Amisulpride 50mg & 200mg Tablets *

  • Company:

    Gerard Laboratories
  • Status:

    No Recent Update
  • Legal 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 04 August 2021

File name

ie-spc-sk0150-clean-v011_1628075558.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_1628075512.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_1627290513.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_1584954403.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_1584954245.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_1560505258.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

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 13 September 2017

File name

PIL_17296_604.pdf

Reasons for updating

  • New PIL for new product