CORNEREGEL

CORNEGEL Fluid Eye Drops

Important notes (mandatory information)

Corneregel Fluid. Active ingredient: Dexpanthenol. Areas of application: for the supportive treatment of healing of skin and mucous membrane lesions of the eye in the case of so-called "dry eye" (conjunctivitis sicca or keratoconjunctivitis sicca).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Corneregel Fluid
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 want 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 that are not listed in this package leaflet. See section 4.
• If you do not feel better or even worse, talk to your doctor.

What is in this package leaflet

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

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

Corneregel Fluid is a supportive agent for promoting healing of the cornea in dry eye. Corneregel Fluid is used for the supportive treatment of healing of skin and mucous membrane lesions of the eye in the case of so-called "dry eye" (conjunctivitis sicca or keratoconjunctivitis sicca).

2. WHAT SHOULD YOU CONSIDER BEFORE USING CORNEREGEL FLUID?

Corneregel Fluid must not be used if you are allergic to dexpanthenol or any of the other ingredients of this medicine listed in section 6. In particular, in the case of allergic reactions to the preservative cetrimide in the form of eyelid and contact eczema. Corneregel Fluid contains the preservative cetrimide, which can cause irritation of the eye (burning, redness, foreign body sensation), especially with frequent use, and can damage the corneal epithelium. Particularly sensitive patients who experience this irritation are recommended to switch to preparations without preservatives.

Warnings and precautions

Please talk to your doctor, pharmacist, or healthcare professional before using Corneregel Fluid. Contact lens wearers should not use Corneregel Fluid while wearing the lenses, as this could lead to incompatibilities with the lens material. In wearers of soft contact lenses, the deposition of the preservative cetrimide in the contact lenses can cause intolerance reactions. Contact lenses should therefore be removed before using Corneregel Fluid and not reinserted until about 15 minutes later.

Use of Corneregel Fluid together with other medicines

Tell your doctor or pharmacist if you are taking or 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 an interval of about 15 minutes between the applications of the different preparations. Corneregel Fluid should always be used last so that the residence time and thus the effect is 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 benefit of using Corneregel Fluid during pregnancy and breastfeeding should be carefully weighed against any possible risk by the doctor.

Driving and using machines

As with all eye drops, blurred vision or other visual impairments can 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?

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 nature of the symptoms, instill 1 drop into the conjunctival sac 3 to 5 times daily or more often and before going to bed.

Type of application

For use on the eye.

Duration of use

The duration of use is not limited. You should use Corneregel Fluid until your symptoms improve.

Instructions for instillation

Tilt your head back and pull down the lower eyelid of the eye with the index finger of one hand. Hold the dropper bottle vertically above the eye (without touching the eye) and gently press the bulb of the dropper bottle with your finger 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.

If you have used more Corneregel Fluid than you should

No overdose reactions are known.

If you forget to use Corneregel Fluid

Do not use twice the amount if you have forgotten the previous application. 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 people treated), patients with severe 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 that are not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, 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?

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 dropper bottle after "use by/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: The eye drops must not be used for more than 6 weeks after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Corneregel Fluid contains

The active ingredient is: 1 ml of eye drops contains 50 mg of dexpanthenol. The other ingredients are: cetrimide (as preservative); sodium edetate (Ph. Eur.); hypromellose, sodium monohydrogen phosphate dodecahydrate (Ph. Eur.); sodium dihydrogen phosphate dihydrate; water for injections.

What Corneregel Fluid looks like and contents of the pack

Clear, colorless eye drops. Packs of 10 ml and 3 x 10 ml eye drops in dropper bottles. 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 package leaflet was last revised in March 2017.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Dexpanthenol. Areas of application: for the supportive treatment of healing of skin and mucous membrane lesions of the eye in the case of so-called "dry eye" (conjunctivitis sicca or keratoconjunctivitis sicca).