Ikervis 1 mg/ml eye drops in emulsion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
IKERVIS 1 mg/ml emulsion eye drops
ciclosporin (ciclosporin)
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, consult your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What IKERVIS is and what it is used for
- What you need to know before using IKERVIS
- How to use IKERVIS
- Possible side effects
- How to store IKERVIS
- 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 called immunosuppressants, which are used to reduce inflammation.
IKERVIS is used to treat adults with severe keratitis (inflammation of the cornea, the transparent layer at the front of the eye). It is used in patients with xerophthalmia (dry eye disease) that has not improved despite treatment with artificial tears.
You should consult a doctor if your condition worsens or does not improve.
You should visit your doctor at least every 6 months so that the effect of IKERVIS can be evaluated.
2. What you need to know before starting to use IKERVIS
DO NOT use IKERVIS:
- if you are allergic to ciclosporine or to any of the other ingredients of this medicine (listed in section 6);
- if you have had or currently have cancer in or around the eye;
- if you have an eye infection.
Warnings and precautions
Use IKERVIS only as an eye drop for the eye(s).
Consult your doctor or pharmacist before starting to use IKERVIS:
- if you have previously had an eye infection caused by the herpes virus that may have damaged the transparent front part of the eye (cornea);
- if you are taking any medicine containing steroids;
- if you are taking any medicine to treat glaucoma.
Contact lenses may worsen damage to the transparent front part of the eye (cornea). Therefore, you should remove contact lenses before going to bed, prior to using IKERVIS; 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Consult your doctor if you are using an eye drop containing steroids together with IKERVIS, as these may increase the risk of adverse effects.
IKERVIS eye drops should be used at least 15 minutes after using any other eye drop.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use IKERVIS if you are pregnant.
If you can become pregnant, you should use contraception while using this medicine.
Very small amounts of IKERVIS are likely to pass into breast milk. If you are breastfeeding (lactating), consult your doctor before using this medicine.
Driving and using machines
You may experience blurred vision immediately after using IKERVIS eye drops. If this occurs, wait until your vision clears before driving or using machines.
3. How to use IKERVIS
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Recommended dose
One drop in the affected eye(s) once daily at bedtime.
Instructions for use
Carefully follow these instructions and consult your doctor or pharmacist if anything is unclear.
1 2 3
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Wash your hands.
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If you wear contact lenses, remove them at bedtime before using the eye drops; you may reinsert them upon waking.
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Open the aluminum pouch containing 5 single-dose units.
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Take one single-dose unit from the aluminum pouch.
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Before use, gently shake the single-dose unit.
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Twist off the cap to open it (image 1).
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Pull down the lower eyelid with one finger (image 2).
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Tilt your head back and look at the ceiling.
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Gently squeeze to release one drop of the medicine into the eye. Make sure not to touch the eye with the tip of the single-dose unit.
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Blink several times to spread the medicine over the eye.
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After using IKERVIS, press with one finger at the inner corner of the eye next to the nose and gently close your eyelids for 2 minutes (image 3). This helps prevent IKERVIS from passing into other parts of the body.
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If you are using the eye drops in both eyes, repeat these steps for the other eye.
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Discard the single-dose unit immediately after use, even if there is some liquid remaining.
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Keep the remaining single-dose units in the aluminum pouch.
If the drop misses the eye, try again.
If you use more IKERVIS than you should, rinse the eye with water. Do not apply additional drops until your next scheduled dose.
If you forget to use IKERVIS, continue with your next planned dose. Do not use a double dose to make up for a missed dose. Do not use more than one drop per day in the affected eye(s).
If you stop treatment with IKERVIS without consulting your doctor, inflammation of the transparent front part of the eye (known as keratitis) will not be controlled and could lead to visual impairment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The following adverse effects have been observed:
The most frequent adverse effects occur in and around the eyes.
Very common (may affect more than 1 in 10 people)
Pain upon instillation of the eye drops.
Common (may affect up to 1 in 10 people)
Irritation, redness, and increased tearing when the drops are applied to the eye, eyelid redness, watery eyes, eye redness, blurred vision. Eyelid swelling, conjunctival redness (thin membrane covering the front part of the eye), eye irritation, eye pain.
Uncommon (may affect up to 1 in 100 people)
Uncommon eye-related adverse effects:
Discomfort, itching or irritation in or around the eye, including the sensation of a foreign body. Irritation or swelling of the conjunctiva (thin membrane covering the front part of the eye), ocular allergy, abnormal tearing, ocular discharge, inflammation of the iris (colored part of the eye) or eyelid, deposits in the eye, bacterial infection or inflammation of the cornea (transparent front part of the eye), abrasion of the outer layer of the cornea, white spots on the cornea, eyelid cyst, eyelid itching, painful skin rash around the eye caused by the herpes zoster virus.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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, the aluminium pouch, and the single-dose containers after "EXP". The expiry date refers to the last day of the month indicated.
Do not freeze.
After opening the aluminium pouches, the single-dose containers should be kept inside them to protect from light and prevent evaporation. Immediately discard any opened single-dose container with residual emulsion after use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of IKERVIS
- The active substance is cyclosporine. One millilitre of IKERVIS contains 1 mg of cyclosporine.
- The other components are medium-chain triglycerides, cetylpyridinium chloride, glycerol, tyloxapol, poloxamer 188, sodium hydroxide (to adjust pH), and water for injections.
Appearance of the product and contents of the pack
IKERVIS is a white, milky emulsion eye drop.
It is supplied in single-dose units made of low-density polyethylene (LDPE).
Each single-dose unit contains 0.3 ml of eye drop emulsion.
The single-dose units are contained in sealed aluminium pouches.
Pack sizes: 30 and 90 single-dose units.
Only some pack sizes may be commercially available.
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
Niittyhaankatu 20
33720 Tampere
Finland
For more information about this medicine, 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
????????Luxembourg/Luxemburg
Santen Oy Santen Oy
Te?.: +359 (0) 888 755 393 Tél/Tel: +352 (0) 27862006
Ceská republika Magyarország
Santen Oy Santen Oy
Tel: +420 234 102 170 Tel.: +36 (06) 16777305
Danmark Malta
SantenPharma AB Santen Oy
Tlf: +45 78737843 Tel: +358 (0) 3 284 8111
Deutschland Nederland
Santen GmbH Santen Oy
Tel: +49 (0) 3030809610 Tel: +31 (0) 207139206
Eesti Norge
Santen Oy SantenPharma AB
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) 221168608
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 SantenPharma AB
Τηλ: +358 (0) 3 284 8111 Tel: +46 (0) 850598833
Latvija United Kingdom
Santen Oy Santen UK Limited
Tel: +371 677 917 80 Tel: +44 (0) 845 075 4863
Date of the most recent revision of this leaflet:
Detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.