NI details were removed in error from the PIL for the submission of DE/H/2184/008/WS/086/G (addition of Lusomedicamenta). The removal of NI details was instead submitted as part of the variation procedure DE/H/2184/008/WS/089 - C.I.z - Type II variation to implement the PRAC Recommendation following the outcome of the Safety Signal about Medication errors associated with accidental overdoses in children and adolescents treated with risperidone 1 mg/mL oral solution (EMA/PRAC/537837/2024). The procedure DE/H/2184/008/WS/089 is currently ongoing. The NI details should still be included in the PIL until DE/H/2184/008/WS/089 is approved.

Section 4.4

The oral solution contains less than 1 mmol sodium (23 mg) per dose, that is to say, essentially ‘sodium free’.

Section 4.8 Undesirable effects

Frequency: Not known

Stevens-Johnson syndrome/toxic epidermal necrolysis

Section 2:

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say, essentially ‘sodium free’.

Section 4:

Not known: frequency cannot be estimated from the available data

●      Severe or life‑threatening rash with blisters and peeling skin that may start in and around the mouth, nose, eyes, and genitals and spread to other areas of the body (Stevens‑Johnson syndrome or toxic epidermal necrolysis).