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.
"Chlorhexidine Digluconate 1.0% w/w (as Chlorhexidine Digluconate Solution)
Excipients: Contains Macrogolglycerol Hydroxystearate1% w/w
For a full list of excipients, see section 6.1." Section 9 (date of Authorisation/Renewal of the Authorisation) was updated to read as follows: "29 April 1975/ 10 January 2010" Section 10 (Date of Revision) was changed to September 2010.
Section 4.8
Irritative skin reactions to chlorhexidine preparations can occasionally occur.
Generalised allergic reactions to chlorhexidine have been reported but are extremely rare. Generalised reactions: Allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare.
Section 9
29 April 1975/ 10 January 2005
Section 10
February 2008
The second sentence in section 4.8 of the SPC, which currently reads "Generalised allergic reactions to chlorhexidine have been reported but are extremely rare" should be deleted and replaced with the following: "Generalised reactions: Allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare."