CORNEREGEL

CORNEGEL Fluid EDO eye drops

Important notes (mandatory information)

Corneregel Fluid EDO. Active ingredient: Dexpanthenol. Areas of application: for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva and for the supportive treatment of healing of skin and mucous membrane lesions of the eye.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Corneregel Fluid EDO
Active ingredient: 1 ml of eye drops contains 50 mg of dexpanthenol

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor, pharmacist, or healthcare professional.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor, pharmacist, or healthcare professional. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse, talk to your doctor.

What this package leaflet contains

1. WHAT IS CORNEREGEL FLUID EDO AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING CORNEREGEL FLUID EDO?
3. HOW TO USE CORNEREGEL FLUID EDO?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CORNEREGEL FLUID EDO?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CORNEREGEL FLUID EDO AND WHAT IS IT USED FOR?

Corneregel Fluid EDO is a corneal healing agent and an artificial tear fluid. Corneregel Fluid EDO is used for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva and for the supportive treatment of healing of skin and mucous membrane lesions of the eye.

2. WHAT SHOULD YOU CONSIDER BEFORE USING CORNEREGEL FLUID EDO?

Corneregel Fluid EDO must not be used if you are allergic to dexpanthenol or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor, pharmacist, or healthcare professional before using Corneregel Fluid EDO.

As a contact lens wearer

Wearers of soft and hard contact lenses should remove them before using Corneregel Fluid EDO and only reinsert them after about 15 minutes.

Use of Corneregel Fluid EDO together with other medicines

Tell your doctor or pharmacist if you are taking, using, have recently taken or used, or plan to take or use any other medicines. No specific interactions with other agents are known.

Notes

If you are also using other medicines on the eye, there should be a time interval of about 15 minutes between the applications of the different preparations. Corneregel Fluid EDO should always be used last so that the residence time and thus the effect are not shortened.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Since it is not known how much dexpanthenol is absorbed into the bloodstream after local application to the eye, the benefits of using Corneregel Fluid EDO during pregnancy and breastfeeding should be carefully weighed against any possible risks.

Driving and using machines

As with all eye drops, blurred vision or other visual impairments may temporarily impair the ability to participate in road traffic or operate machinery. If blurred vision occurs immediately after instillation, you must not participate in road traffic or operate machinery until this impairment has subsided.

3. HOW TO USE CORNEREGEL FLUID EDO?

Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor, pharmacist, or healthcare professional. Check with your doctor, pharmacist, or healthcare professional if you are not sure.

Dosage

Unless otherwise prescribed and depending on the severity and intensity of the symptoms, instill 1 drop into the conjunctival sac 3 to 5 times daily or more often and 1 drop before going to bed.

Type of application

For use on the eye.

Duration of use

Corneregel Fluid EDO is suitable for long-term therapy. However, please consult your doctor before using it for a long period of time.

Correct handling of the single-dose ophtioles (= EDO):

• Detach a single-dose ophtiole from the bar and hold it by the label side.
• Unscrew the cap of the single-dose ophtiole.
• Tilt your head back and pull down the lower eyelid of the eye with the index finger of one hand. With the other hand, hold the single-dose ophtiole vertically above the eye (without touching the eye) and gently press the bulb of the single-dose ophtiole to instill one drop into the pulled-down conjunctival sac.
• Close the eye slowly and move it back and forth so that the drop can spread well.
• The contents of a single-dose ophtiole are sufficient for simultaneous use on both eyes.

If you have used more Corneregel Fluid EDO than you should

No overdose reactions are known.

If you forget to use Corneregel Fluid EDO

Do not use double the amount to make up for the missed application, but continue the therapy at the next scheduled time with the same dosage and at the same time interval/rhythm as described or as prescribed by your doctor.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Not known (frequency cannot be estimated from the available data):

• Eye irritation, e.g. redness, pain, increased tearing, itching, foreign body sensation, swelling.
• Hypersensitivity reactions, e.g. itching, skin redness, rash.

In very rare cases (up to 1 in 10,000 treated patients), patients with pronounced corneal damage developed corneal opacities due to calcium deposits during treatment with phosphate-containing eye drops.

Reporting of side effects

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

5. HOW TO STORE CORNEREGEL FLUID EDO?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and the single-dose ophtiole after "usable until/use by". The expiry date refers to the last day of the month indicated.

Storage

Do not store above 25°C.

Shelf life after opening

Corneregel Fluid EDO does not contain a preservative. Opened single-dose ophtioles should therefore not be stored. The remaining amount left in the ophtiole after use must be discarded.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Corneregel Fluid EDO contains

The active ingredient is: Dexpanthenol. 1 ml of eye drops contains 50 mg of dexpanthenol. The other ingredients are: Sodium edetate (Ph. Eur.); Hypromellose; Sodium monohydrogen phosphate dodecahydrate (Ph. Eur.); Sodium dihydrogen phosphate dihydrate; Water for injections.

What Corneregel Fluid EDO looks like and contents of the pack

Clear, colorless eye drops. Packs of 10, 30, 60, and 120 single-dose ophtioles (bundle pack of 2 x 60 single-dose ophtioles) with 0.6 ml of eye drops each. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur 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 February 2017.

Source: Information from the package leaflet
Status: 01/2021
Active ingredient: Dexpanthenol. Areas of application: for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva and for the supportive treatment of healing of skin and mucous membrane lesions of the eye.