Swissmedic recommends new restrictions on use and plans to amend medicinal product information texts accordingly. These measures were prompted by a recent decision by the European Medicines Agency (EMA).
27.07.2015 - The European Medicines Agency has reviewed codeine-containing medicinal products for the treatment of coughs or colds and, in April this year, approved the following restrictions on their use (Decision EMA/CMDh/206590/2015).
Codeine-containing medicines can lead to respiratory problems in sensitive patients. At risk are children under 12 years of age and babies of breastfeeding mothers who take codeine, as well as people who convert codeine into morphine at a faster rate than normal ("ultra-rapid metabolisers"). Swissmedic therefore recommends treating coughs and colds in these patient groups with preparations that do not contain codeine. Caution is indicated in adolescents over 12 years with breathing problems.
The EMA's decision and corresponding changes to the medicinal product information texts are currently being implemented in the EU countries. Swissmedic has asked companies that distribute authorised codeine-containing cough and cold preparations in Switzerland to incorporate the same restrictions in their medicinal product information texts. Swissmedic is reviewing the possibility of excluding any use in the above-mentioned risk groups (contraindication).