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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: 28/02/2011
SPC Amoxil Paediatric 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 28/02/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   17-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Return of ingredients and container descriptions to match marketed packaging. Was changed with last SPC update in error.

Section

Summary of change

6.1

Correction of excipients list

6.5

Correction of nature of container
Updated on 23/11/2010 and displayed until 28/02/2011
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 5.2 - Pharmacokinetic Properties
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections changed:

4.2 Change from paediatric dosing by age to by weight instead
4.4 Addition of preaution for prenatal and neonatal children
5.2 Addition of information relating to dosing of pre-term infants
8 Correction to PL stem number
10 Date of revision of the text
Updated on 05/03/2010 and displayed until 23/11/2010
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Addition of text with regards to prolongation of prothrombin time

Section 4.5 - Deletion and addition of text with regards to prolongation of prothrombin time

Section 4.8 - Changes made under Blood and lymphatic system disorders

Section 10 - Date of approval added
Updated on 17/10/2008 and displayed until 05/03/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - maximum 500mg twice daily and maximum 500mg added

Section 10 - date changed
Updated on 04/08/2005 and displayed until 17/10/2008
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 02/08/2005 and displayed until 04/08/2005
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 4.9 - Overdose
Updated on 08/03/2005 and displayed until 02/08/2005
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 4.9 - Overdose
Updated on 23/07/2003 and displayed until 08/03/2005
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  amoxicillin trihydrate