Verkazia – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Verkazia, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Verkazia is and what it is used 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 use Verkazia
Do not use Verkazia
- if you are allergic to ciclo sporin 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.
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).
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 mor e 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 u sing 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 ey e 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 use 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 c ontinue 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.
Before administration of the eye drops:
- Wash your hands before opening the bottle .
- Do not use this medicine if you notice that the tamper -proof seal on the bottle neck is broken before you first use it.
- When using the bottle for the very first time, before delivering a drop to the eye, you should practise using the bottle by squeezing it slowly to deliver one drop away from the eye.
- When you are confident that you can deliver one drop at a time, choose the position that you find most comfortable for the instillation of the drops (you can sit down, li e on your back, or stand in front of a mirror).
- Every time when opening a new bottle, place one drop in the waste to activate the bottle.
Administration:
1. Gently shake the bottle. Hold the bottle directly below the cap and turn the cap to open the bottle . Do not touch anything with the tip of the bottle to avoid contamination.
2. Tilt your head backwards and hold the bottle above your eye.
3. Pull the lower eyelid down and look up. Squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard.
4. Close your eye and press the inner corner of the eye with your finger for about two minutes .
This helps to stop the medicine from getting into the rest of the body .
5. Repeat instructions 2 – 4 to deliver a drop into the other eye, if your doctor has instructed you to do this. Sometimes only one eye needs to be treated and your doctor will advise if this applies to you and which eye needs treatment.
6. After each use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual emulsion from the tip. This is necess ary to ensure good delivery of the next drop.
7. Wipe off any excess emulsion from the skin around the eye.
At the end of the 4 weeks in -use shelf life of the medicine, there will be some emulsion left in the bottle. Do not attempt to use the excess medicine remaining in the bottle after you have completed the course of treatment. Do not use the eye drops for longer than 4 weeks after first opening the bottle.
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 med icine, 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 a nd around the eyes.
Very common side effects (may affect more than 1 in 10 people)
Pain when the drops are put into the eye.
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 c ornea (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 via the national reporting system listed in Appendix V . By reporting side effects you can help provide m ore information on the safety of this medicine.
🌡️ 5. How to store 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 carton and bottle label after EXP.
The expiry date refers to the last day of that month.
Do not freeze.
Store below 25 °C.
After first opening the bottle, the emulsion can be used for 4 weeks. The bottle must be kept tightly closed.
Do not use this medicine if you notice that the seal is b roken the first time you use the container.
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 mL of Verkazia contains 1 mg of ciclosporin.
- The other ingredients are medium -chain triglycerides, cetalkonium chloride, glycerol, tyloxapol, 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 a white plastic bottle with a white dropper applicator and a white plastic screw cap.
Each bottle contains 9 mL of the medicine and each pack contains one bottle.
Marketing Authorisation Holder
Santen Oy Niittyhaankatu 20 33720 Tampere Finland
Manufacturers
EXCELVISION 27 rue de la Lombardière ZI la Lombardière 07100 A nnonay France Santen Oy Kelloportinkatu 1 33100 Tampere Finland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Santen Oy Tél/Tel: +32 (0) 24019172 Lietuva Santen Oy Tel: +370 37 366628 България Santen Oy Teл.: +359 (0) 888 755 393 Luxembourg/Luxemburg Santen Oy Tél/Tel: +352 (0) 27862006 Česká republika Santen Oy Tel: +358 (0) 3 284 8111 Magyarország Santen Oy Tel.: +358 (0) 3 284 8111 Danmark Santen Oy Tlf: +45 898 713 35 Malta Santen Oy Tel: +358 (0) 3 284 8111 Deutschland Santen GmbH Tel: +49 (0) 3030809610 Nederland Santen Oy Tel: +31 (0) 207139206 Eesti Santen Oy Tel: +372 5067559 Norge Santen Oy Tlf: +47 21939612 Ελλάδα Santen Oy Τηλ: +358 (0) 3 284 8111 Österreich Santen Oy Tel: +43 (0) 720116199 España Santen Pharmaceutical Spain S.L.
Tel: +34 914 142 485 Polska Santen Oy Tel.: +48(0) 221042096 France Santen S.A.S.
Tél: +33 (0) 1 70 75 26 84 Portugal Santen Oy Tel: +351 308 805 912 Hrvatska Santen Oy Tel: +358 (0) 3 284 8111 România Santen Oy Tel: +358 (0) 3 284 8111 Ireland Santen Oy Tel: +353 (0) 16950008 Slovenija Santen Oy Tel: +358 (0) 3 284 8111 Ísland Santen Oy Sími: +358 (0) 3 284 8111 Slovenská republika Santen Oy Tel: +358 (0) 3 284 8111 Italia Santen Italy S.r.l.
Tel: +39 0236009983 Suomi/Finland Santen Oy Puh/Tel: +358 (0) 974790211 Κύπρος Santen Oy Τηλ: +358 (0) 3 284 8111 Sverige Santen Oy Tel: +46 (0) 850598833 Latvija Santen Oy Tel: +371 677 917 80 United Kingdom (Northern Ireland) Santen Oy Tel: +353 (0) 169 500 08 (UK Tel: +44 (0) 345 075 4863) This leaflet was last revised in month YYYY .
Detailed information on this medicine is available on the European Medicines Agency web site:http://www.ema.europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Verkazia (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/17/1219).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.