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- 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.

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.

• 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.

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 25°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- 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.

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:

This leaflet was last revised in month YYYY

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- 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.

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.

Before administration of the eye drops:

• Wash your hands before opening the bottle.
• Do not use this medicine if you notice that the tamper-proof seal on the bottle neck is broken before you first use it.
• When using the bottle for the very first time, before delivering a drop to the eye, you should practise using the bottle by squeezing it slowly to deliver one drop away from the eye.
• When you are confident that you can deliver one drop at a time, choose the position that you find most comfortable for the instillation of the drops (you can sit down, lie on your back, or stand in front of a mirror).
• Every time when opening a new bottle, place one drop in the waste to activate the bottle.

Administration:

• 1. Gently shake the bottle. Hold the bottle directly below the cap and turn the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contamination.

  
  

• 2. Tilt your head backwards and hold the bottle above your eye.

• 3. Pull the lower eyelid down and look up. Squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard.

  
  

• 4. Close your eye and press the inner corner of the eye with your finger for about two minutes.

This helps to stop the medicine from getting into the rest of the body.

• 5. Repeat instructions 2 – 4 to deliver a drop into the other eye, if your doctor has instructed you to do this. Sometimes only one eye needs to be treated and your doctor will advise if this applies to you and which eye needs treatment.

  6.

  
  

After each use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual emulsion from the tip. This is necessary to ensure good delivery of the next drop.

7. Wipe off any excess emulsion from the skin around the eye.

At the end of the 4 weeks in-use shelf life of the medicine, there will be some emulsion left in the bottle. Do not attempt to use the excess medicine remaining in the bottle after you have completed the course of treatment. Do not use the eye drops for longer than 4 weeks after first opening the bottle.

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.

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 and on the bottle label after “EXP”. The expiry date refers to the last day of that month.

Do not freeze.

Store below 25°C.

After first opening the bottle, the emulsion can be used for 4 weeks. The bottle must be kept tightly closed.

Do not use this medicine if you notice that the seal is broken the first time you use the container.

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- 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 a white plastic bottle with a whitedropper applicator and a white plastic screw cap.

Each bottle contains 9 mL of the medicine and each pack contains one bottle.

Marketing Authorisation Holder

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Manufacturers

EXCELVISION

27 rue de la Lombardiere

ZI la Lombardiere

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:

United Kingdom (Northern Ireland)

Santen Oy

Tel: +353 (0) 169 500 08

(UK 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:.

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- 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.

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.

Before administration of the eye drops:

• Wash your hands before opening the bottle.
• Do not use this medicine if you notice that the tamper-proof seal on the bottle neck is broken before you first use it.
• When using the bottle for the very first time, before delivering a drop to the eye, you should practise using the bottle by squeezing it slowly to deliver one drop away from the eye.
• When you are confident that you can deliver one drop at a time, choose the position that you find most comfortable for the instillation of the drops (you can sit down, lie on your back, or stand in front of a mirror).
• Every time when opening a new bottle, place one drop in the waste to activate the bottle.

• 1. Gently shake the bottle. Hold the bottle directly below the cap and turn the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contamination.

  
  

• 2. Tilt your head backwards and hold the bottle above your eye.

• 3. Pull the lower eyelid down and look up. Squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard.

  
  

• 4. Close your eye and press the inner corner of the eye with your finger for about two minutes.

This helps to stop the medicine from getting into the rest of the body.

• 5. Repeat instructions 2 – 4 to deliver a drop into the other eye, if your doctor has instructed you to do this. Sometimes only one eye needs to be treated and your doctor will advise if this applies to you and which eye needs treatment.

  6.

  
  

After each use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual emulsion from the tip. This is necessary to ensure good delivery of the next drop.

7. Wipe off any excess emulsion from the skin around the eye.

At the end of the 4 weeks in-use shelf life of the medicine, there will be some emulsion left in the bottle. Do not attempt to use the excess medicine remaining in the bottle after you have completed the course of treatment. Do not use the eye drops for longer than 4 weeks after first opening the bottle.

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.

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 and on the bottle label after “EXP”. The expiry date refers to the last day of that month.

Do not freeze.

Store below 25°C.

After first opening the bottle, the emulsion can be used for 4 weeks. The bottle must be kept tightly closed.

Do not use this medicine if you notice that the seal is broken the first time you use the container.

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- 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.