Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
IKERVIS 1 mg/mL eye drops, emulsion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ciclosporin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 take it
e 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 had or have a cancer in or around your eye. if you have an eye infection. Warnings and precautions Only use IKERVIS for dropping in your eye(s). Talk to your doctor or pharmacist before using IKERVIS if you have previously had an eye infection by the herpes virus that might have damaged the transparent front part of the eye (cornea). if you are taking any medicines containing steroids. if you are taking any medicines to treat glaucoma. 1 ikervis-pil-en-uk-ie-APPR 20220221 [storage condition]
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 take it
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.
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Wash your hands. If you wear contact lenses, take them out at bedtime before using the drops; you can reinsert them when you wake up. Open the aluminium pouch, which contains 5 single-dose containers. Take one single-dose container from the aluminium pouch. Gently shake the single dose container prior to use. Twist off the cap (picture 1). Pull down your lower eyelid (picture 2). Tilt your head back and look up at the ceiling. Gently squeeze one drop of the medicine onto your eye. Make sure you do not touch your eye with the tip of the single-dose container. Blink a few times so that the medicine covers your eye. After using IKERVIS, press a finger into the corner of your eye by the nose and close gently the eyelids for 2 minutes (picture 3). This helps to stop IKERVIS getting into the rest of the body. If you use drops in both eyes, repeat the steps for your other eye. Discard the single dose container as soon as you have used it, even if there is still some medicine left in it. The remaining single-dose containers should be kept in the aluminium pouch.
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) Eye pain, 3 ikervis-pil-en-uk-ie-APPR 20220221 [storage condition]
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Eye irritation
Common (may affect up to 1 in 10 people) Redness of the eyelid, Watery eyes, Eye redness, Blurred vision, Swelling of the eyelid, Redness of the conjunctiva (thin membrane covering the front part of the eye), Itching in the eye Uncommon (may affect up to 1 in 100 people) Discomfort in or around the eye when the drops are put into the eye, including feeling that there is something in the eye, Irritation or swelling of the conjunctiva (thin membrane covering the front part of the eye), Tear disorder, Eye discharge, Irritation or inflammation of the conjunctiva (thin membrane covering the front part of the eye), Inflammation of the iris (coloured part of the eye) or eyelid, Deposits in the eye, Abrasion to the outer layer of the cornea, Red or swollen eyelids, Cyst in the eyelid, Immune response or scarring in the cornea, Itching in the eyelid, Bacterial infection or inflammation of the cornea (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 (see contact details below). Ireland HPRA Pharmacovigilance Website: www.hpra.ie United Kingdom (Northern Ireland / Great Britain) Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard 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 it
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. Store below 25°C. 4 ikervis-pil-en-uk-ie-APPR 20220221 [storage condition]
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 The active substance is ciclosporin. One millilitre of IKERVIS contains 1 mg of ciclosporin. The other ingredients are medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol, poloxamer 188, sodium hydroxide (for pH adjustment) and water for injections. 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 SANTEN Oy Niittyhaankatu 20 33720 Tampere Finland Manufacturer SANTEN Oy Kelloportinkatu 1 33100 Tampere Finland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Ireland/United Kingdom (Northern Ireland) Santen Oy Tel: +353 (0) 16950008 (UK Tel: +44 (0) 345 075 4863)
United Kingdom (Great Britain) Santen UK Limited Tel: +44 (0) 345 075 4863
This leaflet was last revised in 01/2022
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu and the Medicines & Healthcare products Regulatory Agency (MHRA) website: www.mhra.gov.uk.
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Frequently asked questions about IKERVIS 1 mg/mL eye drops, emulsion
How do I take IKERVIS 1 mg/mL eye drops, emulsion?
IKERVIS 1 mg/mL eye drops, emulsion comes as eye drops containing 1mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in IKERVIS 1 mg/mL eye drops, emulsion?
The active substance in IKERVIS 1 mg/mL eye drops, emulsion is ciclosporin.
Are there equivalent medicines to IKERVIS 1 mg/mL eye drops, emulsion?
Medicines with the same active substance, strength and form include: Verkazia 1 mg/ml eye drops, emulsion, Vevizye 1 mg/ml Eye drops POM. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for IKERVIS 1 mg/mL eye drops, emulsion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get IKERVIS 1 mg/mL eye drops, emulsion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ciclosporin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1).
4.2. Posology and method of administration
Treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.
Posology
The recommended dose is one drop once daily to be applied to the affected eye(s) at bedtime.
Response to treatment should be reassessed at least every 6 months.
If a dose is missed, treatment should be continued on the next day as normal. Patients should be advised not to instil more than one drop in the affected eye(s).
Special populations
Elderly patients
The elderly population has been studied in clinical studies. No dose adjustment is required.
Patients with renal or hepatic impairment
The effect of ciclosporin has not been studied in patients with hepatic or renal impairment. However, no special considerations are needed in these populations.
Paediatric population
There is no relevant use of ciclosporin in children and adolescents aged below 18 in the treatment of severe keratitis in patients with dry eye disease, which has not improved despite treatment with tear substitutes.
Method of administration
Ocular use.
Precautions to be taken before administering the medicinal product
Patients should be instructed to first wash their hands.
Prior to administration, the single-dose container should be gently shaken.
For single use only. Each single-dose container is sufficient to treat both eyes. Any unused emulsion should be discarded immediately.
Patients should be instructed to use nasolacrimal occlusion and to close the eyelids for 2 minutes after instillation, to reduce the systemic absorption. This may result in a decrease in systemic undesirable effects and an increase in local activity.
If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 15 minutes apart. IKERVIS should be administered last (see section 4.4).
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Ocular or peri-ocular malignancies or premalignant conditions.
Active or suspected ocular or peri-ocular infection.
4.4. Special warnings and precautions for use
IKERVIS has not been studied in patients with a history of ocular herpes and should therefore be used with caution in such patients.
Contact lenses
Patients wearing contact lenses have not been studied. Careful monitoring of patients with severe keratitis is recommended. Contact lenses should be removed before instillation of the eye drops at bedtime and may be reinserted at wake-up time.
Concomitant therapy
There is limited experience with ciclosporin in the treatment of patients with glaucoma. Regular clinical monitoring should be exercised when treating these patients concomitantly with IKERVIS, especially with beta-blockers which are known to decrease tear secretion.
Effects on the immune system
Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies. Therefore, regular examination of the eye(s) is recommended, e.g. at least every 6 months, when IKERVIS is used for years.
Cetalkonium chloride content
IKERVIS contains cetalkonium chloride. Contact lenses should be removed prior to application and may be reinserted at wake-up time. Cetalkonium chloride may cause eye irritation. Patients should be monitored in case of prolonged use.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with IKERVIS.
Combination with other medicinal products that affect the immune system
Co-administration of IKERVIS with eye drops containing corticosteroids could potentiate the effects of ciclosporin on the immune system (see section 4.4).
4.6. Fertility, pregnancy and lactation
Women of childbearing potential/contraception in females
IKERVIS is not recommended in women of childbearing potential not using effective contraception.
Pregnancy
There is no data from the use of IKERVIS in pregnant women.
Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposure considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of IKERVIS.
IKERVIS is not recommended during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
Breast-feeding
Following oral administration, ciclosporin is excreted in breast milk. There is insufficient information on the effects of ciclosporin in newborns/infants. However, at therapeutic doses of ciclosporin in eye drops, it is unlikely that sufficient amounts would be present in breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from IKERVIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
There is no data on the effects of IKERVIS on human fertility.
No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section 5.3).
4.7. Effects on ability to drive and use machines
IKERVIS has moderate influence on the ability to drive and use machines.
This medicinal product may induce temporary blurred vision or other visual disturbances which may affect the ability to drive or use machines (see section 4.8). Patients should be advised not to drive or use machines until their vision has cleared.
4.8. Undesirable effects
Summary of the safety profile
The most common adverse reactions are eye pain (19.0%), eye irritation (17.5%), ocular hyperaemia (5.5%), lacrimation increased (4.9%) and eyelid erythema (1.7%) which are usually transitory and occurred during instillation.These adverse reactions are consistent with those that have been reported during post-marketing experience.
Tabulated list of adverse reactions
The following adverse reactions listed below were observed in clinical studies or during post-marketing experience. They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse reactions
Infections and infestations
Uncommon
Keratitis bacterial,
Herpes zoster ophthalmic.
Eye disorders
Very common
Eye pain,
Eye irritation
Common
Erythema of eyelid,
Lacrimation increased,
Ocular hyperaemia,
Vision blurred,
Eyelid oedema,
Conjunctival hyperaemia,
Eye pruritus
Uncommon
Conjunctival oedema,
Lacrimal disorder,
Eye discharge,
Conjunctival irritation,
Conjunctivitis,
Foreign body sensation in eyes,
Deposit eye,
Keratitis,
Blepharitis,
Chalazion,
Corneal infiltrates,
Corneal scar,
Eyelid pruritus,
Iridocyclitis.
Ocular discomfort
General disorders and administration site conditions
Uncommon
Instillation site reaction
Nervous system disorders
Uncommon
Headache
Description of selected adverse reactions
Eye pain
A frequently reported local adverse reaction associated with the use of IKERVIS during clinical trials. It is likely to be attributable to ciclosporin.
Generalised and localised infections
Patients receiving immunosuppressive therapies, including ciclosporin, are at increased risk of infections. Both generalised and localised infections can occur. Pre-existing infections may also be aggravated (see section 4.3). Cases of infections have been reported uncommonly in association with the use of IKERVIS.
As precautionary measure, action should be taken to reduce the systemic absorption (see section 4.2).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
A topical overdose is not likely to occur after ocular administration. If overdose with IKERVIS occurs, treatment should be symptomatic and supportive.
💬 Ask about this leaflet
Ask anything about IKERVIS 1 mg/mL eye drops, emulsion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Ciclosporin
- Capimune 100 mg, soft capsules
- Capimune 25 mg soft capsules
- Capimune 50 mg soft capsules
- Capsorin 25 mg soft capsules
- Cequa 0.9 mg/ml Eye drops
- Deximune 100 mg soft capsule
- Deximune 25 mg soft capsules
- Deximune 50 mg soft capsules
- Neoral Oral Solution
- Neoral Soft Gelatin Capsules
- SANDIMMUN Concentrate for Solution for Infusion 50mg/ml
- Verkazia 1 mg/ml eye drops, emulsion
- Vevizye 1 mg/ml Eye drops POM