ILONAMOL

Posology Adults, Elderly and Children over 16 years 1 or 2 tablets up to four times daily as required. These doses should not be repeated more frequently than every four hours nor should more than 4 doses be given in any 24-hour period.

Children aged 10 – 15 years:

One tablet every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. Children should not be given Paracetamol 500 mg Tablets for more than 3 days without consulting a doctor.

Children under 10 years:

Not recommended. Alternative presentations of paracetamol are recommended for paediatric usage in order to obtain suitable doses. Method of administration Oral administration only.

Adverse effects of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive postmarketing 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 angioedema Very rare cases of serious reactions have been reported.

Very rare Respiratory, thoracic and mediastinal disorders Bronchospasm* Very rare Hepatobiliary disorders Hepatic dysfunction Very rare Metabolism and nutrition disorders High anion gap metabolic acidosis 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. 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.

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

9). Use with caution in patients with glutathione depletion due to metabolic deficiencies. 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.

If symptoms persist the patient should consult his/her doctor.

Pack Label:

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

Keep out of the sight and reach of children Patient Information Leaflet:

Talk to you doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause serious, delayed liver damage.

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