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.
In Section 4.3, Contraindications, ‘Acute, untreated purulent bacterial infections’ is added, and the whole section is reformatted. In Section 4.4, Special warnings and precautions for use, additional safety information on corticosteroid usage and prolonged use of topical ophthalmic corticosteroids has been added, and the whole section is reformatted. In Section 4.5, Interactions with other medicinal products and other forms of interaction, the following statement is added – ‘If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.’ In Section 4.6, Pregnancy and lactation, additional safety information on the use of Maxidex in pregnancy and during breast-feeding has been added. In Section 4.7, Effects on ability to drive and use machines, the following statements are added – ‘Maxidex has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.’ In Section 4.8, Undesirable effects, the section is replaced with a summary of the safety profile, a tabulated list of adverse reactions, and a description of selected adverse reactions In Section 4.9, Overdose, the following statement has been added – ‘An ocular overdose of Maxidex can be flushed from the eye(s) with lukewarm water.’ In Section 5.3, Preclinical data, additional preclinical data has been added. In Section 10, Date of revision of the text, the date of revision is updated.