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updated on 27 Feb 23 at 15:44
” The codeine is an opiate molecule, like morphine. It therefore exposes you to a risk of abuse and dependence, the consequences of which on your health can be serious. » The National Security Agency of medication and health products (ANSM) alert in a press release regarding the dangers ofcodeine antarene.
This painkiller which combines ibuprofen and codeine can, “in case of abuse and dependence”, cause renal and intestinal toxicity.
A compulsory medical prescription since 2017 in France
In France, all medicines containing codeine have been subject to compulsory medical prescription since 2017, but in other European countries, this medicine is available without a prescription.
Following reports of adverse reactions reported in countries where Antarene codeine is available without a prescription, the Pharmacovigilance Committee (PRAC) of the European Medicines Agency (EMA) had analyzed the pharmacovigilance data, in September 2022.
Conclusion: the association codeine-ibuprofen, at doses higher than those recommended or for a prolonged period, exposes to renal, gastrointestinal and metabolic damage, sometimes with fatal outcome, sums up the drug reference site for the general public, Vidal.fr.
In France, Antarene codeine is the only drug combining ibuprofen and codeine. It is indicated in the treatment of painful episodes of short duration in adults, of moderate to severe intensity or not responding to a non-opioid analgesic alone, lists the Vidal.
The declared cases of toxicity, which sometimes led to the death of the patient, occurred in situations of prolonged intake, at doses higher than the recommended doses, in a context of codeine abuse and dependence.
Nonsteroidal anti-inflammatory drugs: what you need to know
The medicine Antarène codeine contains ibuprofen and codeine. In case of use of a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen, the ANSM reminds some rules:
– Use the lowest effective dose, for the shortest duration
– Stop treatment as soon as symptoms disappear
– Avoid NSAIDs in case of chickenpox
– In case of fever, do not prolong the treatment beyond three days
– In case of pain, do not prolong the treatment beyond five days
– Do not take two NSAID medicines at the same time
In case of pain and/or fever, especially in the context of a common infection such as angina or a cough, favor the use of paracetamol by respecting the rules of good use:
– Take the lowest dose, for the shortest time possible
– Respect the maximum dose per dose, the maximum daily dose, the minimum interval between doses and the maximum duration of recommended treatment (three days in case of fever, five days in case of pain, in the absence of a prescription)
– Check the presence of paracetamol in other medicines (used for pain, fever, allergies, cold symptoms or flu-like illness)
– Alert special populations (-50kg, mild to moderate liver failure, severe kidney failure, chronic alcoholism, etc.)
In addition, all NSAIDs are contraindicated from the beginning of the sixth month of pregnancy.
Kidney damage and low blood potassium levels
An overdose can cause “kidney damage (kidney failure) and a significant drop in potassium levels in the blood (hypokalemia) which can cause muscle weakness and impaired consciousness”, warns the ANSM.
The agency also mentions “perforations and haemorrhages in the stomach or intestines as well as severe anemia”.
The European Medicines Agency (EMA) explains that it has requested that these undesirable effects be added to the summary of product characteristics (SPC) and to the package leaflet of “Antarene codeine”.
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