FENNINGS CHILDRENS COOLING

Oral administration according to the following posology: 3 months to under 1 year 1 powder 1 year to under 6 years 2 powders 6 years to under 12 years 4 powders Do not give more frequently than every 4 – 6 hours. Repeat to a maximum of 4 doses daily.

The powder may be given in a little milk or jam.

Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class.

Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Body System Undesirable effect Frequency Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Very rare Immune system Disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis Very rare Respiratory, thoracic and mediastinal disorders Bronchospasm* Very rare Hepatobiliary Disorders Hepatic dysfunction Very rare Skin and subcutaneous tissue disorders Very rare cases of serious skin reactions have been reported Very rare Metabolism and nutrition disorders High anion gap metabolic acidosis Not known * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

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. uk/yellowcard.

Use with caution in the presence of severe impaired renal or hepatic function. Do not give with any other paracetamol-containing products. Do not exceed the stated dose. If symptoms persist consult your doctor. Keep out of the reach and sight of children.

Contains paracetamol. Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

1 Interaction with other medicinal products and other forms of interaction Liver microsomal inducing agents such as barbiturates, tricyclic antidepressants and alcohol may increase paracetamol hepatotoxicity. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant 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. 4).

Hypersensitivity to paracetamol and/or other constituents. Not to be given to children under 3 months except on medical advice.