PARACETAMOL AND CAFFEINE

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

Two capsules up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 8 capsules in 24 hours.

Children aged 12-15 years:

One capsule up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 4 capsules in 24 hours Paediatric population This medicine is not recommended for children under 12 years. Method of administration For oral administration.

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.

Anaphylaxis Cutaneous hypersensitivity reactions including (amongst others) skin rashes and angioedema. Respiratory, thoracic and mediastinal disorders Bronchospasm – more likely in patients sensitive to aspirin and other NSAIDs Hepatobiliary disorders Hepatic dysfunction 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.

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

Do not exceed stated dose. Keep out of the sight and reach of children. 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.

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 andclose 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. 9). g. coffee, tea and some canned drinks) should be avoided while taking this product.

If symptoms persist, medical advice must be sought.

Pack Label:

Talk to a doctor at once if you take too much of this medicine, even if you feel well. Do not take anything else containing paracetamol while taking this medicine.

Patient Information Leaflet:

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage This medicine contains sorbitol. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

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