Corneregel

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Corneregel

50 mg/g, 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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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.
Corneregel is used to treat non-inflammatory keratopathy, e.g.: corneal degeneration,
corneal dystrophy, recurrent erosion, and damage related to the use of contact lenses.
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, 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 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.

• 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, 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 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 when used correctly, may temporarily blur vision due to the formation of streaks, and may affect your reaction ability. 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.
For 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 any other surface.

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, 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 medicine than recommended is not associated with any additional risk.

Missed dose of Corneregel

A double dose should not be used 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 this leaflet, you should inform your doctor, pharmacist, or nurse. 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
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 gather more information on the safety of the medicine.

5. How to store Corneregel

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Store the tube tightly closed.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Discard any remaining contents 6 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 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.
• Excipients: cetrimide, disodium edetate, sodium hydroxide, carbomer, water for injections.

What Corneregel looks like and what the pack contains

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, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Lithuanian authorization number, in the country of export: LT/1/03/3527/001

Parallel import authorization number: 198/18 Date of approval of the leaflet: 21.04.2023

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