Antarène Codeine, a painkiller that combines ibuprofen and codeine, might be toxic to the kidneys, stomach and intestines, ANSM warns. Potentially fatal effects in case of prolonged intake or overdose.
Medication Antarene Codeine® contains ibuprofen and codeine, two painkillers. Codeine is an opioid that can lead to addiction or misuse. Taken in high doses or over a long period of time, this medication may cause severe kidney failure or bleeding in the stomach, which can lead to deathalert the Medicines Agency (ANSM) in a statement dated February 13, 2023.”Several cases of renal, gastrointestinal and metabolic toxicity have been reported in countries where Antarene Codeine is available without a prescription“, reports the health authority. To limit the risks, theEuropean Medicines Agency (EMA) therefore requested that these undesirable effects be added to the summary of product characteristics (SPC) and in the medicine leaflet.
Indications: why take Antarene Codeine?
Antarène Codeine® (Elerté laboratory) is a drug that combines two painkillers: ibuprofen and codeine. This nonsteroidal anti-inflammatory drug (NSAID) is indicated in case of acute pain of moderate to severe intensity, which are not relieved by taking an analgesic alone. This treatment is reserved for adults (from 15 years old).
Is it available with or without a prescription?
► In France, all drugs containing codeine, including Antarène Codeine®, have been available by prescription only since 2017.
► In other European countriesAntarène Codeine is available over-the-counter, so without a prescription.
What are the risks of Antarene Codeine?
Codeine, the substance contained in this medication, is an opiate molecule, like morphine. It is an opioid (derived from opium) which exposes a risk of abuse and dependence (addiction) whose health consequences can be serious and fatal. In case of prolonged intake or at doses higher than the recommended doses, Antarene Codeine® can cause:
- A renal failure
- A significant drop in potassium levels in the blood (hypokalemia)
- muscle weakness
- Disorders of consciousness
- Perforations and bleeding in the stomach or intestines
- Severe anemia
A patient who feels the need to consume the drug Antarène Codeine® at higher doses or longer durations than those recommended, must consult a doctor.
What precautions if you take Antarene Codeine?
If taking a drug containing ibuprofen, the Medicines Agency (ANSM) advises:
- Use the lowest effective dose, for the shortest duration
- To stop the treatment as soon as the symptoms disappear
- Avoid taking ibuprofen for chickenpox
- In case of fever, do not prolong treatment beyond 3 days
- In case of pain, do not prolong treatment beyond 5 days
- Not to take two NSAID drugs at the same time
In case of pain and/or fever (angina, cough, etc.), it is advisable to 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 (3 days in case of fever, 5 days in case of pain, in the absence of a prescription)
- Check for the presence of paracetamol in other medicines (used for pain, fever, allergies, cold or flu symptoms)
- Doctors must alert special populations (-50kg, mild to moderate liver failure, severe renal failure, chronic alcoholism, etc.)
What are the contraindications of Antarene Codeine?
Antarene Codeine® should not be taken in the following cases:
- history of allergy or asthma caused by taking NSAIDs, including aspirin;
- stomach or duodenal ulcer
- severe liver failure
- severe kidney failure
- severe heart failure
- systemic lupus erythematosus
- respiratory failure
- person known to be an ultra-rapid metabolizer (person whose activity of enzymes involved in drug metabolism is excessive)
- pregnancy (from 6e months) and feeding with milk.
Sources : Antarène Codeine (codeine-ibuprofen): prolonged intake, in the event of abuse and dependence, can lead to renal and intestinal toxicity which can lead to death, ANSM, February 13, 2023 / ANTARENE CODEINE 200 mg/30 mg and 400 mg/ 60 mg (ibuprofen/codeine), NSAID-weak opioid combination, HAS, drug advice / Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022EMA
