When a pharmaceutical company changes an SPC or PIL, 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.
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
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
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
Excipient: Contains 3.32 mg of aspartame (E951) per ml
6.1 List of Excipients
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.
Strawberry flavour
6.2 Incompatibilities
Not applicable
6.3 Shelf-life
Dry powder: 24 months
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.
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.
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.
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.
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.
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
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
20.0
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)
2-6 years 5.0 ml ‘Augmentin-Duo’ suspension b.i.d.
7-12 years 10.0 ml ‘Augmentin-Duo’ suspension b.i.d.
Weight (kg) 25/3.6 mg/kg/day 45/6.4 mg/kg/day
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).
Dry powder: 18 24 months
Reconstituted suspension: 7 days when stored in a refrigerator (2-8°C)
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
............................