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.
4.2 Posology and method of administration Children 6 to 12 years: One capsule every four hours, up to a maximum of 3 doses in 24 hours if needed. Children under 612 years: Not to be given to children under 612 years of age. 4.3 Contraindications Do not give to children under 12 years of age.
Children under 612 years: Not to be given to children under 612 years of age. 4.3 Contraindications Do not give to children under 12 years of age.
4.3 Contraindications Do not give to children under 12 years of age.
4.3 Contraindications
Do not give to children under 12 years of age.
"lso contains Allura Red (E129)
For a full list of excipients see section 6.1." In section 3 (Pharmaceutical form) capsule was placed in brackets after hard. and "It contains a white powder" was added at the end of the last sentence in the section. In section 6.1 (List of excipients) a subheading "Capsule Content" was added at the start . In section 6.5 (Nature and contents of container), "Not all pack sizes may be marketed" was added. In section 9 (Date of Authorisation/Renewal of the Authorisation), the text was changed to read as follows: Date of first authorisation: 04 November 2003 Date of last authorisation: 04 November 2008 In section 10 (date of revision of the text) the date was changed to September 2010
Section 10 Change in date of revision of the text from May 2005 to June 2005