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.
6.5 Nature and contents of container
PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB).
Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets
Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP)
Packs of 14, 20 or 21 tablets
Amber glass bottle
Packs of 30, 50, 100 or 500 tablets
Plastic bottle
Packs of 20, 30 or 100 tablets
Not all pack sizes may be marketed
2009 RENEWAL
SUMMARY OF PRODUCT CHARACTERISTICS CHANGES (in red)
1. TRADE NAME OF THE MEDICINAL PRODUCT
Augmentin-Duo Tablets 500mg/125mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Amoxicillin Trihydrate equivalent to 500mg Amoxicillin and Potassium Clavulanate equivalent to 125mg clavulanic acid. For a full list of excipients, see section 6.1 4.2 Posology and Method of Administration Usual dosages for the treatment of infection Adults and children over 12 years For mild to moderate infections one ‘Augmentin-Duo’ Tablet 500/125mg twice a day. Therapy can be started parenterally and continued with an oral preparation. Not recommended in children of 12 years and under. Dosage in renal impairment Adults: Mild impairment (Creatinine clearance >30 ml/min) Moderate impairment (Creatinine clearance 10-30 ml/min) Severe impairment (Creatinine clearance <10 ml/min) No change in dosage One ‘Augmentin-Duo’ Tablet 500/125mg 12 hourly Not recommended. Haemodialysis Dosage adjustments are based on the maximum recommended level of Amoxicillin. One 500/125mg tablets every 24 hours PLUS one dose during dialysis, to be repeated at the end of dialysis (as serum concentrations of both Amoxicillin and clavulanic acid are decreased). Dosage in hepatic impairment Dose with caution; monitor hepatic function at regular intervals. There is as yet insufficient evidence on which to base a dosage recommendation. Method of administration To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of co-amoxiclav is optimised when taken at the start of a meal. Duration of therapy should be appropriate and should not exceed 14 days without review. Therapy can be started parenterally and continued with an oral preparation. The tablet should not be broken. 6. PHARMACEUTICAL PARTICULARS 6.1 List of Excipients Tablet Core Magnesium stearate, Sodium starch glycollate, Colloidal anhydrous silica, Microcrystalline cellulose Tablet coat Titanium dioxide (E171), Hypromellose (Methocel E5 and E15), Macrogol 4000 Macrogol 6000 Dimeticone. 6.2 Incompatibilities Not applicable 6.3 Shelf-life Blister pack - 2 years Glass bottles: - 3 years 6.4 Special Precautions for Storage Do not store above 25°C Store in the original package in order to protect from moisture. 6.5 Nature and Contents of Container *Blister packs of 10 and 20 tablets in a carton; the blister is comprised of PVC/PVdC with an aluminium overseal. 14 Tablet Pack: Aluminium PVC/PVdC blisters of 7 tablets enclosed within an aluminium laminate pouch containing a dessicant sachet. Amber glass bottles containing 6, 30, 50, 100 and 500 tablets, closed with an ROPP cap with pre-inserted wad 2.5g of molecular sieve per 30 tablets as desiccant will be included. *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack). *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack), medical sample pack only. Not all pack sizes may be marketed *Packs not marketed. PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB). Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP) Packs of 14, 20 or 21 tablets Amber glass bottle Packs of 30, 50, 100 or 500 tablets Plastic bottle Packs of 20, 30 or 100 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product. The tablet should not be broken. No special requirements
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Amoxicillin Trihydrate equivalent to 500mg Amoxicillin and Potassium Clavulanate equivalent to 125mg clavulanic acid. For a full list of excipients, see section 6.1 4.2 Posology and Method of Administration Usual dosages for the treatment of infection Adults and children over 12 years For mild to moderate infections one ‘Augmentin-Duo’ Tablet 500/125mg twice a day. Therapy can be started parenterally and continued with an oral preparation. Not recommended in children of 12 years and under. Dosage in renal impairment Adults: Mild impairment (Creatinine clearance >30 ml/min) Moderate impairment (Creatinine clearance 10-30 ml/min) Severe impairment (Creatinine clearance <10 ml/min) No change in dosage One ‘Augmentin-Duo’ Tablet 500/125mg 12 hourly Not recommended. Haemodialysis Dosage adjustments are based on the maximum recommended level of Amoxicillin. One 500/125mg tablets every 24 hours PLUS one dose during dialysis, to be repeated at the end of dialysis (as serum concentrations of both Amoxicillin and clavulanic acid are decreased). Dosage in hepatic impairment Dose with caution; monitor hepatic function at regular intervals. There is as yet insufficient evidence on which to base a dosage recommendation. Method of administration To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of co-amoxiclav is optimised when taken at the start of a meal. Duration of therapy should be appropriate and should not exceed 14 days without review. Therapy can be started parenterally and continued with an oral preparation. The tablet should not be broken. 6. PHARMACEUTICAL PARTICULARS 6.1 List of Excipients Tablet Core Magnesium stearate, Sodium starch glycollate, Colloidal anhydrous silica, Microcrystalline cellulose Tablet coat Titanium dioxide (E171), Hypromellose (Methocel E5 and E15), Macrogol 4000 Macrogol 6000 Dimeticone. 6.2 Incompatibilities Not applicable 6.3 Shelf-life Blister pack - 2 years Glass bottles: - 3 years 6.4 Special Precautions for Storage Do not store above 25°C Store in the original package in order to protect from moisture. 6.5 Nature and Contents of Container *Blister packs of 10 and 20 tablets in a carton; the blister is comprised of PVC/PVdC with an aluminium overseal. 14 Tablet Pack: Aluminium PVC/PVdC blisters of 7 tablets enclosed within an aluminium laminate pouch containing a dessicant sachet. Amber glass bottles containing 6, 30, 50, 100 and 500 tablets, closed with an ROPP cap with pre-inserted wad 2.5g of molecular sieve per 30 tablets as desiccant will be included. *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack). *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack), medical sample pack only. Not all pack sizes may be marketed *Packs not marketed. PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB). Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP) Packs of 14, 20 or 21 tablets Amber glass bottle Packs of 30, 50, 100 or 500 tablets Plastic bottle Packs of 20, 30 or 100 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product. The tablet should not be broken. No special requirements
Each tablet contains Amoxicillin Trihydrate equivalent to 500mg Amoxicillin and Potassium Clavulanate equivalent to 125mg clavulanic acid.
For a full list of excipients, see section 6.1
4.2 Posology and Method of Administration
Usual dosages for the treatment of infection
Adults and children over 12 years
For mild to moderate infections one ‘Augmentin-Duo’ Tablet 500/125mg twice a day. Therapy can be started parenterally and continued with an oral preparation.
Not recommended in children of 12 years and under.
Dosage in renal impairment
Adults:
Mild impairment
(Creatinine clearance
>30 ml/min)
Moderate impairment (Creatinine clearance
10-30 ml/min)
Severe impairment (Creatinine clearance <10 ml/min)
No change in dosage
One ‘Augmentin-Duo’ Tablet 500/125mg 12 hourly
Not recommended.
Haemodialysis
Dosage adjustments are based on the maximum recommended level of Amoxicillin. One 500/125mg tablets every 24 hours PLUS one dose during dialysis, to be repeated at the end of dialysis (as serum concentrations of both Amoxicillin and clavulanic acid are decreased).
Dosage in hepatic impairment
Dose with caution; monitor hepatic function at regular intervals. There is as yet insufficient evidence on which to base a dosage recommendation.
Method of administration
To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of co-amoxiclav is optimised when taken at the start of a meal. Duration of therapy should be appropriate and should not exceed 14 days without review. Therapy can be started parenterally and continued with an oral preparation. The tablet should not be broken. 6. PHARMACEUTICAL PARTICULARS 6.1 List of Excipients Tablet Core Magnesium stearate, Sodium starch glycollate, Colloidal anhydrous silica, Microcrystalline cellulose Tablet coat Titanium dioxide (E171), Hypromellose (Methocel E5 and E15), Macrogol 4000 Macrogol 6000 Dimeticone. 6.2 Incompatibilities Not applicable 6.3 Shelf-life Blister pack - 2 years Glass bottles: - 3 years 6.4 Special Precautions for Storage Do not store above 25°C Store in the original package in order to protect from moisture. 6.5 Nature and Contents of Container *Blister packs of 10 and 20 tablets in a carton; the blister is comprised of PVC/PVdC with an aluminium overseal. 14 Tablet Pack: Aluminium PVC/PVdC blisters of 7 tablets enclosed within an aluminium laminate pouch containing a dessicant sachet. Amber glass bottles containing 6, 30, 50, 100 and 500 tablets, closed with an ROPP cap with pre-inserted wad 2.5g of molecular sieve per 30 tablets as desiccant will be included. *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack). *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack), medical sample pack only. Not all pack sizes may be marketed *Packs not marketed. PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB). Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP) Packs of 14, 20 or 21 tablets Amber glass bottle Packs of 30, 50, 100 or 500 tablets Plastic bottle Packs of 20, 30 or 100 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product. The tablet should not be broken. No special requirements
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Tablet Core
Magnesium stearate,
Sodium starch glycollate,
Colloidal anhydrous silica,
Microcrystalline cellulose
Tablet coat
Titanium dioxide (E171),
Hypromellose (Methocel E5 and E15),
Macrogol 4000
Macrogol 6000
Dimeticone.
6.2 Incompatibilities
Not applicable
6.3 Shelf-life
Blister pack - 2 years
Glass bottles: - 3 years
6.4 Special Precautions for Storage Do not store above 25°C Store in the original package in order to protect from moisture. 6.5 Nature and Contents of Container *Blister packs of 10 and 20 tablets in a carton; the blister is comprised of PVC/PVdC with an aluminium overseal. 14 Tablet Pack: Aluminium PVC/PVdC blisters of 7 tablets enclosed within an aluminium laminate pouch containing a dessicant sachet. Amber glass bottles containing 6, 30, 50, 100 and 500 tablets, closed with an ROPP cap with pre-inserted wad 2.5g of molecular sieve per 30 tablets as desiccant will be included. *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack). *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack), medical sample pack only. Not all pack sizes may be marketed *Packs not marketed. PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB). Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP) Packs of 14, 20 or 21 tablets Amber glass bottle Packs of 30, 50, 100 or 500 tablets Plastic bottle Packs of 20, 30 or 100 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product. The tablet should not be broken. No special requirements
Do not store above 25°C
Store in the original package in order to protect from moisture.
6.5 Nature and Contents of Container
*Blister packs of 10 and 20 tablets in a carton; the blister is comprised of PVC/PVdC with an aluminium overseal.
14 Tablet Pack: Aluminium PVC/PVdC blisters of 7 tablets enclosed within an aluminium laminate pouch containing a dessicant sachet. Amber glass bottles containing 6, 30, 50, 100 and 500 tablets, closed with an ROPP cap with pre-inserted wad 2.5g of molecular sieve per 30 tablets as desiccant will be included. *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack). *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack), medical sample pack only. Not all pack sizes may be marketed *Packs not marketed. PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB). Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP) Packs of 14, 20 or 21 tablets Amber glass bottle Packs of 30, 50, 100 or 500 tablets Plastic bottle Packs of 20, 30 or 100 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product. The tablet should not be broken. No special requirements
14 Tablet Pack:
Aluminium PVC/PVdC blisters of 7 tablets enclosed within an aluminium laminate pouch containing a dessicant sachet.
Amber glass bottles containing 6, 30, 50, 100 and 500 tablets, closed with an ROPP cap with pre-inserted wad 2.5g of molecular sieve per 30 tablets as desiccant will be included. *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack). *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack), medical sample pack only. Not all pack sizes may be marketed *Packs not marketed. PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB). Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP) Packs of 14, 20 or 21 tablets Amber glass bottle Packs of 30, 50, 100 or 500 tablets Plastic bottle Packs of 20, 30 or 100 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product. The tablet should not be broken. No special requirements
Amber glass bottles containing 6, 30, 50, 100 and 500 tablets, closed with an ROPP cap with pre-inserted wad 2.5g of molecular sieve per 30 tablets as desiccant will be included.
*Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack). *Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack), medical sample pack only. Not all pack sizes may be marketed *Packs not marketed. PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB). Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP) Packs of 14, 20 or 21 tablets Amber glass bottle Packs of 30, 50, 100 or 500 tablets Plastic bottle Packs of 20, 30 or 100 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product. The tablet should not be broken. No special requirements
*Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack).
*Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack), medical sample pack only.
Not all pack sizes may be marketed *Packs not marketed. PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB). Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP) Packs of 14, 20 or 21 tablets Amber glass bottle Packs of 30, 50, 100 or 500 tablets Plastic bottle Packs of 20, 30 or 100 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product. The tablet should not be broken. No special requirements
*Packs not marketed. PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB). Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP) Packs of 14, 20 or 21 tablets Amber glass bottle Packs of 30, 50, 100 or 500 tablets Plastic bottle Packs of 20, 30 or 100 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product. The tablet should not be broken. No special requirements
*Packs not marketed.
PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB). Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP) Packs of 14, 20 or 21 tablets Amber glass bottle Packs of 30, 50, 100 or 500 tablets Plastic bottle Packs of 20, 30 or 100 tablets Not all pack sizes may be marketed 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product. The tablet should not be broken. No special requirements
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product.
The tablet should not be broken.
No special requirements
3. PHARMACEUTICAL FORM
Film coated tablets
White, oval, film-coated tablets engraved ‘Augmentin’
White to off white oval shaped, film coated tablet debossed with ‘AC’ and a score line on one side and plain on the other side.
Instructions for Use/Handling
None
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
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