Ikevris

Package leaflet: Information for the patient

IKERVIS 1 mg/mL eye drops, emulsion

ciclosporin (ciclosporine)
Please read this leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including 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 using 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 IKERVIS is and what it is used for

IKERVIS contains the active substance ciclosporin. Ciclosporin belongs to a group of medicines known as immunosuppressive agents, used to reduce inflammation.
IKERVIS is used to treat adult patients with severe keratitis (inflammation of the cornea, the transparent layer at the front of the eye). It is used in patients who have dry eye syndrome that has not improved despite treatment with tear substitutes (artificial tears).
Talk to your doctor if you do not feel better or if you feel worse.
You must visit your doctor at least every 6 months so that they can assess the effect of IKERVIS.

2. What you need to know before using IKERVIS

DO NOT use IKERVIS:

• 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 currently have a tumour located in the eye or in the area around the eye.
• If you have an eye infection.

Warnings and precautions
IKERVIS should be applied only to the eye/eyes.
Consult your doctor or pharmacist before using IKERVIS

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

Contact lenses may further damage the transparent front part of the eye (cornea). Therefore, you must remove your contact lenses before using IKERVIS at bedtime; you may reinsert them upon waking.
Children and adolescents
IKERVIS must not be used in children and adolescents under 18 years of age.
Other medicines and IKERVIS
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Inform your doctor if you are using a steroid-containing eye drop together with IKERVIS, as these may increase the risk of side effects.
IKERVIS eye drops should be used at least 15 minutes after applying any other eye drop.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
IKERVIS must not be used during pregnancy.
If you are of childbearing age, you should use adequate contraception while taking this medicine.
IKERVIS is likely to be present in breast milk in extremely low concentrations. If you are breastfeeding, speak to your doctor before using this medicine.
Driving and using machines
Immediately after using IKERVIS eye drops, your vision may become blurred. In this case, do not drive and do not operate machinery until your vision returns to normal.
IKERVIS contains cetalkonium chloride
This medicine contains 0.05 mg of cetalkonium chloride per 1 mL. Remove contact lenses before using this medicine; lenses may be reinserted upon waking.
Cetalkonium chloride may cause eye irritation. If you experience an abnormal sensation in the eye, such as burning or pain after using this medicine, speak to your doctor.

3. How to use IKERVIS

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one drop in each affected eye, once daily before going to
bed.
Instructions for use
Follow these instructions carefully and contact your doctor or pharmacist immediately if you
do not understand any part.

1 2 3

• Wash your hands.
• If you wear contact lenses, remove them before administering the drops, prior to going to bed; you may reinsert them upon waking.
• Open the aluminium pouch containing five single-dose containers.
• Remove one single-dose container from the aluminium pouch.
• Gently shake the single-dose container before use.
• Unscrew the cap ( Figure 1 ).
• Pull down the lower eyelid ( Figure 2 ).
• Tilt your head backward and look at the ceiling.
• Gently press the container to release 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 spread over the eye.
• After using IKERVIS, press a finger against the inner corner of the eye, near the nose, and gently close the eyelids for 2 minutes ( Figure 3 ). This helps prevent IKERVIS from reaching other parts of the body.
• If you are treating both eyes, repeat the procedure for the other eye.
• Discard the single-dose container immediately after use, even if a small amount of medicine remains.
• Store the remaining single-dose containers in the aluminium pouch.

If a drop misses the eye, try again.
If you use more IKERVIS than you should, rinse the eye with water. Do not apply further drops until the time of your next scheduled 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 forgotten dose. Do not apply more than one drop per day in the affected eye(s).
If you stop using IKERVIS without first talking to your doctor, inflammation of the front transparent part of the eye (called keratitis) will not be controlled and may lead to long-term vision problems.
If you have any doubts about how to use this medicine, consult 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 in 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 tearing
• Eye redness
• Blurred vision
• Eyelid swelling
• Conjunctival redness (the thin membrane covering the front part of the eye)
• Itchy eyes

Uncommon (may affect up to 1 in 100 people)

• Discomfort in or around the eye at the time of drop application, including a sensation of having something in the eye
• Irritation or swelling of the conjunctiva (the thin membrane covering the front part of the eye)
• Tear disorder
• Ocular discharge
• Irritation or inflammation of the conjunctiva (the thin membrane covering the front part of the eye)
• Inflammation of the iris (the coloured part of the eye) or of the eyelid
• Deposits in the eye
• Abrasion of the outer layer of the cornea
• Redness or swelling of the eyelid
• Cyst in the eyelid
• Immune response or scarring in the cornea
• Itchy eyelid
• Bacterial infection or inflammation of the cornea (the transparent front part of the eye)
• Painful skin rash around the eye caused by the herpes zoster virus
• Headache

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the outer carton, on the aluminium pouch,
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 below 25°C.
After opening the aluminium pouches, the single-dose containers must be kept within the pouches 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 via 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 IKERVIS contains

• The active substance is cyclosporine. One millilitre of IKERVIS contains 1 mg of cyclosporine.
• The other components are: medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol, poloxamer 188, sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of IKERVIS and contents of the pack
IKERVIS is a white, milky emulsion eye drop.
It is supplied in single-dose containers made of low-density polyethylene (LDPE).
Each single-dose container holds 0.3 mL of eye drop emulsion.
The single-dose containers are packed in sealed aluminium sachets.
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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Santen Oy Santen Oy
Tél/Tel: +32 (0) 24019172 Tel: +370 37 366628

България Luxembourg/Luxemburg
Santen Oy Santen Oy
Teл.: +359 (0) 888 755 393 Tél/Tel: +352 (0) 27862006

Česká republika Magyarország
Santen Oy Santen Oy
Tel: +420 234 102 170 Tel.: +36 (06) 16777305

Danmark Malta
Santen Oy Santen Oy
Tlf: +45 898 713 35 Tel: +358 (0) 3 284 8111

Deutschland Nederland
Santen GmbH Santen Oy
Tel: +49 (0) 3030809610 Tel: +31 (0) 207139206

Eesti Norge
Santen Oy Santen Oy
Tel: +372 5067559 Tlf: +47 21939612

Ελλάδα Österreich
Santen Oy Santen Oy
Τηλ: +358 (0) 3 284 8111 Tel: +43 (0) 720116199

España Polska
Santen Pharmaceutical Spain S.L. Santen Oy
Tel: +34 914 142 485 Tel.: +48(0) 221042096

France Portugal
Santen Santen Oy
Tél: +33 (0) 1 70 75 26 84 Tel: +351 308 805 912

Hrvatska România
Santen Oy Santen Oy
Tel: +358 (0) 3 284 8111 Tel: +40 (0) 316300603

Ireland Slovenija
Santen Oy Santen Oy
Tel: +353 (0) 16950008 Tel: +358 (0) 3 284 8111

Ísland Slovenská republika
Santen Oy Santen Oy
Sími: +358 (0) 3 284 8111 Tel: +421 (01) 23 332 5519

Italia Suomi/Finland
Santen Italy S.r.l. Santen Oy
Tel: +39 0236009983 Puh/Tel: +358 (0) 974790211

Κύπρος Sverige
Santen Oy Santen Oy
Τηλ: +358 (0) 3 284 8111 Tel: +46 (0) 850598833

Latvija United Kingdom (Northern Ireland)
Santen Oy Santen Oy
Tel: +371 677 917 80 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.

Patient Information Leaflet

IKERVIS 1 mg/mL eye drops, emulsion

ciclosporin (ciclosporin)
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 using 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 IKERVIS is and what it is used for

IKERVIS contains the active substance cyclosporine. Cyclosporine belongs to a group of medicines known as immunosuppressive agents, used to reduce inflammation.
IKERVIS is used to treat adult patients with severe keratitis (inflammation of the cornea, the transparent layer at the front of the eye). It is used in patients who have dry eye syndrome that has not improved with treatment using tear substitutes (artificial tears).
Contact your doctor if you do not notice improvement or if you notice worsening.
You must visit your doctor at least every 6 months so that they can assess the effect of IKERVIS.

2. What you need to know before using IKERVIS

Do NOT use IKERVIS:

• 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 currently have a tumour localised in the eye or the area around the eye.
• If you have an eye infection.

Warnings and precautions
IKERVIS should be applied only to the eye/eyes.
Talk to your doctor or pharmacist before using IKERVIS

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

Contact lenses may further damage the transparent front part of the eye (cornea). Therefore, you must remove your contact lenses before applying IKERVIS at bedtime; you may reinsert them upon waking.
Children and adolescents
IKERVIS must not be used in children and adolescents under 18 years of age.
Other medicines and IKERVIS
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Inform your doctor if you are using a steroid-containing eye drop together with IKERVIS, as these may increase the risk of side effects.
IKERVIS eye drops should be used at least 15 minutes after applying any other eye drop.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
IKERVIS must not be used during pregnancy.
If you are of childbearing age, you must use adequate contraception while taking this medicine.
IKERVIS is likely to be present in breast milk in very low concentrations. If you are breastfeeding, talk to your doctor before using this medicine.
Driving and using machines
Immediately after using IKERVIS eye drops, your vision may become blurred. In this case, do not drive and do not operate machinery until your vision returns to normal.
IKERVIS contains cetalkonium chloride
This medicine contains 0.05 mg of cetalkonium chloride per 1 mL. Remove contact lenses before using this medicine; lenses may be reinserted upon waking.
Cetalkonium chloride may cause eye irritation. If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use IKERVIS

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose: One drop in each affected eye, once daily, before going to sleep.

Instructions for use

Follow these instructions carefully and contact your doctor or pharmacist immediately if anything is unclear.

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 first use.
• When using the bottle for the first time, before placing a drop into the eye, become familiar with the use of the bottle by slowly squeezing it until a drop appears, away from the eye.
• Once you are confident in your ability to administer 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 one drop into the waste to prime 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 must not come into contact with any object to avoid contaminating the medicine.

2. Tilt your head backward and hold the bottle above the eye.
3. Pull down the lower eyelid and look upward. Gently squeeze the middle of the bottle to release one drop of the medicine into the eye. Note that after squeezing the bottle, it may take a few seconds for the drop to come out. Do not squeeze the bottle too hard.

4. Close the eye and press with a finger on the inner corner of the eye for about two minutes. This helps prevent the medicine from spreading into the rest of the body.

5. Repeat steps 2 to 4 to administer one drop into the other eye, if instructed by your doctor. Sometimes treatment is only required in one eye. Your doctor will tell you if this applies to you and which eye should be treated.
6. After each use and before replacing the cap, shake the bottle once with a downward motion, without touching the dropper tip, to remove any residual emulsion from the tip. This step is necessary to ensure proper delivery of the next drop.

8. Wipe away any excess emulsion around the eye on the surrounding skin.
9. At the end of the medicine's period of use (1, 2 or 3 months), some emulsion may still remain in the bottle. Do not attempt to use any remaining medicine left in the bottle after completing the treatment.

If a drop misses the eye, try again.

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

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

If you stop using IKERVIS without first discussing it with your doctor, inflammation of the front transparent part of the eye (called keratitis) will not be controlled and may lead to long-term vision damage.

If you have any doubts about how to use this medicine, consult 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 in 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
• Eye tearing
• Eye redness
• Blurred vision
• Eyelid swelling
• Conjunctival redness (the thin membrane covering the front part of the eye)
• Itching of the eye

Uncommon (may affect up to 1 in 100 people)

• Discomfort in or around the eye at the time of applying the drops, including a sensation of having something in the eye
• Irritation or swelling of the conjunctiva (the thin membrane covering the front part of the eye)
• Tear disorder
• Ocular discharge
• Irritation or inflammation of the conjunctiva (the thin membrane covering the front part of the eye)
• Inflammation of the iris (the coloured part of the eye) or of the 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 of the eyelid
• Bacterial infection or inflammation of the cornea (the transparent front part of the eye)
• Painful skin rash around the eye caused by the herpes zoster virus
• Headache

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed 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 stated on the outer box and on the label
of the bottle after "SCAD" or "EXP". The expiry date refers to the last day of that month.
Do not freeze.
Store below 25 °C.
After first opening the bottle, to prevent infection, the bottle must be discarded
after a maximum of 3 months. The bottle 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 via 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 IKERVIS contains

• The active substance is cyclosporine. One millilitre of IKERVIS contains 1 mg of cyclosporine.
• The other components are: medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol, poloxamer 188, sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of IKERVIS and contents of the pack
IKERVIS is a white, milky emulsion eye drop.
It is supplied in a white plastic bottle with a white dropper applicator and a white plastic screw cap. 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, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Santen Oy Santen Oy
Tél/Tel : +32 (0) 24019172 Tel: +370 37 366628

България Luxembourg/Luxemburg
Santen Oy Santen Oy
Teл.: +359 (0) 888 755 393 Tél/Tel: +352 (0) 27862006

Česká republika Magyarország
Santen Oy Santen Oy
Tel: +420 234 102 170 Tel.: +36 (06) 16777305

Danmark Malta
Santen Oy Santen Oy
Tlf: +45 -898 713 35 Tel: +358 (0) 3 284 8111

Deutschland Nederland
Santen GmbH Santen Oy
Tel: +49 (0) 3030809610 Tel: +31 (0) 207139206

Eesti Norge
Santen Oy Santen Oy
Tel: +372 5067559 Tlf: +47 21939612

Ελλάδα Österreich
Santen Oy Santen Oy
Τηλ: +358 (0) 3 284 8111 Tel: +43 (0) 720116199

España Polska
Santen Pharmaceutical Spain S.L. Santen Oy
Tel: +34 914 142 485 Tel.: +48(0) 221042096

France Portugal
Santen Santen Oy
Tél: +33 (0) 1 70 75 26 84 Tel: +351 308 805 912

Hrvatska România
Santen Oy Santen Oy
Tel: +358 (0) 3 284 8111 Tel: +40 (0) 316300603

Ireland Slovenija
Santen Oy Santen Oy
Tel: +353 (0) 16950008 Tel: +358 (0) 3 284 8111

Ísland Slovenská republika
Santen Oy Santen Oy
Sími: +358 (0) 3 284 8111 Tel: +421 (01) 23 332 5519

Italia Suomi/Finland
Santen Italy S.r.l. Santen Oy
Tel: +39 0236009983 Puh/Tel: +358 (0) 974790211

Κύπρος Sverige
Santen Oy Santen Oy
Τηλ: +358 (0) 3 284 8111 Tel: +46 (0) 850598833

Latvija United Kingdom (Northern Ireland)
Santen Oy Santen Oy
Tel: +371 677 917 80 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.