PARACETAMOL & CAFFEINE

Posology Paracetamol Plus 500mg/65mg Effervescent Tablets should be dissolved in at least half a tumblerful of water.

Adults and children 16 years and over:

Two tablets every 4-6 hours up to four times daily. Do not exceed 8 tablets in 24 hours.

Elderly:

As for adults.

Children 12 to 15 years of age:

One tablet every 4-6 hours up to four times daily. Do not exceed 4 tablets in 24 hours. Method of Administration Paracetamol Plus 500mg/65mg 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 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.

Post marketing data Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis Very rare cases of serious skin reactions have been reported.

Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction Metabolism and nutrition disorders High anion gap metabolic acidosis* have been reported frequency is 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. Caffeine Central Nervous system Nervousness 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.

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. 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. Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other paracetamol-containing products concurrently. Each 2 tablet dose contains 854 mg of sodium and should not be taken by patients on a low sodium diet. This medicinal product contains 427 mg sodium per effervescent tablet, equivalent to 21% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

This medicine contains 50 mg of sorbitol per effervescent tablet. Sorbitol is a source of fructose. Patients with an intolerance to some sugars or who have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, should talk to their doctor before taking or receiving this medicine.

If symptoms persist consult your doctor. Keep out of the reach and sight 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.

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