1 mg / ml eye drops , emulsion
ciclosporin (ciclosporin)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
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 packaging 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 called immunosuppressants that are used to reduce inflammation.

IKERVIS is used to treat adults with severe keratitis ( inflammation of the cornea, the transparent membrane in the front of the eye). It is used in patients who have chronically dry eyes, which have not improved despite treatment with tear substitutes (artificial tear fluid).

You need to talk to a doctor if you do not feel better or if you feel worse.


You should visit your doctor at least every six months to 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 any of the other ingredients of this medicine (listed in section 6).
  • if you have or have had cancer in or around your eye.
  • if you have an eye infection .

Warnings and cautions

Use IKERVIS only to drip into the eye (s).

Talk to your doctor or pharmacist before using IKERVIS

  • if you have previously had an eye infection with the herpes virus that may have damaged the translucent membrane of the front of the eye (cornea).
  • if you are taking medicines containing corticosteroids ( cortisone ).
  • if you are taking medicines to treat glaucoma .

Contact lenses can cause further damage to the transparent membrane of the front of the eye (the cornea). Therefore, remove contact lenses at bedtime before using IKERVIS. You can put them back in when you get up.

Children and young people

IKERVIS should not be used by 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.

Talk to your doctor if you are using eye drops that contain corticosteroids ( cortisone ) at the same time as IKERVIS, as these may increase the risk of side effects.

IKERVIS eye drops should not be used until at least 15 minutes after the use of other eye drops.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

IKERVIS should not be used if you are pregnant.

If you can get pregnant, you must use contraception while using this medicine.

IKERVIS probably passes into breast milk in very small amounts. If you are breastfeeding, talk to your doctor before using this medicine.

Driving and using machines

You may see blurred right after using IKERVIS eye drops. If this happens, wait until vision has cleared before driving or using machines.

IKERVIS contains cetalkonium chloride

Each ml of this medicine contains 0.05 mg of cetalkonium chloride. Contact lenses should be removed before using this medicine, and you can re-insert the contact lenses when you get up. Cetalkonium chloride may cause eye irritation. If anything feels abnormal in your eyes or if you have burning or pain in the eye after using this medicine, talk to your doctor.

3. How to use IKERVIS

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one drop in each affected eye once daily at bedtime.

Instructions for use

Follow these instructions carefully and ask your doctor or pharmacist if there is anything you do not understand.

1 2 3
  • Wash your hands.
  • If you use contact lenses, remove them at bedtime before using the drops.You can put them back in when you get up.
  • Open the aluminum bag containing 5 single-dose containers .
  • Take a single-dose container out of the aluminum bag .
  • Gently shake the single-dose container before using it.
  • Turn off the top (Fig. 1) .
  • Pull down the lower eyelid (Fig. 2).
  • Tilt your head back and look up at the ceiling.
  • Gently push a drop of the drug onto the eye. Make sure you do not touch the eye with the tip of the single-dose container.
  • Blink a few times so that the medicine covers the eye.
  • After using IKERVIS, press with a finger in the corner of your eye at the nose and close your eyes for 2 minutes (picture 3) . This helps prevent IKERVIS from entering the rest of the body.
  • If you use drops in both eyes, repeat the same step for the other eye.
  • Dispose of the single-dose container as soon as you have used it, even if there is still some liquid left in it.
  • The rest of the single-dose containers should be stored in the aluminum bag.

If a drop falls out of sight, try again.

If you use too much IKERVIS  

rinse your eye with water. Do not drip in more drops until it is time for the next regular dose.

If you forget to use IKERVIS

continue with the next dose as planned. Do not use a double dose to make up for a forgotten dose. Do not use more than one drop each day in the affected eye (s).

If you stop using IKERVIS

without talking to your doctor, inflammation is not kept under control in the transparent membrane of the front of the eye ( inflammation is called keratitis ) which can lead to impaired vision.

If you have any further questions on the use of this product, 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 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
  • Tear flow
  • Redness in the eye
  • Dimsyn
  • Swollen eyelid
  • Redness of the conjunctiva (thin membrane covering the front of the eye)
  • Itching in the eye

Uncommon (may affect up to 1 in 100 people)

  • Discomfort, itching or irritation in or around the eye when the drops are placed in the eye, including a feeling of having something in the eye
  • Irritation or swelling of the conjunctiva (thin membrane covering the front of the eye)
  • Disorder in the tear flow
  • Excretion from the eye
  • Irritation or inflammation of the conjunctiva (thin membrane covering the front of the eye)
  • Inflammation of the iris (the colored part of the eye) or the eyelid
  • Drug residues in the eye
  • Abrasion in the outer layer of the cornea
  • Red or swollen eyelids
  • Cyst in the eyelid
  • Immunological reaction or scarring of the cornea
  • Itching of the eyelid
  • Bacterial infection or inflammation of the cornea (transparent membrane in the front of the eye)
  • Painful rash around the eye due to herpes zoster virus .
  • Headache

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

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 carton, aluminum sachet, and single-dose containers after “EXP”. The expiration date is the last day of the specified month.

Do not freeze.

Once the aluminum bags have been opened, the single-dose containers should be stored in the bags as protection against light and evaporation. Dispose of an opened individual single-dose container with any remaining solution immediately after use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is cyclosporine. One milliliter IKERVIS contains 1 mg ciclosporin.
  • The other ingredients are triglyceride s medium chain, cetalkonium chloride, glycerin , tyloxapol, poloxamer 188, sodium hydroxide (for pH -reglering) and water for injections.

What the medicine looks like and contents of the pack

IKERVIS is a cloudy white eye drop emulsion.

The drug is supplied in single-dose low-density polyethylene (LDPE) containers. A single-dose container contains 0.3 ml of eye drops, emulsion.
The single-dose containers are packed in a sealed aluminum bag.

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

Contact the representative of the marketing authorization holder to find out more about this medicine:

Santen Oy

Tel: +46 (0) 850598833

Muhammad Nadeem

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