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.
In section 4.2, for patients with Renal Insufficiency/dialysis and hepatic insufficiency, the wording of the section has been reformatted for better clarity, from "In patients with severe renal and/or hepatic insufficiency Zydol SR is not recommended. In moderate cases prolongation of the dosage interval should be carefully considered.” to "In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage interval should be carefully considered according to the patients requirements. In cases of severe renal and/or severe hepatic insufficiency Zydol SR prolonged-release tablets are not recommended.” In section 10, the revision date has been updated.
update date to: January 2009
Date updated to November 2008
Section 2 – format/harmonisation of text and additional information on excipients
Section 3 – format/harmonisation of text
Section 4.1 – format/harmonisation of text
Section 4.2 - – format/harmonisation, change in children age limit
Section 4.3 - – format/harmonisation of text
Section 4.4 – format/harmonisation of text
Section 4.5 – format/harmonisation, INR warning updated, additional information
Section 4.6 – format/harmonisation of text
Section 4.7– format/harmonisation of text
Section 4.8 – format/harmonisation including additions and deletion of adverse reaction details
Section 4.9 – format/harmonisation with addition advice.
Section 5.1 – format/harmonisation of text
Section 5.2 – format/harmonisation of text
Section 5.3 – format/harmonisation of text
Section 6.6 – format/harmonisation
Section 10 – updated date of SPC