PARACETAMOL

Posology:

Adults, the elderly and children 16 years and over: One or two tablets to be taken every four to six hours, when necessary up to four times daily. Maximum dose of 8 tablets in 24 hours.

Children aged 10-15 years:

One tablet to be taken every four to six hours, when necessary to a maximum of four doses in 24 hours. Not suitable for children under 10 years of age. Children should not be given tablets for more than 3 days without consulting a doctor.

These doses should not be repeated more frequently than every 4-6 hours nor should more than 4 doses be given in any 24 hour period.

Method of administration:

Paracetamol tablets to be administered orally 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.

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 and angioedema Respiratory, thoracic and mediastinal Bronchospasm* disorders Hepatobiliary disorders Hepatic dysfunction Skin and subcutaneous tissue disorders Very rare cases of serious skin reactions have been reported.

* 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.

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. , 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.

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. Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.

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

Pack Label:

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Talk to a doctor at once if you take too much of this medicine, even if you feel well. Do not take anything else containing paracetamol while taking this medicine.

Patient Information Leaflet:

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

Hypersensitivity to paracetamol or any of the other constituents.