Augmentin DUO Suspension 400/57mg

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/05/18

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Summary of Product Characteristics last updated on medicines.ie: 7/3/2018
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Amoxil Paediatric Suspension Active Ingredients Amoxicillin trihydrate
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 DUO Suspension 400/57mg Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
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
1 - 0 of 136 items.Total: Infinity pages

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

9.

Common MR Renewal Date of 19 October 2014

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 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 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

Change to address of the MA Holder

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

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 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 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 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

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

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

Changes to section 4 & 5

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:

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 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

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 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)