Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
for
Vevizye contains the active substance ciclosporin. Ciclosporin belongs to a group of medicines known as immunosuppressants. These are medicines used to reduce inflammation. Vevizye is used to treat adults with dry eye disease (including inflammation of the cornea, the transparent layer in front of the eye that covers the iris). It is used in patients whose disease has not sufficiently improved despite treatment with tear substitutes (artificial tears). Treatment response generally occurs after 4 weeks of therapy, when the symptoms and ocular surface damage associated with dry eye disease are reduced. 2.
e Vevizye
Do not use Vevizye if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6) have a cancer or precancerous condition in or around the eye have an infection in or around the eye Warnings and precautions The use of Vevizye eye drops has not been studied in people wearing contact lenses. If you wear contact lenses, remove them before using this medicine; you can reinsert them 15 minutes after you have used the eye drops. See section 3 How to use Vevizye. You should visit your doctor after about 3 months of therapy start and thereafter about every six months to assess the effect of Vevizye. Tell your doctor if you have glaucoma and receive glaucoma therapy. If you experience any signs of a local infection (redness, eye discharge) please contact your doctor.
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Children and adolescents Vevizye is not used in children and adolescents under 18 years. Other medicines and Vevizye Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. 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, pharmacist or nurse for advice before using this medicine. Vevizye is not recommended during pregnancy, unless the benefit for the mother outweighs the potential risk for the unborn child. Vevizye is not recommended when breast-feeding. Driving and using machines Your vision may be temporarily blurred immediately after using this medicine. If this happens, wait until your vision clears before you drive or use machines. 3.
Vevizye
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 1 drop in each eye twice daily, approximately 12 hours apart. Method of administration Follow these instructions carefully and ask your doctor, pharmacist or nurse if there is anything you do not understand. –
Wash your hands before using Vevizye. Do not use Vevizye if the tamper-evident ring of a new unopened bottle is not intact. After first opening, the tamper-evident ring of the cap remains on the bottle neck. The Vevizye dropper tip must not touch your eyes to avoid injury or contamination of the medicine; also keep the dropper tip from touching your fingers or other surfaces. If you are using Vevizye with other eye medicines, wait at least 15 minutes between using Vevizye and the other eye medicine. If you wear contact lenses, remove them before using Vevizye. Wait for at least 15 minutes after using the eye drops before placing them back in your eyes.
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Administration Step 1)
Remove the white cap from the bottle
Step 2)
Gently squeeze the bottle in upright position and keep it squeezed
Step 3)
Turn the bottle upside down and release pressure
Step 4)
Tilt your head. Use your finger to pull down the lower eyelid. Squeeze bottle gently while still in upside down position to release one drop (0.01 mL) in the first eye
Step 5)
Repeat Step 4 for second eye
Step 6)
Place the white cap back on the bottle and keep the bottle tightly closed when not in use
Due to the properties of the solution you may not feel when the drop falls into your eye. If it helps, you can use a mirror or ask another person to check when the drop is released from the dropper tip. Do not take a second drop because you did not feel the first falling into your eye. Only take another drop if the first misses your eye (for instance, when you feel it land on your skin). If you use more Vevizye than you should Do not put in any more drops into that eye until it is time for your next regular dose. If you have not done so, you can put an eye drop into your other eye. If you forget to use Vevizye Continue with the next dose as scheduled. Do not use a double dose to make up for the forgotten dose. Do not use more than 1 drop twice daily per eye. If you stop using Vevizye Do not stop treatment without talking to your doctor, as symptoms may return when you stop taking Vevizye. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects reported with Vevizye were transient and of mild intensity. You can usually carry on taking the drops, unless the effects are serious. If you're worried, talk to a doctor or pharmacist. Common (may affect up to 1 in 10 people) burning upon drop instillation in the eye (instillation site pain) Uncommon (may affect up to 1 in 100 people) blurred vision eye irritation eye reddening (eye erythema) eye pain reduced clarity of vision (visual acuity reduced [temporarily]) eye itching (pruritus) Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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.
Vevizye
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 bottle after EXP. The expiry date refers to the last day of that month. Do not store above 25 °C. Do not freeze or refrigerate. This medicine can be used for up to 4 weeks after first opening of the bottle; after this discard this medicine, even if the bottle is not empty. The bottle must be kept tightly closed when not in use. Do not use this medicine if you notice signs of deterioration. 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.
What Vevizye contains The active substance is ciclosporin. One mL of solution contains 1 mg of ciclosporin. The other ingredients are perfluorobutylpentane and ethanol anhydrous. What Vevizye looks like and contents of the pack Vevizye 1 mg/mL is a clear, colourless eye drops, solution. Each multidose bottle contains 2 mL eye drops and each pack contains one bottle. Marketing Authorisation Holder 5
Laboratoires Théa Zone Industrielle du Brézet 12 rue Louis Blériot 63100 Clermont-Ferrand France Manufacturer HWI Development GmbH Strassburger Strasse 77 77767 Appenweier Germany Or Siegfried El Masnou S.A. Calle Camil Fabra 58 08320 El Masnou Spain This leaflet was last revised in June 2025 If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at THEA Pharmaceuticals Ltd, telephone number 0345 521 1290.
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Vevizye 1 mg/ml Eye drops POM 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.
The active substance in Vevizye 1 mg/ml Eye drops POM is ciclosporin.
Medicines with the same active substance, strength and form include: IKERVIS 1 mg/mL eye drops, emulsion, Verkazia 1 mg/ml eye drops, emulsion. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Vevizye 1 mg/ml Eye drops POM, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes (see section 5.1).
Treatment should be initiated and supervised by an ophthalmologist.
Posology
The recommended dose is one drop (corresponding to 0.01 mg ciclosporin) twice daily to be applied to each eye approximately 12 hours apart.
If a dose is missed, treatment should be continued with the next dose as normal. Patients should be advised not to instil more than one drop in each eye.
Elderly patients
No dose adjustment is required for elderly patients.
Paediatric population
There is no relevant use of ciclosporin in the paediatric population for the indication of dry eye disease.
Method of administration
For ocular use only.
Patients should be instructed to first wash their hands. Patients should be advised not to allow the dropper tip to touch the eye or any other surface, as this may contaminate the solution.
If more than one topical ophthalmic medicinal product is being used, the medicinal products should be administered at least 15 minutes apart (see section 4.4). For patients who wear contact lenses, please refer to section 4.4.
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 periocular infections.
Monitoring
Regular examinations of the eye are recommended for topical ocular ciclosporin therapy, e.g. within 3 months after treatment initiation and thereafter approximately every 6 months.
Glaucoma
There is limited experience with ciclosporin in the treatment of patients with ocular hypertension or glaucoma. Regular clinical monitoring should be exercised when treating patients receiving glaucoma medication and ciclosporin eye drops.
Contact lenses
Vevizye should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of Vevizye.
Effects on the immune system
Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defence against local infections and malignancies. In case of signs of an eye infection the patient should seek medical advice.
No interaction studies have been performed with Vevizye.
No systemic interactions are expected, since ciclosporin does not become systemically available after use of Vevizye. Co-administration of eye drops containing corticosteroids could potentiate the effects of ciclosporin on the immune system (see section 4.4).
Pregnancy
There are no data from the use of Vevizye in pregnant women.
Animal studies 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 Vevizye.
Vevizye is not recommended during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
Breast-feeding
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to ciclosporin in Vevizye is negligible. As a precautionary measure, it is preferable to avoid the use of Vevizye during breast-feeding.
Fertility
There is no data on the effects of Vevizye on human fertility.
No effects on fertility are anticipated since the systemic exposure to ciclosporin is negligible.
Vevizye has mild influence on the ability to drive and use machines. If transient blurred vision occurs at instillation, the patient should wait until vision has cleared before driving or using machines.
Summary of the safety profile
The most common adverse reactions are instillation site reactions (8.1%) followed by blurred vision (0.8%). Instillation site reactions were more common in patients ≥ 65 years of age as compared to younger patients.
Tabulated list of adverse reactions
The following adverse reactions listed below were observed in clinical studies.
Adverse reactions are presented below according to MedDRA system organ classification (SOC and preferred term level). They are ranked according to frequency: 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).
Table 1: Adverse reactions
System organ class
Frequency
Adverse reactions
General disorders and administration site conditions
Common
Instillation site pain (burning)
Eye disorders
Uncommon
Vision blurred,
Eye irritation,
Eye pain,
Eye erythema,
Visual acuity reduced,
Eye pruritus
Description of selected adverse reactions:
Instillation site pain (reported as burning) (7.9%) was the most frequently reported adverse reaction associated with the use of Vevizye during clinical trials. Other instillation site reactions such as erythema or pruritus occurred at lower frequency (0.1%). All instillation site reactions are typically mild and transient.
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. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
A topical overdose is unlikely to occur after ocular administration. If overdose with Vevizye occurs, treatment should be symptomatic.
Ask anything about Vevizye 1 mg/ml Eye drops POM. 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.
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