Glucophage 500mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    Merck
  • 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

Updated on 21 March 2022

File name

UK IE 500 PIL vit B12_1647847768.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_1647847609.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_1644403915.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_1644403584.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_1568036047.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_1533129677.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_1533129612.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