HYLOVIS

HYLOVIS lipo eye drops single-dose pipettes

Product features

Hylovis Lipo
Emulsion for moistening the eye without preservatives.

Field of application and dosage form

Hylovis Lipo is a tear substitute that is offered as a sterile, hypoosmolar emulsion with 0.18% sodium hyaluronate (from fermentation), packaged in single-dose containers of 0.4 ml, and is free of preservatives.

Hylovis Lipo is an emulsion that stabilises the tear film. Hylovis Lipo contains sodium hyaluronate, a component that occurs naturally in the eye and contributes to the protection and moistening of the eye surface. Thanks to the physical properties of sodium hyaluronate, Hylovis Lipo has a strong water-binding effect and good viscoelastic properties, which create an even, protective lubricating film on the surface of the eye. In this way, the product acts on the aqueous layer to moisturise and protect the surface of the eye. Hylovis Lipo is hypoosmolar in order to compensate for the harmful reactions (inflammation) resulting from the hyperosmolarity of the tear film in dry eyes. Sodium hyaluronate also has mucomimetic properties, which means that Hylovis Lipo supports the stability of the tear film. For optimum compatibility, Hylovis Lipo contains no preservatives or surfactants.

Instructions for use / recommended use

In which cases is Hylovis Lipo used?
Hylovis Lipo is recommended for adults with moderate to severe dry eyes (no studies have been conducted with children).

How is Hylovis Lipo used?
Hylovis Lipo is used on the eye. Wash hands thoroughly before instillation.

1. Open the sachet and separate a single dose from the strip. Put the other single doses back in the original packaging.
2. Always shake the single dose before instillation.
3. Hold the single dose vertically (cap upwards) and twist off the flat part completely. The single dose is open.
4. Tilt your head back and hold the single dose over the eye with the dropper tip pointing downwards. Pull the lower eyelid down slightly with your index finger and look upwards, then gently squeeze the single-dose container until a drop of Hylovis Lipo falls into the eye.
5. Unless otherwise recommended, instil 1 - 2 drops as often as necessary.
6. After use, the emulsion is distributed evenly over the surface of the eye with a few spontaneous blinks, where it forms a transparent and durable film.
7. Hylovis Lipo is suitable for contact lens wearers.

Warnings / safety instructions

1. For external use only.
2. Do not ingest.
3. Store at 2 to 25°C.
4. Wash hands thoroughly before instillation.
5. Always shake the single dose before instillation.
6. Avoid contact of the dropper tip of the single dose with hands, eyes or eyelids (risk of microbial contamination).
7. These eye drops are supplied in a single-dose ophtiole: The single dose must be disposed of immediately after use and must not be stored for later use (risk of microbial contamination and reduced effectiveness).
8. Do not use if the single dose is damaged (risk of microbial contamination).
9. Do not use after the expiry date stated on the single dose and the box (risk of microbial contamination).

If your ophthalmologist has prescribed other eye drops, a time interval of 15 minutes must be observed between instillation of the two products (risk of interaction or reduced effect of the eye drops). If the symptoms persist during use of Hylovis Lipo, please consult a doctor. Keep out of reach of children.

Contraindications

Do not use if you are hypersensitive to any of the ingredients.

Side effects

In very rare cases, temporary symptoms such as mild irritation of the conjunctiva, foreign body sensation, redness or burning of the eye, and blurred vision for a short time may occur. If side effects persist or if side effects occur that are not listed in this package leaflet, the use of the product should be discontinued and a doctor should be consulted.

Reporting of

Side effects

If you notice any side effects, contact 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.

Dosage form:
30 x 0.4ml

Manufacturer

Horu Pharm
148 Avenue G.Guynemer
Cap Var
06700 Saint-Laurent du Var
France
www.horus-pharma.com

Distribution:
TRB Chemedica AG
Otto-Lilienthal-Ring 26
85622 Feldkirchen München
Germany

Ingredients

Sodium hyaluronate (0.18%), triglycerides and Hylovis Lipo emulsion, phospholipids, lipoic acid, hydroxypropylmethylcellulose, sodium citrate, sodium hydroxide, citric acid, sodium chloride and water for injections.

This information was last revised in April 2016

Source: Information from the package leaflet
Status: 07/2023