Ocutears^® (Solution) Instructions for Use

Marketing Authorization Holder

Santen, Oy (Finland)

Manufactured By

I.com medical, GmbH (Germany)

Dosage Form

Ocutears®

Ophthalmic moisturizing solution 1.5 mg/1 ml: container 10 ml 1 or 420 pcs.

Dosage Form, Packaging, and Product Composition

Ophthalmic moisturizing solution sterile, preservative-free, protects and moisturizes the eye surface.

Composition sodium hyaluronate 0.15%, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, manganese chloride tetrahydrate, hydrochloric acid/sodium chloride to pH 6.8-7.6, purified water.

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

Properties

Ocutears^® is a sterile, preservative-free ophthalmic solution that protects and moisturizes the eye surface.

The composition of Ocutears^® solution includes only components that are naturally present in the eye tissues, which makes its action similar to that of natural tears: it protects, moisturizes, and lubricates the eye surface.

Ocutears^® can be used while wearing soft and rigid contact lenses.

Scope of Application

Of the product Ocutears^®

For the relief of symptoms in dry eye caused by

• Dry keratoconjunctivitis (Sjögren’s syndrome);
• Corneal damage, erosion, or corneal surgeries;
• Contact lens wear;
• Hormonal changes (menopause);
• Environmental factors (wind, cold, dust, smoke, air conditioning, dry or polluted air);
• Working at a computer monitor, long-distance driving, long-haul flights;
• Swimming in chlorinated water.

ICD codes

Dosage Regimen

The recommended dose is 1 drop in each eye 1-4 times/day or as needed.

Instructions for Use

Before first use, remove the protective ring from the cap by pulling the tear-off tab.

Remove the protective cap.

By pressing on the bottle from both sides, instill 1 drop into both eyes or onto contact lenses.

Close the bottle with the protective cap.

After instillation, gentle massage of the eyelids with closed eyes will help distribute the solution over the eye surface more quickly.

Side Effects

As with the use of other eye drops, mild temporary eye discomfort associated with the instillation of the solution may occur.

If any side effects not listed in the instructions are noted, the patient should consult their doctor.

Contraindications

• Hypersensitivity to the components included in the solution.

Special Instructions

In the presence of chronic diseases, it is necessary to consult a doctor before using Ocutears^® solution.

Ocutears^® should not be used in case of an eye infection.

Due to the risk of solution contamination, contact of the bottle tip with other surfaces or hands should be avoided; contact of the bottle tip with the eye should also be avoided.

This solution should not be used if the protective ring or bottle is damaged.

This solution should not be used simultaneously with other topical ophthalmic agents. When using other eye drops, wait at least 5 minutes before instilling Ocutears^®.

The date of first opening should be recorded on the bottle.

The used bottle, the bottle after 6 months from the first opening, or after the expiration date should be disposed of with household waste.

Use in Pediatrics

Clinical studies on the use of Ocutears^® solution in children have not been conducted.

Effect on the Ability to Drive Vehicles and Operate Machinery

Ocutears^® does not affect the ability to drive a car and operate machinery.

As with the use of any other ophthalmic agents, short-term blurred vision may occur after instillation. In this case, it is necessary to wait until vision is completely restored, and only then drive a car or operate mechanical equipment.

Storage Conditions

Ocutears^® should be stored out of the reach of children at a temperature from 2°C (35.6°F) to 25°C (77°F); do not freeze.

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the packaging.

After first opening the bottle, Ocutears^® can be used for 6 months.

Dispensing Status

Over-the-Counter

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.