Pfizer Consumer Healthcare

Paracetamol 500 mg Film Coated Tablets

Each Tablet Contains: Paracetamol 500.0mg

For a full list of excipients, see section 6.1.

Film-coated Tablet.

White capsule shaped film coated tablets embossed on one face with “P-500” and with a break bar on the reverse. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal halves.

Paracetamol is a mild analgesic and anti-pyretic. The tablets are recommended for use in the short-term management of headaches, including migraine and tension headaches, backache, rheumatic and muscle pain, period pains, nerve pains, toothache and for relieving fever, aches and pains of colds and flu.

Posology

Adults:

1-2 tablets 3-4 times daily.

A maximum of 8 tablets should not be exceeded in any 24-hour period

Paediatric Population

Children over 12 years:

1-2 tablets 3-4 times daily.

A maximum of 8 tablets should not be exceeded in any 24-hour period

Children aged 6-12 years:

½ to 1 tablet 3-4 times daily.

A maximum of 4 tablets should not be exceeded in any 24-hour period

Children under 6 years:

Not recommended

Method of Administration: Oral

• Hypersensitivity to Paracetamol or any of the constituents

• Consult the doctor if there is no improvement

• Caution should be exercised in patients with impairment of hepatic or renal function (avoid if severe). The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

• Do not take other Paracetamol containing products

• If symptoms persist for more than 3 days, consult your doctor

• Prolonged use without medical supervision may be harmful

Patients should be advised that Paracetamol may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.

Care should be taken in patients treated with any of the following drugs as interactions have been reported:

None known.

Side effects are rare but hypersensitivity, including skin rash may occur.

Very rare cases of serious skin reactions (including severe cutaneous reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Acute Generalised Exanthematous Pustulosis) have been reported.

Isolated report of thrombocytopenia purpura, methaemogolobinaemia, agranulocytosis and hepato-biliary disorders have been reported for Paracetamol containing products.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Immediate medical advice should be sought in the event of overdosage because of the risk of irreversible liver damage.

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 and this may be manifested in increasing pro-thrombin time, which is a reliable indicator of deteriorating liver function. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, coma 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.

Liver damage is likely in adults who have taken 10g or more of Paracetamol. Acute or chronic ingestion of Paracetamol above the recommended dose may lead to liver damage particularly if the patient has risk factors.

Risk Factors

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.

It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of Paracetamol are ingested), become irreversibly bound to liver tissue.

Management

Immediate treatment is essential in the management of Paracetamol overdose. Despite lack of significant early symptoms, patients should be referred to hospital urgently for immediate attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma Paracetamol concentrations should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).

Or any patient who have ingested about 7.5g or more of Paracetamol in the preceding 4 hours should undergo gastric lavage. Plasma Paracetamol concentrations 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 indigestion.

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. General supportive measures must be available.

Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.

ATC code: N02BE5

Pharmacotherapeutic group: Other analgesics and antipyretics

Analgesic - the mechanism of analgesic action has not been fully determined. Paracetamol may act predominately by inhibiting prostaglandin synthesis in the Central Nervous System (CNS) and to a lesser extent, through a peripheral action by blocking pain-impulse generation.

Antipyretic - Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat / regulation centre to produce peripheral vasodilation resulting in increased blood flow though the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

Absorption

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion.

Metabolism

Paracetamol is metabolised in the liver.

Excretion

Paracetamol is excreted in the urine, mainly as 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 major 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 overdosage and cause liver damage.

Not applicable.

Croscarmellose sodium

Povidone

Pre-gelatinised Maize Starch

Stearic Acid

Hypromellose 3 cps

Hypromellose 5 cps

Macrogol 3350

Not applicable.

5 years (from the date of manufacture of the Paracetamol DC90 mix).

Do not store above 25°C.

uPVC hard tempered aluminium foil blister packs containing 6, 8, 12, 16, 24 and 32 tablets.

Not all pack sizes may be marketed.

No special requirements.

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland.

PA 822/167/1

Date of first authorisation: 2^nd March 1989

Date of last renewal: 2^nd March 2009

November 2014