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

Dexpanthenol

Read the Leaflet Carefully Before Using the Medicinal Product, 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 further questions, ask your doctor or pharmacist.
• This medicinal product 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 any 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 medicinal product is dexpanthenol.
Corneregel is used to treat non-inflammatory keratopathy, e.g., corneal degeneration, corneal dystrophy, recurrent erosion, and damage related to contact lens wear.
Additionally, as an adjunctive therapy to support the healing process in corneal and conjunctival injuries, chemical burns, and burns.
Supportively in specific treatments for bacterial, fungal, and viral corneal damage.
WARNING:
Corneregel is not intended to treat bacterial, fungal, and viral corneal damage, but only as an adjunctive therapy to 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 later.
• 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, which can cause eye infections.

Corneregel and Other Medicinal Products

Tell your doctor or pharmacist about all the medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take.
If Corneregel is used at the same time as other eye drops/ointments, maintain an interval of at least 15 minutes between administration of these medicinal products, and Corneregel should always be administered last.

Pregnancy, Breast-Feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicinal product.
Do not use this medicinal product during pregnancy, unless your doctor advises you to do so.

Driving and Using Machines

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

3. How to Use Corneregel

Always use this medicinal product exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
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 also 1 drop before bedtime.
There are no time limits for use. The medicinal product can be used until the 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 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 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 higher dose 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 medicinal products, Corneregel 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 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 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 to gather more information on the safety of this medicinal product.

5. How to Store Corneregel

Keep the medicinal product out of the sight and reach of children.
Do not store above 25°C. Keep the tube tightly closed.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Discard the remaining contents 6 weeks after first opening the tube.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. 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, water for injections.

What Corneregel Looks Like and Contents of the Pack

Corneregel is a gel for the eyes. The medicinal product is supplied in a white HDPE tube with an HDPE nozzle and an HDPE cap 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 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian, Country of Export Marketing Authorization Number:LT/1/03/3527/001

Parallel Import Authorization Number: 77/23 Date of Approval of the Leaflet: 27.04.2023

[Information about the Trademark]