Risperdal 2 mg Film coated tablet
*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 2 mg 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 10 May 2021
File name
PI-Risperdal 2mg FCT-IE-EN-IB076_EDMS-RIM-217553_1.0_Clean_03 15.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
6.5 Nature and contents of container
RISPERDAL film-coated tablets are packaged in PVC/LDPE/PVDC/aluminium foil blisters and high density polyethylene (HDPE) bottles fitted with a polypropylene (PP) child-resistant closure with induction seal screw cap.
Updated on 10 May 2021
File name
PIL-Risperdal FCT-IE-EN-IB076_EDMS-RIM-217555_1.0_Clean_03 15.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
6. Contents of the pack and other information
What Risperdal contains
What Risperdal looks like and contents of the pack
Risperdal film-coated tablets are packaged in PVC/LDPE/PVDC/aluminium foil blisters and HDPE bottles with a plastic child-resistant screw cap PP screw cap.
This leaflet was last revised in November 2020 July 2019
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 04 April 2019
File name
IE-SMPC-Risperdal 2mg 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 2mg FCT-C28-29mar19-clean.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 2mg 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)