IKERVIS 1 mg /Ml Emulsja Do Kropli Do Oczu

Treść ulotki

1. IKERVIS 1 mg/mL eye drops, emulsion
   1. What is IKERVIS and what it is used for
   2. What you need to know before using IKERVIS
   3. How to use IKERVIS
   4. Possible side effects
   5. How to store IKERVIS
   6. Package contents and other information
2. IKERVIS 1 mg/mL eye drops, emulsion
   1. What is IKERVIS and what is it used for
   2. What you need to know before using IKERVIS
   3. How to use IKERVIS
   4. Possible side effects
   5. How to store IKERVIS
   6. Contents of the pack and other information

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

1. What is IKERVIS and what it is used for

IKERVIS contains the active substance cyclosporine. Cyclosporine belongs to the group of medicines
known as immunosuppressants, used to reduce inflammation.
IKERVIS is used to treat adult subjects affected by severe keratitis (inflammation of the cornea, the
transparent layer located in the front part of the eye). It is used in patients who present a
dry eye syndrome not improved despite treatment with tear substitutes (artificial tears).
Consult your doctor if you do not feel better or if you feel worse.
You must see your doctor at least every 6 months to allow him/her to evaluate the effect of IKERVIS.

2. What you need to know before using IKERVIS

DO NOT use IKERVIS:

• 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 around the eye.
• If you have an eye infection.

Warnings and precautions
IKERVIS must be applied exclusively in the eye/eyes.
Consult your doctor or pharmacist before using IKERVIS

• If you have had an eye infection in the past caused by the herpes virus, which may have damaged the clear front part of the eye (cornea).
• If you are taking medicines containing steroids.
• If you are taking medicines to treat glaucoma.

Contact lenses can further damage the clear front part of the eye
(cornea). Therefore, you must remove contact lenses before using IKERVIS at bedtime; you can put them back in when you wake up.

Children and adolescents
IKERVIS should not be used in children and adolescents under 18 years of age.

Other medicines and IKERVIS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are using an eye drop containing steroids with IKERVIS, as these may
increase the risk of side effects.
IKERVIS eye drops must be used at least 15 minutesafter applying any other eye drops.

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.
IKERVIS must not be usedduring pregnancy.
If you are of childbearing potential, you should use adequate contraception while taking this
medicine.
IKERVIS is likely to be present in breast milk in very small concentrations. If you are
breastfeeding, talk to your doctor before using this medicine.

Driving and operating machinery
Immediately after using IKERVIS eye drops, your vision may be blurred. In this case, do not drive and
do not use machinery until your vision returns to normal.

IKERVIS contains cetalconium chloride
This medicine contains 0.05 mg of cetalconium chloride per 1 mL. Remove contact lenses before
using this medicine; the lenses can be reinserted when you wake up.
Cetalconium chloride may cause eye irritation. If you experience any abnormal eye sensation, burning or pain after using this medicine, talk to your doctor.

3. How to use IKERVIS

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended doseis one drop in each affected eye, once a day before going to sleep.

Instructions for use
Follow these instructions carefully and immediately contact your doctor or pharmacist if you do not understand something.

1 2 3

• Wash your hands.
• If you wear contact lenses, remove them before applying the drops, at bedtime; you can put them back in when you wake up.
• Open the aluminum pouch containing five single-dose containers.
• Take one single-dose container from the aluminum pouch.
• Gently shake the single-dose container before use.
• Unscrew the cap ( figure 1).
• Pull down the lower eyelid (figure 2).
• Tilt your head back and look at the ceiling.
• Gently squeeze the bottle to drop one drop of the medicine into the eye. Be careful not to touch the eye with the tip of the single-dose container.
• Blink several times to allow the medicine to coat the eye.
• After using IKERVIS, press a finger on the corner of the eye, near the nose, and gently close your eyelids for 2 minutes (figure 3). This precaution prevents IKERVIS from reaching other areas of the body.
• If you need to treat both eyes, repeat the procedure for the other eye.
• Dispose of the single-dose container immediately after use, even if there is still a small amount of residual medicine.
• The remaining single-dose containers must be kept in the aluminum pouch.

If a drop does not reach the eye, try again.

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

If you forget to use IKERVIS, continue with the next dose as scheduled.Do not use a double dose to make up for a missed dose. Do not apply more than one drop a day in the affected eye/eyes.

If you stop using IKERVISwithout first talking to your doctor, the inflammation of the clear front part of the eye (called keratitis) will not be controlled and could impair long-term vision.
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:
The most common side effects occur within and around the eyes.

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

• Eye pain
• Eye irritation

Common(may affect up to 1 in 10 people)

• Redness of the eyelid
• Tearing of the eye
• Redness of the eye
• Blurred vision
• Swelling of the eyelid
• Redness of the conjunctiva (the thin membrane that covers the front of the eye)
• Eye itching

Uncommon(may affect up to 1 in 100 people)

• Discomfort inside or around the eye when applying drops into the eye, including a feeling of having something in the eye
• Irritation or swelling of the conjunctiva (the thin membrane that covers the front of the eye)
• Tear flow disorder
• Eye discharge
• Irritation or inflammation of the conjunctiva (the thin membrane that covers the front of the eye)
• Inflammation of the iris (the colored part of the eye) or eyelid
• Deposits in the eye
• Abrasion on the outer layer of the cornea
• Redness or swelling of the eyelid
• Cyst in the eyelid
• Immune response or scarring in the cornea
• Itching in the eyelid
• Bacterial infection or inflammation of the cornea (the transparent front part of the eye)
• Painful rash around the eye caused by the herpes zoster virus
• Headache

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 IKERVIS

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 packaging, on the aluminium
sachet and on the single-dose containers, 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 aluminium sachets, the single-dose containers must be stored in the
sachets to protect the medicine from light and to prevent evaporation. Any single-dose
containers containing residual emulsion must be discarded immediately after use.
Do not dispose of any medicine in waste water 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 IKERVIS contains

• The active ingredient is cyclosporine. One millilitre of IKERVIS 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 IKERVIS and package contents
IKERVIS is an emulsion eye drop of milky white colour.
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 aluminium pouch.
Pack sizes: 30 and 90 single-dose containers.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SANTEN Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer
EXCELVISION
Rue de la Lombardière
ZI la Lombardière
F-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: +420 234 102 170

Magyarország
Santen Oy
Tel.: +36 (06) 16777305

Danmark
Santen Oy
Tlf: +45 898 713 35

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

Nederland
Santen Oy
Tel: +31 (0) 207139206

Eesti
Santen Oy
Tel: +372 5067559

Deutschland
Santen GmbH
Tel: +49 (0) 3030809610

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
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

Ireland
Santen Oy
Tel: +353 (0) 16950008

România
Santen Oy
Tel: +40 (0) 316300603

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 (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 .

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

1. What is IKERVIS and what is it used for

IKERVIS contains the active substance cyclosporine. Cyclosporine belongs to the group of medicines
known as immunosuppressants, used to reduce inflammation.
IKERVIS is used to treat adult subjects affected by severe keratitis (inflammation of the cornea, the
transparent layer located in the front part of the eye). It is used in patients who present
dry eye syndrome that has not improved following treatment with tear substitutes (artificial tears).
Contact your doctor if you do not notice an improvement or if you notice worsening.
You must see your doctor at least every 6 months to allow them to evaluate the effect of IKERVIS.

2. What you need to know before using IKERVIS

DO NOT use IKERVIS:

• 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
IKERVIS must be applied exclusively in the eye/eyes.
Consult your doctor or pharmacist before using IKERVIS

• If you have had an eye infection in the past caused by the herpes virus, which may have damaged the clear front part of the eye (cornea).
• If you are taking medicines containing steroids.
• If you are taking medicines to treat glaucoma.

Contact lenses can further damage the clear front part of the eye
(cornea). Therefore, you must remove contact lenses before applying IKERVIS at bedtime; you can put them back in when you wake up.

Children and adolescents
IKERVIS should not be used in children and adolescents under 18 years of age.

Other medicines and IKERVIS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are using an eye drop containing steroids with IKERVIS, as these may
increase the risk of side effects.
IKERVIS eye drops must be used at least 15 minutesafter applying any other eye drops.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
IKERVIS must not be usedduring pregnancy.
If you are of childbearing potential, you should use adequate contraception while taking this
medicine.
IKERVIS is likely to be present in breast milk in very small concentrations. If you are
breastfeeding, talk to your doctor before using this medicine.

Driving and operating machinery
Immediately after using IKERVIS eye drops, your vision may be blurred. In this case, do not drive and
do not use machinery until your vision returns to normal.

IKERVIS contains cetalconium chloride
This medicine contains 0.05 mg of cetalconium chloride per 1 mL. Remove contact lenses before
using this medicine; the lenses can be reinserted when you wake up.
Cetalconium chloride may cause eye irritation. If you experience an abnormal sensation in your eye, burning or pain after using this medicine, talk to your doctor.

3. How to use IKERVIS

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

The recommended doseis one drop in each affected eye, once a day before going to
sleep.

Instructions for use
Follow these instructions carefully and contact your doctor or pharmacist immediately if
something is not clear.

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 bottle neck is broken before initial use.
• When using the bottle for the first time, before putting a drop in your eye, you should become familiar with using the bottle by gently squeezing it to release a drop away from your eye.
• When you are confident you can put one drop at a time, choose the position 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 any object in order 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 should be shaken once with a downward motion, 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.
• 8. Clean the skin around your eye of any excess emulsion.
• 9. At the end of the period of validity in use of the medicine (1, 2 or 3 months), some emulsion may still remain inside the bottle. Do not attempt to use the medicine remaining in the bottle after completing the treatment.

If a drop does not reach your eye, try again.

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

If you forget to use IKERVIS, continue with the next dose as scheduled.Do not use
a double dose to make up for a missed dose. Do not apply more than one drop a day
to the affected eye(s).

If you stop using IKERVISwithout first talking to your doctor, the inflammation
of the clear front part of your eye (called keratitis) will not be controlled and could
affect your vision in the long term.
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:
The most common side effects occur inside and around the eyes.

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

• Eye pain
• Eye irritation

Common(may affect up to 1 in 10 people)

• Eyelid redness
• Eye watering
• Eye redness
• Blurred vision
• Eyelid swelling
• Redness of the conjunctiva (the thin membrane that covers the front of the eye)
• Eye itching

Uncommon(may affect up to 1 in 100 people)

• Discomfort inside or around the eye when applying drops to the eye, including a feeling of having something in the eye
• Irritation or swelling of the conjunctiva (the thin membrane that covers the front of the eye)
• Tear flow disorder
• Eye discharge
• Irritation or inflammation of the conjunctiva (the thin membrane that covers the front of the eye)
• Inflammation of the iris (the colored part of the eye) or eyelid
• Deposits in the eye
• Abrasion on the outer layer of the cornea
• Redness or swelling of the eyelid
• Eyelid cyst
• Immune response or scarring in the cornea
• Eyelid itching
• Bacterial infection or inflammation of the cornea (the clear front part of the eye)
• Painful rash around the eye caused by the herpes zoster virus
• Headache

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 IKERVIS

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 packaging 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, to prevent infections, the vial must be discarded
within a maximum of 3 months. 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 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 IKERVIS contains

• The active ingredient is cyclosporine. One millilitre of IKERVIS 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 the appearance of IKERVIS and contents of the pack
IKERVIS is an eye drop in the form of a milky white emulsion.
It is supplied in a white plastic bottle with a white dropper applicator and a white screw cap made of
plastic. Each bottle contains 2.5 ml, 4.5 ml or 7 ml of the medicinal product and each pack contains
one bottle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SANTEN Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer
EXCELVISION
Rue de la Lombardière
ZI la Lombardière
F-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: +420 234 102 170

Magyarország
Santen Oy
Tel.: +36 (06) 16777305

Danmark
Santen Oy
Tlf: +45 -898 713 35

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

Nederland
Santen Oy
Tel: +31 (0) 207139206

Eesti
Santen Oy
Tel: +372 5067559

Deutschland
Santen GmbH
Tel: +49 (0) 3030809610

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
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

Ireland
Santen Oy
Tel: +353 (0) 16950008

România
Santen Oy
Tel: +40 (0) 316300603

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 (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 .