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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 500mg/125mg 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 4.6 - 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 5.2 - 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 4.6 - Addition of the sentence "The possibility of sensitisation should be taken into account" in the 'breast-feeding' sub-section (all except for 375 mg tabs)

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 01/12/2015 and displayed until 31/10/2017
Reasons for adding or updating:
  • 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:   19-Nov-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 9 - Common MR Renewal Date of 19 October 2014
Updated on 04/08/2015 and displayed until 01/12/2015
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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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
  • Change to improve clarity and readability
Date of revision of text on the SPC:   29-Jul-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 2 - QRD update
Section 4.2 - Minor administrative/typographical update in line with QRD
Section 4.3 - Minor administrative/typographical update in line with QRD
Section 4.6 - Minor administrative/typographical updates
Section 4.8 - Addition of Reporting of suspected adverse reactions details, formatting
Section 5.1 - Minor administrative/typographical update in line with QRD
Section 6.6 - Minor administrative update in line with QRD
Section 9 - Administrative updates
Section 10 - Update date of revision of text
Updated on 17/07/2015 and displayed until 04/08/2015
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 02/01/2014 and displayed until 17/07/2015
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:   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 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.8 - Undesirable effects

Updated on 22/08/2013 and displayed until 02/01/2014
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Aug-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

3.  Description of tablet amended
4.2 Add information on children weighing less than 25 kg
6.1 Name of excipients - update Marcrogol to Macrogol (4000, 6000)
6.3 Update information on desiccated pouch packs
6.5 Harmonise description of packs - rearrange informationo
10  New revision date
Updated on 06/04/2011 and displayed until 22/08/2013
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



6.5          Nature and contents of container

 

PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB).

Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets

 

Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP)

Packs of 14, 20 or 21 tablets

 

Amber glass bottle

Packs of 30, 50, 100 or 500 tablets

 

Plastic bottle

Packs of 20, 30 or 100 tablets

 

Not all pack sizes may be marketed

Updated on 28/10/2010 and displayed until 06/04/2011
Reasons for adding or updating:
  • 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
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

Canges to Section 1, 4 & 5
Updated on 05/10/2009 and displayed until 28/10/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01-Aug-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



2009 RENEWAL

 SUMMARY OF PRODUCT CHARACTERISTICS CHANGES (in red)

 

 

1.       TRADE NAME OF THE MEDICINAL PRODUCT

 

Augmentin-Duo Tablets 500mg/125mg Film-coated Tablets

 

2.            QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each tablet contains Amoxicillin Trihydrate equivalent to 500mg Amoxicillin and Potassium Clavulanate equivalent to 125mg clavulanic acid.

For a full list of excipients, see section 6.1

         

4.2     Posology and Method of Administration

           

Usual dosages for the treatment of infection

Adults and children over 12 years

For mild to moderate infections one ‘Augmentin-Duo’ Tablet 500/125mg twice a day.  Therapy can be started parenterally and continued with an oral preparation.

Not recommended in children of 12 years and under.

 

Dosage in renal impairment

 

Adults:

Mild impairment

(Creatinine clearance

>30 ml/min)

Moderate impairment (Creatinine clearance

10-30 ml/min)

Severe impairment (Creatinine clearance <10 ml/min)

No change in dosage

One ‘Augmentin-Duo’ Tablet 500/125mg 12 hourly

Not recommended.

 

Haemodialysis

Dosage adjustments are based on the maximum recommended level of Amoxicillin.  One 500/125mg tablets every 24 hours PLUS one dose during dialysis, to be repeated at the end of dialysis (as serum concentrations of both Amoxicillin and clavulanic acid are decreased).

Dosage in hepatic impairment

Dose with caution; monitor hepatic function at regular intervals.  There is as yet insufficient evidence on which to base a dosage recommendation.

 

Method of administration

   To minimise potential gastrointestinal intolerance, administer at the start of a meal.  The absorption of co-amoxiclav is optimised when taken at the start of a meal.  Duration of therapy should be appropriate and should not exceed 14 days without review.  Therapy can be started parenterally and continued with an oral preparation. The tablet should not be broken.

 

6.       PHARMACEUTICAL PARTICULARS

 

6.1     List of Excipients

 

            Tablet Core

Magnesium stearate,

Sodium starch glycollate,

Colloidal anhydrous silica,

Microcrystalline cellulose

 

Tablet coat

Titanium dioxide (E171),

Hypromellose (Methocel E5 and E15),

Macrogol 4000

Macrogol 6000

Dimeticone.

 

6.2     Incompatibilities

 

Not applicable

 

6.3     Shelf-life

 

            Blister pack - 2 years

            Glass bottles: - 3 years

 

6.4         Special Precautions for Storage

           

Do not store above 25°C

            Store in the original package in order to protect from moisture.

 

6.5     Nature and Contents of Container

 

*Blister packs of 10 and 20 tablets in a carton; the blister is comprised of PVC/PVdC with an aluminium overseal.

 

14 Tablet Pack:

Aluminium PVC/PVdC blisters of 7 tablets enclosed within an aluminium laminate pouch containing a dessicant sachet.

 

Amber glass bottles containing 6, 30, 50, 100 and 500 tablets, closed with an ROPP cap with pre-inserted wad 2.5g of molecular sieve per 30 tablets as desiccant will be included.

 

*Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack).

*Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack), medical sample pack only.

 

Not all pack sizes may be marketed

 

*Packs not marketed.

 

            PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold         formed aluminium blister (CFB).

            Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets

 

            Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a   desiccant sachet, referred to as a desiccated pouch pack (DPP)

            Packs of 14, 20 or 21 tablets

 

            Amber glass bottle

            Packs of 30, 50, 100 or 500 tablets

 

            Plastic bottle

            Packs of 20, 30 or 100 tablets

 

            Not all pack sizes may be marketed

 

6.6     Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product.

 

The tablet should not be broken.

 

No special requirements

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 24/10/2007 and displayed until 05/10/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   09/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

3.                  PHARMACEUTICAL FORM

 

Film coated tablets

White, oval, film-coated tablets engraved ‘Augmentin’

White to off white oval shaped, film coated tablet debossed with ‘AC’ and a score line on one side and plain on the other side.

 

 

 

6.6       Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product.

Instructions for Use/Handling

 

The tablet should not be broken.

           

            None

Updated on 20/12/2006 and displayed until 24/10/2007
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 18/01/2006 and displayed until 20/12/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Updated on 09/11/2005 and displayed until 18/01/2006
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 11/10/2005 and displayed until 09/11/2005
Reasons for adding or updating:
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
Updated on 09/08/2004 and displayed until 11/10/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Amoxicillin trihydrate
   Potassium clavulanate