Augmentin DUO Suspension 400/57mg *
Pharmacy Only: Prescription

Updated on 14 March 2022

File name

ie-spc-augmentinduomf400-57mgissue6draft3_1647267181.pdf

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 5.1 - Pharmacodynamic properties

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

Updated on 14 March 2022

File name

ie-pl-augmentinduomf400-57mgissue8draft2_1647266991.pdf

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision

Updated on 07 August 2020

File name

ie-spc-augmentinduomf400-57mgissue5 draft2_1596795386.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-augmentinduomf400-57mgissue6 draft2_1596795020.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 20 December 2019

File name

ie-spc-augmentinduo400-57mgissue5draft1-for.medicines.ie_1576837503.pdf

Reasons for updating

  • Previous version of SPC reinstated

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Previous version reinstated due to upload error.

Updated on 20 December 2019

File name

ie-pl-augmentinduo457mgissue10draft1-for medicines.ie_1576837438.pdf

Reasons for updating

  • Previous version of PIL reinstated

Free text change information supplied by the pharmaceutical company

Previous version reinstated due to upload error.

Updated on 19 December 2019

File name

ie-pl-augmentinduomf400-57mgissue5draft1-medicines.ie_1576774765.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 19 December 2019

File name

ie-spc-augmentinduomf400-57mgissue4draft1-medicines.ie_1576774660.pdf

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

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

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Update to SmPC

Section 6.5 –Type of cap and bottle seal

Section 6.6 – Preparation and reconstitution methods

Updated on 18 May 2018

File name

ie-pl-augmentinduo457mgissue10draft1formedsie.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to name of medicinal product

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)

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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_8336_223.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 31 October 2017

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)

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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 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 17 November 2016

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 01 September 2016

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

9.

Common MR Renewal Date of 19 October 2014

10.

Date of revision of text

Updated on 21 July 2016

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 21 April 2016

Reasons for updating

  • Change to date of revision

Updated on 30 July 2015

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 1 – Product Name Change
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

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

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)

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Change to address of the MA Holder

Updated on 16 July 2015

Reasons for updating

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

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 - 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

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

Reasons for updating

  • Change to side-effects

Updated on 14 April 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

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2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

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 04 November 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

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Section 2 in the previous version was missing the second sentence - from last week

Updated on 02 November 2010

Reasons for updating

  • Change due to harmonisation of patient information leaflet

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

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

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Changes to section 4 & 5

Updated on 05 October 2009

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:

Fill Weight

Volume of water to be added to reconstitute

Nominal bottle size

Final volume of reconstituted oral suspension

3.1g

19 ml

45 ml

20 ml

5.3g

32 ml

107 ml

35 ml

10.6g

64 ml

147 ml

70 ml

21.0

127ml

200ml

140ml

 

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

 

32

35

 

64

70

 

127

140

 

            Shake the bottle well before each dose.

 

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 10 September 2009

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

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 05 November 2007

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

Children under 2 should be dosed according to body weight
 

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

      15                           4.7                            8.4
 

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

Reasons for updating

  • Improved electronic presentation

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

Updated on 23 May 2007

Reasons for updating

  • Improved electronic presentation

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

Updated on 30 January 2007

Reasons for updating

  • Change to section 6.3 - Shelf life

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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

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)

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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 25 September 2006

Reasons for updating

  • Improved electronic presentation

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

Updated on 17 August 2006

Reasons for updating

  • Improved electronic presentation

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

Updated on 25 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 26 August 2005

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 04 August 2005

Reasons for updating

  • Improved electronic presentation

Updated on 18 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 August 2004

Reasons for updating

  • Improved electronic presentation

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

Updated on 09 August 2004

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

Reasons for updating

  • New SPC for medicines.ie

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