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 Inclusion of the statement "each sachet contains 0.016g aspartame" and "for a full list of excipients see section 6.1" 6.2. Incompatibilities replace "none known" with "not applicable" 6.4. Special Precautions for Storage amended text from Store below 30°C. Store in the original package to "Do not store above 30°C. Store in the original package in order to protect from moisture." 6.5. Nature and Contents of Containers inclusion of "not all pack sizes may be marketed" 6.6. Special precautions for disposal and other handling inclusion of "The granules are semi-transparent and buff-coloured with an odour of orange which when added to water form an effervescent suspension"
replace "none known" with "not applicable" 6.4. Special Precautions for Storage amended text from Store below 30°C. Store in the original package to "Do not store above 30°C. Store in the original package in order to protect from moisture." 6.5. Nature and Contents of Containers inclusion of "not all pack sizes may be marketed" 6.6. Special precautions for disposal and other handling inclusion of "The granules are semi-transparent and buff-coloured with an odour of orange which when added to water form an effervescent suspension"
Section 4.3 updated to add: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Patients allergic to peanut or soya should not take this medicine.