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GlaxoSmithKline UK

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

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: 19/04/2010

SPC	Avandamet Film-Coated 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 19/04/2010 and displayed until Current

Reasons for adding or updating:
Change to section 4.4 - Special warnings and precautions for Use Change to section 4.8 - Undesirable Effects Change to section 5.1 - Pharmacodynamic Properties Change to section 10 date of revision of the text
Date of revision of text on the SPC: 01-Apr-2010
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 4.4 - Changes to "Myocardial Ischaemia" and "Bone Disorders" sections Section 4.8 - Text added to "Clinical trial data" section Section 5.1 - Text added to "Clinical trial data" section Section 10 - Dated of approval amended

Updated on 10/02/2010 and displayed until 19/04/2010

Reasons for adding or updating:
Change to section 7 - Marketing Authorisation Holder Change to section 10 date of revision of the text
Date of revision of text on the SPC: 20-Jan-2010
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 7 - Name of MAH changed from plc to Ltd. Section 10 - Date of approval changed to 20/01/2010

Updated on 10/09/2009 and displayed until 10/02/2010

Reasons for adding or updating:
Correction of spelling/typing errors
Date of revision of text on the SPC: 25-Aug-2009
Legal Category: POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company
None provided

Updated on 27/01/2009 and displayed until 10/09/2009

Reasons for adding or updating:
Change to section 6. 3 - Shelf Life Change to section 10 date of revision of the text SPC Submitted in error
Date of revision of text on the SPC: 07-Nov-2008
Legal Category: POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company
Section 6.3 - Shelf life changed from 2 years to 3 years Section 10 - Date of revision of text updated to 07 November 2008

Updated on 02/09/2008 and displayed until 27/01/2009

Reasons for adding or updating:
Change to section 10 date of revision of the text
Date of revision of text on the SPC: 08-Aug-2008
Legal Category: POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company
Section 10 - Updated to 08/08/2008 Minor formatting updates throughout

Updated on 06/03/2008 and displayed until 02/09/2008

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 4.8 - Undesirable Effects
Date of revision of text on the SPC: 03/2008
Legal Category: POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company
Section 4.3: addition of Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) Section 4.4: addition of sections related to Myocardial Ischaemia and Acute Coronary Syndrome (ACS) Section 4.8: update to table 1 foot note 3 related to cardiac ischa

Updated on 13/06/2007 and displayed until 06/03/2008

Reasons for adding or updating:
Change to section 4.4 - Special warnings and precautions for Use Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC: 06/2007
Legal Category: POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company
Section 4.4: Addition of new group "Bone Disorders" Section 4.8: Addition of Bone Fractures into Common

Updated on 22/05/2007 and displayed until 13/06/2007

Reasons for adding or updating:
Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC: 01/2007
Legal Category: POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company
Section 4.8: Change missed in SPC update

Updated on 20/02/2007 and displayed until 22/05/2007

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 4.8 - Undesirable Effects Change to section 10 date of revision of the text
Date of revision of text on the SPC: 01/2007
Legal Category: POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company
For further information, please contact GlaxoSmithKline on +44 (0)800 221 441

Updated on 07/12/2006 and displayed until 20/02/2007

Reasons for adding or updating:
Change to section 4.2 - Posology and method of administration Change to section 5.1 - Pharmacodynamic Properties Change to section 5.2 - Pharmacokinetic Properties Change to section 4.8 - Undesirable Effects Change to section 10 date of revision of the text
Date of revision of text on the SPC: 11/2006
Legal Category: POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company
For further information, please contact GlaxoSmithKline on +44 (0)800 221 441

Updated on 01/11/2006 and displayed until 07/12/2006

Reasons for adding or updating:
Change to section 4.2 - Posology and method of administration Change to section 4.4 - Special warnings and precautions for Use Change to section 4.6 - Pregnancy and Lactation Change to section 4.8 - Undesirable Effects Change to section 10 date of revision of the text
Date of revision of text on the SPC: 10/2006
Legal Category: POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company
For further information, please contact GlaxoSmithKline on +44 (0)800 221 441

Updated on 09/08/2006 and displayed until 01/11/2006

Reasons for adding or updating:
Change to section 4.4 - Special Warnings and Precautions for Use Change to section 10 (date of (partial) revision of the text Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC: 07/2006
Legal Category: POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company
For further information, please contact GlaxoSmithKline on +44 (0)800 221 441

Updated on 08/02/2006 and displayed until 09/08/2006

Reasons for adding or updating:
Change to section 4.4 - Special Warnings and Precautions for Use Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction

Updated on 05/12/2005 and displayed until 08/02/2006

Reasons for adding or updating:
No reasons supplied

Updated on 27/09/2005 and displayed until 05/12/2005

Reasons for adding or updating:
Change to joint SPC covering all presentations Change to section 6.1 - List of Excipients Change to section 6. 5 - Nature and Contents of Container

Updated on 26/09/2005 and displayed until 27/09/2005

Reasons for adding or updating:
Change to section 1 - trade name Change to section 3 - pharmaceutical form Change to section 4.2 - Posology and Method of Administration

Updated on 04/02/2005 and displayed until 26/09/2005

Reasons for adding or updating:
Change to section 4.4 - Special Warnings and Precautions for Use Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction

Updated on 25/10/2004 and displayed until 04/02/2005

Reasons for adding or updating:
Change to section 2 - qualitative and quantitative composition Change to section 1 - trade name Change to section 3 - pharmaceutical form Change to section 6.1 - List of Excipients Change to section 6. 5 - Nature and Contents of Container Change to section 8 - MA number Change to section 9 - Date of Renewal of Authorisation

Updated on 21/09/2004 and displayed until 25/10/2004

Reasons for adding or updating:
Change to section 2 - qualitative and quantitative composition Change to section 6. 6 - Instruction for Use/Handling

Updated on 06/11/2003 and displayed until 21/09/2004

Reasons for adding or updating:
New SPC for new product

Document Links

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from this company

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Active Ingredients/Generics

metformin hydrochloride

rosiglitazone maleate

Versions

	19/04/2010 to Current
	10/02/2010 to 19/04/2010
	10/09/2009 to 10/02/2010
	27/01/2009 to 10/09/2009
	02/09/2008 to 27/01/2009
	06/03/2008 to 02/09/2008
	13/06/2007 to 06/03/2008
	22/05/2007 to 13/06/2007
	20/02/2007 to 22/05/2007
	07/12/2006 to 20/02/2007
	01/11/2006 to 07/12/2006
	09/08/2006 to 01/11/2006
	08/02/2006 to 09/08/2006
	05/12/2005 to 08/02/2006
	27/09/2005 to 05/12/2005
	26/09/2005 to 27/09/2005
	04/02/2005 to 26/09/2005
	25/10/2004 to 04/02/2005
	21/09/2004 to 25/10/2004
	06/11/2003 to 21/09/2004

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GlaxoSmithKline UK

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Document Links

Active Ingredients/Generics

Versions