VERKAZIA 1 mg/ml EMULSION EYE DROPS

Introduction

Patient Information: Summary of Product Characteristics

Verkazia 1 mg/ml eye drops, emulsion

ciclosporin (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.

Contents of the pack

1. What is Verkazia and what is it used for
2. What you need to know before you use Verkazia
3. How to use Verkazia
4. Possible side effects
5. Storage of Verkazia
6. Contents of the pack and other information

1. What is Verkazia and what is it used for

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

Verkazia is used to treat children and adolescents from 4 to 18 years of age with severe vernal keratoconjunctivitis (an allergic eye disorder that occurs most frequently in the spring and affects the transparent layer on the front of the eye and the thin membrane covering the front of the eye).

2. What you need to know before you use Verkazia

Do not use Verkazia:

• if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6);
• if you have an eye infection.

Warnings and precautions

Use Verkazia in the eye only as described in section 3. Do not exceed the treatment period prescribed by your doctor.

Verkazia has not been studied in adult patients.

Consult your doctor or pharmacist before starting treatment with Verkazia:

• if you have had an eye infection or if you suspect you have an eye infection;
• if you have had or have cancer in or around the eye;
• if you have any other type of eye disease;
• if you wear contact lenses (it is not recommended to use Verkazia with contact lenses).

Children and adolescents

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

Other medicines and Verkazia

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

Consult your doctor if you are using an eye drop that contains steroids administered together with Verkazia, as this combination may increase the risk of local infections.

If you use Verkazia for more than 12 months, you should visit your doctor periodically, for example every 3 to 6 months.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should not use Verkazia if you are pregnant. If you can become pregnant, you must use contraception while using this medicine.

It is likely that very small amounts of Verkazia will be present in breast milk. If you are breastfeeding, consult your doctor before using this medicine.

Driving and using machines

You may have blurred vision temporarily after using the Verkazia eye drops or you may experience other changes in vision. In this case, wait until your vision is clear before driving or using machines.

Verkazia contains cetalkonium chloride.

Cetalkonium chloride may cause eye irritation.

3. How to use Verkazia

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

A caregiver should help the child start treatment with Verkazia, especially if the child is under 10 years of age, and should continue to supervise the child until the child is able to use Verkazia correctly without help.

The recommended dose is one drop of Verkazia in each affected eye four times a day (in the morning, at noon, in the afternoon and at night). You should continue using Verkazia as prescribed by your doctor.

Instructions for use

Follow these instructions carefully and consult your doctor or pharmacist if you do not understand anything.

1. Wash your hands.
2. Open the aluminum pouch, which contains 5 single-dose containers.
3. Take a single-dose container from the aluminum pouch, leaving the rest of the contents in the pouch.
4. Gently shake the single-dose container.
5. Turn the cap to open it (image 1).
6. Lower the lower eyelid with the help of a finger (image 2).
7. Tilt your head back and look up at the ceiling.
8. Gently squeeze to release a drop of medicine into the eye. Make sure not to touch the eye with the tip of the single-dose container.
9. Blink several times to spread the medicine throughout the eye.
10. After using Verkazia, gently press the inner corner of the eyelid next to the nose with a finger for 2 minutes (image 3). There is a small duct located there that drains tears from the eye to the nose. By pressing on this point, you close the opening of this drainage duct. This helps Verkazia not to pass into other parts of the body.
11. If you use the eye drops in both eyes, repeat steps 6 to 9 in the 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 the drop falls outside the eye, try again.

If you use more Verkazia than you should,rinse your eye with water. Do not apply more drops until it is time for your next dose.

If you forget to use Verkazia, continue with the next scheduled dose.Do not apply a double dose to make up for forgotten doses. Do not use more than one drop four times a day in the affected eye(s).

If you stop treatment with Verkaziawithout consulting your doctor, the eye allergy will not be controlled and may cause long-term vision problems.

If you have any other questions about 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 observed with Verkazia:

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

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

Pain when applying the drops to the eye.

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 the feeling of having something in it. Increased tearing of the eye and blurred vision when applying the drops to the eye. Swelling and redness of the eyelid.

Common side effects 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 conjunctiva (thin membrane covering the front of the eye). Bacterial infection of the cornea (transparent front part of the eye). Eye infection caused by the herpes zoster virus.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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. Storage of 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, the aluminum pouch, and the single-dose containers after ‘EXP’. The expiry date is the last day of the month shown.

Do not freeze.

Store below 30°C.

Keep the single-dose containers in the pouch to protect them from light and to prevent evaporation. Discard the opened single-dose container immediately after use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Verkazia

• The active substance is ciclosporin. One milliliter of Verkazia contains 1 mg of ciclosporin.
• The other ingredients are medium-chain triglycerides, cetalkonium chloride, glycerol, tiloxapol, poloxamer 188, sodium hydroxide (for pH adjustment), and water for injections. See section 2 “Verkazia contains cetalkonium chloride”.

Appearance and packaging

Verkazia is a white, milky eye drop emulsion.

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

Each single-dose container contains 0.3 ml of eye drop emulsion.

The single-dose containers are packaged in a sealed aluminum pouch.

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

Niittyhaankatu 20

33720 Tampere

Finland

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Liechtenstein

Santen Oy

Tel: +358 (0) 3 284 8111

Date of last revision of this leaflet: AAAA.

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

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