PARACETAMOL

Posology Paediatric population Dose depends on body weight and age. A single dose ranges from 10 to 15 mg/kg bodyweight. The maximum total daily dose is 60 mg/kg body weight for total daily dose. • Children below 12 years of age: this product is not recommended in children aged less than 12 years.

• Adolescents of 12 to 15 years and weighing 41 to 50 kg: one tablet at a time, every 4-6 hours as needed, the maximum being 4 tablets per day (paracetamol 2000 mg per 24 hours). • Adolescents of 16 to 18 years and weighing more than 50 kg: as adults.

Adults For adults and adolescents (aged 16 years and older) weighing more than 50 kg the usual single dose is 1-2 tablets at a time, to be repeated every 6 hours as needed, the maximum being 8 tablets per day (paracetamol 4000 mg per 24 hours).

For adults and adolescents (aged 16 years and older) and weighing less than 50 kg the recommended single dose is 1 tablet. The daily effective dose of paracetamol should not exceed 60 mg/kg/day (upto maximum 2g/day).

Renal impairment In patients with renal insufficiency, the dose should be reduced:

Glomerular filtration rate Dose 10-50 ml/min 500 mg every 6 hours < 10 ml/min 500 mg every 8 hours Hepatic impairment In patients with impaired hepatic function or Gilbert´s syndrome, the dose must be reduced or the dosing interval prolonged.

Method of administration Oral use. Place the tablets in a full tumbler of water and allow to dissolve completely before swallowing. After dissolving the tablets, a slightly opalescent solution will be produced.

The frequency using the following convention should be: 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).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequency System Symptoms Blood and lymphatic system disorders Platelet disorders, stem cell disorders, agranulocytosis, leucopenia, thrombocytopenia, haemolytic anaemia, pancytopenia, methaemoglobenaemia Immune system disorders Allergies (excluding angioedema).

Psychiatric disorders Depression NOS, confusion, hallucinations. Nervous system disorders Tremor NOS, headache NOS. Eye disorders Abnormal vision. Rare >1/10000 - < 1/1000 Cardiac disorders Oedema. Gastrointestinal disorders Haemorrhage NOS, abdominal pain NOS, diarrhoea NOS, nausea, vomiting.

Hepato-biliary disorders Abnormal Hepatic function, hepatic failure, hepatic necrosis, jaundice. Skin and subcutaneous tissue disorders Pruritus, rash, sweating, purpura, angioedema, urticaria General disorders and administration site conditions Dizziness (excluding vertigo), malaise, pyrexia, sedation, drug interaction NOS.

Injury, poisoning and procedural complications Overdose and poisoning Respiratory, thoracic and mediastinal disorders Bronchospasm Very Rare (< 10,000) Hepato-biliary disorders hepatotoxicity Frequency System Symptoms General disorders and administration site conditions hypersensitivity reaction (requiring discontinuation of treatment), serious skin reactions Metabolism and nutrition disorders Hypoglycemia Renal and urinary disorders Sterile pyuria (cloudy urine) and renal side effects Not known (cannot be estimated from the available data) Metabolism and nutrition disorders High anion gap metabolic acidosis Interstitial nephritis has been reported incidentally after prolonged use of high doses.

Some cases of epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme, edema of the larynx, anaphylactic shock, anemia, liver alteration and hepatitis, renal alteration (severe renal impairment, haematuria, anuresis), gastro intestinal effects and vertigo have been reported.

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/ or search for MHRA Yellow Card in the Google Play or Apple App.

Prolonged or frequent use is discouraged. Patients should be advised not to take other paracetamol containing products concurrently. Taking multiple daily doses in one administration can severely damage the liver; in such case unconsciousness does not occur.

However, medical assistance should be sought immediately. Prolonged use except under medical supervision may be harmful. In adolescents treated with 60mg/kg daily of paracetamol, the combination with another antipyretic is not justified except in the case of ineffectiveness.

Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day. 2). Alcohol usage The hazards of overdose are greater in those with non- cirrhotic alcoholic liver disease.

Caution should be exercised in cases of chronic alcoholism. The daily dose should not exceed 2000 mg in such case. Alcohol should not be used during the treatment with paracetamol. ” Other medications and withdrawal: Abrupt discontinuation of long-term use of high-dosed analgesics, taken not as directed, may cause headache, tiredness, muscular pain, nervousness and vegetative symptoms.

The withdrawal symptoms subside within a few days. Patients should be advised to consult their doctor if headaches become persistent. 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.

15% of the WHO recommended maximum daily intake of 2g sodium for an adult. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. Do not exceed the stated dose. If symptoms persist consult a doctor.

Treatment with an antidote is advised if an overdose is suspected. Immediate medical advice should be sought in the event of overdosage even if the patient feels well, because of the risk of delayed serious liver damage. This product should not be used for more than 10 consecutive days without a prescription.

Liver and kidney damage cannot be excluded with prolonged use or excessive doses (more than 2 gram per day).

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