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Treść ulotki
Vevizye 1 mg/mL eye drops, solution
cyclosporine
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Vevizye is and what it is used for
- 2. What you need to know before you use Vevizye
- 3. How to use Vevizye
- 4. Possible side effects
- 5. How to store Vevizye
- 6. Contents of the pack and other information
1. What is Vevizye and what is it used for
Vevizye contains the active ingredient cyclosporine. Cyclosporine belongs to a group of medicines
known as immunosuppressants. These are medicines used to reduce inflammation.
Vevizye is used for the treatment of adults with dry eye syndrome (which includes
inflammation of the cornea, the transparent layer in the front of the eye that covers the iris).
It is used in patients whose condition has not improved adequately despite treatment with
artificial tears.
Response to treatment generally occurs after 4 weeks of therapy, when the symptoms and the
damage to the surface of the eye associated with dry eye syndrome are reduced.
2. What you need to know before using Vevizye
Do not use Vevizye
- if you are allergic to cyclosporine or any of the other ingredients of this medicine (listed in section 6)
- if you have a tumour or pre-cancerous condition inside or around the eye
- if you have an infection inside or around the eye
Warnings and precautions
The use of Vevizye eye drops has not been studied in people who wear contact lenses. If you wear
contact lenses, remove them before using this medicine; you can reinsert them 15 minutes after applying the
eye drops. See section 3 How to use Vevizye.
You should see your doctor approximately 3 months after starting therapy and then every approximately 6 months to
assess the effect of Vevizye. Tell your doctor if you suffer from glaucoma and are receiving treatment for glaucoma.
If you experience signs of local infection (redness, eye discharge) contact your doctor.
Children and adolescents
Vevizye must not be used in children and adolescents under 18 years of age.
Other medicines and Vevizye
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Vevizye is not recommended during pregnancy unless the benefits for the mother outweigh the potential risks to the foetus.
Vevizye is not recommended during breastfeeding.
Driving and using machines
Vision may be temporarily blurred immediately after using this medicine. In
this case, wait until your vision is clear before driving or using machines.
3. How to use Vevizye
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended doseis 1 drop in each eye twice a day, approximately 12 hours apart.
Method of administration
Follow these instructions carefully and contact your doctor or pharmacist 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 broken.
- After first opening, the tamper-evident ring on the cap remains on the bottle neck.
- The tip of the Vevizye dropper should not touch the eyes to avoid injury or contamination of the medicine; also avoid touching the dropper tip with your fingers or other surfaces.
- If you are using Vevizye together with other eye medications, wait at least 15 minutes between using Vevizye and the other eye medications.
- If you wear contact lenses, remove them before using Vevizye. Wait at least 15 minutes after using the eye drops before putting them back in.
Administration
| Step 1) Remove the white cap from the bottle | |
| Step 2) Gently press the bottle in a vertical position and hold it down | m a c o![]() |
| Step 3) Turn the bottle upside down and release the pressure l | F a r![]() |
| e d Step 4) Tilt your head. Pull down your lower eyelid with a finger. Gently press the bottle still in an inverted position to release one drop (0.01 mL) into the first eye a n | |
| a Step 5) Repeat step 4 for the second eye i | ![]() |
| l Step 6) Replace the white cap on the bottle and keep the a bottle tightly closed when not in use |
Due to the properties of the solution, you may not feel the drop falling into your eye. If it may be helpful, use a mirror or ask another person to check that the drop is released
from the dropper tip. Do not put a second drop if you have not felt the first
drop fall into your eye. Put another drop only if the first one missed your eye (for example if you felt
it fall on your skin).
If you use more Vevizye than you should
Do not put any more drops in your eye until the next scheduled dose. If you have
done so, you can put one drop in the 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
missed dose. Do not use more than 1 drop twice a day per eye.
If you stop using Vevizye
Do not stop treatment without talking to your doctor, as symptoms may return
after you stop using Vevizye.
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.
Common(may affect up to 1 in 10 people)
- burning sensation after instilling the drop into the eye (pain at the site of instillation)
Uncommon(may affect up to 1 in 100 people)
- blurred vision
- eye irritation
- eye redness (ocular erythema)
- eye pain
- reduced visual acuity (reduced visual sharpness [temporarily])
- eye itching
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help to provide more information on the safety of this medicine.
5. How to store 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 at a temperature above 25 °C.
Do not refrigerate or freeze.
This medicine can be used for a maximum of 4 weeks after the first opening of the bottle;
after this period, dispose of the 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 dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Vevizye contains
- The active substance is cyclosporine. One mL of solution contains 1 mg of cyclosporine.
- The other ingredients are perfluorobutylpentane and anhydrous ethanol.
Description of the appearance of Vevizye and contents of the pack
Vevizye 1 mg/mL is a clear and colorless solution.
Each multidose bottle contains 2 mL of eye drops and each pack contains one bottle.
Marketing authorisation holder
Laboratoires Théa
Zone Industrielle du Brézet
12 rue Louis Blériot
63100 Clermont-Ferrand
France
Manufacturer
HWI Pharma Services GmbH
Rheinzaberner Strasse 8
76761 Ruelzheim
Germany
More detailed information on this medicine is available on the website of the European
Medicines Agency, https://www.ema.europa.eu .

- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 1 mg/mL
- Kod ATCS01XA18
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki VEVITSYEPostać farmaceutyczna: Eye drops, solution in single-dose container, 0.9 MG/MLSubstancja czynna: ciclosporinProducent: SUN PHARMACEUTICAL INDUSTRIES (EUROPE) B.V.Bez receptyPostać farmaceutyczna: Emulsion eye drops, 1 MG/MLSubstancja czynna: ciclosporinProducent: SANTEN OYBez receptyPostać farmaceutyczna: Emulsion eye drop, 1MG/MLSubstancja czynna: ciclosporinProducent: SANTEN OYBez recepty
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Substancją czynną w VEVITSYE jest ciclosporin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
VEVITSYE jest produkowany przez LABORATOIRES THEA. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie VEVITSYE jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
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