PARACETAMOL

Posology Dose depends on the body weight and age; a single dose ranges from 10 to 15 mg/kg body weight to a maximum of 60 mg/kg body weight for total daily dose.

Warning:

This medicine contains 1000 mg (1 g) of paracetamol per unit. Patients should be advised not to take two simultaneously.

Adults, the elderly and children 16 years and over (weighing more than 50 kg):

Take one tablet every 4-6 hours as required. Not recommended for children under 16 years of age. The dose should not be repeated more frequently than every 4 hours and not more than 4 doses should be taken in any 24 hours. The lowest effective dose should be used for the shortest time possible.

4). If pain persists for more than 5 days, fever for more than 3 days, or pain or fever gets worse or other symptoms appear, the clinical situation should be evaluated.

Renal impairment:

It is recommended when giving paracetamol to patients with renal impairment, to reduce the dose and to increase the minimum interval between each administration to at least 6 hours unless directed otherwise by a physician.

See table:

Glomerular filtration rate Dose 10-50 ml/min 500 mg every 6 hours <10 ml/min 500 mg every 8 hours This product is not suitable for patients with renal insufficiency when a reduced dose is required. More appropriate forms are available for that circumstance.

Hepatic impairment:

In patients with hepatic impairment or Gilbert’s Syndrome, the dose should be reduced or the dosing interval prolonged. The daily effective dose should not exceed 60 mg/kg/day (up to a maximum 2 g/day) in the following situations: Adults weighing less than 50 kg Mild to moderate hepatic insufficiency, Gilbert’s syndrome (familial non-haemolytic jaundice) Dehydration Chronic malnutrition Chronic alcoholism Method of administration Oral.

Adverse events of paracetamol tablets 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.

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 tablets are rare and serious reactions are very rare.

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).

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 skin rashes, angiodema and Very rare cases of serious skin 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 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. • Do not exceed the stated dose. • 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. • Patients should be advised to stop treatment if acute viral hepatitis is diagnosed.

• If symptoms persist consult your doctor. • Keep out of the reach and sight of children. • Underlying liver disease increase 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.

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.

Pack Label:

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

1