Update of the summary of product characteristics and package leaflet following a new safety assessment

Following the introduction of a contraindication for medicines containing promethazine in children under six years of age in New Zealand, Australia and the United Kingdom, the Federal Institute for Drugs and Medical Devices (BfArM) has conducted a national safety assessment and concluded that the introduction of a contraindication for children under six years of age (previously: under two years of age) is also necessary in Germany.

To the risk information (available in German only)