Vevizye

Treatment should be initiated and supervised by an ophthalmologist. 01 mg ciclosporin) twice daily to be applied to each eye approximately 12 hours apart. If a dose is missed, treatment should be continued with the next dose as normal.

Patients should be advised not to instil more than one drop in each eye. Elderly patients No dose adjustment is required for elderly patients. Paediatric population There is no relevant use of ciclosporin in the paediatric population for the indication of dry eye disease.

Method of administration For ocular use only. Patients should be instructed to first wash their hands. Patients should be advised not to allow the dropper tip to touch the eye or any other surface, as this may contaminate the solution.

4). 4. 3

8%). Instillation site reactions were more common in patients ≥ 65 years of age as compared to younger patients. Tabulated list of adverse reactions The following adverse reactions listed below were observed in clinical studies. Adverse reactions are presented below according to MedDRA system organ classification (SOC and preferred term level).

They are ranked according to frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), or not known (cannot be estimated from the available data).

9%) was the most frequently reported adverse reaction associated with the use Vevizye during clinical trials. 1%). All instillation site reactions are typically mild and transient. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 5

g. within 3 months after treatment initiation and thereafter approximately every 6 months. Glaucoma There is limited experience with ciclosporin in the treatment of patients with ocular hypertension or glaucoma. Regular clinical monitoring should be exercised when treating patients receiving glaucoma medication and ciclosporin eye drops.

Contact lenses Vevizye should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to the administration of the solution. Lenses may be reinserted 15 minutes following administration of Vevizye.

Effects on the immune system Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defence against local infections and malignancies. In case of signs of an eye infection the patient should seek medical advice.

1. Ocular or peri-ocular malignancies or premalignant conditions. Active or suspected ocular or periocular infections.