September 27th 2024

By Ailsa Colquhoun

Alert: risperidone 1mg, 2mg and 3mg

Sandoz Ltd. has advised of missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for risperidone 1mg, 2mg and 3mg tablets.

The affected batches are listed online.

The missing information concerns adverse events of Stevens Johnson’s syndrome and toxic epidermal necrolysis in section 4.8 adverse drug reactions listed under ‘skin and subcutaneous tissue disorders’.

The missing information on the Risperidone 1mg, 2mg and 3mg Tablets PIL and SmPC is as follows:

Healthcare professionals should refer to updated SmPC as follows:

SmPC, Risperidone 1mg Tablets, PL 04416/0662

SmPC, Risperidone 2mg Tablets, PL 04416/0663

SmPC, Risperidone 3mg Tablets, PL 04416/0664

Affected batches are not being recalled and patients do not need to take any action.