RELIMOL

Posology For all indications:

Adults, the elderly, and children aged 16 years and over: One or two tablets up to four times daily as required.

Children:

Aged 10 - 15 years: One tablet up to four times daily as required. Not suitable for children under 10 years of age. Children should not be given Paracetamol for more than 3 days without consulting a doctor. These doses should not be repeated more frequently than every four hours, and not more than four doses should be taken in any 24-hour period.

Method of administration Oral administration only.

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 and frequency.

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).

Adverse event frequencies have been estimated from spontaneous reports received through post-marketing data. Post marketing data Body System Undesirable Effect Frequency Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Very rare Immune System disorders Anaphylaxis Cutaneous hypersensitivity reactions including, among others, skin rashes and angiodema.

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. ** There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

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.

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.

2 where relevant): • Hepatic impairment • Chronic alcoholism • Renal impairment (GFR≤50ml/min) • Gilbert’s Syndrome (familial non-haemolytic jaundice) • Concomitant treatment with medicinal products affecting hepatic function • Glucose-6-phosphate dehydrogenase deficiency • Haemolytic anaemia • Glutathione deficiency • Dehydration • Chronic malnutrition • Weight less than 50kg Do not exceed the stated 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 andneed to take painkillers every day. 9). If symptoms persist consult your doctor.

Keep out of the sight and reach of children. 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.

Pack Label:

Immediate medical advice should be sought in the event of an overdose, even if you feelwell. 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 feelwell, because of the risk of delayed, serious liver damage.

Hypersensitivity to paracetamol or any of the other excipients.