HYLO DUAL

HYLO DUAL eye drops

Product features

Hylo Dual eye drops, 10 ml

Description

With sodium hyaluronate and Ectoin. Moisturises dry eyes, stabilises the tear film and thus reduces inflammatory and allergic symptoms such as itching and burning. Sterile, phosphate-free solution without preservatives.

Dear user, please read the following instructions for use carefully, as they contain important information about what you should observe when using this medical device.

Instructions for use

Please read the instructions for use carefully, as they contain important information for you. Keep these instructions for use. You may need to read them again later. Please ask your doctor or pharmacist if you need further information or advice. If your symptoms worsen or do not improve, you must consult a doctor.

What is Hylo Dual?
Hylo Dual is a sterile, phosphate- and preservative-free solution for ophthalmic use.

Composition

1 ml Hylo Dual contains 0.5 mg sodium hyaluronate, 20 mg Ectoin, boric acid, borax and water for injections.

What is Hylo Dual used for?
Hylo Dual moisturises the cornea and conjunctiva and protects against excessive evaporation of tears. This stabilisation of the tear film relieves eye irritations associated with inflammatory symptoms or caused by allergies. The burning and itching sensation in the eyes disappears.

When should Hylo Dual be used?
Hylo Dual is intended for the treatment of dry eyes.
Burning, itching and watery eyes, the sensation of sand in the eyes or dry eyes are symptoms of an irritated eye. Often, these are signs that the eye is not sufficiently moisturised. Another cause can also be hypersensitivity to certain substances (e.g. pollen, animal hair or house dust), so-called allergies. Since an allergy is accompanied by the same symptoms, distinguishing between dry and allergically irritated eyes is difficult.

In these cases, Hylo Dual offers particular advantages due to its dual mechanism of action with sodium hyaluronate and Ectoin:

• Sodium hyaluronate is a natural substance found in the eye, but also in other parts of the body. It has the special physical property of forming a uniform, stable and particularly long-lasting moisturising film on the surface of the eye, without being quickly washed away.
• Ectoin is a natural substance obtained from microorganisms that live in extreme environments (e.g. salt lakes). To protect themselves from the extreme environmental factors prevailing there, these microorganisms form the natural substance Ectoin, whose special properties are used in Hylo Dual. Ectoin increases water binding to the cells of the eye surface, thus forming a physiological barrier on the conjunctiva for allergenic substances. At the same time, Ectoin stabilises the lipid-soluble part of the tear film, which protects against excessive evaporation of tear fluid.
• Through the interaction of sodium hyaluronate and Ectoin, the eye is supplied with an intensive, long-lasting moisturising film and protected from the evaporation of tears. This alleviates environmental irritations that lead to inflammatory symptoms, as well as the typical symptoms of itching and burning that occur with allergic reactions.

How to use Hylo Dual?
Only use Hylo Dual if the seal of the folding carton was intact before first use. Please contact the manufacturer if you have any questions about the correct use of this medical device. A bottle containing 10 ml of solution corresponds to approximately 300 drops. For production reasons, a small amount of liquid always remains in the bottle. The duration of use of Hylo Dual is not limited and it can be used by adults and children aged 6 years and older. The contents of one bottle of Hylo Dual should always be used by the same person.

What other instructions for use should be observed?

• If you do not feel better or if you feel worse after several days of use, speak to your doctor or pharmacist. In the event of additional other medicinal treatment with eye drops, an application interval of at least 30 minutes should be observed. Hylo Dual should always be administered last. Eye ointments should in any case be applied to the conjunctival sac after Hylo Dual.
• Due to its preservative-free nature, Hylo Dual is particularly well tolerated even with long-term use. In very rare individual cases, undesirable reactions such as hypersensitivity reactions, burning, tearing, pain, foreign body sensation or other temporary local irritations have been reported, which subsided after discontinuation of Hylo Dual.
• Due to the viscosity (thickness) of the preparation, temporary blurred vision is possible immediately after using Hylo Dual. In very rare cases, this can lead to temporary headaches in sensitive patients.
• Hylo Dual can be used while wearing contact lenses. We recommend waiting approximately 30 minutes after inserting contact lenses before applying the eye drops to avoid possible intolerance reactions that may occur due to interactions between contact lens care products and Hylo Dual.
• According to current knowledge, Hylo Dual can be used in children over 6 years of age, as well as during pregnancy and breastfeeding.
• If a serious incident has occurred during the use of this medical device or as a result of its use, please report it to the manufacturer.

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 leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. 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.

How often and for how long should Hylo Dual be used?
Generally, adults and children aged 6 years and older instill 1 drop of Hylo Dual into the conjunctival sac of each eye 3 times daily. If you use Hylo Dual more frequently (e.g. more than 10 times daily) or suffer from more severe symptoms, you should regularly consult an ophthalmologist. Hylo Dual is suitable for long-term use. However, as with all illnesses, if symptoms persist for a longer period (e.g. longer than two weeks), you should consult an ophthalmologist for advice.

When should Hylo Dual not be used?
Hylo Dual should not be used in case of hypersensitivity to any of the ingredients and not in children under 6 years of age.

What storage instructions for Hylo Dual should be observed?

• Do not store above 25°C.
• After opening the bottle, Hylo Dual can be used for 6 months.
• Do not use after the expiry date.
• Keep out of reach of children.
• Dispose of this medical device with household waste in accordance with your national legislation. This measure contributes to the protection of the environment.

The following pack sizes are available

10 ml eye drops.

Distributor in Germany

Ursapharm Arzneimittel GmbH,
Industriestraße 35
66129 Saarbrücken