Pfizer Consumer Healthcare

Paraextra Hard Capsules

Paracetamol 500mg

Caffeine 32mg

Each hard capsule contains Paracetamol 500 mg and Caffeine 32 mg.

For a full list of excipients, see section 6.1.

Capsules, hard

Size 0, hard gelatin capsules with an opaque blue cap and an opaque yellow body, imprinted on both sections with “500/32”, containing a white, free flowing granule mix.

As an analgesic and antipyretic agent. The capsules are recommended for use in short term management of headaches, migraine and tension headaches, backache, rheumatic pain, muscle pain, period pain, neuralgia, toothache and for relieving fever, aches and pains of colds and influenza including the pain of sore throat.

Posology:

Adults(including the elderly):

1 to 2 capsules which may be repeated 4 hourly as necessary.

A maximum of 8 capsules in any 24 hour period.

Children:

Not recommended for children under 12 years of age.

Method of Administration: Oral.

• Use in children under 12 years.

• Hypersensitivity to any of the active substances or to any of the excipients.

• 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.

• If symptoms persist, consult your doctor.

• Prolonged use without medical advice may be harmful.

• Do not exceed the stated dose.

• Do not take this medicine with other Paracetamol containing products.

• Immediate medical advice should be sought in the event of overdosage even if you feel well.

• Use only when clearly necessary.

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.

Paracetamol:

Cholestyramine - The absorption of Paracetamol is reduced by cholestyramine. Therefore the Cholestyramine should not be taken within one hour if maximal analgesia is required.

Metoclopramide and Domperidone - The absorption of Paracetamol is increased by Metoclopramide and Domperidone. However, concurrent use need not be avoided.

Warfarin - Potentiation of Warfarin with continual high dosage of Paracetamol

Chloramphenicol - Increased plasma concentration of Chloramphenicol.

PARAEXTRA has no or negligible influence on the ability to drive and use machines.

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 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, 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 likely in adults who have taken 10g or more of Paracetamol. 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. 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 depleted due to e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Treatment

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 medical attention and any patient who has ingested around 7.5g or more of Paracetamol in the preceding 4 hours should undergo gastric lavage. Intravenous N-Acetylcysteine or oral Methionine protect the liver if administered within 8 to 12 hours of ingesting the overdose. N-Acetylcysteine is effective up to and possibly beyond 24 hours, but expert advice is essential. General supportive measures must be available.

Paracetamol has analgesic and antipyretic activity but it has no useful anti-inflammatory properties.

Caffeine is thought to increase the pain-relieving effect of Paracetamol.

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

Caffeine is absorbed readily after oral administration and is widely distributed through the body.

Metabolism - Paracetamol is metabolised in the liver. A minor hydroxylated metabolite which is usually produced in very small amounts by mixed function oxidases in the liver may accumulate following overdosage and cause liver damage.

Caffeine is metabolised almost completely via oxidation, demethylation and acetylation.

Excretion - Less than 5% is excreted in the urine as unchanged Paracetamol.

Caffeine is excreted in the urine as 1-methyluric acid, 1-methylxanthine and other metabolites with only 1% unchanged.

Not applicable

Maize Starch

Magnesium Stearate

Sodium Laurilsulfate

Croscarmellose Sodium

Capsule Shell

Gelatin

Purified water

Erythrosine (E127)

Patent blue V (E131)

Titanium dioxide (E171)

Quinoline Yellow (E104)

Printing Ink

Shellac

Titanium dioxide (E171)

Iron oxide, black (E172)

Propylene glycol

Ammonium hydroxide

Simeticone

Not applicable.

3 years.

Do not store above 25°C.

Cartons of 8, 10, 12 or 24 capsules in blister strips, composed of white, opaque, unplasticised polyvinyl chloride and printed aluminium foil, coated on the bright side with heat seal lacquer, compatible to PVC.

Not all pack sizes may be marketed.

No special requirements.

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

P.A. 822/169/1

Date of first authorisation: 02 December 2005

Date of last renewal: 02 December 2010

December 2014