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.
Due to the content of corticosteroid, Fucibet® Lipid is contraindicated in the following conditions: skin infections primarily caused by bacteria, fungi or virus (such as herpes or varicella), skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea. In section 4.4, there have been the following changes: 1. Warning has been included regarding the preparation entering the eye. 2. A statement regarding bacterial resistance with the use of fusidic acid has been included. 3. The use of a steroid/antibiotic should be limited to two weeks. This has been changed from a previous limit of 3 weeks. In section 4.6, there has been editorial changes. In section 4.8, the amount of patients expected to experience an undesirable effect, based on clinical study data has changed from 5% to 3%. The undesirable effects have been listed under the frequency heading. In section 5.1, the ATC code has been added.