Corneregel

Package Leaflet: Information for the User

Warning: Keep the leaflet! Information on the immediate packaging in a foreign language!

Corneregel

50 mg/g (5%), eye gel
Dexpanthenolum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 inform 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 pack 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 erosion,
and damage related to contact lens use. Additionally, as a supportive treatment for corneal and conjunctival healing,
chemical burns, and burns.
Supportively in specific treatments for bacterial, fungal, and viral corneal damage.
WARNING:
Corneregel is not intended to treat bacterial, fungal, and viral corneal damage, but only as a supportive treatment for these corneal diseases.

2. Important information before using Corneregel

When not to use Corneregel

Warnings and precautions

• Before starting to use Corneregel, 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.
• Do not wear contact lenses while using Corneregel, as the lenses may become discolored and there is a risk of incompatibility with the lens material. Remove contact lenses before instillation and do not put them back on until at least 10-15 minutes have passed.

Do not touch the dropper tip 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 the patient is taking or has recently taken, as well as any medicines the patient plans to take.
If Corneregel is used with other eye drops or ointments, maintain an interval of at least 15 minutes between administration of these medicines, and Corneregel should always be administered last.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 when used correctly, may temporarily blur vision due to the formation of streaks, which may affect the ability to react. Do not drive vehicles, perform work without stable support, or operate machines until the symptoms have resolved.

3. How to use Corneregel

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Use in the eye.
Recommended dose:
Depending on the severity and intensity of the disorder, 1 drop into the conjunctival sac 4 times a day, and 1 drop before bedtime.
There are no time limits for use. The medicine can be used until 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 tube tip 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 enter the eye, repeat the administration attempt.
After administration, try to keep the eye open and move it to distribute the gel evenly.

Overdose of Corneregel

Administration of a larger amount of medicine than recommended is not associated with any additional risk.

Missed dose of Corneregel

Do 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):
hypersensitivity 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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,
Aleje Jerozolimskie 181 C 02-222 Warsaw
Phone: +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

Keep the 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 month.
Discard any remaining contents 4 weeks after first opening the tube.
Medicines should 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 pack and other information

What Corneregel contains

• The active substance 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 contents of the pack

Corneregel is an eye gel. The medicine is supplied in a tube, in a cardboard box.
Pack size: 10 g of gel.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, country of export:

PharmaSwiss Česká Republika s.r.o.
Jankovcova 1569/2c
Holesovice, Prague 7
Czech Republic

Manufacturer:

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

Parallel importer:

Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Cesky Tesin, Czech Republic

Repackaged by:

Euceryna Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Krakow
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw

Marketing authorization number in Greece, country of export: 76459/21-12-2015

4768/05-02-2003

Parallel import authorization number: 213/12 Date of approval of the leaflet: 14.04.2022