CORNEREGEL

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Corneregel
50 mg/g, eye gel
Dexpanthenolum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Corneregel is and what it is used for

The active substance in Corneregel is dexpanthenol.
This medicine is used in the treatment of non-inflammatory keratopathy, e.g.: corneal dystrophy, corneal degeneration, recurrent erosion, and injuries related to contact lens use.
Additionally, as an adjunctive agent supporting the healing process in corneal and conjunctival injuries, chemical burns, and thermal burns.
Supportively in specific treatment of bacterial, fungal, and viral corneal lesions.
WARNING:
Corneregel is not intended for the treatment of bacterial, fungal, and viral corneal lesions, but only as an adjunctive agent supporting the appropriate 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, discuss it with your doctor or pharmacist. Corneregel contains cetrimide (a preservative), which may cause stinging, redness, or a foreign body sensation in the eye, and with frequent use may damage the corneal epithelium.
• Do not wear contact lenses during treatment with Corneregel, as lenses may become discolored and there is a risk of incompatibility with the lens material. Contact lenses should be removed before instilling the drops and not reinserted until at least 10–15 minutes afterwards.
• Do not touch the eye's surface or surrounding area, or any other surface, with the dropper tip, as this may contaminate the dropper or gel with bacteria that could cause eye infection.

Corneregel with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If Corneregel is used together with other eye drops/ointments, a minimum interval of at least 15 minutes should be maintained between the administration of these medicines, and Corneregel should always be administered last.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy unless advised by a doctor.

Driving and operating machinery
Corneregel, even when used correctly, may temporarily impair visual acuity by causing streaks or smearing, thus possibly affecting the ability to react. Do not drive, perform work without stable support, or operate machinery until these symptoms have resolved.

3. How to use Corneregel

This medicine should always be used according to the instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Apply to the eye.
Recommended dose:
Depending on the severity and intensity of symptoms, instill 1 drop into the conjunctival sac 4 times daily, and also 1 drop before bedtime.
There are no time limitations for use. The product may be used until subjective symptoms resolve.

Caution!
Instructions for administration
Wash your hands.
Tilt your head backward and gently pull down the lower eyelid with your index finger.
With the other hand, hold the tube in a vertical position above the eye.
Do not touch the tip of the tube to the eye, eyelid, surrounding areas of the eye, or any other surface.
This may lead to contamination of the gel. Using contaminated gel may result in dangerous complications and even loss of vision.
Instill one drop into the conjunctival sac.
If the drop does not enter the eye, repeat the procedure.
After administration, try to keep the eye open and move it around so that the gel spreads evenly.
If more Corneregel medicine is used than recommended
Using more than the recommended amount of medicine is not associated with any additional risk.
If you forget to use a dose of Corneregel
Do not use a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Very rare adverse reactions (may occur in up to 1 in 10,000 people): hypersensitivity reactions (e.g. itching, rash).
Adverse reactions of unknown frequency include: eye irritation, e.g. redness, pain, sensation of a foreign body in the eye, lacrimation, eye itching, conjunctival swelling.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a 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 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables better monitoring of the safety of the medicine.

5. How to store Corneregel

Keep this medicine out of the 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 stated month.
Discard any remaining contents 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. This will help protect the environment.

6. Contents of the package and other information

What Corneregel contains

• The active substance is dexpanthenol. 1 g of gel contains 50 mg of dexpanthenol.
• The other ingredients are: cetrymid, disodium edetate, sodium hydroxide, carbomer 980, water for injections.

What Corneregel looks like and contents of the pack
Corneregel is an eye gel. The medicine is supplied in tubes within a cardboard box.
Pack size: 10 g gel

For more detailed 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Marketing Authorisation Number in Germany, the country of export: 32475.00.00
Parallel Import Licence Number: 253/23