Artelac^® Night (Solution) Instructions for Use

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH (Germany)

Contact Information

BAUSH HEALTH LLC (Russia)

Dosage Form

Artelac® Night

Ophthalmic solution 0.24%: bottle 10 ml with dispenser

Dosage Form, Packaging, and Product Composition

Excipients: carbomer, glycerol, lipid component (medium-chain triglycerides), sodium hydroxide, purified water.

10 ml – bottles (1) with dispenser – cardboard packs.

Therapeutic Category

Medical device for eye hydration

Properties

Artelac^® Night is an ophthalmic solution containing 0.24% hyaluronic acid (as sodium hyaluronate) as the main component.

The advanced formula has very good tolerability as it is free of preservatives and buffers. The medical device does not contain a medicinal product.

The ophthalmic solution is presented in a refined innovative multi-dose, preservative-free system that is simple and safe to use. After opening, the bottle with drops can be used for 6 months.

Artelac^® Night is a comprehensive hydration product that supports all three layers of the tear film: the lipid, aqueous, and mucin phases to improve and maintain the hydration of the ocular surface for any symptoms of dryness and discomfort in the eyes.

The lipid component – medium-chain triglycerides – has a protective effect by reducing evaporation of the lipid layer in the tear film.

The natural moisturizer – Hyaluronic acid (as sodium hyaluronate), which is found in the structures of a healthy human eye and in the natural tear film, together with glycerol (glycerin) attracts moisture, supporting and restoring the aqueous layer in the tear film.

The carbomer component, due to its viscous structure, binds water molecules and restores the mucin layer. Carbomer also has a long-lasting moisturizing effect.

Artelac^® Night is a product for maintaining the healthy condition of the eye surface, it distributes over the surface and provides intensive hydration for immediate and long-lasting relief of symptoms. It is an ideal product for any user suffering from dry eye symptoms such as fatigue, irritation, burning and/or watering.

Can be used both at home and in healthcare facilities.

Scope of Application

Of the Artelac^® Night product

For moisturizing the anterior surface of the eye (cornea and conjunctiva)

• For dry eye syndrome requiring additional moisturization of the conjunctiva and cornea, moderate and severe degrees, Sjögren’s syndrome;
• To eliminate dryness, sensation of grit in the eyes, burning, tearing, itching, redness, eye fatigue that have arisen as a result of past diseases, including conjunctivitis, keratoconjunctivitis;
• To eliminate increased eye dryness in case of systematic use of medicinal products such as anti-inflammatory, hormonal agents, antibiotics, antihistamines, antiglaucoma, antidepressants, beta-blockers, antispasmodics, diuretics;
• For eye hydration after ophthalmic surgical interventions, including laser refractive surgeries (LASIK and others), as well as for corneal microtraumas;
• To eliminate discomfort in patients who use contact lenses, including for the prevention of dry eyes;
• For the prevention of conjunctival-corneal xerosis in case of environmental pollution (smoke, smog, dust and other negative factors);
• For increased visual strain with frequent work at a computer or any display medium;
• For dry eyes due to being in a room with dry air from air conditioning or heating;
• For dryness or tearing due to windy weather.

ICD codes

Dosage Regimen

Instill 1 drop of Artelac^® Night into the conjunctival sac of the eye as needed. Can be used every day and as often as necessary, during the day and at night.

There are no restrictions on the duration of use.

Method of Application

Before first use of the bottle, and also if the bottle has not been used for a long time, it is necessary to remove the cap, point the bottle downwards, and press repeatedly (up to 20 times) until a drop appears. The bottle is now ready for use. It is recommended to press the dispenser valve sharply.

1. It is necessary to remove the protective cap from the tip before each use.

2. Attention! Before first use of the bottle, and also if the bottle has not been used for a long time, turn the bottle upside down as shown in the illustration and press several times until the first drop appears.

3. Hold the bottle as indicated in the illustration: place your thumb on the convenient thumb rest and grasp the lower part with your fingers. Place two fingers on the bottom of the bottle.

4. Point the bottle tip downwards, gently pull down the lower eyelid with the finger of your free hand, holding the bottle vertically above the eye. Press the dispenser lightly to apply one drop into the eye.

After this, close your eyes and slowly move your eyes in all directions so that the drop distributes over the surface of the eye.

The innovative pump mechanism of the Artelac^® Night bottle allows the use of the ophthalmic solution without preservatives.

Side Effects

Local hypersensitivity reactions have been reported very rarely. Use in such cases should be discontinued and a doctor should be consulted.

Contraindications

• Hypersensitivity to any of the components.

Special Precautions

Avoid contact of the bottle tip with fingers or any other surfaces to prevent possible contamination of the solution.

After use, shake off any remaining drops after application.

Remove contact lenses before use.

Wait approximately 15 minutes before using another ophthalmic product or before inserting contact lenses.

Do not use if the packaging or bottle is damaged.

Disposal

Artelac^® Night subject to disposal after use, as well as upon expiration of the shelf life or in case of packaging integrity violation, belongs to hazard class A. When used at home, disposal in household waste containers is permitted.

Medical devices after use for their intended purpose in healthcare facilities are classified as hazard class B. After hardware methods of deactivation using physical methods and changing the appearance of the waste, which excludes the possibility of their reuse, class B waste can be accumulated, temporarily stored, transported, destroyed, and disposed of together with class A. The packaging of deactivated class B medical waste must be marked indicating the deactivation of medical waste. Disposal must be carried out by accredited organizations.

Effect on the Ability to Drive Vehicles and Operate Machinery

This product may cause temporary blurred vision after instillation due to the presence of the carbomer component, which may negatively affect the ability to drive vehicles or operate machinery.

Storage Conditions

Artelac^® Night should be stored out of the reach of children at a temperature from 1°C (33.8°F) to 25°C (77°F).

Shelf Life

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

After opening the bottle, Artelac^® Night should be used within 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.