Product features:

Artelac - Nighttime Gel
Our nighttime solution for all forms of dry eye*.

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

Description:
Artelac NighttimeGel is specially formulated as a nighttime protection for all forms of dry eye*. The gel provides long-lasting moisture to the eye's surface, protecting it from drying out. It can be used in addition to a thin, liquid eye moisturizer such as Artelac Splash.

*Can be used as a supplement; treatment should be discontinued in case of hypersensitivity reactions.

Intended purpose:
Artelac NighttimeGel is an eye moisturizer.

What is Artelac NighttimeGel used for?
Artelac NighttimeGel is suitable for people who suffer from symptoms of dry eye such as tired, stressed, burning and/or watery eyes or a foreign body sensation in the eye.

You can also use this product as a supplement to your existing eye moisturizers and thus benefit from additional protection.

When should Artelac NighttimeGel be used:
Artelac NighttimeGel is a highly viscous ocular moisturizer that replenishes all three layers of the tear film and provides long-lasting moisture and protection to the ocular surface in cases of dry eye symptoms.

Artelac NighttimeGel is formulated to replenish the tear film, including the important outer lipid layer. It provides comprehensive symptom relief and locks in moisture on the eye's surface. It moisturizes and soothes the eyes while providing long-lasting symptom relief by sealing in moisture.

Dry eyes are caused by:

• External factors such as extensive computer use, air conditioning, heating, cigarette smoke, windy environments, and wearing contact lenses
• Other factors, such as certain medications (like birth control pills, antihistamines, beta-blockers, antispasmodics and diuretics) or certain diseases, may play a role in the development of dry eyes.

How often should Artelac NighttimeGel be used?
Apply one drop of Artelac NighttimeGel to the eye 15 minutes before bedtime (if you prefer nighttime application). You can use Artelac NighttimeGel up to 4 times a day. Once opened, the product can be used for 6 weeks.

How should Artelac NighttimeGel be applied?

1. Remove the protective cap from the tip of the tube before each use.
2. Tilt your head back slightly, gently pull down your lower eyelid with a finger of your free hand, and hold the tube vertically above your eye with the dropper tip pointing downwards. Squeeze the tube gently to dispense one drop of gel into your eye.
3. Replace the protective cap on the tube after each use. Close your eye and slowly move your eyeball from side to side to distribute the gel drop as evenly as possible across the surface of the eye.

When should Artelac NighttimeGel not be used:
Do not use the product if you are hypersensitive to any of the ingredients.

Important information on the use of Artelac NighttimeGel:

• Local hypersensitivity reactions have been reported very rarely. In these cases, treatment should be discontinued. If you experience persistent discomfort or irritation, discontinue use of the product and consult your doctor.
• This product may temporarily cause blurred vision after instillation, which may negatively affect the ability to drive motor vehicles or operate machinery.
• To avoid possible injury, do not touch the surface of the eye with the dropper tip.
• Avoid touching your eye or fingers with the dropper tip to prevent possible contamination of the solution.
• Do not share the tube with other people once you have opened it.
• Contact lenses must be removed before use.
• Wait approximately 15 minutes before applying any other eye medication or reinserting your contact lenses.
• Dispose of the medical device 6 weeks after first opening.
• Do not use after the expiry date.
• Do not use if packaging or tube is damaged.
• Artelac NighttimeGel contains small plastic parts (tube cap) that could be swallowed by small children. Choking hazard. Therefore, Artelac NighttimeGel should be kept out of the reach of children.
• This product can be used independently by laypersons. No special training is required to use the product.
• Consult a doctor before using an eye moisturizer on children.
• Do not use during concurrent Oxervat therapy for neurotrophic keratitis.

How should Artelac NighttimeGel be stored?
Store the product at a maximum temperature of 25°C.

Disposal:
The product must be disposed of in accordance with local regulations.

Any serious incident related to the product must be reported to the manufacturer and the relevant authority.

Package sizes:
Artelac NighttimeGel is available in pack sizes of 10 g and 3 x 10 g tubes.

Manufacturer:
Dr. Gerhard Mann
chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 16
13581 Berlin
Germany

This leaflet was last revised in September 2023.

Ingredients:
Carbomer, medium-chain triglycerides, water for injection, sorbitol, and sodium hydroxide. Cetrimide is used as a preservative.

Source: www.bausch-lomb.de and information from the package insert
As of May 2025