Corneregel

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging 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, 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 someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions 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 this medicine 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 adjunctive treatment to support the healing process in 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 or viral corneal lesions, but only as an adjunctive medicine to support the appropriate treatment of these corneal diseases.

2. Important 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 treatment with Corneregel, consult your doctor or pharmacist. Corneregel contains cetrimide (a preservative) which may cause stinging, redness, or a foreign body sensation in the eye; with frequent use, it may damage the corneal epithelium.
• Do not wear contact lenses during treatment with Corneregel, as lenses may become discolored and there is a risk of incompatibility with the lens material. Contact lenses must be removed before instilling the drops and should not be reinserted earlier than approximately 10–15 minutes after administration.
• Do not let the dropper tip touch the eye surface, surrounding areas, or any other surface, as this may contaminate the dropper or gel with bacteria, potentially causing eye infection.

Corneregel and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
If Corneregel is used simultaneously with other eye drops or ointments, a minimum interval of 15 minutes between administrations should be maintained, and Corneregel should always be administered last.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, 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 streaking or blurred vision, thus potentially affecting reaction ability. Do not drive, perform work without stable support, or operate machinery until these symptoms have resolved.

3. How to use Corneregel

This medicine should always be used according to the recommendations of a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Apply to the eye.

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.

Warning!
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 above the eye.
Do not touch the tip of the tube to the eye, eyelid, surrounding areas of the eye, or any other surface. This could 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 so that the gel spreads evenly.

Use of more Corneregel than recommended
Using more Corneregel 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in every individual.
Very rare adverse effects (may occur in not more than 1 in 10,000 people): hypersensitivity reactions (e.g. itching, rash).
Adverse effects of unknown frequency include: eye irritation, e.g. redness, pain, sensation of a foreign body in the eye, lacrimation, eye itching, conjunctival swelling.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 adverse effects enables the collection of further information on the safety of medicine use.

5. How to store Corneregel

Keep this medicine out of 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 stated month.
Discard any remaining contents 6 weeks after first opening the tube.
Medicines must 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 is dexpanthenol. 1 g of gel contains 50 mg of dexpanthenol.
• Other ingredients are: cetyltrimethylammonium bromide (cetrimide), disodium edetate, sodium hydroxide, carbomer 980, water for injections.

What Corneregel looks like and contents of the pack
Corneregel is available as an eye gel. The medicine is supplied in a tube with a screw cap,
packaged in a cardboard box.
Pack size: 10 g gel.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged at:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Germany, the country of export: 32475.00.00
Parallel import authorisation number: 89/22