Corneregel

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging 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, 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 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 packaging 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 use.
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.
• 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.
• The dropper tip should not be touched 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 at the same time as other eye drops/ointments, a minimum of 15 minutes should be allowed 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. The patient should not drive, perform tasks 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, 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 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 the 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, 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 any side effects not listed in the leaflet, 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help gather more information on the safety of the 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 stated.
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 packaging and other information

What Corneregel contains

• 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, carbomer 980, water for injections.

What Corneregel looks like and contents of the pack

Corneregel is an eye gel. The medicine is supplied in a tube with a screw cap, 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 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:

InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:32475.00.00

Parallel import authorization number: 89/22 Date of approval of the leaflet: 16.02.2022

[Information about the trademark]