PARACETAMOL AND CAFFEINE

Posology:

Adults: 1 – 2 tablets dissolved in water not more frequently than every 4 – 6 hours as required up to a maximum of 8 tablets in 24 hours.

Elderly:

No special dosage regimen required, but care should be taken to observe the contraindications, precautions and warnings, which may be particularly applicable to elderly persons.

Paediatric population Children aged 16 – 18 years:

One to two tablets dissolved in water every 4 – 6 hours when necessary to a maximum of 8 tablets in 24 hours.

Children aged 12-15 years:

One tablet dissolved in water every 6 hours when necessary to a maximum of 4 tablets in 24 hours. Not recommended for children under 12 years. Method of administration Paracetamol and Caffeine 500mg / 50mg Soluble Tablets should be dissolved in at least half a tumbler of water.

Adverse events 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.

Hypersensitivity, including skin rash, may occur but is rare. There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol. Post marketing data Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction Skin and Subcutaneous disorders Very rare cases of serious skin reactions have been reported *There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Caffeine Central nervous system Dizziness When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store

• Paracetamol should be used with caution in patients with severe renal disease or liver dysfunction. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. • Excessive intake of caffeine from coffee and tea should be avoided while taking this product.

• Keep out of the sight and reach of children. • Do not exceed the stated dose. • If symptoms persist consult your doctor. • The label will say: Contains paracetamol. Do not take with any other paracetamol - containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

8% of the WHO recommended maximum daily intake of 2 g sodium for an adult. • These tablets contain sorbitol. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. • These tablets contain lactose.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. g. chronic alcoholism), as well as those using maximum daily doses of paracetamol.

Close monitoring, including measurement of urinary 5-oxoproline, is recommended.

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