Augmentin DUO Suspension 400/57mg
- Name:
Augmentin DUO Suspension 400/57mg
- Company:
GlaxoSmithKline (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/05/18
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
GlaxoSmithKline (Ireland) Ltd
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Company Products
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 18 May 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to name of medicinal product
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 4 - possible side effects
- Change to section 6 - date of revision
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 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the 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
Updates to SPC:
Section 4.2 - Update to wording regarding administration with meals and, for duo suspensions only, direction towards Section 6.6 for reconstitution instructions
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
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 6.6 - Update of precautions for disposal
Section 9 - Addition of date of first authorisation
Section 10 - Update of date of revision of the text
Updated on 17 November 2016 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 1 September 2016 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
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9. |
Common MR Renewal Date of 19 October 2014 |
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10. |
Date of revision of text |
Updated on 21 July 2016 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
Updated on 21 April 2016 PIL
Reasons for updating
- Change to date of revision
Updated on 30 July 2015 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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)
Free text change information supplied by the pharmaceutical company
Section 4.8 – Update to HPRA reporting of suspected adverse reactions details
Section 10 - Update date of revision of text
Updated on 29 July 2015 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change to date of revision
- Addition of information on reporting a side effect.
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
Updated on 16 July 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
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 - how to report a side effect
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 PIL
Reasons for updating
- Change to side-effects
Updated on 14 April 2011 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
2. QUALITATIVE
When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 80 mg amoxicillin and potassium clavulanate equivalent to 11.4 mg of clavulanic acid.
Each 5ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 400mg amoxicillin and potassium clavulanate equivalent to 57mg clavulanic acid.
Excipients: Contains 3.32 mg of aspartame (E951) and 3.51 mg of maltodextrin per ml
For a full list of excipients see Section 6.1
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Crospovidone
Carmellose sodium
Xanthan gum
Colloidal anhydrous silica
Magnesium stearate
Sodium benzoate (E211)
Aspartame (E951)
Strawberry flavour (containing maltodextrin)
Silicon dioxide
Updated on 4 November 2010 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 2 November 2010 PIL
Reasons for updating
- Change due to harmonisation of patient information leaflet
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
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 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 Suspension 400mg/57 mg/5ml Powder for Oral Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of reconstituted product contains Amoxicillin trihydrate equivalent to Amoxicillin 400 mg and potassium clavulanate equivalent to clavulanic acid 57 mg.
For excipients see 6.1
When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 80 mg amoxicillin and potassium clavulanate equivalent to 11.4 mg of clavulanic acid.
Excipient: Contains 3.32 mg of aspartame (E951) per ml
For a full list of excipients see Section 6.1
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Crospovidone
Carmellose sodium
Xanthan gum
Colloidal anhydrous silica
Magnesium stearate
Sodium benzoate (E211)
Aspartame (E951)
Strawberry flavour
Silicon dioxide
6.2 Incompatibilities
Not applicable
6.3 Shelf-life
Dry powder: 24 months
Reconstituted suspension: 7 days when stored in a refrigerator (2-8°C)
6.4 Special Precautions for Storage
Dry powder: Do not store above 25°C. Keep the container tightly closed.
Store in the original package
Reconstituted suspension: Store at 2°C - 8°C.
Store in the original package in order to protect from moisture.
The dry powder should be stored in the original container.
Do not store above 25 °C.
Reconstituted suspensions should be stored at 2 °C – 8 °C (but not frozen) for up to seven days.
6.5 Nature and Contents of Container
Clear, glass bottles moulded from Type III Ph Eur glass fitted with an aluminium roll-on pilfer-proof internally lacquered closure containing screw cap, containing a flowed-in PVC liner. The bottles are supplied in nominal sizes of 45ml, 107ml, 147ml and 200 ml to accommodate 20ml, 35ml, 70ml or 140ml reconstituted suspension. The 35ml pack is packed in a carton which contains a syringe dosing device which replaces the screw-cap after constitution. The syringe plunger is composed of polystyrene and the cap of polyethylene.
Clear glass bottle containing powder for reconstitution to 20, 35, 70 or 140 ml.
This may be supplied with a plastic measuring spoon or plastic measuring cup or dosing syringe.
Not all pack sizes may be marketed
6.6 Instructions for use/handling
At time of dispensing, the dry powder should be reconstituted to form an oral suspension containing 457mg co-amoxiclav/5ml, as detailed below:
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Check cap seal is intact before using. Shake bottle to loosen powder. Add volume of water (as indicated below) invert and shake well. Alternatively fill the bottle with water to just below the mark on bottle label, invert and shake well, Then top up with water exactly to the mark, invert and again shake well.
|
Strength |
Volume of water to be added at reconstitution (ml) |
Final volume of reconstituted oral suspension (ml) |
|
400 mg/57 mg/5 ml |
19 |
20 |
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32 |
35 |
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64 |
70 |
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127 |
140 |
Shake the bottle well before each dose.
Updated on 10 September 2009 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change of inactive ingredient
- Change to storage instructions
- Change to dosage and administration
Updated on 29 October 2008 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 5 November 2007 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
4.2 Posology and Method of Administration
[…]
The table below gives guidance for children. It is recommended that Augmentin Duo Suspension is administered twice daily. Children under 2 years should be dosed according to body weight.
|
Age |
Weight (kg) |
25/3.6 mg/kg/day (Total daily dose (mls)) |
45/6.4 mg/kg/day (Total daily dose (mls)) |
|
Children aged 2 months to 2 years |
2 3 4 5 6 7 8 9 10 11 12 13 14 15 |
0.6 0.9 1.3 1.6 1.9 2.2 2.5 2.8 3.1 3.4 3.8 4.1 4.4 4.7 |
1.1 1.7 2.3 2.8 3.4 3.9 4.5 5.1 5.6 6.2 6.8 7.3 7.9 8.4 |
|
Children aged 2-6 years |
13-21 |
5.0 |
10.0 |
|
Children aged 7-12 years |
22-40 |
10.0 |
20.0 |
Children over 2 years
25/3.6 mg/kg/day
2-6 years 2.5 ml ‘Augmentin-Duo’ suspension b.i.d.
(13-21 kg)
7-12 years 5.0 ml ‘Augmentin-Duo’ suspension b.i.d.
(22-40 kg)
45/6.4 mg/kg/day
2-6 years 5.0 ml ‘Augmentin-Duo’ suspension b.i.d.
(13-21 kg)
7-12 years 10.0 ml ‘Augmentin-Duo’ suspension b.i.d.
(22-40 kg)
Children aged 2 months to 2 years
Weight (kg) 25/3.6 mg/kg/day 45/6.4 mg/kg/day
(Total daily dose (mls))
2 0.6 1.1
3 0.9 1.7
4 1.3 2.3
5 1.6 2.8
6 1.9 3.4
7 2.2 3.9
8 2.5 4.5
9 2.8 5.1
10 3.1 5.6
11 3.4 6.2
12 3.8 6.8
13 4.1 7.3
14 4.4 7.9
5.1 Pharmacodynamic Properties
Pharmacoterapeutic group: Antibacterial
ATC Code: J01 CR02
'Augmentin-Duo' is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital.Septrin should be discontinued at the first appearance of skin rash (see 4.8 Undesirable Effects).
[…]
Updated on 29 May 2007 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 23 May 2007 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 30 January 2007 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
6.3 Shelf-life
Dry powder: 18 24 months
Reconstituted suspension: 7 days when stored in a refrigerator (2-8°C)
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 25 September 2006 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 17 August 2006 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 25 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 26 August 2005 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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)
Updated on 4 August 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 18 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 10 August 2004 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 9 August 2004 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 25 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)