17.01.2014
To the attention of stakeholder
In the past two days, Romanian television and written press representatives have displayed particular interest in the potential adverse reactions of Paracetamol, following an article from the US press. The article does not contribute with additional aspects to known information available in the package leaflet of all paracetamol-containing medicinal products in the European Union.
The respective information refers to recommended usual doses, i.e. 1-2 tablets taken every 4 hours, as needed, the maximum recommended dose (4g for adults, 60 mg/kg/day divided into equal doses for children 6 to 12 years old), potential adverse reactions (skin rash, itching, low platelet count, agranulocytosis accompanied by unexpected pharyngitis and fever, liver impairment, renal colic. Elevated paracetamol doses and prolonged treatment may determine impaired renal function leading to chronic kidney failure.
Product information also specifies the potential renal impairment risk when taking paracetamol with alcohol, or the risk of combining paracetamol with other medicinal products.
This information is detailed, harmonised in the entire European Union and, as in all package leaflets, stresses that adverse reactions are an issue for all medicinal products, although they may not occur in all individuals.
The NAMMD hereby points out the importance of compliance with recommended doses to ensure the health of all patients by avoiding, as much as possible, the occurrence of adverse reactions.