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Augmentin 250 mg/125 mg film-coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/08/20

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Summary of Product Characteristics last updated on medicines.ie: 19/8/2020

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
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 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
Medicine Name Bexsero, suspension for injection in pre-filled syringe Active Ingredients Meningococcal group-B vaccine (rDNA, component, adsorbed)
Medicine Name Boostrix - Suspension for injection Active Ingredients Diphtheria, Tetanus and Pertussis vaccine
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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 19 August 2020 SmPC

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 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 2 July 2019 SmPC

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 PIL

Reasons for updating

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

Updated on 1 June 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 21 May 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - 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 SmPC

Reasons for updating

  • Other

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

Updated on 16 May 2018 SmPC

Reasons for updating

  • Other

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

Updated on 16 May 2018 SmPC

Reasons for updating

  • Other

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

Updated on 16 May 2018 SmPC

Reasons for updating

  • Other

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

Updated on 11 May 2018 SmPC

Reasons for updating

  • New SmPC 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 6 March 2018 PIL

Reasons for updating

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

Updated on 6 March 2018 PIL

Reasons for updating

  • New PIL for new product

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 16 July 2015 PIL

Reasons for updating

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

Updated on 26 June 2015 PIL

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 PIL

Reasons for updating

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

Updated on 2 November 2010 PIL

Reasons for updating

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

Updated on 24 June 2008 PIL

Reasons for updating

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

Updated on 15 March 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 26 October 2006 PIL

Reasons for updating

  • Change to side-effects

Updated on 18 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie