Paracetamol 500mg Tablets

Paracetamol 500 mg per tablet.

For excipients, see 6.1.

Tablet

White, uncoated caplet with inscription on one side and plain on the other side

Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, neuralgia, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, aches and pains of colds and flu. Also recommended for the symptomatic relief of pain due to non-serious arthritis,

Adults:

Two tablets up to four times daily as required,

Children:

6-12 years: Half to one tablet three or four times daily as required. Not suitable for children under six years of age, Children should not be given paracetamol for more than 3 days without consulting a doctor.

These doses should not be repeated more frequently than every four hours nor should more than four doses be given in any 24 hour period.

Oral administration only.

Hypersensitivity to paracetamol or any of the other constituents.

Care is advised in the administration of paracetamol to patients with severe renal or hepatic impairment. The hazard of overdosage is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the recommended dose.

Patients should be advised to consult their doctor if their headaches become persistent. Patients should be advised not to take other paracetamol-containing products concurrently. Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.

If symptoms persist, consult your doctor. Keep out of reach of children.

Pack Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with other paracetamol-containing products.

Patient Information Leaflet:

Immediate medical advice should be sought in the event of an overdose even if you feel well, because of the risk of delayed, serious liver damage.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

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

None known.

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

Symptoms of paracetamol overdose 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patient, 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. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

N02B E01

Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependant on the inhibition of prostaglandin synthesis. The inhibition appears however to be on a selective basis.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 to 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 50% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 to 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.

No relevant information additional to that already contained elsewhere in the SPC.

maize starch

gelatin

colloidal anhydrous silica

Purified Talc

sodium starch glycollate (Type A)

magnesium stearate

The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes.

36 months.

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

Paracetamol Tablets are packaged in to blister packs containing 8 tablets.

The blister packs are constructed of clear, transparent PVC (0.25mm ) backed up with child resistant push through foil ( 20 micron aluminium foil /15 micron PVC film )

The tablets are available in packs of 16 tablets

No special instructions for use / handling

Accord Healthcare Limited

Sage House , 319 Pinner Road

North Harrow

Middlesex , HA1 4HF

United Kingdom

PL 20075/0062

9 June 2004

27/10/2009