PARAVESCENT

For oral administration only. Dissolve the tablets in water (about 200 ml) before swallowing. These tablets are effervescent, stir before use.

Adults, the elderly and children over 16 years:

One or two tablets to be taken up to four times daily. Maximum dose of 8 tablets in 24 hours.

Children 12-15 years :

One tablet,every 4-6 hours when necessary to a maximum of 4 doses in 24 hours.

Children under 12 years of age:

Not recommended. The dose should not be repeated more frequently than every 4 hours, and not more than 4 doses should be taken in any 24 hour period. Dosage should not be continued for more than 3 days without consulting a doctor.

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

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.

The following convention has been utilised for the classification of the undesirable effects: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data) Post marketing data Body System Undesirable effects Frequency Skin and subcutaneous disorders Very rare cases of serious skin reactions have been reported Very Rare 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 Bronchospasm* Very Rare Hepatobiliary disorders Hepatic dysfunction Very Rare Metabolism and nutrition disorders High anion gap metabolic acidosis** Not Known Description of selected adverse reactions * 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 isimportant.

Contains paracetamol. Do not use with any other paracetamol-containing products. Underlying liver disease increases the risk or paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.

Do not exceed the recommended dose. Patients should be advised to consult their doctor if their headaches become persistent. Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers everyday.

This medicinal product contains 438mg of sodium per dose, equivalent to 22% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 175% of the WHO recommended maximum daily intake for sodium.

Paracetamol Effervescent tablets are considered high in sodium. This should be particularly taken into account for those on a low salt diet. 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.

The tablets also contain aspartame (a source of phenylalanine) and so should not be taken by people with phenylketonuria. Neither nonclinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. If symptoms persist, medical advice must be sought .

Keep out of the sight and reach of children 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

Hypersensitivity to paracetamol and/or other constituents