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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: 03/06/2010
SPC Augmentin-Duo 400/57

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 03/06/2010 and displayed until Current
Reasons for adding or updating:
  • 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 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. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
  • 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
Date of revision of text on the SPC:   01-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 3 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 4.1 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 4.2 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 4.3 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 4.4 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 4.5 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 4.6 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 4.7 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 4.8 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 4.9 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 5.1 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 5.2 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 5.3 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 6.5 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 6.6 - Changes have been made to all sections of the SPC following an article 30 procedure

Section 10 - Changes have been made to all sections of the SPC following an article 30 procedure
Updated on 11/07/2007 and displayed until 03/06/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 - update to this section with regard to interactions with probenecid, oral contraceptives and methotrexate
Section 10 - date updated to 9 July 2007
Updated on 14/03/2007 and displayed until 11/07/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
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 16/02/2007 and displayed until 14/03/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 15/02/2007 and displayed until 16/02/2007
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:   01/2007
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 07/03/2005 and displayed until 15/02/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 21/09/2004 and displayed until 07/03/2005
Reasons for adding or updating:
  • Change from the BAN of the active substance to the rINN
Updated on 27/03/2003 and displayed until 21/09/2004
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 10/03/2003 and displayed until 27/03/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 19/12/2002 and displayed until 10/03/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 22/10/2002 and displayed until 19/12/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 17/10/2002 and displayed until 22/10/2002
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Updated on 26/07/2002 and displayed until 17/10/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 09/07/2002 and displayed until 26/07/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 24/08/2001 and displayed until 09/07/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 15/05/2001 and displayed until 24/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 15/05/2001
Reasons for adding or updating:
  • No reasons supplied

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