Augmentin 500mg/125mg Film-coated Tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/03/18

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Summary of Product Characteristics last updated on medicines.ie: 7/3/2018
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Amoxil Paediatric Suspension Active Ingredients Amoxicillin trihydrate
Medicine Name Amoxil Vial for Injection 500mg Active Ingredients Amoxicillin sodium
Medicine Name ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed Active Ingredients Umeclidinium bromide, Vilanterol trifenatate
Medicine Name Augmentin 250 mg/125 mg film-coated tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 500mg/125mg Film-coated Tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 875/125mg Film Coated tablets Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin Duo Mixed Fruit 400 mg/57 mg /5 ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin DUO Suspension 400/57mg Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin Intravenous 1.2g Active Ingredients Amoxicillin sodium, Potassium clavulanate
Medicine Name Augmentin Paediatric 125mg/31.25mg per 5ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name AVAMYS 27.5 micrograms/spray nasal spray suspension Active Ingredients Fluticasone furoate
Medicine Name Avodart Soft Capsules 0.5mg Active Ingredients Dutasteride
Medicine Name Babyhaler Active Ingredients No Active Ingredients
Medicine Name Bactroban Nasal Ointment Active Ingredients Mupirocin calcium
Medicine Name Bactroban Ointment Active Ingredients Mupirocin
Medicine Name Becotide Evohaler 100 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 250 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 50 Active Ingredients Beclometasone Dipropionate
Medicine Name Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion Active Ingredients Belimumab
Medicine Name Betnovate C 0.1% / 3% w/w Cream Active Ingredients Betamethasone Valerate, Clioquinol
Medicine Name Betnovate Cream 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Ointment 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Cream Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Ointment Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Scalp Application 0.1% w/v Cutaneous Solution Active Ingredients Betamethasone Valerate
1 - 0 of 136 items.Total: Infinity pages

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 7 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 7 March 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Addition of the agreed wording from a PRAC recommendation on Drug Reaction with eosinophilia and systemic symptoms (DRESS) syndrome to:

 

SmPC Sections 4.4 Special warnings and precautions for use - change to statement: "Serious and occasionally fatal hypersensitivity reactions (including anaphylaxisctoid and severe cutaneous adverse reactions) (including anaphylactoid) reactions have been reported in patients on penicillin therapy."
SmPC 4.8 Undesirable effects: added new adverse effect: drug reaction with eosinophilia and systemic symptoms (DRESS) with a frequency of 'Not known'.

 

Updated on 6 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 March 2018 PIL

Reasons for updating

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

Updated on 31 October 2017 PIL

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 31 October 2017 SmPC

Reasons for 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

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 1 December 2015 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 9 - Common MR Renewal Date of 19 October 2014

Updated on 4 August 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 4 August 2015 SmPC

Reasons for 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

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

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 July 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Change to address of the MA Holder

Updated on 16 July 2015 PIL

Reasons for updating

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

Updated on 1 July 2014 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 2 January 2014 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

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

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 23 December 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 22 August 2013 SmPC

Reasons for 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

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

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 21 August 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to date of revision
  • Change to appearance of the medicine

Updated on 6 April 2011 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

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 2 November 2010 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change due to harmonisation of PIL

Updated on 28 October 2010 SmPC

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

Canges to Section 1, 4 & 5

Updated on 14 October 2009 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision
  • Change of special precautions for disposal

Updated on 5 October 2009 SmPC

Reasons for 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

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

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 October 2007 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.6 - Special precautions for disposal and other handling

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

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 23 October 2007 PIL

Reasons for updating

  • Change to appearance of the medicine

Updated on 20 December 2006 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

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

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 26 October 2006 PIL

Reasons for updating

  • Change to side-effects

Updated on 18 January 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

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

Updated on 9 November 2005 SmPC

Reasons for 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

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

Updated on 11 October 2005 PIL

Reasons for updating

  • Change to date of revision

Updated on 11 October 2005 SmPC

Reasons for updating

  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

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

Updated on 18 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 August 2004 SmPC

Reasons for updating

  • New SPC for medicines.ie

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