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.
Section 2 – Include excipient details for lactose
Sections 4.4 - Update warning on prolonged use of painkillers for headaches, add reference to lactose.
Section 4.9 – Update information on overdose
Section 6.1 – Update details for the film coat (Macrogel 3000)
Sections 9 and 10 – Update date of renewal and revision of the text