Tramadol and codeine are opioid medicines. The risks of misuse, dependence, abuse and overdose associated with them are significant. In order to make their use safer and reduce these risks, medicines containing tramadol or codeine (or dihydrocodeine) will have to be prescribed on a secure prescription from 1 December 2024. We are also aligning the maximum prescription duration of codeine with that of tramadol: these medicines cannot be prescribed for more than three months (12 weeks) without requiring a new secure prescription. Tramadol and codeine can be present in medicines alone or in combination with other substances, such as paracetamol or ibuprofen. Medicines containing tramadol or codeine are indicated for the treatment of moderate to severe pain and some medicines containing codeine are indicated for the treatment of troublesome dry coughs. They can only be dispensed on presentation of a prescription.
Drug dependency and addiction monitoring surveys show the persistence of cases of misuse (abuse, overdoses), dependency and presentation of falsified prescriptions for these drugs. In order to reduce these risks, we have already taken several measures:
We have also repeatedly raised awareness among prescribers about the need to prevent and treat disorders related to the use of opioid analgesics.
These measures have not sufficiently reduced the misuse associated with these drugs, which is why we are taking new measures:
- As of December 1, 2024, medicines containing tramadol or codeine, alone or in combination with other substances (paracetamol, ibuprofen, etc.) will be dispensed only upon presentation of a secure prescription. The prescriber must have written the dosage, the dose and the duration of treatment in full;
- As with tramadol, we are reducing the maximum prescription period for codeine to 12 weeks (three months). Beyond this, continued treatment with codeine will require a new prescription.
These two measures also concern dihydrocodeine.
At the same time, we are working on implementing additional measures to better inform patients about the risks of addiction and overdose associated with these drugs. In particular, we are considering asking laboratories to place warning notices on boxes of drugs containing tramadol or codeine.
Information for healthcare professionals
Prescription / dispensation
As of December 1, 2024, medications containing tramadol or codeine must be prescribed with a secure prescription. The dosage, dosage and duration of treatment must be written in full.
Dispensing can only be done upon presentation of a secure prescription.
The validity period of prescriptions for drugs containing codeine will be reduced to three months, as for tramadol. A new prescription will be required to extend the treatment.
Prescriptions established before December 1 will remain valid until their expiry date.
Reminders of good practices
We ask that you remain vigilant when prescribing or dispensing medications containing tramadol or codeine.
- To limit the risk of dependence, prescribe medications containing tramadol or codeine for the shortest possible durations. For acute pain, treatment should be prescribed for 3 to 14 days. For chronic pain, reassess the treatment every three months (when renewing the prescription).
- To avoid withdrawal syndrome, regardless of the duration of treatment, gradually reduce the dosage until stopping.
- As a reminder, opioids should be used with caution in epileptic patients, given their ability to reduce the seizure threshold.
These medicines must be dispensed by pharmacists in the smallest possible packaging, adapted to the prescription.
Information for patients
From 1 December 2024, medicines containing tramadol or codeine will only be dispensed to you upon presentation of a secure prescription issued by your treating physician. If you have a prescription issued before this date, it will remain valid until the end of the prescribed treatment period.
Your doctor will need to fill the next prescription on a secure prescription.
Codeine prescriptions will only be valid for a maximum of three months, as with tramadol.
Reminders for the proper use of medicines containing tramadol or codeine
- Respect the dosage, duration of treatment and interval between doses;
- Do not stop your treatment abruptly to avoid withdrawal side effects. Your doctor or pharmacist will tell you how to stop it gradually;
- 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, immediately contact a poison control center or emergency service: 15 (Samu), 18 (fire brigade) or 112 (all emergencies: medical, fire, security) ;
- For people at risk of overdose who have a naloxone kit (opioid antidote): If the person is drowsy, call for help, give them naloxone, and keep them awake until help arrives.
If you experience any side effects related to taking these treatments, consult your doctor and report them on the reporting portal. Report an adverse effect
