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PAEDIATRIC PARACETAMOL ORAL SOLUTION B.P
NAME OF THE MEDICINAL PRODUCT
Paediatric Paracetamol Oral Solution B.P.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol B.P. 120.0 mg/5 ml
Therapeutic Indications For the relief of mild to moderate pain in children. As an antipyretic for children.
Posology and Method of Administration Children aged from 3 months to 1 year 2.5 -5 ml (60- 120mg). Children aged from 1 year to 5 years One to two 5 ml spoonfuls (120 - 240 mg) Children aged from 6 years to 12 years Two to four 5 ml spoonfuls (240-480 mg) The dose may be given not more than four times daily at not less than four hourly intervals. Do not exceed the stated dose. Dosing should not continue for more than three days without consulting a doctor.
The product should not be given to children under the age of 3 months except on the advice of a doctor. Route of administration Oral.
Contra-Indications Contraindicated in patients with known hypersensitivity to paracetamol and/or other constituents.
Special Warnings and Precautions for Use If symptoms persist for more than three days, seek medical advice. Do not exceed the stated dose. It should be given with care to patients with impaired kidney or liver function. The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease. Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage. Do not give with any other paracetamol-containing products.
Interactions with other Medicaments and other forms of Interaction The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of paracetamol; alcohol can increase the hepatotoxicity of paracetamol overdosage. The anti coagulant 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.
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.
Undesirable Effects When taken at the usual recommended dosage, side-effects are mild and infrequent - adverse reactions are rare. Skin rashes and other allergic reactions occur rarely. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
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 had ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous Nacetylcysteine 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 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, 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.
Pharmacodynamic Properties Paracetamol has analgesic and antipyretic properties and is used in the treatment of pain, such as toothache, headache and neuralgia.
Pharmacokinetic Properties Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring at 0.5-2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with less than 5% being excreted as unchanged paracetamol. The elimination half-life varies from 1-4 hours. Plasma protein binding is negligible at normal therapeutic concentrations. A minor hydroxylated metabolite, which is usually produced in very small amounts in the liver by mixed function-oxidases and which is usually detoxified by conjugation with liver glutathione, may accumulate following paracetamol overdosage and cause liver damage.
Preclinical Safety Data There are no preclinical data of relevance which are additional to that already covered in other sections of the SPC.
List of Excipients Invert sugar Potable water Ethanol 96% Propylene glycol Citric acid monohydrate Powdered blackcurrant flavour Powdered raspberry flavour Blackcurrant colour Chloroform Amaranth solution Glycerol
Incompatibilities No significant incompatibilities known.
Shelf Life 36 months.
Special Precautions for Storage Do not store above 25C
Nature and Contents of Container Dispensing packs 2000 ml white HDPE polythene bottle with plastic screw cap and aluminium foiled lined expanded polyethylene liner. 500 ml white HDPE polythene bottle with plastic wadless screw cap. Patient or OTC packs as appropriate 100 ml and 200 ml amber glass bottle with plastic J caps.
Instruction for Use/Handling None.
MARKETING AUTHORISATION HOLDER Wise Pharmaceuticals Ltd Hani Wells Business Park, Unit 7, Hardicker Street, Manchester, M19 2RB
MARKETING AUTHORISATION NUMBER PL 18374/0018
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION 17th February 2005
DATE OF REVISION OF THE TEXT
25th February 2009