PASTA ROZENTALA

INSTRUCTIONS for medical use of the medicinal product HYLO-COMOD Forte

Composition

active substance: hyaluronic acid; 1 ml of solution contains 2 mg of sodium hyaluronate; excipients: anhydrous citric acid, sodium citrate, sorbitol (E 420), water for injection.

Pharmaceutical form

Eye drops.

Main physical and chemical 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 treating dry eye is to increase the stability and volume of the precorneal tear film. Hyaluronic acid, which is part of the preparation in the form of sodium hyaluronate, has a chemical structure, molecular weight, and rheological properties similar to those of mucin, a component of human tears. Due to its properties, hyaluronic acid moisturizes the eye without impairing vision. Additionally, its ability to bind water allows it to maintain the moisture of the eye surface.

When applied locally, hyaluronic acid increases the stability of the precorneal tear film, has a positive effect on the epithelial layer, contributes to an increase in the volume of tear fluid and corneal moisture, and also reduces the evaporation of tears from the eye surface.

Pharmacokinetics

Sodium hyaluronate is not absorbed after local application. In fact, there are no facts that would indicate that hyaluronic acid can penetrate the cornea. Even after direct administration into the inner chamber of the eye, only immeasurably small concentrations of hyaluronic acid were found in the bloodstream, which were quickly metabolized by the liver; therefore, when using the preparation, the development of systemic toxic reactions is not expected.

Clinical characteristics

Indications

Symptomatic treatment of dryness of the cornea and conjunctiva (dry eye syndrome), including severe forms, as well as after surgical interventions.

Contraindications

Hypersensitivity to any component of the preparation.

Interaction with other medicinal products and other types of interactions

It is recommended to avoid simultaneous use of HYLO-COMOD eye drops with other ophthalmic preparations. If such a need still exists, these preparations should be instilled no later than 30 minutes before applying HYLO-COMOD eye drops. However, eye ointments should always be applied last.

Since, when used locally in ophthalmology, the preparation immediately reaches the target organ and has a physical effect (moisturizing the eye surface) and does not have a systemic effect, no medicinal interactions of the preparation are expected, except for physical interactions with eye drops for local use.

Special instructions

The preparation is compatible with all types of contact lenses and can improve the feeling of comfort when wearing contact lenses. In case of severe or persistent dry eye, it is necessary to consult a doctor.

Use during pregnancy or breastfeeding

Controlled studies of the use of the preparation during pregnancy or breastfeeding have not been conducted.

However, the HYLO-COMOD Forte preparation can be used during pregnancy or breastfeeding, since it does not have a systemic pharmacological effect.

Ability to affect the speed of reaction when driving vehicles or using other mechanisms

In individual cases, immediately after instillation, HYLO-COMOD eye drops can cause short-term blurring of vision, even with proper use in usual doses. Since this can increase the reaction time, it is recommended to start driving a car or working with complex mechanisms after some time after instillation, provided that vision clarity is restored.

Method of application and dosage

Usually, 1 drop of the preparation is instilled into each eye three times a day. If necessary, the frequency of instillation can be increased. A significant increase in the frequency of instillation of the HYLO-COMOD Forte preparation (for example, more than 10 times a day) is allowed to be carried out by the decision of the ophthalmologist and under their supervision.

In the absence of contraindications due to the underlying disease, the HYLO-COMOD Forte preparation can be used when wearing contact lenses, since it does not lead to the formation of a film or sediment on them.

The HYLO-COMOD Forte preparation is intended for individual use by only one person. The duration of treatment is determined by the doctor individually.

When instilling eye drops, it is necessary to avoid any contact between the container nozzle and the eye or skin.

Method of application

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

Children

Data on the use of the preparation for the treatment of children are not available.

Overdose

Cases of overdose of the preparation have not been reported.

Adverse reactions

Since the HYLO-COMOD Forte preparation does not contain preservatives, it is well tolerated even with prolonged use. In extremely rare cases, the development of hypersensitivity reactions, such as irritation, burning sensation, redness, pain, itching, swelling of the eyelids, or lacrimation, has been reported, which disappeared immediately after stopping the use of the preparation.

Shelf life

3 years.

The preparation should not be used after the expiration date stated on the packaging.

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

Storage conditions

Store at a temperature not exceeding 25°C.

Store in a place inaccessible to children.

Packaging

10 ml of eye drop solution in a multidose plastic container with a tamper-evident pump and closed with a cap. 1 container in a cardboard box.

Release category

Without a prescription.

Manufacturer

URSAPHARM Arzneimittel GmbH.

Location of the manufacturer and address of the place of business

Industriestrasse 35, 66129 Saarbrucken, Germany.