Corneregel

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

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

Corneregel

50 mg/g (5%), eye gel

Dexpanthenolum

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Corneregel and what is it used for

The active substance of the medicine is dexpanthenol.
The medicine is used to treat non-inflammatory keratopathy, e.g.: corneal degeneration, corneal dystrophy,
recurrent erosion and damage related to contact lens wear.
Additionally, as a supportive treatment for the healing process in corneal and conjunctival damage, chemical burns and burns.
Supportively in specific treatment of bacterial, fungal and viral corneal damage.
WARNING:
Corneregel is not intended for the treatment of bacterial, fungal and viral corneal damage, but only as a supportive treatment for the proper treatment of these corneal diseases.

2. Important information before using Corneregel

When not to use Corneregel

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Before starting to use Corneregel, you should discuss it with your doctor or pharmacist. Corneregel contains cetrimide (a preservative), which may cause burning, redness, a feeling of a foreign body in the eye, and with frequent use, may damage the corneal epithelium.
• Contact lenses should not be worn during the use of Corneregel, as the lenses may become discolored and there is a risk of incompatibility with the lens material. Contact lenses should be removed before administration and not put back on until at least 10-15 minutes have passed.

Do not touch the tip of the dropper to the surface or area of the eye, or any other surface, as this may contaminate the dropper or gel with bacteria that can cause eye infections.

• Do not touch the tip of the dropper to the surface or area of the eye, or any other surface, as this may contaminate the dropper or gel with bacteria that can cause eye infections.

Corneregel and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
If Corneregel is used at the same time as other eye drops/ointments, you should keep a 15-minute interval between the administration of these medicines, and Corneregel should always be administered 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.
The medicine should not be used during pregnancy, unless advised by a doctor.

Driving and using machines

Corneregel, even if used correctly, may temporarily blur your vision by creating streaks, and may affect your ability to react. You should not drive, perform work without stable support, or operate machines until the symptoms have resolved.

3. How to use Corneregel

This medicine should always be used exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Use in the eye.
Recommended dose:
Depending on the severity and intensity of the disorders, 1 drop into the conjunctival sac 4 times a day, and also 1 drop before bedtime.
There are no time limits for use. The medicine can be used until the subjective symptoms have resolved.

Warning!

Administration instructions

Wash your hands.
Tilt your head back and gently pull down the lower eyelid with your index finger.
With your other hand, position the tube vertically over the eye.

Do not touch the tip of the tube to the eye, eyelid, eye area, or other

surfaces.This can lead to infection of the gel. Using infected gel can lead to dangerous complications and even vision loss.
Administer one drop into the conjunctival sac.
If the drop does not get into the eye, you should repeat the attempt.
After administration, try to keep the eye open and move it so that the gel is evenly distributed.

Overdose of Corneregel

Administering more of the medicine than recommended is not associated with any additional risk.

Missed dose of Corneregel

You should not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects (may affect up to 1 in 10,000 people): allergic reactions (e.g. itching, rash).
Side effects of unknown frequency include: eye irritation, e.g. redness, pain, feeling of a foreign body in the eye, tearing, eye itching, conjunctival edema.

Reporting side effects

If you experience any side effects, including any side effects not listed in this 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 of 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Corneregel

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Discard any remaining contents 4 weeks after first opening the tube.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

• The active substance of the medicine is dexpanthenol. 1 g of gel contains 50 mg of dexpanthenol.
• The other ingredients are: cetrimide, disodium edetate, sodium hydroxide, polyacrylic acid (carbomer), water for injections.

What Corneregel looks like and what the package contains

Corneregel is an eye gel. The medicine is supplied in tubes with a screw cap, in a cardboard box.
Package size: 10 g of gel
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus 24
Dublin, Ireland

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
Marketing authorization number in Greece, the country of export: 76459/21-12-2015
Parallel import authorization number: 124/20

Date of leaflet approval: 21.03.2025

[Information about the trademark]