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In patients with a history of, or an existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs (see Section 4.4).
Adults and adolescents weighing under 50 kg: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day. Do not take with any other paracetamol containing products. Immediate medical advice should be sought if this occurs, even if you feel well as this can result in an overdose (see section 4.9).A one tablet dose of this product provides more effective pain relief than a combination of paracetamol 1000 mg / codeine phosphate 30 mg (p=0.0001) and was shown to be non-inferior to a combination of ibuprofen 400 mg / codeine phosphate 25.6 mg.
Symptoms of paracetamol overdose in the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion as liver function tests become abnormal. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.In serious poisoning metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur.