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PARALINK SUPPOSITORIES 240MG

Active substance(s): PARACETAMOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Paracetamol or Paralink Suppositories 240mg

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QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains Paracetamol Ph.Eur. 240mg

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PHARMACEUTICAL FORM
White, tapered, cylindrical suppositories with a smooth surface and rounded head, containing 240mg Paracetamol Ph.Eur.

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4.1

CLINICAL PARTICULARS
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 Children 5 12 years (18 39kg): 1 2 suppositories; maximum of 2g 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. 5 years (18 kg) (240mg) 1 suppository 12 years (39 kg) (480mg) 2 suppositories

4.3

Contraindications Hypersensitivity to paracetamol or any of the 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 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 Epidemologal 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 necessarily causally related to paracetamol.

4.9

Overdose 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. Johns 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 Nacetylcysteine, 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.

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5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Paracetamol is an antipyretic and analgesic proven in paediatric use. Paracetamol produces antipyresis through action on the hypothalmic heatregulation centre and analgesia by elevation of the pain threshold. Paracetamol has analgesic and antipyretic actions similar to those of aspirin but it 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 20mcg/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.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients Adeps Solidus Ph Eur. and Macrogol ester USP

6.2

Incompatibilities None

6.3

Shelf life 2 years

6.4

Special precautions for storage Store at a temperature not exceeding 25C

6.5

Nature and contents of container Suppositories are presented in strips five peel-apart, plastilaminate moulds. Two strips (ten suppositories) are packed into a cardboard carton. The plastilaminate consists of a layer of polyethylene, an outer layer of polyvinylchloride and a polyurethane adhesive layer.

6.6

Special precautions for disposal For use on one occasion only. Discard any unused material. Do not use if mould is damaged.

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MARKETING AUTHORISATION HOLDER
Ricesteele Manufacturing Limited Cookstown Industrial Estate Tallaght Dublin 24 Ireland.

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MARKETING AUTHORISATION NUMBER
PL 01648/0012

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/01/1996 / 25/10/2005

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DATE OF REVISION OF THE TEXT
20/10/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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