PARACETAMOL

Posology Adults, Elderly and Children over 16 years:

Two tablets every four hours as required. Not more than eight tablets in 24 hours. Do not take for more than 3 days without consulting your doctor. These doses should not be repeated more frequently than every four hours nor should more than four doses be given in any 24 hour period.

Paediatric population Children under 10 years:

Not recommended for children under 10 years of age.

Children aged 10 to 15 years:

One tablet every four to six hours when necessary to a maximum of four doses in 24 hours. Do not take for more than 3 days without consulting your doctor. These doses should not be repeated more frequently than every four to six hours nor should more than four doses be given in any 24 hour period .

Method of administration For oral administration

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 information below lists reported adverse reactions, ranked using the following frequency classification: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Body system class_ Undesirable effect Frequency Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Very rare Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angioedema Very rare Respiratory, thoracic and mediastinal disorders Bronchospasm* Very rare Hepatobiliary disorders Hepatic dysfunction Very rare Skin and subcutaneous tissue disorders Very rare cases of serious skin reactions have been reported Very rare 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; patients must seek medical advice before taking this medicine. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5- oxoproline, is recommended. 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. Caution is advised in asthmatic patients sensitive to aspirin, because light reaction bronchospasm with paracetamol (cross-reaction) has been reported in less than 5% of the patients tested.

In case of high fever, or signs of secondary infections or persistence of symptoms a doctor should be consulted.

The Pack Label will state:

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

The Patient Information Leaflet will state:

Do not take anything else containing paracetamol while taking this medicine. 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.

1.