EvoTears

EVOTEARS Omega Eye Drops

Product Features

Evotears Omega Eye Drops, 3 ml

Description

For stabilizing the lipid layer of the tear film, wetting and protecting the eye surface and relieving symptoms of dry eyes. Sterile, phosphate-free eye drops, without preservatives, with perfluorohexyloctane and 0.2% omega-3 fatty acids.

Instructions for Use

Please read the instructions for use carefully, as they contain important information for you. Keep this instruction leaflet. You may need to read it again later. If you need more information or advice, ask your doctor or pharmacist. If your symptoms worsen or do not improve, you must see a doctor in any case.

What is EvoTears Omega and what is it used for?

• EvoTears Omega is a medical device made of a water-free eye drop liquid that contains no preservatives or phosphate.
• EvoTears Omega contains perfluorohexyloctane (EyeSol) with 0.2% omega-3 fatty acids (derived from algae).
• EvoTears Omega stabilizes the lipid layer of the tear film and reduces evaporation of the underlying aqueous layer. EvoTears Omega wets and protects the eye surface and thus relieves symptoms of dry eyes, such as burning, itching, stinging and foreign body sensation.

What should you be aware of before using EvoTears Omega?

• EvoTears Omega must not be used if you are hypersensitive (allergic) to the ingredients perfluorohexyloctane or omega-3 fatty acids.
• Special care is required when using EvoTears Omega if you are also using other eye medications at the same time.
• An application interval of at least 15 minutes should be observed.
• If you wear contact lenses, you should not use EvoTears Omega, as there is insufficient data on compatibility with contact lens materials.

Use in pregnant women, nursing women and children

There are no data on safety in children, pregnant women or nursing mothers, so the use of EvoTears Omega is not recommended here.

How is EvoTears Omega used?
Unless otherwise recommended by your doctor, instill 1 drop into the lower eyelid up to 4 times a day. Since EvoTears Omega is free of preservatives, you can use it daily.

Note:
Due to the special nature of EvoTears Omega, it is possible that you will not feel the drop in your eye. In this case, we recommend applying it in front of a mirror.

EvoTears Omega can be used for 8 weeks after first opening. Please note the date of first opening on the folding box. If you have any further questions about the use of the medical device, ask your doctor or pharmacist.

What side effects can occur when using EvoTears Omega?
Signs of temporary eye irritation (such as burning, itching or redness of the eye) and temporary blurred vision are possible side effects after using EvoTears Omega. If you experience persistent eye irritation, discontinue use and seek advice from your doctor or pharmacist. Please report serious incidents to the manufacturer and the competent supervisory authority.

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 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 on the safety of this medicine.

Further information

Do not use EvoTears Omega if the bottle or original cap is damaged. EvoTears Omega must not be used after the expiry date printed on the bottle. Do not ingest liquid.

How should EvoTears Omega be stored?
Keep out of reach of children. Do not store above 25°C.

The following pack size is available

Pack of 3 ml eye drops. Non-saleable sample with 1 ml eye drops.

For easier handling, the eye drops are filled into bottles with a nominal volume of 5 ml, which are therefore only about half full. The filling is carried out under constant control, so that an underfilling of the bottle is excluded.

Manufacturer

Novaliq GmbH
Im Neuenheimer Feld 515
69120 Heidelberg
Germany

Distributor in Germany

URSAPHARM Arzneimittel GmbH,
Industriestraße 35
66129 Saarbrücken
Phone: +49 6805 9292-0
Fax: +49 6805 9292-88,
E-mail: info@ursapharm.de
www.ursapharm.de

This information was last revised in January 2023.

Source: Information from the package insert
Status: 08/2023