Vidisic

Patient Information Leaflet

Warning! Keep this leaflet! The packaging contains information in a foreign language.
Vidisic
2 mg/g, eye gel
Carbomerum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms do not improve or worsen, contact your doctor.

Table of contents:

1. What Vidisic is and what it is 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 pack and other information

1. What Vidisic is and what it is used for

The active substance in Vidisic is carbomer, a high-molecular-weight compound that binds water. Vidisic has high viscosity and a physiological pH similar to natural tears. It replaces natural tears in cases of impaired tear secretion. Vidisic is used for symptomatic treatment of dry eye syndrome (also known as keratoconjunctivitis sicca).

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

What is dry eye syndrome?
Dry eye syndrome is an eye condition characterized by inadequate lubrication of the eye surface. It may result from reduced production of natural tears, abnormal tear composition, or excessive evaporation. When the quantity or quality of the tear film is disrupted, drying of the cornea and conjunctiva occurs, leading to symptoms such as burning, dryness, a sensation of sand in the eye, pressure, and light sensitivity. Dry eye syndrome is a very common eye disorder. It may be caused by various factors, including working in air-conditioned rooms, computer use, 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 you are allergic to the active substance or to any of the excipients listed in section 6.

Warnings and precautions
Before starting Vidisic, discuss it with your doctor or pharmacist.
If symptoms of dry eye syndrome persist or worsen, discontinue use and consult your doctor.
If you wear contact lenses, remove them before applying Vidisic.
Contact lenses may be reinserted at least 15 minutes after administration of Vidisic.
Vidisic is a sterile product until first opening. It is very important to keep the tube clean and prevent contamination of its contents. When using the medicine, take special care to avoid touching the eyes, eyelids, or other surfaces with the tip of the tube (see also section 3: "Instructions for administration").

Children and adolescents
No data available. Clinical studies on the use of Vidisic in children and adolescents have not been conducted.

Important information about certain ingredients
Vidisic contains cetylpyridinium chloride as a preservative, which, when used frequently or over a prolonged period, may cause eye irritation (burning, redness, foreign body sensation) and may damage the corneal epithelium. If any of these adverse effects occur, discontinue use of Vidisic and contact your doctor or pharmacist, who may recommend alternative products without preservatives.

Vidisic and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
No studies have been conducted to determine whether Vidisic affects the action of other medicines or whether other medicines affect the action of Vidisic.

Note:
Vidisic may prolong the contact time of other ophthalmic medicines with the eye surface.
If another eye medicine (e.g., eye drops) needs to be administered simultaneously with Vidisic, a minimum interval of 5 minutes should be maintained between administrations. If Vidisic is used together with an eye ointment, the interval between applications should be 15 minutes. Vidisic should always be administered last.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Due to lack of data on the use of carbomer in pregnant women, it is recommended to avoid using Vidisic during pregnancy.

Breastfeeding
It is not known whether carbomer or its metabolites pass into human milk. Therefore, the use of Vidisic during breastfeeding is not recommended unless otherwise decided by a physician.

Fertility
No data on the effect on fertility are available.

Driving and operating machinery
Vidisic has a moderate effect on the ability to drive and operate machinery.
Immediately after application, Vidisic may cause temporary blurred vision. Do not drive, operate machinery, or perform potentially hazardous tasks until visual acuity is restored.

3. How to use Vidisic

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
The dosage for the treatment of dry eye syndrome depends on the individual condition of the patient.
Apply the drops into the conjunctival sac 3 to 5 times daily, or more frequently if needed, and approximately 30 minutes before sleep (otherwise there is a risk of eyelid adhesion).
Regular consultation with an ophthalmologist is recommended during treatment with Vidisic for dry eye syndrome, which usually requires long-term or continuous therapy.
If you feel that the effect of Vidisic is too strong or too weak, consult a doctor or pharmacist.
Instructions for administering the medicine:

1. Wash hands thoroughly.
2. Unscrew the protective cap.
3. Tilt the head backward.
4. Hold the tube in an upright position above the eye, grasping it between the thumb and index finger.
5. With the index finger of the other hand, gently pull down the lower eyelid to create a "pocket" between the eyeball and the eyelid, into which the gel will be administered.
6. Bring the tip of the tube close to the eye, taking care not to touch the eye, eyelid, surrounding areas, or any other surfaces with the tube tip.
7. Gently squeeze the tube to release 1 drop.
8. Look upward and place 1 drop of gel into the formed "pocket." If the drop misses the eye, repeat the procedure.
9. Close and open the eye gently several times to spread the gel evenly 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, tightly replace the cap on the tube.

Administration assistance from another person or the use of a mirror may facilitate application.
Vidisic gel is supplied in a tube with a flat cap, allowing the tube to be stored in an upright position.

Use of a higher than recommended dose of Vidisic
If a larger than recommended dose of the medicine is accidentally used, it may cause transient visual disturbances, which quickly resolve.

Missed dose of Vidisic
If a dose is missed, take the next dose at the usual time according to the recommended dosing schedule. Do not use a double dose to make up for the missed dose.

If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Vidisic may cause adverse reactions, although not everyone experiences them.

Very rare adverse reactions (may occur in up to 1 in 10,000 people):

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

The above reactions, including allergic-type 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 corneal epithelial damage. Blurred vision after administration of Vidisic may be related to the high viscosity of the product.

Children and adolescents
No data available.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vidisic

Keep this medicine out of sight and reach of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Discard unused medicine 6 weeks after first opening the tube.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the packaging and other information

What Vidisic contains
The active substance is carbomer. 1 g of gel contains 2 mg of carbomer.
The other ingredients are: cetrymid, sodium hydroxide, sorbitol, water for injections.

What Vidisic looks like and contents of the pack
Vidisic is an eye gel.
The medicine is available in a tube containing 10 g of gel.
For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Germany, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa

Marketing Authorisation Number in Germany, the country of export: 40612.00.00
Parallel Import Licence Number: 144/23