RISPERDAL 1 mg/ml oral solution

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Pharmacy Only: Prescription DHPC
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COM Updated on 28 February 2025

File name

Risperidone 1 mg per ml OS-Risk of medication errors leading to accidental overdoses in children and adolescents.pdf

Reasons for updating

  • Add New Doc

Updated on 30 August 2022

File name

PI-Risperdal OS-IE-English-IB-080 & WS_1877.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Updated on 30 August 2022

File name

PIL-Risperdal OS-IE-English-IB080-WS_1877.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to date of revision

Free text change information supplied by the pharmaceutical company

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). 


Updated on 12 April 2019

File name

PIL-Risperdal OS-C01-29mar19.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 April 2019

File name

IE-SMPC-Risperdal Oral Solution-C29-29mar19-clean.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Janssen Sciences Ireland (a Johnson & Johnson Company)

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