Expectorants, updates to information

The CMDh of the EMA has approved new recommendations for updating the product information for  medicinal expectorants based on ambroxol and bromhexine to include safety information regarding the risk of severe allergic reactions and allergic skin reactions. The recommendations come from the PRAC who reviewed the profile of the active substances and confirmed the known risks, which must now be listed among the side effects with unknown frequency. Ambroxol and bromhexine are widely used in the European Union as expectorants for short and long-term diseases involving the airways and lungs.