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 4.4, the following excipient warning has been added: Benzoic acid (E210) can mildly irritate the skin, eyes and mucosal membranes. Butylated hydroxyanisole (E320) may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucosa membranes.
In Section 6.1, the Macrogol content has been clarified: Macrogol 6 (PEG 6) Macrogol 32 (PEG 32)
1.
Changed to Daktarin 2% w/w Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Addition of : Excipients; contains 0.2% w/w benzoic acid (E210) and 0.005% w/w butylated hydroxyanisole (E320) Addition of Full statement added: For a full list excipients, see section 6.1. 6.1 List of excipients Name change: unsaturated polyglycolysed glycerides to oleoylmacroglycerides 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Renewal of product licence 31 March 2008 10. DATE OF REVISION OF THE TEXT Changed to May 2009
2.
Addition of : Excipients; contains 0.2% w/w benzoic acid (E210) and 0.005% w/w butylated hydroxyanisole (E320)
Addition of Full statement added: For a full list excipients, see section 6.1.
6.1
List of excipients
Name change: unsaturated polyglycolysed glycerides to oleoylmacroglycerides
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Renewal of product licence 31 March 2008
10.
DATE OF REVISION OF THE TEXT
Changed to May 2009