RISPERDAL 1 mg/ml oral solution
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company

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)

Address:
Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, IRL - Co. Cork P43 FA46Medical Information E-mail:
medinfo@its.jnj.comTelephone:
+353 1 4665200Website:
https://innovativemedicine.jnj.com/ireland/Medical Information Direct Line:
1800 709 122