Defislez^® (Drops) Instructions for Use

Marketing Authorization Holder

Sintez PJSC (Russia)

Contact Information

Sintez PJSC Kurgan Joint Stock Company of Medical Preparations and Products (Russia)

ATC Code

S01KA02 (Hypromellose)

Active Substance

Hypromellose (Rec.INN registered by WHO)

Dosage Form

Defislez®

Eye drops 3 mg/1 ml: dropper bottle 5 ml or 10 ml; bottle 5 ml or 10 ml.

Dosage Form, Packaging, and Composition

Eye drops as a transparent or slightly opalescent, colorless or slightly colored liquid.

Excipients: benzalkonium chloride (100 µg/ml), sodium chloride (2 mg/ml), disodium edetate (1 mg/ml), sodium phosphate monobasic dihydrate (3.5 mg/ml), sodium phosphate dibasic dodecahydrate (24 mg/ml), water for injections.

10 ml – polyethylene dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for moisturizing and protecting the cornea

Pharmacotherapeutic Group

Keratoprotector

Pharmacological Action

Corneal epithelium protector. It has a moisturizing and protective effect on the cornea with reduced secretion of tear fluid. Having high viscosity, it increases the duration of contact of the solution with the cornea. The refractive index of the solution is similar to natural tears.

It restores, stabilizes, and reproduces the optical characteristics of the tear film.

Subjective and objective improvement of the condition (reduction of hyperemia, epithelialization of lesions) usually occurs within 3-5 days, pronounced improvement or complete cure – within 2-3 weeks.

Pharmacokinetics

Data on the pharmacokinetics of the drug Defislez^® are not provided.

Indications

• Erosion and trophic ulcers of the cornea;
• Microtraumas of the corneal epithelium;
• Bullous dystrophic changes of the cornea;
• Keratopathy;
• Ectropion;
• Lagophthalmos;
• Deformation of the eyelids;
• Condition after plastic surgery on the eyelids;
• Condition after thermal and chemical burns of the cornea and conjunctiva;
• Condition after keratoplasty, keratectomy;
• Replacement therapy for reduced secretion of tear fluid;
• Dry eye syndrome (Sjogren’s syndrome), xerosis, keratosis (as part of combination therapy);
• Increased sensitivity of the eyes;
• After performing diagnostic procedures: gonioscopy, electroretinography, electrooculography, echobiometric examination of the eyeball.

ICD codes

Dosage Regimen

Instill 1-2 drops into the conjunctival sac of the affected eye(s) 4-8 times per day.

For severe symptoms of dry eye or significant corneal damage, increase the frequency to 1-2 drops every hour as needed.

Adhere to a standard treatment course of 2-3 weeks.

Wash hands thoroughly before the procedure.

Avoid contact between the dropper tip and the eye, eyelids, or any other surface to prevent contamination.

If using more than one topical ophthalmic medication, administer Defislez^® last and maintain an interval of at least 15 minutes between instillations.

Immediately after instillation, transient blurred vision may occur; wait until clear vision is fully restored before driving or operating machinery.

Do not wear soft contact lenses during therapy.

Remove hard contact lenses before application and reinsert them no sooner than 20-30 minutes post-instillation.

Do not use the preparation for longer than the recommended duration without medical supervision.

Adverse Reactions

Local reactions feeling of eyelid sticking (due to the high viscosity of the solution), allergic reactions.

Contraindications

• Hypersensitivity to the components of the drug.

It is not recommended to use the drug in the acute phase of a burn (until the toxic substance is completely removed).

Use in Pregnancy and Lactation

There are no data on the possibility and safety of using the drug during pregnancy and lactation.

Special Precautions

It is not recommended to wear soft contact lenses during the period of drug use. When wearing hard contact lenses, they should be removed before instilling the drug and reinserted no earlier than 20-30 minutes after applying the drug.

Long-term use of the drug Defislez^® is not recommended.

Effect on the ability to drive vehicles and mechanisms

Immediately after instillation, blurred vision is possible, which may lead to difficulties in driving vehicles or operating machinery. Therefore, work requiring clear vision should be started no earlier than 15 minutes after instillation.

Overdose

Overdose is unlikely when using Defislez^® eye drops.

Drug Interactions

The drug Defislez^® is pharmaceutically incompatible with eye drops containing metal salts.

Storage Conditions

The drug should be stored in a light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F); do not freeze.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.