Summary of track changes for the SPC:
Amoxil Paediatric 125mg/1.25ml Powder for Oral Suspension
Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
125mg amoxicillin per 1.25ml as amoxicillin trihydrate
For excipients see section 6.1.
Section 3. PHARMACEUTICAL FORM
Powder for oral suspension
White free flowing powder
Section 4.4 Special warnings and precautions for use
Addition of the following warnings:
‘Amoxil’ Paediatric Suspension contains sodium benzoate.
Deletion of the following warning:
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Section 6.1.List of excipients
Sodium benzoate (E211)
carmellose sodium (E466)
peach dry flavour
strawberry dry flavour
lemon dry flavour
Section 6.5. Nature and contents of container
A clear 45ml glass bottle moulded from type III Ph. Eur. glass. The bottles are fitted with an aluminium roll-on pilfer-proof (ROPP), internally lacquered, externally enamelled closure containing a flowed-in PVC liner.
Section 6.6. 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, as detailed below:
Volume of water to be added to reconstitute 13ml
Nominal bottle size
Final volume of reconstituted oral suspension 20ml