Verkazia

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 



2 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Verkazia 1 mg/mL eye drops, emulsion 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

One mL of emulsion contains 1 mg of ciclosporin. 

 

Excipient with known effect: 

 

One mL of emulsion contains 0.05 mg cetalkonium chloride (see section 4.4). 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Eye drops, emulsion. 

Milky white emulsion. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indication 

 

Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and 

adolescents.   

 

4.2 Posology and method of administration 

 

Verkazia treatment must 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. 

 

Efficacy and safety of Verkazia have not been studied beyond 12 months. (see section 4.4).  

 

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). 

 

Children below 4 years 

There is no relevant use of Verkazia in children below 4 years in the treatment of severe vernal 

keratoconjunctivitis. 

 

Adults 

The effect of Verkazia has not been studied in patients above 18 years of age. 



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. Any unused emulsion 

should be discarded immediately. 

 

Patients should be instructed to use nasolacrimal occlusion and to close the eyelids for 2 minutes after 

instillation, to reduce the systemic absorption. This may result in a decrease in systemic undesirable 

effects and an increase in local activity (see section 4.4).  

 

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be 

administered at least 15 minutes apart. Verkazia should be administered last (see section 4.4). 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  

Ocular or peri-ocular malignancies or premalignant conditions  

Active or suspected ocular or peri-ocular infection. 

 

4.4 Special warnings and precautions for use 

 

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. Therefore, caution should be exercised 

when corticosteroids are administered concomitantly with Verkazia.  (see section 4.5) 

 

Effects on the immune system 

Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect 

host defences against local infections and malignancies. Therefore, regular examination of the eye(s) is 

recommended, e.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 

 

 

Treatment duration 

Efficacy and safety of Verkazia have not been studied beyond 12 months. Therefore, regular 

examination of the eye(s) is recommended, e.g. every 3 to 6 months, when Verkazia is used for more 

than 12 months. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

No interaction studies have been performed with Verkazia. 

 

Combination with other medicinal products that affect the immune system 

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 of the risk of 

adverse reactions related to the immune system were identified. (see section 4.4) 

 

4.6 Fertility, pregnancy and lactation 

 

Women of childbearing potential/contraception in females 

Verkazia is not recommended in women of childbearing potential not using effective contraception.  

 

Pregnancy  

There are no data from the use of  Verkazia in pregnant women.  

 

Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin 

at exposures considered sufficiently in excess of the maximum human exposure indicating little 

relevance to the clinical use of  Verkazia. 

  

 Verkazia is not recommended during pregnancy unless the potential benefit to the mother outweighs 

the potential risk to the foetus. 

 

Breast-feeding  

Following oral administration, ciclosporin is excreted in breast milk. There is insufficient information 

on the effects of ciclosporin in newborns/infants. However, at therapeutic doses of ciclosporin in eye 

drops, it is unlikely that sufficient amounts would be present in breast milk. A decision must be made 

whether to discontinue breast-feeding or to discontinue/abstain from Verkazia therapy taking into 

account the benefit of breast-feeding for the child and the benefit of therapy for the woman.  

 

Fertility 

There are no data on the effects of Verkazia on human fertility.  

 

No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see 

section 5.3). 

 

4.7 Effects on ability to drive and use machines 

 

Verkazia has moderate influence on the ability to drive and use machines. 

 

This medicinal product may induce temporary blurred vision or other visual disturbances which may 

affect the ability to drive or use machines (see section 4.8). Patients should be advised not to drive or 

use machines until their vision has cleared. 

 



5 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

The most common adverse reactions in the clinicial trials with Verkazia were eye pain (11%) and eye 

pruritus (9%) which were 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). 

 

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.  

 

4.9 Overdose 

 

A topical overdose is not likely to occur after ocular administration. If overdose with Verkazia occurs, 

treatment should be symptomatic and supportive. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: Ophthalmologicals, other ophthalmologicals, ATC code: S01XA18. 

 

Mechanism of action and pharmacodynamic effects 

Following ocular administration, ciclosporin is passively absorbed by T-lymphocytes where its 

binding to cyclophilin A inactivates calcineurin, and prevents NF-AT translocation into the nucleus, 

thus blocking the release of pro-inflammatory cytokines such as IL-2 and hence T-lymphocyte 

activation. Blocking NF-AT also interferes in the allergy process. Ciclosporin inhibits histamine 

release from mast cells and basophils through a reduction in IL-5 production, and may reduce 

eosinophil recruitment and effects on the conjunctiva and cornea. Ciclosporin is also known to up-

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


6 

 

regulate the release of anti-inflammatory cytokines. All available evidence suggests that ciclosporin 

acts specifically and reversibly on lymphocytes and does not depress haematopoiesis or have any 

effect on the function of phagocytic cells. 

 

Clinical efficacy 

In a 12 month double-masked, vehicle controlled, pivotal clinical trial (VEKTIS study), 169 patients 

with severe VKC and severe keratitis (grade 4 or 5 on the modified Oxford scale) were randomised to 

4 drops of Verkazia (high dose) or 2 drops of Verkazia (low dose) and 2 drops of vehicle or 4 drops of 

vehicle for the first 4 months (Period 1). Patients randomised to the vehicle group were switched to 

Verkazia (four times or twice daily) from Month 4 to Month 12 (Period 2). 

 

168 patients [127 children (75.6%) and 41 adolescents (24.4%)] were included in the efficacy 

analyses. Mean age was 9.2 years (SD: 3.3, age range: 4-17 years). There were more male [n=132 

(78.6%)] than female patients [n=36 (21.4%)]. 

 

The primary efficacy endpoint which was the average penalties adjusted change of the Corneal 

Fluorescein Staining (CFS) score from baseline and over Period 1, considered all patients (n=168). 

Efficacy was assessed every month during the 4 month treatment period and compared with baseline 

using a composite criterion based on keratitis assessed by the modified Oxford scale, the need for 

rescue medicinal product (use of topical steroids) and the occurrence of corneal ulceration. 

 

The difference in the Least Square (LS) mean vs. vehicle was 0.76 (95% CI: 0.26, 1.27) for the high 

dose group and 0.67 (95% CI: 0.16, 1.18) for the low dose group. Both differences were statistically 

significant with p=0.007 for the high dose and p=0.010 for the low dose group. 

 

Clinical relevance of the primary efficacy endpoint was however difficult to address. In that context, 

responder rate’s results were considered as more reliable endpoint. A responder was defined as a 
patient 1) with a mean CFS score over the 4 months of treatment ≤ 50% of baseline, 2) who did not 
withdraw from the study for a reason possibly due to treatment, 3) with no experience of corneal 

ulceration and 4) no use of rescue medicinal product in the last 4 months of treatment. There was a 

significantly higher number of CFS responders in both active groups as compared to vehicle (p=0.005 

for the high dose group, and p=0.010 for the low dose group) with 55.4%, 50.0% and 27.6% of 

responders in the high dose, low dose and vehicle groups respectively. The excess rate with respect to 

vehicle was 27.8% for the high dose regimen and 22.4% for the low dose one. 

 

Rescue medicinal product (topical steroids) was used more often in the vehicle than in the high dose 

regimen: 32.1% in the high dose group and 31.5% in the low dose group received at least one course 

of rescue medicinal product while they were 53.4% in the vehicle group. 

 

All four symptoms (photophobia, tearing, itching and mucous discharge) improved over time and the 

difference from baseline at Month 4 for each symptom largely exceeded 10 mm.  

 

For the average of VKC symptoms, the difference in the LS mean vs. vehicle in the high dose group 

was statistically significant at all time points compared to vehicle: -19.4 mm (p<0.05).  

 

Patient quality of life (Quick questionnaire) improved significantly better in the high dose group 

compared to vehicle. The improvement was clinically relevant as illustrated by the effect size over 4 

months (symptoms domain: 0.67 and daily activities domain: 0.44).  

 

In Period 2, analyses demonstrated stability of improvements achieved during Period 1 for both doses 

regimen.  

 

5.2 Pharmacokinetic properties 

 

Formal pharmacokinetic studies have not been conducted in humans with Verkazia.  



7 

 

 

Blood concentrations of Verkazia were measured using a specific high-pressure liquid 

chromatography-mass spectrometry assay. In 166 patients at baseline from one efficacy study (55 

patients in the high dose group, 53 in the low dose group and 58 in the vehicle group), plasma 

concentrations of ciclosporin were measured before administration and after 2, 4 and 12 months of 

treatment. 

In the high dose group after 4 months of ocular instillation of Verkazia 4 times daily (n=50), 20 

patients had values below the lower limit of detection (0.050 ng/mL) and 13 patients had values below 

the lower limit of quantification (0.100 ng/mL). Quantifiable values not exceeding 0.670 ng/mL were 

measured in 14 patients, values considered to be negligible. Ciclosporinemia was not measured for 3 

patients. At Month 12, (n= 68 patients) values were below the lower limit of detection for 38 patients 

and below the lower limit of quantification in 10 patients. 12 patients had measurable values 

(maximum 0.291 ng/mL), all considered to be negligible values. Ciclosporinemia was not measured 

for 8 patients. 

In the low dose group, after 4 months of ocular instillation of Verkazia 2 times daily (n= 47 patients), 

34 patients had values below the lower limit of detection (0.050 ng/mL) and 7 patients had values 

below the lower limit of quantification (0.100 ng/mL). Quantifiable values not exceeding 

0.336  ng/mL were measured in 5 patients, values considered to be negligible. Ciclosporinemia was 

not measured for 1 patient. At Month 12 (n= 61 patients), values were below the lower limit of 

detection for 47 patients and below the lower limit of quantification in 6 patients. 5 patients had 

measurable values (maximum 0.300 ng/mL), all considered to be negligible values. Ciclosporinemia 

was not measured for 3 patients. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology, repeated dose toxicity, phototoxicity and photoallergy, genotoxicity, carcinogenic 

potential, toxicity to reproduction and development. 

 

Effects in non-clinical studies were observed only with systemic administration or at exposures 

considered sufficiently in excess of the maximum human exposure indicating little relevance to 

clinical use. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Medium-chain triglycerides 

Cetalkonium chloride  

Glycerol 

Tyloxapol 

Poloxamer 188 

Sodium hydroxide (to adjust pH) 

Water for injections 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

3 years. 



8 

 

 

6.4 Special precautions for storage 

 

Do not freeze.  

Store below 30°C. 

Keep single-dose containers in the pouch in order to protect from light and avoid evaporation. 

Discard the opened single-dose container immediately after use. 

 

6.5 Nature and contents of container 

 

0.3 mL single-dose, low-density polyethylene (LDPE) containers in a sealed laminate aluminium 

pouch. 

 

One pouch contains 5 single-dose containers.  

 

Pack sizes of 30, 60, 90 or 120 single-dose containers. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Santen Oy 

Niittyhaankatu 20 

33720 Tampere  

Finland 

 

 

8. MARKETING AUTHORISATION NUMBERS  

 

EU/1/17/1219/001 

EU/1/17/1219/002 

EU/1/17/1219/003 

EU/1/17/1219/004 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

 

10. DATE OF REVISION OF THE TEXT 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu 

 

  



9 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE  

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

 



10 

 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

Name and address of the manufacturers responsible for batch release 

EXCELVISION 

27 rue de la Lombardière 

ZI la Lombardière 

07100 Annonay 

France 

 

Santen Oy 

Kelloportinkatu 1 

33100 Tampere 

FINLAND 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 

Characteristics, section 4.2). 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  

 Periodic safety update reports  

The requirements for submission of periodic safety update reports for this medicinal product are set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and any subsequent updates published on the European medicines web-portal. 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 Risk Management Plan (RMP) 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 

updates of the RMP. 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 

 Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile or 

as the result of an important (pharmacovigilance or risk minimisation) milestone being 

reached.  

 

 

 

 

 

 



11 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

 

  



12 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

  



13 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Verkazia, 1 mg/mL eye drops, emulsion  

ciclosporin 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

A single-dose container of 0.3 mL eye drops emulsion contains 0.3 mg of ciclosporin. 

 

 

3. LIST OF EXCIPIENTS 

 

Excipients: medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol, poloxamer 188, 

sodium hydroxide (to adjust pH) and water for injections. 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Eye drops, emulsion 

30 single-dose containers 

60 single-dose containers 

90 single-dose containers 

120 single-dose containers 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Single use only. 

Read the package leaflet before use. 

Ocular use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

Discard the opened single-dose container immediately after use. 

 



14 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not freeze. 

Store below 30°C. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Santen Oy 

Niittyhaankatu 20 

33720 Tampere 

Finland 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/17/1219/001 

EU/1/17/1219/002 

EU/1/17/1219/003 

EU/1/17/1219/004 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

verkazia 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 
2D barcode carrying the unique identifier included.  

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



15 

 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

POUCH LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Verkazia 1 mg/mL eye drops, emulsion  

ciclosporin 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Santen Oy 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

Ocular use. 

5 single-dose containers. 

Single use only. 

Do not freeze. 

See leaflet for further information. 

Keep single-dose containers in the pouch in order to protect from light and avoid evaporation. 

Discard the opened single-dose container immediately after use. 

  



16 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SINGLE-DOSE CONTAINER LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Verkazia 1 mg/mL eye drops, emulsion  

ciclosporin 

 

 

2. METHOD OF ADMINISTRATION 

 

Ocular use 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

 

0.3 mL 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  



17 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

 



18 

 

Package leaflet: Information for the patient 

 

Verkazia 1 mg/mL eye drops emulsion 

ciclosporin 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again.  

- If you have any further questions, ask your doctor or pharmacist. 

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

 

1. What Verkazia is and what it is used for  

2. What you need to know before you use Verkazia 

3. How to use Verkazia 

4. Possible side effects  

5. How to store Verkazia 

6. Contents of the pack and other information 

 

 

1. What Verkazia is and what it is used for 

 

Verkazia contains the active ingredient, ciclosporin. Ciclosporin reduces the activity of the body’s 
immune (defence) system and in this way it reduces inflammation (body response to harmful stimuli). 

 

Verkazia is used to treat children and adolescents aged 4 to 18 years with severe vernal 

keratoconjunctivitis (an allergic condition of the eye that occurs more frequently in spring and affects 

the transparent layer in the front part of the eye and the thin membrane covering the front part of the 

eye).  

 

 

2. What you need to know before you use Verkazia 

 

Do not use Verkazia 

- if you are allergic to ciclosporin or to any of the other ingredients of this medicine (listed in 

section 6) 

- if you have had or have a cancer in or around your eye. 

- if you have an eye infection. 

 

Warnings and precautions  

Only use Verkazia in your eye as described under section 3. Do not exceed the treatment period 

prescribed by your doctor. 

Verkazia has not been studied in adult patients. 

 

Talk to your doctor or pharmacist before using Verkazia: 

- if you have had an eye infection or if you suspect you have an eye infection  

- if you have any other kind of eye disease 

- if you wear contact lenses (the use of Verkazia is not recommended with contact lenses). 

Children and adolescents 

Do not use Verkazia in children under the age of 4 years. 



19 

 

 

Other medicines and Verkazia 

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 

 

Talk to your doctor if you are using eye drops containing steroids administered in association with 

Verkazia as this association may increase the risk of local infections.  

 

If you are using Verkazia for more than 12 months, you should visit your doctor regularly, e.g. every 3 

to 6 months. 

 

If you are using other eye drops, use Verkazia at least 15 minutes after using the other eye drops. 

 

Pregnancy and breast-feeding  

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor or pharmacist for advice before using this medicine. 

 

Verkazia should not be used if you are pregnant. If you could become pregnant you must use 

contraception while using this medicine. 

 

Verkazia is likely to be present in breast milk in very small amounts. If you are breast feeding talk to 

your doctor before using this medicine. 

 

Driving and using machines 

Your vision may be temporarily blurred after using Verkazia eye drops or you may get other 

disturbances with your vision. If this happens, wait until your vision clears before you drive or use 

machines. 

 

Verkazia contains cetalkonium chloride  

Cetalkonium chloride may cause eye irritation. 

 

 

3. How to use Verkazia 

 

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are not sure. 

 

A caregiver should help a child starting Verkazia treatment, particularly if the child is aged under 10 

years, and should continue to supervise the child until the child is able to use Verkazia properly 

without help. 
 
The recommended dose is 1 drop of Verkazia in each affected eye 4 times a day (morning, mid-day, 

afternoon and evening). You should continue Verkazia as prescribed by your doctor.  

 

Instructions for use 

Follow these instructions carefully and ask your doctor or pharmacist if there is anything you do not 

understand. 

 



20 

 

 

 

1. Wash your hands 

2. Open the aluminium pouch, which contains 5 single-dose containers 

3. Take 1 single-dose container from the aluminium pouch, leaving the remaining containers 

in the pouch  

4. Gently shake the single-dose container 

5. Twist off the cap (picture 1) 

6. Pull down your lower eyelid (picture 2) 

7. Tilt your head back and look up at the ceiling 

8. Gently squeeze one drop of the medicine onto your eye. Make sure that the tip of the 

single-dose container does not touch your eye 

9. Blink a few times so that the medicine spreads across your eye 

10. After using Verkazia, press a finger lightly on the inner corner of your eyelid, next to your 

nose for 2 minutes (picture 3). A small duct that drains tears away from your eye and into 

your nose is located here. By pressing at this point, you close down the opening of this 

drainage duct. This helps to stop Verkazia getting into the rest of the body.  

11. If you use drops in both eyes, repeat the steps 6 to 9 for your other eye. 

12. Discard the single-dose container as soon as you have used it, even if there is still some 

medicine left in it 

 

If a drop misses your eye, try again. 

If you put in more Verkazia than you should, rinse your eye with water. Do not put in any more 

drops until it is time for your next regular dose. 

 

If you forget to use Verkazia, continue with the next dose as planned. Do not take a double dose 

to make up for the forgotten dose. Do not use more than 1 drop 4 times a day in the affected eye(s). 

 

If you stop using Verkazia without speaking to your doctor, your eye allergy will not be controlled 

and could lead to long-term problems with your sight. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

The following side effects have been reported for Verkazia: 

The most common side effects are in and around the eyes. 

 

Very common side effects (may affect more than 1 in 10 people) 

Pain when the drops are put into the eye. 

 



21 

 

Common side effects (may affect up to 1 in 10 people) 

Common side effects related to the eye: 

Itching, redness, irritation and discomfort in or around the eye including a feeling that there is 

something in the eye. Increased watering of the eye and blurred vision when the drops are put into the 

eye. Swelling and redness of eyelid. 

 

Common side effects which are not related to the eye: 

Upper respiratory tract infection, cough, headache. 

  

Uncommon side effects (may affect up to 1 in 100 people) 

Swelling of the eyelid and of the conjunctiva (thin membrane covering the front part of the eye). 

Bacterial infection of the cornea (transparent front part of the eye). Eye infection caused by herpes 

zoster virus. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

 

5. How to store Verkazia 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the outer carton, on the aluminium 

pouch label, and on the single-dose containers label after “EXP”. The expiry date refers to the last day 
of that month. 

 

Do not freeze. 

 

Store below 30°C. 

 

Keep single-dose containers in the pouch in order to protect from light and avoid evaporation. 

Discard the opened single-dose container immediately after use. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Verkazia contains  

- The active substance is ciclosporin. One millilitre of Verkazia contains 1 mg of ciclosporin. 

- The other ingredients are medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol, 

poloxamer 188, sodium hydroxide (to adjust pH) and water for injections. 

 

What Verkazia looks like and contents of the pack 

Verkazia is a milky white eye drops emulsion. 

 

It is supplied in single-dose containers made of a low-density polyethylene (LDPE). 

 

Each single-dose container contains 0.3 mL eye drops emulsion. 

 

The single-dose containers are wrapped in a sealed aluminium pouch. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


22 

 

 

Pack sizes: 30, 60, 90 and 120 single-dose containers. 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder  

Santen Oy 

Niittyhaankatu 20 

33720 Tampere 

Finland 

 

Manufacturers 

EXCELVISION 

27 rue de la Lombardière 

ZI la Lombardière 

07100 Annonay 

France 

 

Santen Oy 

Kelloportinkatu 1 

33100 Tampere 

Finland 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Santen Oy 

Tél/Tel : +32 (0) 24019172 

Lietuva 

Santen Oy 

Tel: +370 37 366628 

България 
Santen Oy 

Teл.: +359 (0) 888 755 393 

Luxembourg/Luxemburg 

Santen Oy 

Tél/Tel : +352 (0) 27862006 

Česká republika 
Santen Oy 

Tel: : +420 234 102 170 

Magyarország 

Santen Oy 

Tel: +36 (06) 16777305 

Danmark 

Santen Oy 

Tlf: +45 78737843 

Malta 

Santen Oy 

Tel: +358 (0) 3 284 8111 

Deutschland 

Santen GmbH 

Tel: +49 (0) 3030809610 

Nederland 

Santen Oy 

Tel: +31 (0) 207139206 

Eesti 

Santen Oy 

Tel: +372 5067559 

Norge 

Santen Oy 

Tlf: +47 21939612 

Ελλάδα 
Santen Oy 

Τηλ: +358 (0) 3 284 8111 

Österreich 

Santen Oy 

Tel: +43 (0) 720116199 

España 

Santen Pharmaceutical Spain S.L. 

Tel: +34 914 142 485 

Polska 

Santen Oy 

Tel.: +48 (0) 221168608 

France 

Santen  

Tél: +33 (0) 1 70 75 26 84 

Portugal 

Santen Oy 

Tel: +351 308 805 912 



23 

 

Hrvatska 

Santen Oy 

Tel: +358 (0) 3 284 8111 

România 

Santen Oy 

Tel: +40 (0) 316300603 

Ireland 

Santen Oy 

Tel: +353 (0) 16950008 

Slovenija 

Santen Oy 

Tel: +358 (0) 3 284 8111 

Ísland 

Santen Oy 

Sími: +358 (0) 3 284 8111 

Slovenská republika 

Santen Oy 

Tel: +421 (01) 23 332 5519 

Italia 

Santen Italy S.r.l. 

Tel: +39 0236009983 

Suomi/Finland 

Santen Oy 

Puh/Tel: +358 (0) 974790211 

Κύπρος 
Santen Oy 

Τηλ: +358 (0) 3 284 8111 

Sverige 

Santen Oy 
Tel: +46 (0) 850598833 

Latvija 

Santen Oy 

Tel: +371 677 917 80 

United Kingdom 

Santen UK Limited 

Tel: +44 (0) 345 075 4863 

 

 

This leaflet was last revised in month YYYY. 

 

 

Detailed information on this medicine is available on the European Medicines Agency web site:  

http://www.ema.europa.eu. 

 
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET