SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Paracetamol or Paralink Suppositories 500mg

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each suppository contains Paracetamol Ph.Eur. 500mg

3    PHARMACEUTICAL FORM

White, tapered, cylindrical suppositories with a smooth surface and rounded head, containing 500mg Ph.Eur.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment of mild to moderate pain and pyrexia. The suppositories may be particularly useful in patients unable to take oral forms of Paracetamol e.g. post-operatively or with nausea and vomiting.

4.2.    Posology and Method of Administration

Adults, elderly and children 12 - 18 years: 1 - 2 suppositories; maximum of 4g in 24 hours

Dose may be repeated every 4 - 6 hours with a maximum of 4 doses in 24 hours.

The dose should be based on age and weight i.e.

12 years (39kg) - (500mg) 1 suppository Adults and the elderly (1g) 2 suppositories

4.3    Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

Special Warnings and Precautions for Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the recommended dose. Patients should be advised not to take other paracetamol containing products concurrently. If symptoms persist, consult your doctor. Keep out of the sight and reach of children.

4.5    Interaction with other medicinal products and other forms of interaction

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. The rate of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by coleystyramine.

4.6    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 regarding its use.

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 a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not casually related to paracetamol.

4.9    Overdose

Liver damage is possible in adults who have paracetamol.

Ingestion of 5g or more of paracetamol may lead to 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,    It 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, haemorrage, 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 antipyretic and analgesic proven in paediatric use. Paracetamol produces antipyresis through action on the hypothalmic heat-regulation centre and analgesia by elevation of the pain threshold. Paracetamol has analgesic and antipyretic actions similar to those of aspirin but has no useful anti-inflammatory properties.

5.2    Pharmacokinetic properties

Paracetamol has analgesic and antipyretic actions but only weak antiinflammatory properties.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations occur within 0.5 to 2 hours, with slightly faster absorption of liquid preparations. Usual analgesic doses produce total serum concentrations of 5 to 20pg/ml. A good correlation between serum concentration and analgesic effect has not been found. Serum protein binding varies from 20% to 50% at toxic serum concentrations.

Paracetamol is excreted in the urine mostly as metabolites; 2-4% is excreted unchanged. The average elimination half-life is 1 to 4 hours: half-life is slightly prolonged in neonates (2.2 to 5 hours) and in cirrhotics.

The overall elimination rate constant for paracetamol in children, from birth to 12 years of age, is the same as for adults but neonates have diminished capacity to form glucuronide conjugates of paracetamol.

5.3    Preclinical safety data

Paracetamol is a well established drug substance whose preclinical profile has been investigated thoroughly and is established.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Hard Fat Macrogol Ester

6.2    Incompatibilities

None

6.3    Shelf life

2 years

6.4    Special precautions for storage

Store at a temperature not exceeding 25°C

6.5    Nature and contents of container

Each suppository filled by the machine is contained in a plastic cavity, part of a strip of five. Two strips (10 suppositories) are then packed into a cardboard carton.

The layer of the cavity next to the suppository is composed of polyethylene, the outside layer is polyvinylchloride and they are held together with polyurethane.

6.6    Special precautions for disposal

For use on one occasion only. Discard any unused material. Do not use if the mould is damaged.

7    MARKETING AUTHORISATION HOLDER

Ricesteele Manufacturing Limited,

Cookstown Industrial Estate,

Belgard Road,

Tallaght,

Dublin 24,

Ireland

8    MARKETING AUTHORISATION NUMBER

PL 01648/0013

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24/02/1995    /    12/09/2001

10 DATE OF REVISION OF THE TEXT

02/11/2009