elderly

Dosage as for adults.

Renal insufficiency (creatinine clearance <10 ml/min)

The interval between doses should be at least 8 hours. The maximum daily dose should not exceed 2 g of paracetamol (4 Analgiser tablets).

Method of administration

Analgiser tablets should be taken with a liquid (water, milk, juice).

Symptoms

In case of a paracetamol overdosage patients may appear well for the first 3 days and then succumb to liver damage. Liver damage is due to the accumulations in the hepatocytes of a highly reactive intermediate metabolite.

Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion as liver function tests become abnormal. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe cases liver failure may lead to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, coma and death. Acute renal failure with acute tubular necrosis (symptoms of loin pain, haematuria and proteinuria) may develop with or without severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Liver damage is likely in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite become irreversibly bound to liver tissue. Ingestion of 5 g or more may lead to liver damage if the patient has risk factors (on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John’s Wort or other drugs that induce liver enzymes, or regularly consumes ethanol in excess of recommended amounts, or is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia).

Management

Immediate treatment is essential in the management of paracetamol overdosage.

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 but results should not delay initiation of treatment beyond 8 hours after ingestion. N-acetylcysteine intravenously or methionine orally may have a beneficial effect, provided they are given within 48 hours of ingesting an overdosed. Patients may be particularly sensitive to the toxic effects of paracetamol overdosed if they are chronic alcoholics, receive barbiturates or they are chronically malnourished.

Gastric lavage is recommended. Despite the lack of significant early symptoms patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Treatment is symptomatic and supportive.

5 years.

Store below 25°C, in the original package, in order to protect from light and moisture.

PVC – Aluminum blisters.

Blister packs with 20, 50 or 100 tablets and hospital packs with 500 or 1000 tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.