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 4.2, Posology and method of Administration, a statement about nasolacrimal occlusion after administration is included.
In Section 4.4, Special warnings and precautions for use, a statement is included to warn the patients about discomfort, or stinging or transient burning upon instillation in the initial stages.
In Section 4.5, Interaction with other medicines and other forms of interaction, the following text is included – ‘No interaction studies have been performed. 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, statements have been included to state that there is no sufficient data to suggest the safety of use in pregnancy and breast-feeding, and hence is preferable to avoid usage of the medicine.
In Section 4.7, Effects on ability to drive and use machines, the following statement is added - ‘Lodoxamide has no or negligible influence on the ability to drive and use machines.’
In Section 4.8, Undesirable effects, summary of safety profile and a tabulated list of adverse events are included.
In Section 4.9, Overdose, the following statement is added – ‘Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product’; and information on accidental overdose has been modified.
In Section 10, Date of revision of the text, the date of revision is updated.