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.
Section 2 –Wording updated to include information on the quantities of the excipients and to also include the wording “For a full list of excipients see section, 6.1.”
Section 3-To change the descriptive wording of the Film-Coated Tablets, and to also include the wording “The scoreline is to allow breaking for ease of swallowing and not to divide into equal halves.”
Update to sections 4.3, 4.4, 4.6 and 5.2 of the SPC with the Pharmacovgilance Working Party wording relating to the use of ACE inhibitors during pregnancy and lactation.