Tears naturale^® (Drops) Instructions for Use

Marketing Authorization Holder

Alcon Laboratories, Inc. (USA)

Manufactured By

Alcon-Couvreur N.V., S.A. (Belgium)

ATC Code

S01XA20 (Artificial tears and other indifferent preparations)

Active Substances

Hypromellose (Rec.INN registered by WHO)

Dextran 70 (Rec.INN registered by WHO)

Dosage Form

Tears naturale®

Eye drops: dropper bottle 15 ml

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent, slightly viscous liquid from colorless to slightly yellowish in color.

Excipients: benzalkonium chloride – 0.1 mg, disodium edetate – 0.5 mg, sodium chloride – 7.7 mg, potassium chloride – 1.2 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water – up to 1 ml.

15 ml – polyethylene dropper bottles “Droptainer^®” (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for moisturizing and protecting the cornea

Pharmacotherapeutic Group

Keratoprotector

Pharmacological Action

A preparation for moisturizing the cornea. Tears naturale^® contains a water-soluble polymer system (Duasorb) which, in combination with the eye’s natural tear fluid, increases the stability of the tear film.

The preparation replenishes the deficiency of tear fluid and improves corneal hydration.

After a single instillation, the effect of the preparation lasts for 90 minutes.

Pharmacokinetics

Data on the pharmacokinetics of Tears naturale^® are not available.

Indications

• Dry eye syndrome;
• Relief of corneal syndrome (including discomfort, burning, sensation of a foreign body).

ICD codes

Dosage Regimen

Instill 1-2 drops into the conjunctival sac of the affected eye(s) as needed for symptom relief.

Administer the drops while awake; frequency depends on the severity of dryness and environmental factors.

For severe dry eye syndrome, use the preparation more frequently, up to several times per hour if necessary.

If symptoms persist or worsen despite regular use, discontinue the preparation and consult a physician.

Remove contact lenses before instillation and reinsert them no sooner than 15 minutes after application.

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

Do not use the solution if it becomes discolored or cloudy.

Discard the opened bottle after one month to reduce the risk of microbial contamination, even if solution remains.

Adverse Reactions

Possible allergic reactions.

Contraindications

• Hypersensitivity to the components of the preparation.

Use in Pregnancy and Lactation

Adequate and strictly controlled clinical studies on the safety and efficacy of Tears naturale^® use during pregnancy and lactation (breastfeeding) have not been conducted.

Pediatric Use

There are no data on the possibility of using the preparation in children.

Special Precautions

The preparation is not intended for injection.

Patients using contact lenses should remove them before instilling the preparation and reinsert them 15 minutes after instillation.

The patient must be informed that when using the preparation, the tip of the dropper should not be touched to any surface to avoid contamination of the bottle contents.

Use in pediatrics

There are no data on the possibility of using the preparation in children.

Overdose

Currently, there is no information on overdose of the preparation.

Drug Interactions

Clinically significant interaction of Tears naturale^® has not been established.

Storage Conditions

The preparation should be stored out of the reach of children at a temperature from 8°C (46.4°F) to 30°C (86°F).

Shelf Life

Shelf life – 3 years.

After opening the bottle, the preparation should be used within 1 month.

Dispensing Status

The preparation 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.