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

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Summary of Product Characteristics last updated on the eMC: 11/08/2011

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 11/08/2011 and displayed until Current

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 2004/18^th March 2011 750 mg: 21st February 2008 1000 mg: 16^th September 2008 10. Date of revision of the text 18^th 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