Vidisic

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Vidisic

2 mg/g, eye gel

Carbomer

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Vidisic and what is it used for
• 2. Important information before using Vidisic
• 3. How to use Vidisic
• 4. Possible side effects
• 5. How to store Vidisic
• 6. Contents of the packaging and other information

1. What is Vidisic and what is it used for

The active substance of Vidisic is carbomer (carbomer 980), a high molecular weight water-binding compound. The medicine is characterized by high viscosity and physiological pH, close to that of natural tears. It replaces natural tears in cases of disturbed secretion. Vidisic is used for the symptomatic treatment of dry eye syndrome (also known as dry keratoconjunctivitis).

Properties of Vidisic

Vidisic is a liquid gel that binds water, forming a transparent protective layer on the surface of the eye, providing adequate hydration of the cornea and conjunctiva. It is easy to use if used according to the administration instructions.

What is dry eye syndrome?

Dry eye syndrome is an eye condition in which the eye's surface is not properly moisturized. This can be due to reduced production of natural tears, their abnormal composition, or excessive evaporation. If the amount or composition of the tear film is disturbed, the cornea and conjunctiva become dry, resulting in burning, feeling of dryness, feeling of sand in the eye, feeling of pressure, and hypersensitivity to light. Dry eye syndrome is a very common eye condition and can be caused by many factors, including working in air-conditioned spaces, computer work, environmental pollution, taking certain medications, hormonal changes during menopause, or decreased tear production in older age.

2. Important information before using Vidisic

When not to use Vidisic

• if the patient is allergic to the active substance or any of the excipients (listed in section 6).

Warnings and precautions

Before starting to use Vidisic, you should discuss it with your doctor or pharmacist. If the symptoms of dry eye syndrome persist or worsen, you should stop using the medicine and consult your doctor. If the patient wears contact lenses, they should remove them before using Vidisic. Contact lenses can be put back in at least 15 minutes after administering Vidisic. Vidisic is a sterile medicine until first opening. It is very important to keep the tube clean and not contaminate its contents. When using the medicine, you should pay special attention to avoid touching the eyes, eyelids, and other surfaces with the tube tip (see also section 3: "Administration instructions").

Children and adolescents

There are no available data. No clinical trials have been conducted on the use of Vidisic in children and adolescents.

Important information about some ingredients of Vidisic

Vidisic contains cetrimide as a preservative, which may cause eye irritation (burning, redness, feeling of a foreign body) and may damage the corneal epithelium if used frequently or for a long time. If the above side effects occur, you should stop using Vidisic and consult your doctor or pharmacist, who will recommend using other medicines that do not contain preservatives.

Vidisic and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. No studies have been conducted to determine whether Vidisic affects the action of other medicines or whether other medicines may affect the action of Vidisic.

Warning:

Vidisic may prolong the contact time of other eye medicines with the eye surface. If it is necessary to administer another eye medicine while using Vidisic, you should maintain a 5-minute interval between administering the medicines. If Vidisic is used in addition to eye ointment, the interval between administering the medicines should be 15 minutes. Vidisic should always be used last.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. Pregnancy Due to the lack of data on the use of carbomer (carbomer 980) in pregnant women, it is recommended to avoid using Vidisic during pregnancy. Breastfeeding It is not known whether carbomer (carbomer 980) or its metabolites pass into breast milk. Therefore, it is not recommended to use Vidisic during breastfeeding, unless your doctor decides otherwise. Fertility There are no data on fertility.

Driving and using machines

Vidisic has a moderate effect on the ability to drive and use machines. Immediately after administration, the medicine may cause blurred vision for a short period, resulting in unclear vision. You should not drive, operate machinery, or perform potentially hazardous activities until your vision is clear.

3. How to use Vidisic

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. Recommended dose The dosage in the treatment of dry eye syndrome depends on the individual patient's condition. Drops should be administered into the conjunctival sac 3 to 5 times a day or as needed, and about 30 minutes before bedtime (otherwise, there is a risk of eyelid adhesion). You should consult an ophthalmologist while using Vidisic in the treatment of dry eye syndrome, which usually requires long-term or continuous treatment. If you feel that the effect of Vidisic is too strong or too weak, you should consult your doctor or pharmacist.

Administration instructions:

Warning!

You should not touch the tube tip with your fingers or touch the eye surface or any other surface with the tube tip, as this may contaminate the tube contents. Using contaminated eye medicines can lead to serious vision damage, including vision loss.

• 1. Wash your hands thoroughly.
• 2. Remove the protective cap.
• 3. Tilt your head back.
• 4. Hold the tube vertically over the eye, holding it with your thumb and index finger.
• 5. With the index finger of your other hand, gently pull down the lower eyelid to create a "pocket" between the eyeball and the eyelid, where the gel will be administered.
• 6. Bring the tube tip close to the eye, without touching the tube tip to the eye, eyelid, or surrounding areas.
• 7. Gently squeeze the tube to release 1 drop.
• 8. Looking up, administer 1 drop of gel into the created "pocket". If the drop does not get into the eye, repeat the action.
• 9. Several times, gently close and open your eye to spread the gel over the entire eye surface.
• 10. If the gel is to be administered to both eyes, repeat the above steps for the second eye.
• 11. Immediately after use, carefully close the tube.

Having someone else help you or using a mirror can make it easier to administer the medicine.

Vidisic is available in a tube with a flat cap, allowing the tube to be stored in a vertical position.

Using a higher dose of Vidisic than recommended

If a higher dose of Vidisic is used than recommended, it may cause temporary vision disturbances, which quickly resolve.

Missing a dose of Vidisic

If a dose is missed, the next dose should be taken at the normal time, according to the recommended dosing schedule. You should not take a double dose to make up for the missed dose. If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vidisic can cause side effects, although not everybody gets them. Very rare side effects (may affect up to 1 in 10,000 people):

• eye burning
• eye redness
• eyelid rash
• feeling of a foreign body in the eye
• giant papillary conjunctivitis
• eye itching
• feeling of stickiness in the eye
• superficial punctate keratitis
• tearing
• blurred vision.

The above reactions, including allergic reactions, may be caused by the preservative contained in the medicine (cetrimide) or may be related to intolerance to one of the other ingredients of the medicine. Cetrimide may also cause damage to the corneal epithelium. Blurred vision after administering Vidisic may be related to the high viscosity of the product. Children and adolescents There are no data.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vidisic

The medicine should be stored out of sight and reach of children. Store in a temperature below 25 °C. Do not use this medicine after the expiry date stated on the outer packaging or after the "EXP" date. Unused medicine should be discarded 6 weeks after first opening.

6. Contents of the packaging and other information

What Vidisic contains

The active substance of Vidisic is carbomer (carbomer 980). 1 g of gel contains 2 mg of carbomer (carbomer 980).

The other ingredients of the medicine are: cetrimide, sodium hydroxide, sorbitol, water for injections.

What Vidisic looks like and contents of the packaging

Vidisic is an eye gel. The medicine is available in a tube (HDPE, Al, LDPE) with an HDPE cap in a cardboard box, containing 10 g of gel. For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Dr. Gerhard Mann, Chem-pharm. Fabrik GmbH, Brunsbütteler Damm 165-173, 13581 Berlin, Germany

Manufacturer:

Dr. Gerhard Mann, Chem-pharm. Fabrik GmbH, Brunsbütteler Damm 165-173, 13581 Berlin, Germany

Parallel importer:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa, SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź, Marketing authorization number in the Czech Republic, the country of export: 64/366/00-C, Parallel import authorization number: 29/23, Date of leaflet approval: 01.03.2023, [Information about the trademark]