CHILD SUGAR FREE PAIN RELIEF SOLUBLE TABLETS, CHILDRENS SOLUBLE PARACETAMOL TABLETS 120 MG - summary of medicine characteristics

Summary of medicine characteristics - CHILD SUGAR FREE PAIN RELIEF SOLUBLE TABLETS, CHILDRENS SOLUBLE PARACETAMOL TABLETS 120 MG

SUMMARY 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 6 to 8 years: 2 tablets every 4–6 hours when necessary to a maximum of 4 doses in 24 hours.

Children 9 to 10 years: 3 tablets every 4–6 hours when necessary to a maximum of 4 doses in 24 hours.

Children 11 to 12 years: 4 tablets every 4–6 hours when necessary to a maximum of 4 doses in 24 hours.

Children under 6 years: not recommended except on medical advice.

For oral administration.

The tablets should be dissolved in half a glass of water or fruit juice before taking.

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 alcoholic liver disease.

Do not exceed the stated dose.

Not to be given to children under 16 years.

Dosage should not be continued for more than three days without consulting your doctor.

If symptoms persist, consult your doctor.

Do not take with any other paracetamol-containing

products. Keep all medicines out of the reach and sight of

children.

Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet or combined label/leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel 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 Fertility, pregnancy and lactation

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

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.

Very rare cases of serious skin reactions have been reported. Very rarely there have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causality related to paracetamol.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard.

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

Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.

6 PHARMACEUTICAL PARTICULARS

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

24 tablets in an aluminium/polythene laminate in a carton.

2 × 12 tablets in a nylon/aluminium/polyethylene laminate sealed to an aluminium/polyethylene laminate in a carton.

A cold form blister of nylon/aluminium/pvc laminate sealed to an aluminium foil.

Pack sizes: 6, 10, 12, 18, 20, 24, 25, 30

6.6 Special precautions for disposal