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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Paracetamol 500mg Tablets BP

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol BP 500mg

3 PHARMACEUTICAL FORM

Tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Taken orally for relief from:

1.    Headache

2.    Toothache

3.    Rheumatic Pains

4.    Neuralgia

5.    The symptoms of colds and influenza

4.2 Posology and method of administration

Dose to be taken every four hours (not more than 4 times in 24 hours)

Adults, including the elderly, and children over 12 years: 1 to 2 tablets Children 6 to 12 years: U to 1 tablet

Do not give to children under 6 years except on medical advice.

Do not take these tablets for more than three days except on medical advice. Use with care in patients with liver or kidney problems, and in patients taking other drugs that affect the liver.

Do not exceed the stated dose. An overdose is dangerous: medical attention should be sought immediately.

4.3 Contraindications

Hypersensitivity to Paracetamol and/or other constituents

4.4 Special warnings and precautions for use

Care is advised in the administration of Paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the recommended dose.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

4.5 Interaction with other medicinal products and other forms of interaction

The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone and the absorption reduced by cholestyramine.

The anticoagulant effect of Warfarin and other coumarins may be enhanced by prolonged regular use of Paracetamol with increased risk of bleeding; Occasional doses have no significant effect.

4.6 Fertility, Pregnancy and lactation

Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol used in the recommended dosage, but patients should follow the advice of their doctor.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to Paracetamol.

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, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.

Or

(b)    Regularly consumes ethanol in excess of recommended amounts.

Or

(c)    Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, 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 poisoning, 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 declines 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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Paracetamol is an effective analgesic and antipyretic agent but has only weak anti-inflammatory properties. Its mechanism of action is not fully understood, as it is only a weak inhibitor of prostaglandin bio-synthesis, but it has been suggested that it is more effective against enzymes in the CNS than those in the periphery. The drug has no effect on the cardiovascular and respiratory systems and it does not cause gastric irritation or bleeding like salicylates.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged Paracetamol. The elimination half-life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

A minor hydroxylated metabolite which is usually produced in very small amounts by mixed function oxidases in the liver, and which is usually detoxified by conjugation with liver glutathione, may accumulate following Paracetamol overdose and cause liver damage.

5.3 Preclinical safety data

None Stated

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Povidone (Kollidone K30) Ph. Eur.

Lactose 200# Ph. Eur.

Starch (Maize) Ph. Eur.

Magnesium Stearate Ph. Eur.

Sodium Starch Glycollate Ph. Eur.

6.2 Incompatibilities

None Known

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28/03/2002

DATE OF REVISION OF THE TEXT

19/11/2011

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