Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Children aged 3 months to 12 years:
Mild to moderate pain due to sore throat, teething pain, toothache, headache, minor aches and pains, symptoms of cold and influenza, post-immunisation pyrexia and reduction of fever.
For oral administration and short-term use only.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
For pain and fever – 20mg/kg/day in divided doses.
Infants from 3 up to 6 months:
Weighing more than 5 kg: One 2.5 ml dose may be given 3 times in 24 hours. Do not use for more than 24 hours
Infants from 6 up to 1 year: 2.5 ml three to four times a day.
Children from 1 up to 4 years: 5 ml three times a day.
Children from 4 up to 7 years: 7.5 ml three times a day.
Children from 7 up to 12 years: 10 ml threetimes a day.
Doses should be given every 6 to 8 hours if required. Leave as least 4 hours between doses.
Post-immunisation fever: 2.5ml (50mg) followed by one further dose of 2.5ml (50mg) six hours later if necessary. No more than 2 doses in 24 hours. If fever is not reduced, consult a doctor.
Do not give to children under 3 months of age.
For infants aged 3-5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist.
If in children aged from 6 months and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5–3 hours.
Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.
Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.
36 months.
Do not store above 25°C.
Keep out of sight and reach of children.
An amber glass bottle sealed with child resistant, tamper evident cap.
Pack sizes available: 100 ml. A double ended spoon with measures of 2.5ml and 5ml is provided.
Shake well before use. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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