Artelac^® Splash (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® Splash

Ophthalmic moisturizing solution 0.24%: bottle 10 ml with dispenser

Dosage Form, Packaging, and Product Composition

Excipients: potassium chloride, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, purified water.

10 ml – plastic bottles (1) with dispenser – cardboard packages.

Therapeutic Category

Medical device for eye hydration

Properties

Crystal clear ophthalmic moisturizing solution. Does not contain preservatives! Sterile.

It contains hyaluronic acid – a natural polymer that is part of the natural tear film and eye tissues. Ideal for wearing both soft and rigid contact lenses throughout the day. The solution can be used for 3 months after first opening.

The tear fluid consists of three layers that provide the eye surface with nutrients, form a protective lubricating barrier between the eyelid and the cornea, and also ensure their normal functioning and clear vision. The natural tear film is distributed over the eye surface with each blink, protecting the eyes from drying out and promoting the healing of superficial corneal damage. When the balance of the tear film is disturbed, a sensation of dryness, burning, foreign body sensation in the eye, eye irritation and redness, a feeling of tiredness, and in some cases, tearing may occur.

Artelac^® Splash moisturizes the eyes for a long time and helps stabilize the tear film to ensure a healthy eye surface condition.

Scope of Application

Of Artelac^® Splash product

• For intensive and long-lasting hydration in cases of pronounced “dry eye” caused by:
  • Lifestyle and exposure to environmental factors, such as prolonged computer work and, as a result, infrequent blinking, staying in an air-conditioned room, cigarette smoke, strong wind;
  • Systemic diseases, eye surgeries, or taking certain medications, such as contraceptives, antihistamines, beta-blockers, antispasmodics, diuretics.
• To eliminate discomfort when wearing rigid and soft contact lenses.

ICD codes

Dosage Regimen

It is recommended to instill Artelac^® Splash into the conjunctival sac of each eye, 1 drop as needed.

Method of Application

How to use Artelac^® Splash

Thanks to the specially designed pumping mechanism of the bottle, the solution remains sterile without preservatives. The figures show how to use Artelac^® Splash.

1. Before each use, it is necessary to remove the protective cap from the bottle tip with a twisting motion.

2. Attention! Before first use and if the bottle has not been used for some time, it is necessary to point the bottle tip downwards and press the pump mechanism repeatedly until a drop appears.

3. Hold the bottle as shown: place the thumb on the ergonomic support and grasp the lower part with the fingers. Two fingers should be placed on the bottom of the bottle.

4. Point the bottle tip downwards. Tilt the head back slightly. Gently pull down the lower eyelid of the eye with a finger of the free hand and hold the bottle vertically above the eye. Gently press the pump mechanism to administer one drop into the eye. Close the eyes and blink to optimally distribute the drop over the eye surface.

5. Immediately after use, it is necessary to remove any possible residual drops and put the transparent white protective cap on the bottle tip.

Contraindications

• Hypersensitivity to any of the components included in the solution (local allergic reactions occurring in rare cases). In such cases, the use of the solution should be discontinued.

Special Instructions

When wearing soft and rigid contact lenses, Artelac^® Splash can be instilled into the conjunctival sac without removing the lenses.

Drug Interactions

In case of concomitant use with ophthalmic drugs, it is recommended to observe a pause of at least 15 minutes between instillation of Artelac^® Splash solution and the use of eye drops.

Eye ointments should always be applied after instillation of Artelac^® Splash solution.

Storage Conditions

Artelac^® Splash 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 in the closed original packaging is 2 years; after opening the bottle – 3 months. Do not use after the expiration date printed on the packaging.

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.