Augmentin Paediatric 125mg/31.25mg per 5ml Powder for Oral Suspension
*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 14 March 2022
File name
ie-pl-augmentinsusp125-31issue9draft4.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
Updated on 14 March 2022
File name
ie-spc-augmentinsusp125-31issue8draft4.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 05 March 2021
File name
ie-pl-augmentinsusp125-31issue8 draft1 medie.pdf
Reasons for updating
- Change of manufacturer
Free text change information supplied by the pharmaceutical company
Inactive Batch Release Site Removed
Updated on 07 August 2020
File name
ie-spc-augmentinsusp125-31issue7draft2.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- 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 07 August 2020
File name
ie-pl-augmentinsusp125-31issue7 draft1.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 02 July 2019
File name
ie-spc-augmentinsusp125-31issue6draft1.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 from word to PDF. Approval date of SPC 03 July 2018.
Updated on 04 July 2018
File name
ie-spc-augmentinsusp125-31issue6draft2medicines.ie.docx
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 6.5 – Update of description of dosing devices which may be supplied (including addition of dosing syringe)
Section 6.6 – Update to explain the use of the bottle seal which will be present on bottles supplied from Mayenne and update to reflect that a fill line will be present on bottles supplied from Mayenne.
Updated on 04 July 2018
File name
ie-pl-augmentinsusp125-31issue5draft2medicinescompendia.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 5 - how to store or dispose
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 07 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 March 2018
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 06 March 2018
File name
PIL_9760_814.pdf
Reasons for updating
- New PIL for new product
Updated on 06 March 2018
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 07 June 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- 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
Updated on 06 June 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 04 January 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 December 2015
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 17 July 2015
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
Updated on 16 July 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 13 April 2015
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 09 April 2015
Reasons for 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 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 - 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 5.3 - Preclinical safety data
- 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
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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 2 – inclusion of aspartame
Section 4.2 – clarification for dosing weight for children from “For children ≤ 40 kg” to “For children <40 kg”
Section 6.4 - addition of “do not store above 25oC” for dry powder
Section 6.5 “Nature and contents of container” - the below statement (in green) has been added. Both dosing devices our registered in the approved licence.
- “Clear glass bottles containing powder for reconstitution to 100 ml. This may be supplied with a measuring spoon or cup”
Section 6.6 – addition of instructions to shake bottle to loosen powder
Section 4.8 - Addition of reporting details
Plus Administrative Changes
Updated on 08 April 2015
Reasons for updating
- Change of contraindications
- Change to storage instructions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to further information section
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 11 March 2015
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
Updated on 11 February 2014
Reasons for updating
- Change to, or new use for medicine
Updated on 28 January 2014
Reasons for updating
- 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
Updated on 02 January 2014
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
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.8 - Undesirable effects
Updated on 23 December 2013
Reasons for updating
- Change to side-effects
Updated on 29 January 2013
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
Glass bottles with aluminium screw caps or a ROPP, internally lacquered closure, containing a Polymer (PVC or Polyolefin) liner, containing powder for reconstitution to 100 ml.
Updated on 16 August 2012
Reasons for updating
- Change to further information section
Updated on 07 June 2012
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 02 November 2010
Reasons for updating
- Change due to harmonisation of PIL
- Change due to user-testing of patient information
Updated on 28 October 2010
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
- Change to section 5.4 - Radiation dosimetry
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 24 February 2010
Reasons for updating
- Change of trade or active ingredient name
- Change of inactive ingredient
- Change to storage instructions
Updated on 22 February 2010
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- 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 6.6 - 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
SUMMARY OF SPC CHANGES (MARKED IN RED)
1. Trade Name of the Medicinal Product
Augmentin Paediatric 125mg/31.25mg per 5ml Paediatric Powder for Oral Suspension
2. Qualitative and Quantitative Composition
Each 5 ml of reconstituted suspension contains Amoxicillin Trihydrate Ph.Eur. equivalent to 125 mg of amoxicillin and potassium clavulanate equivalent to 31.25 mg of clavulanic acid.
Excipient: Each 5ml of reconstituted oral suspension contains 12.5mg of Aspartame (E951).
For a full list of excipients, see section 6.1
6. Pharmaceutical Particulars
6.1 List of Excipients
Xanthan gum (E415)
Hypromellose (E464)
Aspartame (E951)
Silicon dioxide Colloidal hydrated Silica
Silica colloidal anhydrous silica
Succinic acid
Raspberry dry flavour
Orange dry flavour 1
Orange dry flavour 2
Golden syrup dry flavour
6.3 Shelf-life
Dry powder: 24 months 2 Years
Reconstituted suspension according to directions: 7 days
Discard any unused suspension seven days after reconstitution.
6.4 Special Precautions for Storage
Dry powder should be stored in the original container: Do not store above 25°C. Store in the original container to protect from moisture.
Reconstituted suspensions should be according to directions: Stored at between 2°C and 8°C. (but not frozen) for up to seven days. Do not freeze.
6.6 Instructions for Use/Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
At time of dispensing the dry powder should be reconstituted to form an oral suspension.
Updated on 04 July 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
OLD SPC Wording
Renal impairment
In patients with moderate or severe renal impairment dosages should be adjusted according to the degree of impairment.
|
Creatinine clearance Dosage ml/min |
Interval mg |
hr |
|
10 - 30 |
15/3.75* mg/kg |
12 (b.i.d.) |
|
< 10 |
15/3.75* mg/kg |
24 (o.d.) |
* using the Paediatric Suspension
NEW SPC Wording
Renal impairment
In patients with moderate or severe renal impairment dosages should be adjusted according to the degree of impairment.
|
Creatinine clearance Dosage ml/min |
Interval mg |
hr |
|
10 - 30 |
15/3.75* mg/kg (maximum 500/125mg twice daily) |
12 (b.i.d.) |
|
< 10 |
15/3.75* mg/kg (maximum 500/125mg) |
24 (o.d.) |
* using the Paediatric Suspension
Updated on 20 December 2006
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
Reasons for updating
- Change to side-effects
Updated on 18 January 2006
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 19 May 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 12 May 2004
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)