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 4.1. Therapeutic indications Addition of autoimmune hepatitis indication.
Section 4.2. Posology and method of administration Addition of posology and duration of treatment for the autoimmune hepatitis indication. Details on paediatric use added.
Section 4.3. Contra-indications Removed reference to portal hypertension.
Section 4.4. Special warnings and special precautions for use
Information on changing from systemically acting corticosteroids, particularly in adolescents.
Section 4.8. Undesirable Effects Added reference to effects in paediatrics when taken for autoimmune hepatitis. Added section “Side effects in clinical studies with paediatric patients:“
Section 5.1. Pharmacodynamic Properties Added clinical efficacy and safety information from clinical studies in patients with autoimmune hepatitis. Added paediatric information.
Section 5.2. Pharmacokinetic Properties Updated the section: Specific patient populations - Liver diseases. Added section on Paediatric patients:
Section 10. Date of (partial) revision of the text Updated
Section 2: Added: Excipients: Each capsule contains 240mg Sucrose and 12mg Lactose Monohydrate.
Section 3: Added: (gastro-resistant capsules)
Section 4.4: Added: Information on the systemic effects of corticosteroids (2nd paragraph)
Section 10: Changed: October 2006 to April 2009