PARACETAMOL & CAFFEINE

Paracetamol/Caffeine effervescent tablets should be dissolved in at least half a tumblerful of water.

Adults (including the elderly) and children 16 years and over:

Two tablets up to four times daily. Do not exceed 8 tablets in 24 hours. Children aged 12 years to 15 years: 1 tablet dissolved in water every 4 to 6 hours when necessary up to a maximum of 4 tablets in 24 hours.

Paediatric population:

Paracetamol/Caffeine effervescent tablets are not recommended for children under 12 years. Method of administration Paracetamol/Caffeine effervescent tablets are for oral administration only.

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 MedDRA System Organ Class.

Adverse reactions identified during post-marketing use are reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown but likely to be very rare (<1/10,000).

Post marketing data:

PARACETAMOL Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Immune system disorders Very rare cases of serious skin reactions have been reported. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

CAFFEINE 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. Body System Undesirable effect Central Nervous system Dizziness Headache Cardiac disorders Palpitation Psychiatric disorders Insomnia Restlessness Anxiety and irritability Gastrointestinal disorders Gastrointestinal disturbances 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/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

Contains paracetamol. Do not use with any other paracetamol containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. 9). g. coffee, tea and some canned drinks) should be avoided while taking this product.

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. Do not exceed the stated dose. If symptoms persist consult your doctor. Keep out of the sight and reach of children.

Pack label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.

Patient information 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. 5 mg aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

This medicinal product contains 409 mg sodium per dose, equivalent to >20% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 167% of the WHO recommended maximum daily intake for sodium.

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