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Health Products
Colds: Prescription is now mandatory for certain drugs
Publié le 11 décembre 2024 - Directorate for Legal and Administrative Information (Prime Minister)
The National Agency for the Safety of Medicines and Health Products reports that some treatments used to relieve cold symptoms are at risk of rare but very serious side effects. As of December 11, 2024, you must have a prescription for these medicines at your pharmacy.
The National Agency for the Safety of Medicines and Health Products (ANSM) is changing the conditions for obtaining oral vasoconstrictors containing pseudoephedrine, which are distributed as tablets used to relieve cold symptoms. The ANSM indicates that these treatments can cause serious side effects in very rare cases, including:
- stroke;
- myocardial infarction
- psychiatric disorders.
These adverse reactions can occur in patients without risk factors or medical history, regardless of dose and duration of treatment. In view of these adverse reactions and the mild character of the common cold, ANSM, as a public institution responsible for assessing the health risks posed by medicinal products and health products, has decided that from 11 December 2024:
- oral pseudoephedrine-based vasoconstrictor drugs are available by prescription only;
- the use of these treatments requires prior and systematic medical advice.
The 8 medicines concerned are:
- Active common cold;
- Active Cold day and night;
- The common cold Paracetamol and Pseudoephedrine;
- Dolirhumepro Paracetamol Pseudoephedrine and Doxylamine;
- Humex Cold;
- Nurofen Cold;
- Rhinadvil Cold Ibuprofen / Pseudoephedrine;
- Rhinadvilcaps Cold Ibuprofen / Pseudoephedrine.
ANSM has published a document which lists some things you need to know before you take these medicines (possible side effects, what to do if you get them...).
Physicians are encouraged to:
- assess the benefit/risk balance on each occasion;
- inform each patient of the risks of using these pseudoephedrine medicinal products before they are prescribed or dispensed.
Reminder
In 2023, as the winter season approaches, ANSM had issued a statement discouraging the use of oral pseudoephedrine vasoconstrictors to relieve cold symptoms.
Moreover, for several years it has already been compulsory to have a medical prescription in order to obtain vasoconstrictors distributed in the form of a nasal spray, in particular because of possible neurological and cardiovascular adverse effects.
What should I do if I have a cold?
The cold resolves spontaneously in 7 to 10 days without treatment. Pending spontaneous resolution, to relieve discomfort related to cold symptoms, the following are recommended:
- moisten the inside of your nose with suitable washing solutions (physiological saline, sprays of thermal water or sea water, etc.);
- drink sufficient quantities of water;
- sleeping with the head elevated;
- maintain a cool atmosphere (18-20°C) in the indoor spaces where you are, and regularly air the rooms.
In addition, the following should be avoided:
- Use an air conditioner because it dehumidifies the air and dries the nasal mucous membranes.
- smoking or breathing in other people's smoke.
Additional topics
National Agency for the Safety of Medicines and Health Products (ANSM)
National Agency for the Safety of Medicines and Health Products (ANSM)
National Agency for the Safety of Medicines and Health Products (ANSM)
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