Medicines

As of March 1, 2025

Safe prescription now mandatory for codeine and tramadol

Publié le 01 octobre 2024 - Mise à jour le 21 mars 2025 - Directorate for Legal and Administrative Information (Prime Minister)

Since 1er march 2025, drugs containing codeine, dihydrocodeine or tramadol must be prescribed on a secure prescription. The implementation of this measure, initially planned for the end of 2024, has been delayed to ease the transition for healthcare professionals and ensure patients’ access to their treatments.

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The National Agency for the Safety of Medicines and Health Products (ANSM) advocates for the safe use of codeine, dihydrocodeine and tramadol (which are opioid medicines) to prevent the risks of addiction, misuse and falsification of prescriptions related to these medicines.

New measures have been put in place on 1er March 2025 (following a ANSM decision):

  • medicinal products containing tramadol, codeine and dihydrocodeine, alone or in combination with other substances (paracetamol, ibuprofen, etc.), are supplied only on presentation of a secure order. The prescriber must have written in full: dosage, dosage and duration of treatment ;
  • the maximum duration of codeine (and dihydrocodeine) prescription is reduced to 12 weeks (3 months), as is the case with tramadol. After this time, continued codeine treatment will require a new prescription.

Cartons containing fewer tablets are marketed to respond to short-term treatments.

FYI  

Orders made before 1er March 2025 remain valid until the end of the prescribed treatment period.

By way of derogation, the ANSM requests that the requirements established between 1er and March 31, 2025, which would not be on secure prescription, are still honored for the duration of the prescribed treatment, including any renewal.

What is a secure prescription?

One secure order, also known as a “protected order”, must meet the criteria to make it unforgery. These criteria are defined by the Association française de normalization (AFNOR):

  • on the prescription, mention of mandatory information pre-printed in blue allowing to identify the prescribing healthcare professional, even if he belongs to a multidisciplinary structure (a secure prescription cannot be blank);
  • presence of systems to combat fraud, counterfeiting, falsification and theft;
  • recognition immediately possible by the pharmacist, without specific means;
  • appearance of a watermark representing a deciduous mark;
  • no optical brightener at the paper level;
  • minimum weight set at 77 g/m2.

Recommendations for use of tramadol- or codeine-containing drugs

The ANSM reminds you of the instructions to respect in case of use of these 2 medicines:

  • the dosage, duration of treatment and dosing interval should be respected;
  • do not stop your treatment abruptly to avoid withdrawal-related side effects. Your doctor or pharmacist will tell you how to do this;
  • never offer your treatment to someone you know, even if they seem to have symptoms similar to yours;
  • if a person (child or adult) has ingested tramadol or codeine that was not intended for them, contact a poison control center or emergency department immediately 15 (Samu) 18 (firefighters) or 112 (all emergencies: medical, fire, safety);
  • for people at risk of overdose who have a naloxone kit (opioid antidote): if the person is drowsy, call for help, give naloxone, and keep the person awake until help arrives.

FYI  

If you experience adverse reactions related to these treatments, consult your treating physician and report these effects on the patient’s adverse health event reporting portal.

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