Augmentin 250 mg/125 mg film-coated tablets
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 17 September 2024
File name
ie-spc-augmentintabs250-125mgissue9draft1-Master.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 17 September 2024
File name
ie-pl-augmentintabs375mgissue10draft1-Master.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 May 2024
File name
ie-spc-augmentintabs250-125mgissue8draft1-Master.pdf
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)
Updated on 14 May 2024
File name
ie-pl-augmentintabs375mgissue9draft1-Master.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 August 2022
File name
ie-spc-augmentintabs250-125mgissue7draft2 emc.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of EUCAST Breakpoints
Updated on 22 February 2021
File name
ie-pl-augmentintabs375mgissue8draft2-medie.pdf
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
File name
ie-pl-augmentintabs375mgissue7draft1.pdf
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
File name
ie-spc-augmentintabs250-125mgissue6draft1.pdf
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
File name
ie-pl-augmentintabs375mgissue7draft1.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 02 July 2019
File name
ie-spc-augmentintabs250-125mgissue5draft1.pdf
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
File name
ie-pl-augmentintabs375mgissue6draft2 for Meds.ie.pdf
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
File name
ie-spc-augmentintabs250-125mg.docx
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
File name
ie-spc-augmentintabs250-125mgissue5draft1.docx
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
File name
ie-spc-augmentintabs250-125mgissue5draft1.docx
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 May 2018
File name
ie-spc-augmentintabs250-125mgissue5draft1.docx
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 May 2018
File name
ie-spc-augmentintabs250-125mgissue5draft1.docx
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 May 2018
File name
ie-spc-augmentintabs250-125mgissue5draft1.docx
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 May 2018
File name
ie-spc-augmentintabs250-125mgissue5draft1.docx
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
File name
PIL_8338_467.pdf
Reasons for updating
- New PIL for new product
Updated on 06 March 2018
Reasons for updating
- Change to section 6 - date of revision
- Change to section 4 - possible side effects
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