Risperdal 1 mg/ml oral solution
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
No Recent UpdateLegal 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 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)