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GlaxoSmithKline (Ireland) Ltd

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 495 5000
Fax: +353 1 4955225
Medical Information Direct Line: 1 800 244 255
Medical Information Facsimile: +353 1 495 5225
Summary of Product Characteristics last updated on medicines.ie: 31/10/2017
SPC Augmentin 250 mg/125 mg film-coated tablets

When a pharmaceutical company changes an SPC or PIL, 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 31/10/2017 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 4.8 – Undesirable effects - how to report a side effect
  • 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 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   19-Oct-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Updates to SPC:

Section 4.2 - Update to wording regarding administration with meals.

Section 4.4 - Typographical and grammatical updates.Section 4.8 - Update to wording regarding administration with meals (UK only, update of MHRA adverse events reporting details)

Section 5.1 - Typographical/grammatical updates

Section 5.2 - Removal of reference to taking medicine at the start of a meal

Section 5.3 - Grammatical correction

Section 6.4 - Grammatical correction

Section 10 - Update of date of revision of the text

Updated on 17/07/2015 and displayed until 31/10/2017
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to address of the MA Holder
Updated on 26/06/2015 and displayed until 17/07/2015
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11-Jun-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 2 – typographical update
Section 4.2 - minor administrative/typographical updates
Section 4.3 - minor administrative/typographical updates
Section 4.6 - alignment headings with QRD, minor administrative/typographical updates
Section 4.8 - alignment headings with QRD 9 – addition of Reporting of suspected adverse reactions details, formatting
Section 5.1 - minor administrative/typographical updates
Section 5.3 - typographical updates
Section 6.3 – typographical update
Section 6.6 - alignment headings with QRD, minor administrative update in line with QRD
Section 9 - administrative updates
Section 10 - update date of revision of text
Updated on 29/01/2014 and displayed until 26/06/2015
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   20-Nov-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Changes to:

Section 2 - QUALITATIVE AND QUANTITATIVE COMPOSITION,
Section 3 - PHARMACEUTICAL FORM,
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.8 - Undesirable effects,
Section 6.1 - List of excipients,
Section 6.3 - Shelf life,
Section 6.4 - Special precautions for storage,
Section 6.5 - Nature and contents of container

Updated on 28/10/2010 and displayed until 29/01/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 1 - Name of medicinal product
  • 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 4.5 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 5.4 - Radiation dosimetry
Date of revision of text on the SPC:   30-Sep-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Changes to Section 1, 4 & 5
Updated on 30/10/2008 and displayed until 28/10/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 26/08/2008 and displayed until 30/10/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   12/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

1.         Trade Name of the Medicinal Product

 

            AUGMENTIN Tablets 250 mg/125 mg

 

2.         Qualitative and Quantitative Composition

 

            Each tablet contains Amoxicillin trihydrate equivalent to 250 mg Amoxicillin with potassium clavulanate equivalent to 125 mg of clavulanic acid .

 

For a full list of excipients, see section 6.1

 

3.         Pharmaceutical Form

 

Film-coated tablets (tablet)

White to off-white, oval shaped, film-coated tablets engraved ‘Augmentin’ on one side.

 

 

6.4       Special Precautions for Storage

           

Do not store above 25°C.

            Bottles : Keep container tightly closed.  The enclosed desiccants should not be removed. Store in the original package.

            Blisters and foil strips: Store in the original package. Keep blister in the outer carton.

Updated on 20/12/2006 and displayed until 26/08/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.5...............

Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of amoxicillin-clavulanate and allopurinol.

In common with other antibiotics, amoxicillin-clavulanate may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives....................

4.8...................

Gastrointestinal disorders

Very common Diarrhoea

Common Nausea, vomiting

Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking AUGMENTIN at the start of a meal.

Uncommon Indigestion

Very Rare Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis).

Black hairy tongue

............................

Updated on 29/05/2006 and displayed until 20/12/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 31/01/2006 and displayed until 29/05/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Updated on 04/07/2003 and displayed until 31/01/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Amoxicillin trihydrate
   Potassium clavulanate