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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

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Summary of Product Characteristics last updated on the eMC: 23/11/2010
SPC Amoxil Capsules 500mg

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 23/11/2010 and displayed until Current
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 04/03/2010 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 04/03/2010
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:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
   amoxicillin trihydrate