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.
Following approval of the DBP free formulation the following sections of the SPC have been changed;
In section 6.1 the excipient dibutylphthalate and liquid paraffin have been removed and replaced with cetyl alcohol and triethyl citrate.
In section 6.4 storage conditions have been changed from 25 to 30 degrees C.
Date of first authorisation: 24th April 1997
Date of last renewal: 21st March 2007
6.1 List of Excipients
Capsules: Gelatin, Red and Yellow Iron Oxides (E172), Titanium Dioxide (E171), sodium lauryl sulphate.
6.5. Nature and Contents of Container
HDPE container with polypropylene closure, containing 50 or 100 capsules.
10. Date of Revision of the Text
March 2007