IKERVIS 1 mg/mL eye drops, emulsion

5.       How to store IKERVIS

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Do not freeze.

Store below 25°C.

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This leaflet was last revised in 0112/20221

6.4     Special precautions for storage

Do not freeze.

Store below 25°C.

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.

Any opened individual single-dose container with any remaining emulsion should be discarded immediately after use.

10.     DATE OF REVISION OF THE TEXT

0112/20221

Section 3 …Instructions for use

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• 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 liquid medicine left in it.
• The remaining single-dose containers should be kept in the aluminium pouch.

If a drop misses your eye, try again.

Section 4 …Reporting of side effects

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 www.hpra.ie

 United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

This leaflet was last revised in March 202012/2021

correction of typos and removal of HPRA address in section 4 to align with published leaflet

2.       What you need to know before you use IKERVIS

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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 also cause eye irritation. If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

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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)

• Pain when the drops are put into the eye.Eye pain,
• Eye irritation

Common (may affect up to 1 in 10 people)

• Irritation, redness, and increase in tears when the drops are put into the eye,
• rRedness of the eyelid,
• wWatery eyes,
• eEye redness,
• bBlurred vision,
• . Swelling of the eyelid,
• rRedness of the conjunctiva (thin membrane covering the front part of the eye),eEye irritation, eEye p
• Iching in the eye

Uncommon (may affect up to 1 in 100 people)

Uncommon side effects related to the eye:

• 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),
• eEye allergy,
• tTear disorder,
• eEye discharge,
• Irritation or inflammation of the conjunctiva (thin membrane covering the front part of the eye),
• iInflammation of the iris (coloured part of the eye) or eyelid,
• dDeposits in the eye,
• aAbrasion to the outer layer of the cornea,wWhitish patches on the cornea,
•  cRed or swollen eyelids,
• Cyst in the eyelid,
• Immune response or scarring in the cornea,
•   iItching in the eyelid,or in the eye,
• 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

6.       Contents of the pack and other information

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Manufacturer

EXCELVISION

Rue de la Lombardière

ZI la Lombardière

F-07100 Annonay

France

SANTEN Oy

Kelloportinkatu 1

33100 Tampere

Niittyhaankatu 20

33720 Tampere

Finland

This leaflet was last revised in March 2020  07/2019

4.4          Special warnings and precautions for use

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Concomitant therapy

There is limited experience with IKERVIS ciclosporin in the treatment of patients with glaucoma. Regular Caution clinical monitoring should be exercised when treating these patients concomitantly with IKERVIS, especially with beta-blockers which are known to decrease tear secretion.

Co-administration of IKERVISIkervis with eye drops containing corticosteroids may potentiate the effects of IKERVISIkervis on the immune system. Therefore, caution should be exercised when corticosteroids are administered concomitantly with IKERVISIkervis (see section  4.5).

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Cetalkonium chloride content

IKERVIS contains cetalkonium chloride which may cause eye irritation.

 Contact lenses should be removed prior to application and may be reinserted at wake-up timewait at least 15 minutes before reinsertion. Cetalkonium chloride is known to discolour soft contact lenses.

 Cetalkonium chloride mayhas been reported to cause eye irritation., symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

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4.8     Undesirable effects

Summary of the safety profile

In five clinical studies including 532 patients who received IKERVIS and 398 who received IKERVIS vehicle (control), IKERVIS was administered at least once a day in both eyes, for up to one year. The most common adverse reactions are were eye pain (19.02%), eye irritation (17.58%), ocular hyperaemia (5.5%), lacrimation increased (6.44.9%) and eyelid erythema (1.7%) which were are usually transitory and occurred during instillation. These adverse reactions are consistent with those that have been reported during post-marketing experience.

The majority of adverse reactions reported in clinical studies with the use of IKERVIS were ocular and mild to moderate in severity.

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 (³1/10), common (³1/100 to <1/10), uncommon (³1/1,000 to <1/100), rare (³1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

Description of selected adverse reactions

Instillation siteEye pain

waaA frequently reported local adverse reaction associated with the use of IKERVIS during clinical trials. It is likely to be attributable to ciclosporin.

One case of severe epithelial erosion of the cornea identified as corneal decompensation by the investigator resolved without sequeleae was reported

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 t To reduce the systemic absorption, (see section  4.2).

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9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19 March 2015

Date of latest renewal: 09 March 2020

10.     DATE OF REVISION OF THE TEXT

16 March 2020 07/2019

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 IKERVIS in the treatment of patients with glaucoma. Caution should be exercised when treating these patients concomitantly with IKERVIS, especially with beta-blockers which are known to decrease tear secretion.

Co-administration of Ikervis with eye drops containing corticosteroids may potentiate the effects of Ikervis on the immune system. Therefore, caution should be exercised when corticosteroids are administered concomitantly with Ikervis (see section 4.5).

Effects on the immune system

MedicinalOphthalmic 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.

Co-administration of IKERVIS with eye drops containing corticosteroids could potentiate the effects of IKERVIS on the immune system (see section 4.5).

Excipient

IKERVIS contains cetalkonium chloride which may cause eye irritation.

10.     DATE OF REVISION OF THE TEXT

July 2016

07/2019

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 (see contact details below).

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.