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.
SUMMARY OF SPC CHANGES (MARKED IN RED)
1. Trade Name of the Medicinal Product Augmentin Paediatric 125mg/31.25mg per 5ml Paediatric Powder for Oral Suspension 2. Qualitative and Quantitative Composition Each 5 ml of reconstituted suspension contains Amoxicillin Trihydrate Ph.Eur. equivalent to 125 mg of amoxicillin and potassium clavulanate equivalent to 31.25 mg of clavulanic acid. Excipient: Each 5ml of reconstituted oral suspension contains 12.5mg of Aspartame (E951). For a full list of excipients, see section 6.1 6. Pharmaceutical Particulars 6.1 List of Excipients Xanthan gum (E415) Hypromellose (E464) Aspartame (E951) Silicon dioxide Colloidal hydrated Silica Silica colloidal anhydrous silica Succinic acid Raspberry dry flavour Orange dry flavour 1 Orange dry flavour 2 Golden syrup dry flavour 6.3 Shelf-life Dry powder: 24 months 2 Years Reconstituted suspension according to directions: 7 days Discard any unused suspension seven days after reconstitution. 6.4 Special Precautions for Storage Dry powder should be stored in the original container: Do not store above 25°C. Store in the original container to protect from moisture. Reconstituted suspensions should be according to directions: Stored at between 2°C and 8°C. (but not frozen) for up to seven days. Do not freeze. 6.6 Instructions for Use/Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product At time of dispensing the dry powder should be reconstituted to form an oral suspension.
Augmentin Paediatric 125mg/31.25mg per 5ml Paediatric Powder for Oral Suspension
2. Qualitative and Quantitative Composition Each 5 ml of reconstituted suspension contains Amoxicillin Trihydrate Ph.Eur. equivalent to 125 mg of amoxicillin and potassium clavulanate equivalent to 31.25 mg of clavulanic acid. Excipient: Each 5ml of reconstituted oral suspension contains 12.5mg of Aspartame (E951). For a full list of excipients, see section 6.1 6. Pharmaceutical Particulars 6.1 List of Excipients Xanthan gum (E415) Hypromellose (E464) Aspartame (E951) Silicon dioxide Colloidal hydrated Silica Silica colloidal anhydrous silica Succinic acid Raspberry dry flavour Orange dry flavour 1 Orange dry flavour 2 Golden syrup dry flavour 6.3 Shelf-life Dry powder: 24 months 2 Years Reconstituted suspension according to directions: 7 days Discard any unused suspension seven days after reconstitution. 6.4 Special Precautions for Storage Dry powder should be stored in the original container: Do not store above 25°C. Store in the original container to protect from moisture. Reconstituted suspensions should be according to directions: Stored at between 2°C and 8°C. (but not frozen) for up to seven days. Do not freeze. 6.6 Instructions for Use/Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product At time of dispensing the dry powder should be reconstituted to form an oral suspension.
Each 5 ml of reconstituted suspension contains Amoxicillin Trihydrate Ph.Eur. equivalent to 125 mg of amoxicillin and potassium clavulanate equivalent to 31.25 mg of clavulanic acid.
Excipient: Each 5ml of reconstituted oral suspension contains 12.5mg of Aspartame (E951).
For a full list of excipients, see section 6.1
6. Pharmaceutical Particulars 6.1 List of Excipients Xanthan gum (E415) Hypromellose (E464) Aspartame (E951) Silicon dioxide Colloidal hydrated Silica Silica colloidal anhydrous silica Succinic acid Raspberry dry flavour Orange dry flavour 1 Orange dry flavour 2 Golden syrup dry flavour 6.3 Shelf-life Dry powder: 24 months 2 Years Reconstituted suspension according to directions: 7 days Discard any unused suspension seven days after reconstitution. 6.4 Special Precautions for Storage Dry powder should be stored in the original container: Do not store above 25°C. Store in the original container to protect from moisture. Reconstituted suspensions should be according to directions: Stored at between 2°C and 8°C. (but not frozen) for up to seven days. Do not freeze. 6.6 Instructions for Use/Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product At time of dispensing the dry powder should be reconstituted to form an oral suspension.
6.1 List of Excipients
Xanthan gum (E415)
Hypromellose (E464)
Aspartame (E951) Silicon dioxide Colloidal hydrated Silica Silica colloidal anhydrous silica Succinic acid Raspberry dry flavour Orange dry flavour 1 Orange dry flavour 2 Golden syrup dry flavour 6.3 Shelf-life Dry powder: 24 months 2 Years Reconstituted suspension according to directions: 7 days Discard any unused suspension seven days after reconstitution. 6.4 Special Precautions for Storage Dry powder should be stored in the original container: Do not store above 25°C. Store in the original container to protect from moisture. Reconstituted suspensions should be according to directions: Stored at between 2°C and 8°C. (but not frozen) for up to seven days. Do not freeze. 6.6 Instructions for Use/Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product At time of dispensing the dry powder should be reconstituted to form an oral suspension.
Silicon dioxide Colloidal hydrated Silica
Silica colloidal anhydrous silica
Succinic acid
Raspberry dry flavour
Orange dry flavour 1
Orange dry flavour 2
Golden syrup dry flavour
6.3 Shelf-life
Dry powder: 24 months 2 Years Reconstituted suspension according to directions: 7 days Discard any unused suspension seven days after reconstitution. 6.4 Special Precautions for Storage Dry powder should be stored in the original container: Do not store above 25°C. Store in the original container to protect from moisture. Reconstituted suspensions should be according to directions: Stored at between 2°C and 8°C. (but not frozen) for up to seven days. Do not freeze. 6.6 Instructions for Use/Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product At time of dispensing the dry powder should be reconstituted to form an oral suspension.
Reconstituted suspension according to directions: 7 days
Discard any unused suspension seven days after reconstitution.
6.4 Special Precautions for Storage
Dry powder should be stored in the original container: Do not store above 25°C. Store in the original container to protect from moisture. Reconstituted suspensions should be according to directions: Stored at between 2°C and 8°C. (but not frozen) for up to seven days. Do not freeze. 6.6 Instructions for Use/Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product At time of dispensing the dry powder should be reconstituted to form an oral suspension.
Reconstituted suspensions should be according to directions: Stored at between 2°C and 8°C. (but not frozen) for up to seven days. Do not freeze. 6.6 Instructions for Use/Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product At time of dispensing the dry powder should be reconstituted to form an oral suspension.
6.6 Instructions for Use/Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product At time of dispensing the dry powder should be reconstituted to form an oral suspension.
At time of dispensing the dry powder should be reconstituted to form an oral suspension.
OLD SPC Wording
Renal impairment
In patients with moderate or severe renal impairment dosages should be adjusted according to the degree of impairment.
Creatinine clearance
Dosage ml/min
Interval mg
hr
10 - 30
15/3.75* mg/kg
12 (b.i.d.)
< 10
24 (o.d.)
* using the Paediatric Suspension
NEW SPC Wording
(maximum 500/125mg twice daily)
(maximum 500/125mg)
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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