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.
section 3 : Capsules, hard changed to
21 March 1997/21 March 2002 changes to
Date of first authorisation: 21st March 1997
Date of last renewal: 21st March 2007
6.1. List of Excipients
Capsule shell: Gelatin, red, yellow and black iron oxides (E172), titanium dioxide (E171), sodium lauryl sulphate.
6.5. Nature and Contents of Containers
HDPE container with polypropylene cap. Containers hold 100, 250 or 300 capsules.
10. DATE OF REVISION OF THE TEXT
March 2007