PARACETAMOL

Adults, the elderly and children 16 years and over:

Dose to be taken every four hours (not more than 4 times in 24 hours). Adults, including the elderly, and children over 15 years: 1 to 2 tablets Maximum dose of 8 tablets in 24 hours Paediatric population Children aged 10 to 15 years: 1 tablet every 4-6 hours when necessary to a maximum of 4 doses in 24 hours Children under 10 years: Not recommended for children under 10 years of age.

Under no circumstances must the daily dose of paracetamol exceed four grams in 24 hours. Do not take these tablets for more than three days except on medical advice. Use with care in patients with liver or kidney problems, and in patients taking other drugs that affect the liver.

Do not exceed the stated dose. An overdose is dangerous: medical attention should be sought immediately.

The following convention has been utilised for the classification of the frequency of adverse reactions: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

Adverse effects of Paracetamol are rare. Very rare cases of serious skin reactions have been reported There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia and agranulocytosis, but these were not necessarily causally related to Paracetamol.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Blood and lymphatic system disorders Very rare Thrombocytopaenia Immune system disorders Very rare Anaphylaxis, Cutaneous hypersensitivity reactions including, among others, skin rashes, angioedema, Stevens Johnson syndrome and Toxic Epidermal Necrolysis Respiratory, thoracic and mediastinal disorders Very rare Bronchospasm in patients sensitive to aspirin and other NSAIDs Hepatobiliary disorders Very rare Hepatic dysfunction 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.

Care is advised in the administration of Paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Do not take more medicine than the label tells you to.

If you do not get better, talk to your doctor. Contains Paracetamol. Do not take anything else containing paracetamol while taking this medicine. Talk to your 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. Patients should be advised that paracetamol may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.

7mg of lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 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.

Cases of hepatic dysfunction/ failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index, dehydrated, are chronic heavy users of alcohol or have sepsis.

In patients with glutathione depleted states the use of paracetamol may increase the risk of metabolic acidosis. If symptoms persist, medical advice must be sought. Keep out of sight and reach of children.

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