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PARACETAMOL SUPPOSITORIES 240MG

Active substance(s): PARACETAMOL / PARACETAMOL / PARACETAMOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Paracetamol or Paralink Suppositories 240mg

2

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

3

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

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 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.

6

PHARMACEUTICAL PARTICULARS

6.1

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 25°C

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.

7

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

8

MARKETING AUTHORISATION NUMBER
PL 01648/0012

9

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

10

/ 25/10/2005

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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