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Merck Serono
Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Telephone: +44 (0)208 818 7200
Fax: +44 (0)208 818 7267
Medical Information Direct Line: +44 (0)208 818 7373
Medical Information e-mail: medinfo.uk@merckserono.net
Medical Information Fax: +44 (0)208 818 7274

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 23/05/2012
SPC Glucophage SR 500mg, 750mg and 1000mg prolonged release tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 23/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   22-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
There is a CORRECTION (in red) in section 4.5, changing the heading from:

Inadvisable combinations      to      Concomitant use not recommended

 

 
Updated on 11/08/2011 and displayed until 23/05/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   22-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
changes widespread throughout document
Updated on 24/03/2011 and displayed until 11/08/2011
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Following are the changes:

9.    Date of first authorisation/Renewal of the authorisation

 

500 mg: 26th November 2004/18th March 2011

750 mg: 21st February 2008

1000 mg: 16th September 2008

10. Date of revision of the text

 

18th March 2011

 
Updated on 25/08/2009 and displayed until 24/03/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   05-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


3 PHARMACEUTICAL FORM

Prolonged release tablet

White to off-white capsule-shaped, biconvex tablet, debossed on one side with '1000' and on the other side with 'MERCK'.
Updated on 01/04/2009 and displayed until 25/08/2009
Reasons for adding or updating:
  • Introduction of new strength
Date of revision of text on the SPC:   16-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
addition of Glucophage SR 1000mg strength
Updated on 26/08/2008 and displayed until 01/04/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   15-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
change to section 7 - MA Holder

From:

Merck Ltd. (t/a Merck Pharmaceuticals (A division of Merck Ltd.))

Harrier House

High Street

West Drayton

Middlesex UB7 7QG

To:

Merck Serono Ltd,

Bedfont Cross

Stanwell Road

Feltham

Middlesex,

TW14 8NX

UK

Updated on 30/06/2008 and displayed until 26/08/2008
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  metformin hydrochloride