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

Summary of Product Characteristics last updated on the eMC: 07/06/2010
SPC Augmentin 125/31 SF Suspension

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 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 4.7 - 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
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 to nearly all sections following an Article 30 Procedure

Section 3 - Changes to nearly all sections following an Article 30 Procedure

Section 4.1 - Changes to nearly all sections following an Article 30 Procedure

Section 4.2 - Changes to nearly all sections following an Article 30 Procedure

Section 4.3 - Changes to nearly all sections following an Article 30 Procedure

Section 4.4 - Changes to nearly all sections following an Article 30 Procedure

Section 4.5 - Changes to nearly all sections following an Article 30 Procedure

Section 4.6 - Changes to nearly all sections following an Article 30 Procedure

Section 4.7 - Changes to nearly all sections following an Article 30 Procedure

Section 4.8 - Changes to nearly all sections following an Article 30 Procedure

Section 4.9 - Changes to nearly all sections following an Article 30 Procedure

Section 5.1 - Changes to nearly all sections following an Article 30 Procedure

Section 5.2 - Changes to nearly all sections following an Article 30 Procedure

Section 6.5 - Changes to nearly all sections following an Article 30 Procedure

Section 6.6 - Changes to nearly all sections following an Article 30 Procedure

Section 10 - Changes to nearly all sections following an Article 30 Procedure
Updated on 28/08/2007 and displayed until 07/06/2010
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:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.3 Shelf-life
 
Augmentin 125/31 SF Suspension Dry powder: 18M 24 months                                                                       
                                                            Reconstituted suspensions: 7 days"


Section 10:
To change the date from "3 April 2006" to "15 August 2007"
Updated on 24/11/2006 and displayed until 28/08/2007
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations
Date of revision of text on the SPC:   04/2006
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

Active Ingredients/Generics

 
   co-amoxiclav