SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Paracetamol Elixir Paediatric BP l20mg/5ml

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol BP 120mg per 5ml

3 PHARMACEUTICAL FORM

Elixir

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the relief of pain and feverish conditions in children.

4.2 Posology and method of administration

Oral - every 4-6 hours, as required, up to a maximum of four doses in 24 hours.

Infants under 3 months:	on doctor’s advice only.
Children 3 months - 1 year:	half to one 5ml teaspoon.
Children 1 year - 6 years:	one to two 5ml teaspoons.

Not more than 4 doses should be administered in any 24-hour period.

4.3 Contraindications

Hypersensitivity to Paracetamol and/or other constituents.

Do not give to children under 3 months without medical advice.

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 hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the recommended dose.

If symptoms persist for more than three days, consult your doctor.

The product should not be diluted.

Keep out of reach and sight of children.

4.5 Interaction with other medicinal products and other forms of interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Fertility, 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.

Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

4.9 Overdose

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 and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 24 hours after ingestion. 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 possible in adults who have taken 10g or more of paracetamol.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

None stated.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol (96%) BP Propylene Glycol BP Chloroform Spirit BP Concentrated Raspberry Juice BPC Invert Syrup BPC Amaranth Solution BPC Glycerol (Glycerin) BP

6.2 Incompatibilities

None stated.

6.3 Shelf life

24 Months

6.4 Special precautions for storage

Keep out of the reach and sight of children.

6.5 Nature and contents of container

Amber glass bottles and plastic cap 100ml.

Plastic container and cap 2000ml.

6.6 Special precautions for disposal

None stated.

7    MARKETING AUTHORISATION HOLDER

Cox Pharmaceutical Limited 788-790 Finchley Road London NW11 7TJ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 42671/0002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30 September 1982 / 2 September 1999

10 DATE OF REVISION OF THE TEXT

06/11/2014