BERBERIL

BERBERIL Dry Eye 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, also during the wearing of hard contact lenses for wetting and rewetting.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Berberil Dry Eye Eye Drops
Active ingredient: 1 ml solution contains 3.20 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 or pharmacist.
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 notice any side effects, contact your doctor or pharmacist. 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, contact your doctor.

What this package leaflet contains

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

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

Berberil Dry Eye Eye Drops are tear substitutes 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, also during the wearing of hard contact lenses for wetting and rewetting.

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

Berberil Dry Eye Eye Drops 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 or pharmacist before using Berberil Dry Eye Eye Drops. The preservative cetrimide contained in Berberil Dry Eye Eye Drops can cause irritation of the eye (burning, redness, foreign body sensation), especially with more frequent and prolonged use, and can damage the corneal epithelium. If you notice such irritation, you should use a preparation without preservatives. Wearers of soft contact lenses should remove them from the eye before using Berberil Dry Eye Eye Drops and only reinsert them about 15 minutes after application. Hard contact lenses can remain in the eye during the use of Berberil Dry Eye Eye Drops.

Use of Berberil Dry Eye 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. If other eye drops/eye ointments are used additionally, the effect of the respective previous medicine can be impaired, as it can be diluted or displaced from the conjunctival sac by the introduction of the subsequent medication. For this reason, a time interval of approx. 15 minutes should be observed between the applications of the various preparations. Berberil Dry Eye Eye Drops should always be used last, as a long dwell time and thus a long moisturizing effect are important for them.

Pregnancy and breast-feeding

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

Driving and ability to operate machinery

Since this medicine, even when used as intended, can briefly affect vision and thus the ability to react by forming streaks, you should not participate in road traffic, work without a secure hold or operate machinery during this period.

3. HOW TO USE BERBERIL DRY EYE EYE DROPS?

Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. For use on the eye. 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. The same applies to wetting and rewetting hard contact lenses. Wearers of soft contact lenses should remove them from the eye before using Berberil Dry Eye Eye Drops and only reinsert them about 15 minutes after application. Hard contact lenses do not need to be removed during the use of Berberil Dry Eye.

Instructions for use

Tilt your head back. Pull the lower eyelid of the eye down with the index finger of one hand. Hold the dropper bottle vertically above the eye (without touching the eye) and instill one drop into the pulled-down conjunctival sac. Close the eye slowly and move it back and forth so that the liquid is distributed well.

Duration of use

The application is usually carried out as long-term or permanent therapy.

Note

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

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

No overdose symptoms known and no measures required.

If you forget to use Berberil Dry Eye Eye Drops

Do not use double the amount to make up for the missed application.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. In rare cases (may affect up to 1 in 1000 people), hypersensitivity reactions may occur on the eye when using Berberil Dry Eye Eye Drops. Berberil Dry Eye Eye Drops contain the preservative cetrimide, which can cause irritation of the eye (burning, redness, foreign body sensation), especially with frequent use, and can damage the cornea with prolonged use. If such hypersensitivity reactions or irritation of the eye occur, please discontinue treatment and consult your doctor. Patients who are particularly sensitive to the preservative are recommended to switch to preparations without preservatives. In very rare cases (may affect up to 1 in 10000 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 get 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 SHOULD BERBERIL DRY EYE EYE DROPS BE STORED?

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. The eye drops must not be used for more than 6 weeks after opening. Do not store above 30°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Berberil Dry Eye Eye Drops contain

The active ingredient is: Hypromellose. 1 ml solution contains 3.20 mg hypromellose. The viscosity of the solution is between 7 and 11 mPa * s. The other ingredients are: Cetrimide; Sodium monohydrogen phosphate dodecahydrate (Ph.Eur.); Sodium dihydrogen phosphate dihydrate; Sorbitol (Ph.Eur.); Sodium edetate (Ph.Eur.); Water for injections.

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

Eye drops in dropper bottles. Packs of 10 ml solution Packs of 3 x 10 ml solution.

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 2017.

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, also during the wearing of hard contact lenses for wetting and rewetting.