Following cases of accidental overdose in paediatric patients due to errors in the use of the dosing device, particularly for small volumes, the Italian Medicines Agency has published a DHPC, agreed with the marketing authorisation holders, concerning risperidone 1 mg/mL oral solution.

The communication highlights the need to:

• use only the dosing device provided with the medicinal product;
• provide clear and complete instructions for correct use;
• update the package leaflets to include illustrations for correctly measuring volumes;
• adopt dosing devices with readable graduation marks at 0.25 ml intervals.

Healthcare professionals, parents, and caregivers should pay close attention and consult a doctor immediately if overdose symptoms occur.

It is important to report any suspected adverse reactions through the official reporting system.

Risperidone is a second-generation atypical antipsychotic. In children aged 5 years and older and in adolescents, it is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in patients with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment.

The related document provides further information