VERKAZIA 1 мг/мл Эмульсия для глаз

Содержание инструкции

1. What is Verkazia and what is it used for
2. What you need to know before using Verkazia
3. How to use Verkazia
4. Possible side effects
5. How to store Verkazia
6. Package Contents and Other Information
7. What is Verkazia and what is it used for
8. What you need to know before using Verkazia
9. How to use Verkazia
10. Possible side effects
11. How to store Verkazia
12. Contents of the pack and other information

Verkazia1 mg/ml eye drops, emulsion
cyclosporine (cyclosporin)

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Verkazia and what is it used for

Verkazia contains the active substance cyclosporine. Cyclosporine reduces the activity of the body's immune system (defense system) and in this way reduces inflammation (the body's response to harmful stimuli).
Verkazia is used in the treatment of severe Vernal Keratoconjunctivitis (an allergic eye condition that occurs more frequently in spring and affects the transparent layer located in the front of the eye and the thin membrane covering the front of the eye).

2. What you need to know before using Verkazia

Do not use Verkazia

• if you are allergic to cyclosporine or to any of the other ingredients of this medicine (listed in section 6)
• if you have had, or have, a tumor located in the eye or the area around the eye
• 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.
Consult your doctor or pharmacist before using Verkazia:

• if you have had, or suspect you have, an eye infection
• if you have any other 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 4 years of age.

Other medicines and Verkazia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Consult your doctor if you are using eye drops containing steroids administered simultaneously with Verkazia
because this combination may increase the risk of local infections.
If you are using Verkazia for more than 12 months, consult a doctor regularly, for example
every 3 - 6 months.
If you are using other eye drops, use Verkazia at least 15 minutesafter using the other eye drop.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Verkazia should not be used during pregnancy. If there is a possibility of becoming pregnant, you should use
contraception while using this medicine.
Verkazia may be present in breast milk in very small amounts. If you are breastfeeding, consult
your doctor before using this medicine.

Driving and operating machinery
After using Verkazia eye drops, you may experience temporary blurred vision, or other
visual disturbances may occur. If this happens, wait until your vision improves before driving
vehicles or operating machinery.

Verkazia contains cetalconium chloride
Cetalconium chloride may cause eye irritation.

3. How to use Verkazia

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
It is necessary for a family member/a person who takes care of the child to help at the beginning of the
treatment with Verkazia, especially if the child is less than 10 years old, and to continue to monitor
them until the child is able to use Verkazia correctly without help.
The recommended dose is 1 drop of Verkazia in each affected eye 4 times a day (morning,
noon, afternoon and evening). Continue treatment with Verkazia as prescribed by your
doctor.

Instructions for use
Follow these instructions carefully. If there is something you do not understand, ask your doctor or
pharmacist.

• 1. Wash your hands.
• 2. Open the aluminum sachet containing 5 single-dose containers.
• 3. Take one single-dose container from the aluminum sachet, leaving the others in the sachet.
• 4. Gently shake the single-dose container.
• 5.Unscrew the cap (figure 1).
• 6. Lower the lower eyelid (figure 2).
• 7. Tilt your head back and look upwards.
• 8. Gently squeeze out one drop of medicine, letting it fall onto the eye. Be careful not to let the tip of the single-dose container come into contact with the eye.
• 9. Open and close your eyelid so that the medicine spreads over the surface of the eye.
• 10. After applying Verkazia, apply gentle pressure with a finger on the inner corner of the eyelid, near the nose, for 2 minutes (figure 3). In this area is a small duct that serves to drain tears from the eye to the nose. Applying pressure precisely at this point closes the opening of this drainage duct. This prevents Verkazia from spreading throughout the body.
• 11. If you are applying the eye drops to both eyes, repeat steps 6 to 9 for the other eye.
• 12. Immediately discard the single-dose container after use, even if there is still some medicine residue.

If the drop does not fall onto the eye, repeat the operation.

If you use more Verkazia than you should,rinse the eye with water. Do not apply any more drops until the
time of the next dose.

If you forget to use Verkazia,wait for the next dose, as scheduled.Do not use a double
dose to make up for the missed dose. Do not use more than 1 drop 4 times a day per affected eye.

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

Very common side effects (may affect more than 1 in 10 people)
Pain when the drops come into contact with the eye.

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

Common side effects affecting the eye:
Itching, redness, irritation and discomfort to the eye or the periocular region, including a sensation of
foreign body in the eye. Increased tear secretion and blurred vision when the
drops come into contact with the eye. Swelling and redness of the eyelid.

Common side effects not affecting 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 portion
of the eye). Bacterial infection of the cornea (transparent front portion of the eye). Infection
of the eye caused by the 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 through the national reporting system listed in Annex 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 package, on the label of the
aluminium sachet and on the label of the single-dose container after “Scad.” or “EXP”. The expiry
date refers to the last day of that month.
Do not freeze.
Store at a temperature below 25°C.
Keep the single-dose containers in pouches to protect the medicine from light and to prevent
evaporation.
Dispose of any open single-dose containers immediately after use.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Verkazia Contains

• The active ingredient is cyclosporine. One ml of Verkazia contains 1 mg of cyclosporine.
• The other ingredients are medium-chain triglycerides, cetalkonium chloride, glycerol, tiloxapol, poloxamer 188, sodium hydroxide (for pH adjustment) and water for injections.

Description of Verkazia and Package Contents
Verkazia is an eye drop, a milk-white emulsion.
It is supplied in low-density polyethylene (LDPE) single-dose containers.
Each single-dose container contains 0.3 ml of eye drop, emulsion .
The single-dose containers are wrapped in a sealed aluminum pouch.
Packs: of 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 further information on this medicinal product, 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: +358 (0) 3 284 8111

Magyarország
Santen Oy
Tel.: +358 (0) 3 284 8111

Danmark
Santen Oy
Tlf: +45 898 713 35

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) 221042096

France
Santen S.A.S.
Tél: +33 (0) 1 70 75 26 84

Portugal
Santen Oy
Tel: +351 308 805 912

Hrvatska
Santen Oy
Tel: +358 (0) 3 284 8111

România
Santen Oy
Tel: +358 (0) 3 284 8111

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: +358 (0) 3 284 8111

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 (Northern Ireland)
Santen Oy
Tel: ++353 (0) 169 500 08
(UK Tel: +44 (0) 345 075 4863)
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .

Verkazia 1 mg/ml eye drops, emulsion
cyclosporine (cyclosporin)

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, see your doctor or pharmacist. See section 4.

Contents of 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 is Verkazia and what is it used for

Verkazia contains the active substance cyclosporine. Cyclosporine reduces the activity of the body's immune (defense) system and in this way reduces inflammation (the body's response to harmful stimuli).
Verkazia is used in the treatment of severe Vernal Keratoconjunctivitis (an allergic eye condition that occurs more frequently in spring and affects the transparent layer located in the front of the eye and the thin membrane that covers the front of the eye).

2. What you need to know before using Verkazia

Do not useVerkazia

• if you are allergic to cyclosporine or any of the other ingredients of this medicine (listed in section 6)
• if you have had, or have, a tumor located in the eye or the area around the eye
• 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.
Consult your doctor or pharmacist before using Verkazia:

• if you have had, or suspect you have, an eye infection
• if you have any other 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 4 years of age.

Other medicines and Verkazia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Consult your doctor if you are using eye drops containing steroids administered simultaneously with Verkazia
because this combination may increase the risk of local infections.
If you are using Verkazia for more than 12 months, consult a doctor regularly, for example
every 3 - 6 months.
If you are using other eye drops, use Verkazia at least 15 minutesafter using the other eye drop.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Verkazia must not be used during pregnancy. If there is a possibility of becoming pregnant, you should use
contraception while using this medicine.
Verkazia may be present in breast milk in very small amounts. If you are breastfeeding, consult
your doctor before using this medicine.

Driving and using machines
After using Verkazia eye drops, you may experience temporary blurred vision, or other
visual disturbances may occur. If this happens, wait until your vision improves before driving
vehicles or using machines.

Verkazia contains cetalkonium chloride
Cetalkonium chloride may cause eye irritation.

3. How to use Verkazia

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
It is necessary that a family member/a person who takes care of the child helps him/her at the beginning of
treatment with Verkazia, especially if the child is less than 10 years old, and continues to monitor him/her
until the child is able to use Verkazia correctly without help.
The recommended dose is 1 drop of Verkazia in each affected eye 4 times a day (morning,
noon, afternoon and evening). Continue treatment with Verkazia as prescribed by
your doctor.

Instructions for use
Follow these instructions carefully. If there is something you do not understand, ask your doctor or
pharmacist.

Before administering the eye drops:
Wash your hands before opening the bottle.
Do not use this medicine if you notice that the tamper-evident seal on the neck of the bottle is
broken before initial use.
When using the bottle for the first time, before administering a drop into the eye,
you will need to become familiar with using the bottle by gently squeezing it to allow
a drop to come out away from the eye.
When you are confident that you can administer one drop at a time, choose the position that
you find most comfortable (sitting, lying on your back or standing in front of a mirror).
Each time you open a new bottle, discard a drop into the waste to activate the bottle.

Administration:

• 1. Gently shake the bottle. To open the bottle, hold the bottle immediately below the cap and unscrew the cap. The open end of the bottle should not come into contact with anything to avoid contaminating the medicine.
• 2. Tilt your head back and hold the bottle above your eye.
• 3. Lower your lower eyelid and look upwards. Gently squeeze the middle part of the bottle and let one drop of medicine fall into your eye. Keep in mind that, while squeezing the bottle, it may take a few seconds for the drop to come out of the bottle. Do not squeeze the bottle excessively.

• 4. Close your eye and press on the inner corner of your eyewith your finger for about two minutes. This will help to prevent the medicine from spreading throughout the body.
• 5. Repeat the instructions from point 2 to point 4 to administer a drop into the other eye, if these are the instructions you have received from your doctor. Sometimes the treatment concerns only one eye. Your doctor will tell you if this is the case and which eye should be treated.

• 6. After each use and before re-applying the cap, the bottle must be shaken once with a downward movement, without touching the tip of the dropper, to eliminate any residual emulsion from the tip. This operation is necessary to ensure the correct release of the next drop.
• 7. Clean the skin around the eye from any excess emulsion.

At the end of the 4 weeks of the period of use of the medicine, some emulsion will remain
in the bottle. Avoid using the residual medicine in the bottle after completing the
treatment. Do not use the eye drops for more than 4 weeks after the first opening of the bottle.
If the drop does not fall into the eye, repeat the operation.

If you use more Verkazia than you should,rinse the eye with water. Do not apply any more drops until the
time of the next dose.

If you forget to use Verkazia,wait for the next dose, as scheduled.Do not use a double dose to make up for a missed dose. Do not use more than 1 drop 4 times a day per affected eye.

If you stop treatment with Verkaziawithout consulting your doctor, the ocular allergy will not
be controlled and you may develop long-term vision problems.
If you have any questions about using 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 affect the eye and the periocular region.

Very common side effects (may affect more than 1 in 10 people)
Pain when the drops come into contact with the eye.

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

Common eye-related side effects:
Itching, redness, irritation and discomfort to the eye or periocular region including a feeling of
foreign body in the eye. Increased tear secretion and blurred vision when the
drops come into contact with the eye. Swelling and redness of the eyelid.

Common non-eye-related side effects:
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 that covers the front portion
of the eye). Bacterial infection of the cornea (transparent front portion of the eye). Infection
of the eye caused by the herpes zoster virus.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 package and on the label of the
vial after “Scad.” or “EXP”. The expiry date refers to the last day of that month.
Do not freeze.
Store at a temperature below 25°C.
After opening the vial for the first time, the emulsion can be used for 4 weeks. The
vial must be kept tightly closed.
Do not use this medicine if you notice that the seal has been tampered with the first time you use the
container.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Verkazia contains

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

Description of Verkazia and contents of the pack
Verkazia is an eye drop, an emulsion of milky white colour.
It is supplied in a white plastic bottle, with a white dropper applicator and a white screw cap
of white plastic.
Each bottle contains 9 ml of medicine and each pack contains one bottle .
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 further information on this medicine, 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: +358 (0) 3 284 8111

Magyarország
Santen Oy
Tel.: +358 (0) 3 284 8111

Danmark
Santen Oy
Tlf: +45 898 713 35

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) 221042096

France
Santen S.A.S.
Tél: +33 (0) 1 70 75 26 84

Portugal
Santen Oy
Tel: +351 308 805 912

Hrvatska
Santen Oy
Tel: +358 (0) 3 284 8111

România
Santen Oy
Tel: +358 (0) 3 284 8111

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: +358 (0) 3 284 8111

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 (Northern Ireland)
Santen Oy
Tel: +353 (0) 169 500 08
(UK Tel: +44 (0) 345 075 4863)
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu .