Antarene Codeine is a combination of two painkillers ibuprofen and codeine.
“Several cases of renal, gastrointestinal and metabolic toxicity have been reported in countries where it is available without a prescription”, reports this Monday the National Medicines Safety Agency (ANSM).
However, “the declared cases of toxicity, which sometimes led to the death of the patient, took place in situations of prolonged intake, at doses higher than the recommended doses, in a context of abuse and dependence on codeine”, molecule opiate in the same way as morphine, adds the agency.
In detail, prolonged intake of this drug is responsible for kidney damage (kidney failure) and a significant drop in the level of potassium in the blood which can cause muscle weakness and impaired consciousness. Perforations and haemorrhages in the stomach or intestines as well as severe anemia have also been observed.
What recommendations?
In this context, the European Medicines Agency has requested that these undesirable effects be added to the summary of product characteristics and the package leaflet, and recalls that in France, all medicines containing codeine are subject to a prescription mandatory medical since 2017.
The ANSM recommends for its part that patients feeling “the need to consume the drug Antarène Codeine at higher doses or for longer periods than those recommended” to consult a doctor.
It also recommends, when using a non-steroidal anti-inflammatory such as ibuprofen, to use the minimum effective dose for the shortest duration, and to stop the treatment as soon as the symptoms disappear.
And in the event of pain and/or fever, particularly in the context of a common infection such as angina or a cough, the ANSM calls on patients to favor the use of paracetamol by respecting the rules for the proper use of the drug.