Vidisic

Leaflet attached to the packaging: patient information

Vidisic

2 mg/g, eye gel,
Carbomer

Please read carefully 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.

• Please keep this leaflet, you may need to read it again.
• 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, you should tell your doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, you should contact your 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. Package contents and other information

1. What is Vidisic and what is it used for

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

Properties of Vidisic

Vidisic is a liquid gel that binds water, creating a transparent protective layer on the surface of the eye, providing proper 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 surface of the eye is not properly moistened. This can be caused by 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 dry out, 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. It can be caused by many factors, including working in an air-conditioned room, working on a computer, 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

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 a doctor. If the patient wears contact lenses, they should be removed before using Vidisic. Contact lenses can be put back on at least 15 minutes after administering Vidisic. Vidisic is a sterile medicine until the first opening. It is very important to keep the tube clean and not to contaminate its contents. When using the medicine, you should pay special attention to avoid touching the eyes, eyelids, and other surfaces with the tip of the tube (see also section 3: subsection "Instructions for administering the medicine").

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, when used frequently or for a long period, may cause eye irritation (burning, redness, feeling of a foreign body) and may damage the corneal epithelium. If the above side effects occur, you should stop using Vidisic and consult a 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 and whether other medicines may affect the action of Vidisic.

Note:

Vidisic may prolong the contact time of other ophthalmic medicines with the surface of the eye. If it is necessary to administer another medicine or medicines to the eyes at the same time as Vidisic, e.g., eye drops, you should maintain an interval of at least 5 minutes 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 the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. Pregnancy Due to the 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 breast milk. Therefore, it is not recommended to use Vidisic during breastfeeding, unless the 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 transient vision disturbances for a short period, resulting in blurred vision. You should not drive, operate machines, or perform potentially hazardous tasks 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 have any doubts, you should consult a 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 sleep (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 a doctor or pharmacist.

Instructions for administering the medicine:

Caution!

You should not touch the tip of the tube with your fingers or touch the tip of the tube to the surface of the eye or any other surface, as this may contaminate the contents of the tube. Using contaminated eye medicines can lead to serious eye 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 eye and the eyelid, into which the gel will be inserted.
• 6. Bring the tip of the tube close to the eye, without touching the tip of the tube to the eye, eyelid, or surrounding areas.
• 7. Gently squeeze the tube to release 1 drop.
• 8. Looking up, insert 1 drop of gel into the created "pocket".

If the drop did not get into the eye, repeat the action.

• 9. Several times, gently close and open your eye to spread the gel over the entire 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 close the tube.

Having someone else help you or using a mirror can make it easier to administer the medicine. Vidisic gel 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 accidentally used than recommended, it may cause transient vision disturbances, which will quickly resolve.

Missing a dose of Vidisic

If a dose is missed, the next dose should be taken at the usual 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 a 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 available.

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 Monitoring of Adverse Reactions to Medicinal Products, 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, e-mail: ndl@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Vidisic

The medicine should be stored out of sight and reach of children.
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 the first opening of the tube.

6. Package contents and other information

What Vidisic contains

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

What Vidisic looks like and what the pack contains

Vidisic is an eye gel. The medicine is available in a tube containing 5 or 10 g of gel.

Shelf life after first opening the tube: 6 weeks

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: