Risperdal 3 mg Film coated tablets
*Company:
Janssen Sciences IrelandStatus:
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 3mg FCT-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 film-coated tablets contain less than
1 mmol sodium (23 mg) per dose, that is to say, essentially ‘sodium free’.
Section 4.8
Frequency: Not known
Stevens-Johnson syndrome/toxic epidermal
necrolysis
Updated on 30 August 2022
File name
PIL-Risperdal FCT-IE-English-IB080-WS_1877.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2
The film coated tablets contain 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 23 October 2020
File name
PIL-Risperdal FCT-C02-31July19-clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 20 August 2019
File name
ie-spc-risperdal-fct-071-clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 April 2019
File name
IE-SMPC-Risperdal 3mg FCT-C28-29mar19-clean.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 April 2019
File name
PIL-Risperdal FCT-C01-29mar19.pdf
Reasons for updating
- New PIL for new product
Updated on 03 April 2019
File name
IE-SMPC-Risperdal 3mg FCT-C28-29mar19-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 April 2019
File name
IE-SMPC-Risperdal 3mg FCT-C28-29mar19-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)