Amisulpride 50mg & 200mg Tablets
*Company:
Gerard LaboratoriesStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 25 April 2024
File name
ie-combined-skh0150-v024-clean_ Amisulpride 50mg & 200mg Tablets.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 15 April 2024
File name
ie-combined-skh0150-v021-final-rtq-clean_PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 April 2024
File name
ie-combined-skh0150-v021-final-rtq-clean_SPC.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 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 April 2023
File name
pl-ie-combined-skh0150-v016-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 20 April 2023
File name
smpc -ie-combined-skh0150-v016-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 March 2022
File name
ie-pl-sk0150-v014g-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 04 August 2021
File name
ie-spc-sk0150-clean-v011.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 August 2021
File name
ie-pl-skh0150-clean-v011.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
Addition of 150 (3 cartons of 50) tablets pack size for 200mg strength
Updated on 26 July 2021
File name
ie-PIL-skh0150-clean-v0010.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 23 March 2020
File name
ie-spc-skh0150-clean-v008.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 March 2020
File name
ie-pil-skh0150-clean-v008.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 June 2019
File name
SPC_Amilsulpride.pdf
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 May 2018
File name
SPC_Amilsulpride.docx
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 April 2018
File name
PACKAGE LEAFLET Amisulphide.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - driving and using machines
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
Updated on 13 September 2017
File name
PIL_17296_604.pdf
Reasons for updating
- New PIL for new product
Updated on 13 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)