BERBERIL

BERBERIL Dry Eye EDO eye drops

Important notes (mandatory information)

Berberil Dry Eye Eye Drops Active ingredient: Hypromellose. Areas of application: for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva (dry eye) due to tear secretion and tear function disorders, as a result of local or systemic diseases, as well as in the case of insufficient or incomplete eyelid closure, which can manifest itself, for example, in burning eyes, a foreign body sensation and photophobia in wind, heat and fatigue.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Berberil Dry Eye EDO Eye Drops
Active ingredient: 1 ml contains 3.2 mg hypromellose

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.
o Keep the package leaflet. You may want to read it again later.
o Ask your pharmacist if you need more information or advice.
o 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.
o If you do not feel better or even worse, talk to your doctor.

What this package leaflet contains

1. WHAT ARE BERBERIL DRY EYE EDO EYE DROPS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BERBERIL DRY EYE EDO EYE DROPS?
3. HOW TO USE BERBERIL DRY EYE EDO EYE DROPS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BERBERIL DRY EYE EDO EYE DROPS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE BERBERIL DRY EYE EDO EYE DROPS AND WHAT ARE THEY USED FOR?

Berberil Dry Eye EDO Eye Drops are a synthetic tear fluid. Berberil Dry Eye EDO Eye Drops are used for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva (dry eye) due to tear secretion and tear function disorders, as a result of local or systemic diseases, as well as in the case of insufficient or incomplete eyelid closure, which can manifest itself, for example, in burning eyes, a foreign body sensation and photophobia in wind, heat and fatigue. Berberil Dry Eye EDO Eye Drops are - since they are unpreserved - particularly suitable for users who do not tolerate preserved artificial tear substitutes.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BERBERIL DRY EYE EDO EYE DROPS?

Berberil Dry Eye EDO must not be used if you are allergic to hypromellose 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 Berberil Dry Eye EDO.

Use of Berberil Dry Eye EDO Eye Drops 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.

Note

If you are also using other medicines on your eye, there should be a time interval of about 15 minutes between the applications of the various preparations. Berberil Dry Eye EDO Eye Drops should always be used last so that the residence time and thus the effect is not shortened.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. No specific studies have been conducted on pregnant patients with Berberil Dry Eye EDO Eye Drops. However, Berberil Dry Eye EDO Eye Drops should only be used during pregnancy and breast-feeding after careful consideration of the benefits and risks by the doctor.

Driving and using machines

Since this medicine can cause blurred vision for a few minutes after instillation into the conjunctival sac, no machinery should be operated, no work should be done without a secure hold, and no road traffic should be participated in during this time.

3. HOW TO USE BERBERIL DRY EYE EDO EYE DROPS?

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

The clinical picture of dry eye requires individual dosing. Unless otherwise prescribed, instill 1 drop into the conjunctival sac 3 to 5 times daily or more often as required.

Type of use

For use on the eye.

The correct handling of single-dose ophtioles (=

EDO)

1. Separate a single-dose ophtiole from the bar and hold it by the label side.
2. Unscrew the cap of the single-dose ophtiole.
3. Tilt your head back and pull down the lower eyelid of the eye with the index finger of one hand. Hold the single-dose ophtiole vertically above the eye (without touching the eye or contact lens) and gently press the finger on 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 use on both eyes.

Duration of use

The use for the clinical picture of dry eye is as long-term or permanent therapy.

Note

In the case of long-term or permanent use for the therapy of dry eye, an ophthalmologist should always be consulted.

If you have used more Berberil Dry Eye EDO Eye Drops than you should

No overdose reactions are known.

If you forget to use Berberil Dry Eye EDO

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. If necessary, you can also use Berberil Dry Eye EDO between two scheduled times.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. In very rare cases (may affect up to 1 in 10,000 people), local intolerances (burning eyes, redness, itching, blurred vision) may occur. In very rare cases (may affect up to 1 in 10,000 people), 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, Dept. 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 BERBERIL DRY EYE EDO EYE DROPS?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after "use by/expiry date". The expiry date refers to the last day of the month indicated.

Storage condition

Do not store above 25°C!

Note on shelf life after opening

Berberil Dry Eye EDO Eye Drops (single-dose ophtioles) do 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 Berberil Dry Eye EDO Eye Drops contain

The active ingredient is: Hypromellose. 1 ml solution contains 3.2 mg hypromellose. The other ingredients are: Sodium monohydrogen phosphate dodecahydrate (Ph.Eur.); sodium dihydrogen phosphate dihydrate; sorbitol (Ph.Eur.); water for injections.

What Berberil Dry Eye EDO Eye Drops look like and contents of the pack

Clear, colourless eye drops. Pack of 10 single-dose ophtioles with 0.6 ml eye drops each. Packs of 20, 30, 60, 90 and 120 single-dose ophtioles with 0.6 ml 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 July 2016.

Source: Information from the package leaflet
Status: 12/2020
Active ingredient: Hypromellose. Areas of application: for the symptomatic treatment of symptoms of dryness of the cornea and conjunctiva (dry eye) due to tear secretion and tear function disorders, as a result of local or systemic diseases, as well as in the case of insufficient or incomplete eyelid closure, which can manifest itself, for example, in burning eyes, a foreign body sensation and photophobia in wind, heat and fatigue.