ARTELAC Splash MDO eye drops

Pack size:1 x 10 mlDosage form:eye dropsArtelac - Splash MDO
Our thirst quencher for burning, dry eyes with a gritty feeling.

Please read the following instructions for use carefully, as they contain important information about what you should bear in mind when using this medical device.

Description:
With the natural moisturizer hyaluronic acid, Artelac Splash provides fast and long-lasting relief from the symptoms of dry eyes. The hyaluronic acid is present in a carefully selected concentration, which improves the stability of the natural tear film and binds water. Users experience a noticeably long-lasting feeling of freshness.

Hard and soft contact lenses can be moistened with Artelac Splash while wearing them. The lenses' wearing comfort is noticeably increased throughout the day.

Artelac Splash is preservative-free and therefore very well tolerated. The eye moisturizer is available both in the proven bottle with the patented pump mechanism as Artelac Splash MDO and as practical one-dose ophthalmic tablets for on the go (Artelac Splash EDO).

Intended use:
Eye moisturizer, moisturizing soft and hard contact lenses while wearing them.

What is Artelac Splash MDO?
Artelac Splash MDO is a clear eye drop solution containing 0.24% hyaluronic acid (as sodium hyaluronate). The formulation is very well tolerated because it is preservative-free.

Directions:
Artelac Splash MDO is indicated for the immediate soothing and moisturizing of dry eyes. It naturally refreshes and moisturizes your dry eyes, relieving the symptoms of tired, stressed, and even watery eyes. Artelac Splash MDO is suitable for moisturizing soft and hard contact lenses during wear, noticeably improving the comfort of your contact lenses throughout the day.

When should Artelac Splash MDO be used?
Artelac Splash MDO is designed to remain on the surface of the eye and provide immediate moisture for all symptoms of dry eyes. It is a suitable product for people suffering from a range of mild to moderate dry eye symptoms, such as tired, stressed, burning, and/or watery eyes.

How often and for how long should Artelac Splash MDO be used?
Apply one drop of Artelac Splash MDO to the eye as needed. The drops can be used every day and as often as desired. There is no limit to the duration of use.

How should Artelac Splash MDO be used?
Thanks to Artelac Splash MDO's patented pump mechanism, the eye drop solution requires no preservatives.

General information:
Wash your hands before each use. Avoid contact of the bottle tip with your fingers or eyes to prevent possible contamination of the solution or eye injury.

• Before each use, remove the transparent white protective cap from the tip of the bottle with a twisting motion.
• Caution! Before first use and if the bottle hasn't been used for a while: Point the bottle upside down and repeatedly press the pump mechanism until a drop is released.
• Hold the bottle as directed: Place your thumb on the ergonomic thumb rest and wrap your fingers around the bottom. Two fingers should be placed on the bottom of the bottle.
• Point the bottle with the tip facing down. Lean your head back slightly. Gently pull down your lower eyelid with a finger of your free hand and hold the bottle vertically over your eyes as shown. Gently squeeze the pump mechanism to dispense one drop into your eye. Then close your eye and blink to distribute the drop evenly over the surface of the eye.

Immediately after use, shake off any remaining drops and replace the cap on the bottle tip. Due to the bottle design, a small amount of solution will remain in the bottle. However, the specified amount will be completely dispensed from the bottle.

When should Artelac Splash MDO not be used?
Do not use this product if you are sensitive to any of the ingredients.

Important information about using Artelac Splash MDO:

• In very rare cases, local hypersensitivity reactions may occur. In these cases, treatment must be discontinued. If persistent discomfort or irritation occurs, discontinue use of the product and consult your doctor.
• Safety information for patients with severe corneal damage: In very rare cases, deposits of calcium phosphate on the cornea have been reported during treatment with phosphate-containing products for ophthalmic use.
• Do not touch the surface of the eye with the tip of the bottle to avoid possible injury to the surface of the eye or contamination of the solution.
• Do not touch the tip of the bottle with your fingers to avoid possible contamination of the solution.
• Once opened, do not give the bottle to other people for their use.
• Careless handling of the product contrary to the instructions for use may cause the product to slip out of your hand and cause eye injuries.
• Wait about 15 minutes before using any other eye product.
• Dispose of the medical device 6 months after first opening.
• Do not use after the expiry date.
• Do not use if the package or bottle is damaged.
• Artelac Splash MDO contains small plastic parts that could be swallowed by children. Choking hazard. Therefore, Artelac Splash MDO must be kept out of reach of children.
• Artelac Splash MDO is suitable for use with soft and hard contact lenses.
• No special training is required to use this product.
• Consult a doctor before using lubricating eye drops on children. Based on current knowledge and market experience, this product can also be used by pregnant women and nursing mothers.

Storage:
Store between 1°C and 25°C.

Disposal: Dispose of the product in accordance with local regulations.

Serious incidents associated with the product should be reported to the manufacturer and the relevant authorities.

Dosage form:
Artelac Splash MDO is available in packs of 10 ml and 2 x 15 ml eye drops. Artelac Splash MDO is also available in convenient, preservative-free unit-dose (EDO) containers.

Manufacturer:
Dr. Gerhard Mann
chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 16
13581 Berlin
Email: kontakt@bausch.com

This leaflet was last revised in September 2024.

Ingredients:
0.24% sodium hyaluronate, sodium chloride, potassium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, and water for injection.

Version: 05/2025 0.24% sodium hyaluronate, sodium chloride, potassium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injection.