Italian Medicines Agency Agenzia Italiana del Farmaco

Medicinal products containing RISPERIDONE, in oral solution formulation, and cases of accidental overdose following administration errors - Medicinal products containing RISPERIDONE, in oral solution formulation, and cases of accidental overdose following administration errors

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Medicinal products containing RISPERIDONE, in oral solution formulation, and cases of accidental overdose following administration errors

The Italian Medicines Agency, following reports of accidental overdose cases due to administration errors of medicines containing risperidone, in oral solution formulation, in children and adolescents, draws attention to the importance of administering the correct dose.

Overdose can lead to serious adverse events, especially affecting the CNS, cardiovascular and gastrointestinal levels, such as drowsiness, sedation, tachycardia, hypotension, extrapyramidal symptoms, vomiting, QT interval prolongation and convulsions.

It is recommended that prescribing physicians and pharmacists carefully instruct parents and/or carers on how to measure the exact dose to be administered and ensure that they understand it correctly.
In case of any doubt about the use of the medicine, parents and/or carers should consult their doctor or pharmacist.


Published on: 03 May 2024

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