Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use

RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between milligram (mg) and millili- tre (ml), which could result in accidental overdose and death (see section 4.2).

Prolonged or frequent use is discouraged. It is recommended that a suitable analgesic oral treatment will be used as soon as this route of administration is possible.

In order to avoid the risk of overdose, check that other medicines administered do not contain either paracetamol or propacetamol. The dose may require adjustment (see section 4.2).

Doses higher than those recommended entail the risk of very serious liver damage. Clinical signs and symptoms of liver damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cyto- lytic hepatitis) are usually first seen after two days of drug administration with a peak seen, usually after 4 – 6 days. Treatment with antidote should be given as soon as possible (See section 4.9).

Paracetamol should be used with caution in cases of:

●     hepatocellular insufficiency
●     severe renal insufficiency (creatinine clearance ≤ 30 ml/min) (see sections 4.2 and 5.2) ●     chronic alcoholism
●     chronic malnutrition (low reserves of hepatic glutathione)
●     dehydration
●     patients suffering from a genetically caused G-6-PD deficiency (favism), the occurrence of a haemolytic anaemia is possible due to the reduced allocation of glutathione following the admin- istration of paracetamol.

Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g.
chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.

This medicinal product contains less than 1 mmol sodium (23 mg) per container , i.e. essentially ‘so- dium- free’.

Effects on Driving

4.7     Effects on ability to drive and use machines

Not relevant.