DOLVAN

2 Posology To be taken by mouth Adults and children over 12 years: One or two tablets three times a day Elderly: One tablet three times a day Children under 12 years: Not recommended

Frequency unknown:

Drowsiness may occasionally occur but is less likely with this combination. 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 causality related to paracetamol.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in 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.

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Dolvan may potentiate the effects of alcohol or other sedatives, use with caution in patients with cardiovascular disorders, prostatic enlargement or bladder dysfunction. Care is advised in the administration of Paracetamol to patients with severe renal or severe hepatic impairment.

Patients are advised not to take any other paracetamol containing products concurrently. If symptoms persist the patient should consult their doctor. Keep out of the reach of children. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or 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 case of HAGMA in patients with multiple risk factors.

Hypersensitivity to paracetamol and/or any of the active ingredients and porphyria. Contraindicated in persons under treatment with monoamine oxidase inhibitors and within two weeks of stopping such treatment. Known hepatic or renal impairment.