CALPROFEN Oral suspension Ref.[6922] Active ingredients: Ibuprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

Therapeutic indications

Children aged 3 months to 12 years: Mild to moderate pain, post-immunisation pyrexia, rheumatic or muscular pain, headache, reduction of fever, sore throat, teething pain, toothache, minor aches and pains, symptoms of cold and influenza.

Posology and method of administration

To be taken orally. For short term use only.

Children aged 3 months to 12 years

Not recommended for children weighing less than 5 kg.

For pain and fever – 20mg/kg/day in divided doses.

Infants 3-6 months: 2.5 ml three times a day. Do not use for more than 24 hours.

Infants 6-12 months: 2.5 ml three times a day.

Children 1-2 years: 2.5 ml three to four times a day.

Children 3-7 years: 5 ml three to four times a day.

Children 8-12 years: 10 ml three to four times a day.

Doses should be taken every 6–8 hours when required, and at least 4 hours should be left between doses.

Post-immunisation fever

2.5 ml (50 mg) followed by one further dose of 2.5 ml (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 children aged ≥3 months to ≤5 months

If the child’s symptoms worsen or if the symptoms persist for more than 24 hours, consult a doctor.

For children aged 6 months and over

If symptoms worsen or if the symptoms persist for more than 3 days, consult a doctor.

Overdose

In children, ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear-cut. The half-life in overdose is 1.5–3 hours.

Symptoms

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

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.

Shelf life

36 months.

Special precautions for storage

Do not store above 25°C.

Keep out of reach and sight of children.

Nature and contents of container

Amber glass bottle sealed with a child resistant, tamper evident cap. A syringe with a 2.5 ml and 5 ml measure is supplied with this pack.

Pack sizes: 100ml.

Special precautions for disposal and other handling

Shake well before use. Return any left over medicine to the Pharmacist.

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