HILO-COMOD®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ХІЛО-КОМОДâ (HYLO-COMODâ)

Composition:

Active ingredient: hyaluronic acid;

1 ml of solution contains 1 mg of sodium hyaluronate;

Excipients: citric acid anhydrous, sodium citrate, sorbitol (E 420), water for injections.

Pharmaceutical form. Eye drops.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group. Agents used in ophthalmology. Artificial tear substitutes and other neutral preparations. ATC code S01X A20.

Pharmacological properties.

Pharmacodynamics.

The main goal of dry eye treatment is to increase the stability and volume of the precorneal tear film. The hyaluronic acid contained in the formulation as sodium hyaluronate has a chemical structure, molecular weight, and rheological properties similar to those of mucin, a component of human tears. Due to these properties, hyaluronic acid moisturizes the eye without impairing vision. In addition, its ability to bind water helps maintain moisture on the ocular surface.

When applied topically, hyaluronic acid enhances the stability of the precorneal tear film, exerts a positive effect on the epithelial layer, promotes an increase in tear volume and corneal hydration, and reduces tear evaporation from the ocular surface.

Pharmacokinetics.

Sodium hyaluronate is not absorbed following topical administration. There is no evidence that hyaluronic acid can penetrate through the cornea. Even after direct injection into the anterior chamber of the eye, only immeasurably low concentrations of hyaluronic acid were detected in the systemic circulation, which were rapidly metabolized by the liver; therefore, systemic toxic reactions are not expected with the use of this medicinal product.

Clinical characteristics.

Indications.

Symptomatic treatment of corneal and conjunctival dryness (dry eye syndrome).

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of Xilo-Comod® eye drops with other ophthalmic medicinal products should be avoided. If such use is nevertheless necessary, these products should be administered no later than 30 minutes before applying Xilo-Comod® eye drops. However, ophthalmic ointments should always be applied last.

Since, upon topical ophthalmic administration, the drug immediately reaches the target organ and exerts primarily a physical effect (moisturizing the eye surface) without systemic activity, no medicinal interactions of the drug are expected, except for physical interactions with other topically applied ophthalmic drops.

Special precautions for use.

The product is compatible with all types of contact lenses and may improve comfort during contact lens wear. In cases of severe or persistent dry eye symptoms, medical advice should be sought.

Use during pregnancy or breastfeeding.

There have been no controlled studies on the use of this product during pregnancy or breastfeeding.

Nevertheless, XELO-COMOD® can be used during pregnancy or breastfeeding, as it has no systemic pharmacological effect.

Effect on the ability to drive or operate machinery.

In individual cases, immediately after instillation, XELO-COMOD® eye drops may cause transient blurred vision, even when properly administered at the recommended doses. Since this could increase reaction time, it is recommended to wait some time after instilling the drops and ensure visual clarity has been restored before driving or operating complex machinery.

Method of administration and dosage

Usually, instill 1 drop of the medication into each eye three times a day. If necessary, the frequency of instillation may be increased. A significant increase in the frequency of instillation of the medication XİLO-COMOD® (e.g., more than 10 times a day) is allowed only upon decision and under supervision of an ophthalmologist.

In the absence of contraindications related to the underlying disease, XİLO-COMOD® may be used while wearing contact lenses, as it does not cause film formation or deposit on the lenses.

XİLO-COMOD® is intended for individual use by a single person only. The duration of treatment is determined individually by the physician.

When instilling eye drops, avoid any contact between the container tip and the eye or skin.

Method of administration

Note. The COMOD® system allows the release of 10 ml of solution, which amounts to approximately 300 drops. Due to technical reasons, a small amount of drops remains in the container at the end of use.

Children.

Data on the use of the drug for the treatment of children are lacking.

Overdose.

There have been no reports of overdose with this drug.

Side effects.

Since the Xylo-Comod® product does not contain preservatives, it is well tolerated even during prolonged use. In extremely rare cases, hypersensitivity reactions such as irritation, burning sensation, redness, pain, itching, eyelid swelling or lacrimation have been reported, which disappeared immediately after discontinuation of the product.

Shelf life. 3 years.

The product should not be used after the expiry date stated on the packaging.

The product can be used for 6 months after first opening the container.

Storage conditions.

Store at temperatures not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 ml of ophthalmic solution in a multidose plastic container equipped with an air-tight pump and closed with a cap. 1 container per cardboard box.

Supply category. Over-the-counter.

Manufacturer. URSAPHARM Arzneimittel GmbH / URSAPHARM Arzneimittel GmbH.

Manufacturer's address and place of business.

Industriestrasse 35, 66129 Saarbrucken, Germany / Industriestrasse 35, 66129 Saarbrucken, Germany.