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.
Verkazia 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
Verkazia contains the active ingredient, ciclosporin. Ciclosporin reduces the activity of the body's immune (defence) system and in this way it reduces inflammation (body response to harmful stimuli). Verkazia is used to treat children and adolescents aged 4 to 18 years with severe vernal keratoconjunctivitis (an allergic condition of the eye that occurs more frequently in spring and affects the transparent layer in the front part of the eye and the thin membrane covering the front part of the eye).
2.
What you need to know before you take it
e Verkazia
Do not use Verkazia
- if you are allergic to ciclosporin or to 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 Verkazia in your eye as described under section 3. Do not exceed the treatment period prescribed by your doctor. Verkazia has not been studied in adult patients. Talk to your doctor or pharmacist before using Verkazia:
- if you have had an eye infection or if you suspect you have an eye infection
- if you have any other kind of eye disease
- if you wear contact lenses (the use of Verkazia is not recommended with contact lenses).
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Children and adolescents Do not use Verkazia in children under the age of 4 years. Other medicines and Verkazia 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 administered in association with Verkazia as this association may increase the risk of local infections. If you are using Verkazia for more than 12 months, you should visit your doctor regularly, e.g. every 3 to 6 months. If you are using other eye drops, use Verkazia at least 15 minutes after using the other eye drops. 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. Verkazia should not be used if you are pregnant. If you could become pregnant you must use contraception while using this medicine. Verkazia 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 temporarily blurred after using Verkazia eye drops or you may get other disturbances with your vision. If this happens, wait until your vision clears before you drive or use machines. Verkazia contains cetalkonium chloride Cetalkonium chloride may cause eye irritation.
3.
How to take it
Verkazia
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. A caregiver should help a child starting Verkazia treatment, particularly if the child is aged under 10 years, and should continue to supervise the child until the child is able to use Verkazia properly without help. The recommended dose is 1 drop of Verkazia in each affected eye 4 times a day (morning, mid-day, afternoon and evening). You should continue Verkazia as prescribed by your doctor. 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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1. Wash your hands 2. Open the aluminium pouch, which contains 5 single-dose containers 3. Take 1 single-dose container from the aluminium pouch, leaving the remaining containers in the pouch 4. Gently shake the single-dose container 5. Twist off the cap (picture 1) 6. Pull down your lower eyelid (picture 2) 7. Tilt your head back and look up at the ceiling 8. Gently squeeze one drop of the medicine onto your eye. Make sure that the tip of the single-dose container does not touch your eye 9. Blink a few times so that the medicine spreads across your eye 10. After using Verkazia, press a finger lightly on the inner corner of your eyelid, next to your nose for 2 minutes (picture 3). A small duct that drains tears away from your eye and into your nose is located here. By pressing at this point, you close down the opening of this drainage duct. This helps to stop Verkazia getting into the rest of the body. 11. If you use drops in both eyes, repeat the steps 6 to 9 for your other eye. 12. Discard the single-dose container as soon as you have used it, even if there is still some medicine left in it If a drop misses your eye, try again. If you put in more Verkazia 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 Verkazia, continue with the next dose as planned. Do not take a double dose to make up for the forgotten dose. Do not use more than 1 drop 4 times a day in the affected eye(s). If you stop using Verkazia without speaking to your doctor, your eye allergy will not be controlled and could lead to long-term problems with your sight. 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 for Verkazia: The most common side effects are in and around the eyes. Very common side effects (may affect more than 1 in 10 people) Pain when the drops are put into the eye.
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Common side effects (may affect up to 1 in 10 people) Common side effects related to the eye: Itching, redness, irritation and discomfort in or around the eye including a feeling that there is something in the eye. Increased watering of the eye and blurred vision when the drops are put into the eye. Swelling and redness of eyelid. Common side effects which are not related to the eye: Upper respiratory tract infection, cough, headache. Uncommon side effects (may affect up to 1 in 100 people) Swelling of the eyelid and of the conjunctiva (thin membrane covering the front part of the eye). Bacterial infection of the cornea (transparent front part of the eye). Eye infection caused by herpes zoster virus. 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
Verkazia
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, on the aluminium pouch label, and on the single-dose containers label after "EXP". The expiry date refers to the last day of that month. Do not freeze. Store below 25°C. Keep single-dose containers in the pouch in order to protect from light and avoid evaporation. Discard the opened single-dose container 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 Verkazia contains
- The active substance is ciclosporin. One millilitre of Verkazia contains 1 mg of ciclosporin.
- The other ingredients are medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol, 4 verkazia-pil-en-uk-ie-APPR 20220221 [storage condition]
poloxamer 188, sodium hydroxide (to adjust pH) and water for injections. What Verkazia looks like and contents of the pack Verkazia 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, 60, 90 and 120 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 Verkazia 1 mg/ml eye drops, emulsion
How do I take Verkazia 1 mg/ml eye drops, emulsion?
Verkazia 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 Verkazia 1 mg/ml eye drops, emulsion?
The active substance in Verkazia 1 mg/ml eye drops, emulsion is ciclosporin.
Are there equivalent medicines to Verkazia 1 mg/ml eye drops, emulsion?
Medicines with the same active substance, strength and form include: IKERVIS 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 Verkazia 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 Verkazia 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 vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.
4.2. Posology and method of administration
Verkazia treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.
Posology
Children from 4 years of age and adolescents
The recommended dose is one drop of Verkazia 4 times a day (morning, noon, afternoon and evening) to be applied to each affected eye during the VKC season. If signs and symptoms of VKC persist after the end of the season, the treatment can be maintained at the recommended dose or decreased to one drop twice daily once adequate control of signs and symptoms is achieved. Treatment should be discontinued after signs and symptoms are resolved, and reinitiated upon their recurrence.
Efficacy and safety of Verkazia have not been studied beyond 12 months (see section 4.4).
If a dose is missed, treatment should be continued on the next instillation as normal. Patients should be advised not to instil more than one drop for each instillation in the affected eye(s).
Children below 4 years
There is no relevant use of Verkazia in children below 4 years in the treatment of severe vernal keratoconjunctivitis.
Adults
The effect of Verkazia has not been studied in patients above 18 years of age.
Patients with renal or hepatic impairment
The effect of Verkazia has not been studied in patients with renal or hepatic impairment. However, no special dose adjustment is needed in these populations.
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 (see section 4.4).
If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 15 minutes apart. Verkazia 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
Contact lenses
Patients wearing contact lenses have not been studied. Therefore, the use of Verkazia with contact lenses is not recommended.
Concomitant therapy
Co-administration of Verkazia with eye drops containing corticosteroids may potentiate the effects of Verkazia on the immune system. However, in clinical studies, 18 patients received Verkazia (4 times daily) in co-administration with eye drops containing corticosteroids and no increase in the risk of adverse reactions related to the immune system was identified. Therefore, caution should be exercised when corticosteroids are administered concomitantly with Verkazia (see section 4.5).
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. every 3 to 6 months, when Verkazia is used for more than 12 months.
Verkazia has not been studied in patients with an active orofacial herpes simplex infection, a history of ocular herpes, varicella-zoster, or vaccinia virus infection and should therefore be used with caution in such patients.
Excipient
Verkazia contains cetalkonium chloride which may cause eye irritation.
Treatment duration
Efficacy and safety of Verkazia have not been studied beyond 12 months. Therefore, regular examination of the eye(s) is recommended, e.g. every 3 to 6 months, when Verkazia is used for more than 12 months.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Verkazia.
Combination with other medicinal products that affect the immune system
Co-administration of Verkazia with eye drops containing corticosteroids may potentiate the effects of Verkazia on the immune system. However, in clinical studies, 18 patients received Verkazia (4 times daily) in co-administration with eye drops containing corticosteroids and no increase of the risk of adverse reactions related to the immune system were identified (see section 4.4).
4.6. Fertility, pregnancy and lactation
Women of childbearing potential/contraception in females
Verkazia is not recommended in women of childbearing potential not using effective contraception.
Pregnancy
There are no data from the use of Verkazia in pregnant women.
Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of Verkazia.
Verkazia 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 Verkazia therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data on the effects of Verkazia 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
Verkazia 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 in the clinicial trials with Verkazia were eye pain (11%) and eye pruritus (9%) which were usually transitory and occurred during instillation.
Tabulated list of adverse reactions
The following adverse reactions listed below were observed in clinical studies. 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).
MedDRA system organ class
MedDRA frequency
Adverse reaction
Infections and infestations
Common
Upper respiratory tract infection.
Uncommon
Keratitis bacterial, herpes zoster ophthalmic.
Nervous system disorders
Common
Headache.
Eye disorders
Very common
Eye pain.
Common
Eye pruritus, ocular hyperaemia, eye irritation, ocular discomfort, foreign body sensation in eyes, lacrimation increased, vision blurred, erythema of eyelid, eyelid oedema.
Uncommon
Blepharitis, conjunctival oedema.
Respiratory, thoracic and mediastinal disorders
Common
Cough.
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 Verkazia occurs, treatment should be symptomatic and supportive.
💬 Ask about this leaflet
Ask anything about Verkazia 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
- IKERVIS 1 mg/mL eye drops, emulsion
- Neoral Oral Solution
- Neoral Soft Gelatin Capsules
- SANDIMMUN Concentrate for Solution for Infusion 50mg/ml
- Vevizye 1 mg/ml Eye drops POM