Augmentin 250 mg/125 mg film-coated tablets

Product Information *

  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 22 February 2021

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Document did not upload initially. Removed UK non active batch release site from manfuacturer section of IE PIL

Updated on 22 February 2021

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

UK batch release site removed - not active batch release site for Ireland.

Updated on 19 August 2020

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 19 August 2020

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 02 July 2019

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

File format updated to PDF.  SPC approved on 28 February 2018.

Updated on 28 January 2019

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 01 June 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 May 2018

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 16 May 2018

Reasons for updating

  • Other

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 16 May 2018

Reasons for updating

  • Other

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 16 May 2018

Reasons for updating

  • Other

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 16 May 2018

Reasons for updating

  • Other

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 11 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Reason for Update: Update to SPC, PIL and labelling in line with HU comments, absorption statements and QRD 10 - combination with Type IB WS to include PRAC recommendation on DRESS

Agency Approval Date: 28/02/2018

Text Date: 23/10/2017

Issue No.: 5

Draft No.: 1

Updated on 06 March 2018

Reasons for updating

  • Change to section 6 - date of revision
  • Change to section 4 - possible side effects

Updated on 06 March 2018

Reasons for updating

  • New PIL for new product

Updated on 31 October 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 16 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 26 June 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 29 January 2014

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions

Updated on 02 November 2010

Reasons for updating

  • Change due to harmonisation of PIL
  • Change due to user-testing of patient information

Updated on 24 June 2008

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions

Updated on 15 March 2007

Reasons for updating

  • Improved electronic presentation

Updated on 26 October 2006

Reasons for updating

  • Change to side-effects

Updated on 18 August 2004

Reasons for updating

  • New PIL for medicines.ie