Active ingredient
- ciclosporin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/15/990/002, EU/1/15/990/001.
IKERVIS 1 mg/mL eye drops, emulsion
Package leaflet: Information for the patient
IKERVIS 1 mg/mL, eye drops, emulsion
ciclosporin
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in 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 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 that are used to reduce inflammation.
IKERVIS is used to treat adults with severe keratitis (inflammation of the cornea, the transparent layer in the front part of the eye). It is used in those patients who have dry eye disease, which has not improved despite treatment with tear substitutes (artificial tears).
Talk to a doctor if you do not feel better or if you feel worse.
You should visit your doctor at least every 6 months to assess the effect of IKERVIS.
2. What you need to know before you use IKERVIS
Do NOT use IKERVIS
Warnings and precautions
Only use IKERVIS for dropping in your eye(s).
Talk to your doctor or pharmacist before using IKERVIS
Contact lenses can further damage the transparent front part of the eye (cornea). Therefore, you should remove your contact lenses at bedtime before using IKERVIS; you can reinsert them when you wake up.
Children and adolescents
IKERVIS should not be used in children and adolescents below 18 years old.
Other medicines and IKERVIS
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Talk to your doctor if you are using eye drops containing steroids with IKERVIS as these might increase the risk of side effects.
IKERVIS eye drops should be used at least 15 minutes after any other eye drops are used.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
IKERVIS should not be used if you are pregnant.
If you could become pregnant you must use contraception while using this medicine.
IKERVIS is likely to be present in breast milk in very small amounts. If you are breast feeding talk to your doctor before using this medicine.
Driving and using machines
Your vision may be blurred immediately after using IKERVIS eye drops. If this happens, wait until your vision clears before you drive or use machines.
IKERVIS contains cetalkonium chloride
This medicine contains 0.05 mg cetalkonium chloride in 1 mL. You should remove contact lenses before using this medicine and you can reinsert them when you wake up. Cetalkonium chloride may cause eye irritation. If you feel abnormal eye sensation, stinging 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. Check with your doctor or pharmacist if you are not sure.
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.
If a drop misses your eye, try again.
If you use more IKERVIS than you should, rinse your eye with water. Do not put in any more drops until it is time for your 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 the forgotten dose. Do not use more than one drop each day in the affected eye(s).
If you stop using IKERVIS without speaking to your doctor, the inflammation of the transparent front part of your eye (known as keratitis) will not be controlled and could lead to impaired 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 are in and around the eyes.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
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 (see contact details below).
Ireland
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
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 carton, the aluminium pouch and on the single-dose containers after “EXP”. The expiry date refers to the last day of that month.
Do not freeze.
After opening of the aluminium pouches, the single-dose containers should be kept in the pouches in order to protect from light and avoid evaporation. Discard any opened individual single-dose container with any remaining emulsion immediately after use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What IKERVIS contains
What IKERVIS looks like and contents of the pack
IKERVIS is a milky white eye drops emulsion.
It is supplied in single-dose containers made of a low-density polyethylene (LDPE).
Each single-dose container contains 0.3 mL eye drops, emulsion.
The single-dose containers are wrapped in a sealed aluminium pouch.
Pack sizes: 30 and 90 single-dose containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in March 2020.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Ikervis UK/IE 20200316 [renewal_ISA2]
Salisbury Hall, St Albans, AL2 1BU, UK
+44 (0)1727 615 110
0345 075 4863
+44 (0)1727 615 110