Corneregel

Package leaflet: information for the user

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, 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 the 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 the use of contact lenses.
Additionally, as an adjunct in the healing process of corneal and conjunctival injuries, chemical burns and thermal burns.
Supportively in the 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 adjunct to appropriate therapy for these corneal diseases.

2. Information before using Corneregel

When not to use Corneregel

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Before starting to use Corneregel, consult 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 while using 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 should not be reinserted earlier than approximately 10–15 minutes after application.
• 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, potentially causing eye infection.

Corneregel with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
If Corneregel is used simultaneously with other eye drops or ointments, an interval of at least 15 minutes should be maintained between the administration of these products, 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 blurring, thereby affecting reaction ability. Do not drive, perform tasks without stable support, or operate machinery until these symptoms have subsided.

3. How to use Corneregel

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
For ophthalmic use.
Recommended dose:
Depending on the severity and intensity of symptoms, 1 drop into the conjunctival sac 4 times daily,
and also 1 drop before bedtime.
There are no time limitations for use. The medicine 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 vertically over the eye.
Do not touch the tip of the tube to the eye, eyelid, surrounding areas, 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 to ensure even distribution of the gel.
Overdose of Corneregel
Administering more than the recommended amount of Corneregel 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very rare adverse reactions (may occur in less than 1 in 10,000 people): hypersensitivity reactions (e.g. itching, rash).
Adverse reactions of unknown frequency include: eye irritation, such as redness, pain, sensation of a foreign body in the eye, tearing, eye itching, conjunctival swelling.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Corneregel

Keep the medicine out of sight and reach of children.
Do not store above 25°C. Store the tube tightly closed.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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: cetylpyridinium chloride, disodium edetate, sodium hydroxide, carbomer, water for injections.

What Corneregel looks like and contents of the pack
Corneregel is a gel for ophthalmic use. The medicine is supplied in a white tube made of HDPE/aluminium foil with a tip made of HDPE and a cap made of HDPE, packed in a cardboard box.
Pack size: 10 g of gel.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Lithuania, 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.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Lithuania, country of export: LT/1/03/3527/001
Parallel Import Authorisation Number: 77/23