Corneregel
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Warning! Keep the leaflet, information on the outer packaging in a foreign language!
Corneregel
50 mg/g (5%) 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 another person, 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:
- What Corneregel is and what it is used for
- Important information before using Corneregel
- How to use Corneregel
- Possible side effects
- How to store Corneregel
- Contents of the packaging 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 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.
NOTE:
Corneregel is not intended for the treatment of bacterial, fungal, or viral corneal lesions, but only as an adjunctive treatment to support proper therapy for these corneal diseases.
2. Important information before using Corneregel medicine
When not to use Corneregel
- if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- Before starting to use Corneregel, discuss it with 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 during treatment with Corneregel, as lenses may become discoloured and there is a risk of incompatibility with the lens material. Contact lenses must be removed before instillation and should not be reinserted earlier than 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 and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
If Corneregel is used simultaneously with other eye drops/ointments, a minimum interval of 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, thus possibly affecting reaction ability. Do not drive, perform work without stable support, or operate machinery until these symptoms have subsided.
3. How to use Corneregel
This medicine should always be used according to the recommendations of a doctor or pharmacist. In case of doubts, 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 have resolved.
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 in a vertical position above 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 or 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 around so that the gel spreads evenly.
Taking more than the recommended dose of Corneregel
Administering more than the recommended amount of Corneregel is not associated with any additional risk.
Missing a dose of Corneregel
Do not use a double dose to make up for a missed dose.
4. Possible adverse reactions
Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Very rare adverse reactions (may occur in not more than 1 in 10,000 people): hypersensitivity reactions (e.g. itching, rash).
Adverse reactions with unknown frequency include: eye irritation, e.g. redness, pain, sensation of a foreign body in the eye, lacrimation, eye itching, conjunctival oedema.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor or pharmacist. Adverse reactions 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 Warszawa
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, more information on the safety of the medicine can be collected.
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 4 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 you no longer use. This will help protect the environment.
6. Contents of the pack and other information
- The active substance is dexpanthenol. 1 g of gel contains 50 mg of dexpanthenol.
- Other ingredients: cetylpyridinium chloride, disodium edetate, sodium hydroxide, polyacrylic acid (carbomer), water for injections.
What Corneregel looks like and contents of the pack
Corneregel is a gel for ocular use. The medicine is supplied in tubes with a cap, packed 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 Greece, country of export:
Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus 24
Dublin, Ireland
Manufacturer:
Dr Gerhard Mann
Chem-Pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Germany
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Greece, country of export: 76459/21-12-2015
Parallel import licence number: 124/20