Corneregel

Package Leaflet: Information for the User

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

Corneregel

50 mg/g, eye gel

Dexpanthenolum

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 degeneration, 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

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 you are taking, or have recently taken, and about medicines you plan to take.
If Corneregel is used at the same time as other eye drops/ointments, keep a 15-minute interval between 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Do not use this medicine during pregnancy, unless your doctor advises you to do so.

Driving and using machines:

Corneregel, even when used correctly, may temporarily blur vision due to the formation of streaks, and may affect your reaction ability. Do not drive, operate machinery, or perform tasks that require stable support until the symptoms have resolved.

3. How to use Corneregel

Always use this medicine exactly as your doctor or pharmacist has told you.
In case of doubt, consult your doctor or pharmacist.
Apply to the eye.
Recommended dose:
Depending on the severity and intensity of the disorder, 1 drop into the conjunctival sac 4 times a day, and also 1 drop before bedtime.
There are no time limits for use. The product 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, hold the tube in a vertical position over the eye.

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

This may 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, try again.
After administration, try to keep the eye open and move it so that the gel is evenly distributed.

Overdose of Corneregel

Administration of a larger amount of the 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 experience any side effects, including those not listed in this leaflet, 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 181 C, 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

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 specified month.
Discard any remaining contents 6 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, 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, in a cardboard box.
Pack size: 10 g of gel
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization 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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Germany, the country of export: 32475.00.00
Parallel import authorization number: 253/23

Date of approval of the leaflet: 03.11.2023

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