Description
Medical device.
THEALOZ DUO is indicated for the protection, hydration and lubrication of the eye in the treatment of moderate to severe dry eye syndrome. For ophthalmic use only.
THEALOZ DUO is an ophthalmic solution composed of trehalose (3%), sodium hyaluronate (0.15%), sodium chloride, trometamol, hydrochloric acid and water for injections.
THEALOZ DUO is a sterile, phosphate-free, isotonic, and pH-neutral solution.
The solution is provided in an ABAKR multi-dose bottle. This innovative and patented device dispenses the eye drops through a 0.2 mcm filter, preventing any bacterial contamination of the solution without the use of preservatives. Therefore, THEALOZ DUO is gentle on the eyes as it is preservative-free. The absence of preservatives protects ocular tissues and does not cause reactions in users sensitive to preservatives.
THEALOZ DUO is recommended for discomfort, stinging, foreign body sensation, or eye irritation due to moderate to severe dry eye. Such symptoms can be caused, for example, by external factors such as wind, smoke, pollution, dust, exposure to sun or cold, dry heat, air conditioning, air travel, and long hours spent in front of a computer screen. THEALOZ DUO provides immediate relief from dry eye symptoms, lasting all day. THEALOZ DUO is well tolerated on the ocular surface and can be used by contact lens wearers, regardless of the type of lenses. The main ingredients of THEALOZ DUO are trehalose and sodium hyaluronate. Trehalose is a natural substance found in many plants and animals, which can survive in conditions of extreme dryness. It provides protective and moisturizing properties. Sodium hyaluronate, present in the human eye, retains water to hydrate and lubricate the surface of the eye. It keeps the solution on the surface of the eye, providing long-lasting relief and shortening the healing time of the corneal epithelium. Thanks to the combination of trehalose and sodium hyaluronate, THEALOZ DUO offers long-term protection, hydration and lubrication of the eye surface.

Directions for use
Dosage: 1 drop in each eye, 4 to 6 times a day.
No special training is required to use THEALOZ DUO. Wash hands thoroughly before use. Do not use any tools to open the bottle. When using THEALOZ DUO for the first time, the first drop takes longer to come out due to the bottle's filtration system (see Device Description). Apply one drop into the eyelid cavity, gently pulling down the lower eyelid and looking up. Gently close the eye after application. Replace the cap on the bottle after use.

Warnings
Do not inject or swallow. Do not use THEALOZ DUO if you are allergic to any of its ingredients.
Multi-dose product for a single patient. Do not use the same bottle for multiple people to prevent cross-contamination.
Check that the packaging is intact before using this product. Check that the tamper-evident seal on the bottle is intact before first use. To avoid contamination, do not touch the tip of the bottle with any surface. You should contact a healthcare professional if symptoms worsen or do not improve.
Keep out of sight and reach of children. After use, do not drive or operate machinery. If vision is blurred, wait a few minutes for vision to clear. Wait at least 10 minutes between the use of two different ophthalmic products. Do not dilute THEALOZ DUO or mix with other solutions. After first use, if exposed to low atmospheric pressure, the bottle may leak.
The following side effects have been reported: rare possibility of mild eye irritation and eye redness. In such cases, contact lens wearers should remove contact lenses.
When using eye drops, annoying symptoms may occur, such as burning sensation, stinging sensation, foreign body sensation in the eyes and blurred vision for a short period. If you notice side effects or unusual sensations after using this product, contact a healthcare professional and report the information to the local distributor, manufacturer or local health authority (see contacts at the end of the instructions for use).

Storage
Store at a temperature between 8 °C and 30 °C. Do not expose the product to direct light and humidity. Do not use after the expiry date, which is stated on the bottle and outer packaging. The expiry date refers to the last day of that month, provided the packaging is intact and has been stored correctly. After this time, dispose of any remaining product responsibly. Dispose of the product responsibly and according to local guidelines (the bottle should be disposed of as household waste, the outer carton and leaflet are recyclable).
Shelf life after opening: 3 months.

Format
15 ml bottle.