Glucophage 500mg film-coated tablets
*Company:
MerckStatus:
No Recent UpdateLegal 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 10 October 2022
File name
Glucophage 500-850-1000mg Tabs IE approved SPC v9.0 TW3355392.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated the section 5.1 Pharmacodynamic properties for Mechanism of action
Internal Reference number: TW3355392
Updated on 21 March 2022
File name
UK IE 500 PIL vit B12.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Change to section 4 for the side effect of vitamin B12 deficiency with metformin treatment.
Internal Reference: TW2998508
Updated on 21 March 2022
File name
Glucophage 500-850-1000mg Tabs IE approved SPC v8 TW2998508.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update of sections 4.4 and 4.8 of the SmPC to include a warning and side effect of vitamin B12 deficiency with metformin treatment.
Internal Reference: TW2998508
Updated on 09 February 2022
File name
UK IE 500 PIL.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
Update to allow the use of metformin during pregnancy and in the periconceptional phase.
Updated on 09 February 2022
File name
Glucophage 500-850-1000mg Tabs IE current SPC v7.0 TW2762201.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update of section 4.6 of the SmPC to allow the use of metformin if clinically needed during pregnancy and in the periconceptional phase.
(Our ref: TW2762201)
Updated on 09 September 2019
File name
IE - OPI - Glucophage 500mg tabs - PIL mock up 13.05.2019.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 01 August 2018
File name
PL metformin hydrochloride Glucophage 500mg fct 2018Jul27 en Clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 01 August 2018
File name
IE SPC metformin hydrochloride Glucophage 500mg fct 2018Jul27 en 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 be renewed (B)
Updated on 27 April 2018
File name
Glucophage_500-850-1000mg_Tabs_IE_SPC_v4.0.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 January 2017
File name
PIL_15328_726.pdf
Reasons for updating
- New PIL for new product
Updated on 19 January 2017
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 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 05 January 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 27 February 2015
Reasons for updating
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Addition of information on reporting a side effect.
- Change to warnings or special precautions for use
Updated on 25 June 2014
Reasons for updating
- Change of distributor details
Updated on 10 April 2012
Reasons for updating
- New PIL for medicines.ie