CORNEREGEL eye gel

Important Information (Mandatory Information)

Corneregel 1 g eye gel. Active substance: Dexpanthenol. Areas of application: For the treatment of non-inflammatory corneal diseases of the eye (keratopathies), e.g. corneal dystrophies (nutritional disorders), corneal degenerations (regressions), recurrent corneal erosions (peeling) and corneal lesions (injuries) in contact lens wearers, as additional medication to support the healing process in corneal and conjunctival damage, chemical burns and burns, and as additional medication to a specific therapy of infectious corneal processes of bacterial, viral or mycogenic (caused by fungi) origin.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


INFORMATION FOR THE USER

Corneregel 1 g eye gel, for the treatment of non-inflammatory corneal diseases of the eye
Active substance: Dexpanthenol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

• WHAT IS CORNEREGEL AND WHAT IT IS USED FOR
• WHAT YOU NEED TO KNOW BEFORE YOU USE CORNEREGEL
• HOW TO USE CORNEREGEL
• POSSIBLE SIDE EFFECTS
• HOW TO STORE CORNEREGEL
• CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CORNEREGEL AND WHAT IT IS USED FOR

Corneregel is a medicine that promotes wound healing.

Corneregel is used:

• for the treatment of non-inflammatory corneal diseases of the eye (keratopathies), e.g. corneal dystrophies (nutritional disorders), corneal degenerations (regressions), recurrent corneal erosions (peeling) and corneal lesions (injuries) in contact lens wearers.
• as additional medication to support the healing process in corneal and conjunctival damage, chemical burns and burns.
• as additional medication to a specific therapy of infectious corneal processes of bacterial, viral or mycogenic (caused by fungi) origin.

Corneregel is not suitable for curing infectious corneal processes of bacterial, viral or mycotic origin, but only as additional medication to a specific therapy of these corneal diseases.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE CORNEREGEL

Do not use Corneregel

- if you are allergic to dexpanthenol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Corneregel.

Contact lens wearers should not use Corneregel while wearing lenses, as this could lead to smearing of the contact lens and incompatibility with the lens material.

Corneregel contains the preservative cetrimide, which can cause eye irritation (burning, redness, foreign body sensation) and damage the corneal epithelium, especially with frequent use. For the long-term treatment of chronic keratoconjunctivitis sicca, preservative-free preparations should therefore be preferred. Contact lenses should be removed before instillation and can be reinserted after approx. 15 minutes.

Other medicines and Corneregel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Specific interactions with other agents are not known, however, if you are using other eye drops/eye ointments at the same time, there should be an interval of at least 15 minutes between applications of the different medications. Corneregel should always be administered last.

Pregnancy and breast-feeding

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 medicine.

Special caution is required when using Corneregel during pregnancy and breast-feeding.

Since it is not known how much dexpanthenol is absorbed into the bloodstream after local application to the eye, the doctor should carefully weigh the benefits of using Corneregel during pregnancy and breast-feeding against any possible risk.

You should tell or show both your ophthalmologist and your family doctor all medicines you are taking or applying locally to the eye.

Driving and using machines

Since this medicine, even when used as directed, temporarily affects visual performance and thus reaction capacity due to streak formation, you should not drive, work without a secure hold or operate machines during this time.

3. HOW TO USE CORNEREGEL

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:
Depending on the severity and expression of the disease, instill one drop into the conjunctival sac 4 times a day and before going to bed.
The duration of use is not limited.

The application should be continued until subjective improvement of the symptoms occurs.

Instructions for use
Tilt your head back. Pull the lower eyelid of the eye down with the index finger of one hand. With the other hand, hold the tube vertically over the eye (without touching the eye) and instill one drop into the pulled-down conjunctival sac. Close your eye slowly and move it back and forth so that the gel is well distributed.

Please close the tube again with the protective cap after use.

Note

The new cap is also suitable as a stand and allows you to place the tube vertically. This means you can always use Corneregel quickly and easily. The tube must not be put down or stored without the cap.

If you use more Corneregel

than you should

Overdose of Corneregel is not associated with any known risks. The therapeutic effect is neither improved nor worsened.

If you forget to use Corneregel

Do not use a double dose to make up for a forgotten dose, but make up for the application as soon as possible, and then continue dosing with the same amount and at the same time interval/rhythm as specified above or as prescribed by your doctor.

If you stop using Corneregel

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very rare (may affect up to 1 in 10,000 people):
Hypersensitivity reactions (e.g. itching, skin rash)

Not known (frequency cannot be estimated from the available data):
Eye irritation, e.g. redness, pain, foreign body sensation, increased tear flow, itching or conjunctival swelling.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CORNEREGEL

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and tube after "EXP" or "use by". The expiry date refers to the last day of that month. Corneregel must not be used for longer than 6 weeks after opening. Do not store above 25°C.

Never throw away any medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. More information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Corneregel contains

The active substance is:
Dexpanthenol. 1 g eye gel contains 50 mg dexpanthenol.

The other ingredients are

Cetrimide; carbomer (viscosity 40,000-60,000 mPa·s); disodium edetate (Ph. Eur.); sodium hydroxide; water for injections.

What Corneregel looks like and contents of the pack

Corneregel is an aqueous, colorless and clear gel.

Corneregel is available in packs of 5 g, 10 g and 3 x 10 g eye gel in tubes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin
E-mail: kontakt@bausch.com

This leaflet was last revised in August 2022.

Source: Information from the package leaflet
Status: 05/2025
Active substance: Dexpanthenol. Areas of application: For the treatment of non-inflammatory corneal diseases of the eye (keratopathies), e.g. corneal dystrophies (nutritional disorders), corneal degenerations (regressions), recurrent corneal erosions (peeling) and corneal lesions (injuries) in contact lens wearers, as additional medication to support the healing process in corneal and conjunctival damage, chemical burns and burns, and as additional medication to a specific therapy of infectious corneal processes of bacterial, viral or mycogenic (caused by fungi) origin.