Childrens 1 Year Plus Pain Relief Soluble Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Children’s Soluble Paracetamol Tablets 120 mg or Child Sugar Free Pain Relief Soluble Tablets or Children’s 1 Year Plus Pain Relief Soluble Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Paracetamol 120 mg/tablet
3 PHARMACEUTICAL FORM
A white round tablet with an odour of strawberries.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
To relieve pain and reduce fever in many conditions including headache, toothache, feverishness, colds and influenza.
4.2 Posology and method of administration
Children 1 to 6 years: 1 to 2 tablets
Children 6 to 12 years: 2 to 4 tablets
These doses may be given 3 or 4 times daily, if required, but not more frequently than every 4 hours.
Children under 1 year: not recommended except on medical advice.
For oral administration.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
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 liver disease.
Do not exceed the stated dose
Do not give more than 4 doses in 24 hours.
Do not give for more than 3 days without consulting your doctor.
Do not give to children under 1 year, except on the advice of a doctor.
Do not give with any other paracetamol-containing products.
If symptoms persist consult your doctor.
Keep all medicines out of the reach of children.
Label:
Immediate medical advice should be sought in the event of an overdose, even if the child seems well.
Leaflet or combined label/leaflet:
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.
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 regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
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
No adverse effects known.
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 overdosage, may be required.
General supportive measures must be available.
Symptoms of paracetamol overdosage in the first 24 hours include 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paracetamol is a peripherally acting analgesic with antipyretic activity.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentration occurring about 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10% as glutathione conjugates. Less than 5% is excreted as unchanged paracetamoL The elimination half life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose dependent.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included.
6.1 List of excipients
Citric acid Ph Eur
Sodium saccharin Ph Eur
Sorbitol Ph Eur
Sodium bicarbonate Ph Eur
Anhydrous sodium carbonate BPC
Strawberry flavour
Purified water Ph Eur
Gelatin
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
A cold form blister of nylon/aluminium/pvc laminate sealed to an aluminium foil. Pack sizes: 36, 48, 96.
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Special precautions for disposal
The tablets should be dissolved in half a glass of water or fruit juice before taking.
MARKETING AUTHORISATION HOLDER
Max Remedies Limited 10 Town End View Holmfirth West Yorkshire HD9 1AX
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of First Authorisation: 30 April 1991 Date of Last RenewaL: 17 July 1996
INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)