Corneregel

Package Leaflet: Information for the User

Corneregel

50 mg/g, eye gel
Dexpanthenol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 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. Package contents and other information

1. What is Corneregel and what is it used for

The active substance of the medicine is dexpanthenol.
The medicine is used to treat non-inflammatory keratopathy, e.g.: corneal degeneration, corneal dystrophy,
recurrent erosion and damage related to contact lens wear.
Additionally, as a supportive treatment for corneal and conjunctival healing in injuries, 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 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 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.

Corneregel and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
If you are using Corneregel with other eye drops or ointments, keep a 15-minute interval between administration of these medicines, and always administer Corneregel last.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
The medicine should not be used during pregnancy, unless your doctor advises you to do so.

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. Do not drive, operate machinery, or perform tasks that require a stable base until the symptoms have resolved.

3. How to use Corneregel

Always use this medicine 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 1 drop before bedtime.
There are no time limits for use. The product 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 may contaminate the gel. Using contaminated gel may lead to serious 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:

Administering more of the medicine 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 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): allergic reactions (e.g., itching, rash).
Undesirable 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 those not listed in this package leaflet, please inform 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 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Corneregel

Keep the medicine out of the sight and reach of children.
Store the medicine at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the outer packaging or on the blister/foil after “Expiry Date”. The expiry date refers to the last day of the month.
Discard any remaining contents 6 weeks after first opening the tube.

6. Package contents 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, polyacrylic acid (Carbopol 980), water for injections.

What Corneregel looks like and contents of the pack

Corneregel is an eye gel. The medicine is supplied in tubes, in a cardboard box.
Package sizes: 5 g and 10 g of gel

Marketing authorization holder and manufacturer

Dr. Gerhard Mann
Chem.-Pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin, Germany
customerservice.pharma.poland@bausch.com

Date of last revision of the package leaflet: