Verkazia

Verkazia treatment should only be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology. Posology Children from 4 years of age and adolescents The recommended dose is one drop of Verkazia 4 times a day (morning, noon, afternoon and evening) to be applied to each affected eye during the VKC season.

If signs and symptoms of VKC persist after the end of the season, the treatment can be maintained at the recommended dose or decreased to one drop twice daily once adequate control of signs and symptoms is achieved. Treatment should be discontinued after signs and symptoms are resolved, and reinitiated upon their recurrence.

Missed dose If a dose is missed, treatment should be continued on the next instillation as normal. Patients should be advised not to instill more than one drop for each instillation in the affected eye(s). Paediatric population There is no relevant use of Verkazia in children below 4 years in the treatment of severe vernal keratoconjunctivitis.

3 Patients with renal or hepatic impairment The effect of Verkazia has not been studied in patients with renal or hepatic impairment. However, no special dose adjustment is needed in these populations. Method of administration Ocular use Precautions to be taken before administering the medicinal product Patients should be instructed to first wash their hands.

Prior to administration, the single-dose container should be gently shaken. For single use only. Each single-dose container is sufficient to treat both eyes. Patients should be instructed to use nasolacrimal occlusion and to close the eyelids for 2 minutes after instillation, to reduce the systemic absorption.

4). If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 15 minutes apart. 4).

Summary of the safety profile The most common adverse reactions with Verkazia are eye pain (11%) and eye pruritus (9%) which are usually transitory and occurred during instillation. Tabulated list of adverse reactions The following adverse reactions listed below were observed in clinical studies.

They are ranked according to system organ class and classified according to the following convention: 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).

5 MedDRA system organ class MedDRA frequency Adverse reaction Infections and infestations Common Upper respiratory tract infection. Uncommon Keratitis bacterial, herpes zoster ophthalmic. Nervous system disorders Common Headache. Eye disorders Very common Eye pain.

Common Eye pruritus, ocular hyperaemia, eye irritation, ocular discomfort, foreign body sensation in eyes, lacrimation increased, vision blurred, erythema of eyelid, eyelid oedema. Uncommon Blepharitis, conjunctival oedema. Respiratory, thoracic and mediastinal disorders Common Cough.

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.

Contact lenses Patients wearing contact lenses have not been studied. Therefore, the use of Verkazia with contact lenses is not recommended. Concomitant therapy Co-administration of Verkazia with eye drops containing corticosteroids may potentiate the effects of Verkazia on the immune system.

However, in clinical studies, 18 patients received Verkazia (4 times daily) in co-administration with eye drops containing corticosteroids and no increase in the risk of adverse reactions related to the immune system was identified.

5). Effects on the immune system Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies. g. every 3 to 6 months, when Verkazia is used for more than 12 months.

Verkazia has not been studied in patients with an active orofacial herpes simplex infection, a history of ocular herpes, varicella-zoster, or vaccinia virus infection and should therefore be used with caution in such patients. Excipient Verkazia contains cetalkonium chloride which may cause eye irritation.

4

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