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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: 07/06/2010
SPC Avandia 4mg & 8mg 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 07/06/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - Minor text and formatting changes

Section 2 - Minor text and formatting changes

Section 3 - Minor text and formatting changes

Section 4.1 - Minor text and formatting changes

Section 4.2 - Minor text and formatting changes, addition of method of administration

Section 4.3 - Minor text and formatting changes

Section 4.4 - Minor text and formatting changes

Section 4.5 - Minor text and formatting changes

Section 4.6 - Minor text and formatting changes, addition of fertility information

Section 4.8 - Minor text and formatting changes, update of adverse events information

Section 4.9 - Minor text and formatting changes

Section 5.1 - Minor text and formatting changes, addition of paediatric population information

Section 5.2 - Minor text and formatting changes

Section 5.3 - Minor text and formatting changes

Section 6.1 - Minor text and formatting changes

Section 6.3 - Minor text and formatting changes

Section 6.6 - Minor text and formatting changes

Section 10 - Minor text and formatting changes
Updated on 12/04/2010 and displayed until 07/06/2010
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 12/04/2010
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:   28-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 07/09/2009 and displayed until 10/09/2009
Reasons for adding or updating:
  • 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:   25-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.8 - Changes to figures in paragraph 5 of this section
5.1 - Addition of ADOPT wording paragraph
10 -Date changed to 25 August 2009
Updated on 24/08/2009 and displayed until 07/09/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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:   28-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Deletion of sentence "Experience from clinical trials with rosiglitazone is currently limited to three years. The long-term benefits of therapy with rosiglitazone have not been demonstrated (see section 5.1)
Section 4.8 - Changes to figures in paragraph 5 of this section
Section 5.1 - Addition of ADOPT wording paragraph
Section 10 - Date changed to 28/05/09
Updated on 08/06/2009 and displayed until 24/08/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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:   28-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3 - Deletion of sentence "Experience from clinical trials with rosiglitazone is currently limited to three years. The long-term benefits of therapy with rosiglitazone have not been demonstrated (see section 5.1)."

 

Section 4.8 - Changes to figures in paragraph 5 of this section

 

Section 5.1 - Addition of ADOPT wording paragraph

 

Section 10 -Date changed to 28/05/09
Updated on 06/03/2008 and displayed until 08/06/2009
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):   NO

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 ischaemia
Updated on 28/11/2007 and displayed until 06/03/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 Removal of contraindication of use with insulin and addition of diabetic ketoacidosis and diabetic pre-coma
 
Section 4.4 Increased monitoring of the patient is recommended if rosiglitazone is used in combination with metformin and insulin
Updated on 13/06/2007 and displayed until 28/11/2007
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 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

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 - Common
Section 10: Updated
Updated on 14/05/2007 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:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8: Change missed in SPC update
Updated on 07/12/2006 and displayed until 14/05/2007
Reasons for adding or updating:
  • 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):   NO

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):   NO

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 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 11/08/2005 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 4.8 - Undesirable Effects
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 11/08/2005 and displayed until 11/08/2005
Reasons for adding or updating:
  • Removal of Black Triangle
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 11/07/2005 and displayed until 11/08/2005
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
Updated on 27/01/2005 and displayed until 11/07/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 21/09/2004 and displayed until 27/01/2005
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 08/09/2003 and displayed until 21/09/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 05/09/2003 and displayed until 08/09/2003
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
Updated on 03/09/2003 and displayed until 05/09/2003
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
Updated on 13/05/2003 and displayed until 03/09/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 05/12/2002 and displayed until 13/05/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 15/11/2002 and displayed until 05/12/2002
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 17/10/2002 and displayed until 15/11/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 03/12/2001 and displayed until 17/10/2002
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 30/11/2001 and displayed until 03/12/2001
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 16/08/2001 and displayed until 30/11/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 15/05/2001 and displayed until 16/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 11/08/2000 and displayed until 15/05/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  rosiglitazone maleate