Descriptive sheet THEALOZ GEL
Description
Medical device.
Ophthalmic gel indicated for the protection, hydration and lubrication of the eye in the treatment of moderate to severe dry eye syndrome.
It is recommended in case of discomfort, stinging sensation, foreign body or eye irritation due to moderate to severe dry eyes.
THEALOZ GEL provides immediate relief from dry eye symptoms that lasts all day. The main ingredients of THEALOZ GEL are trehalose, sodium hyaluronate, and carbomer (Carbopol 974P). Trehalose is a natural substance found in many plants and animals that can survive extremely dry conditions. 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 speeding up healing of the ocular surface. Carbomer allows THEALOZ GEL to remain on the surface of the eye for a long time, providing long-lasting relief from the signs and symptoms of dry eye.
Thanks to the combination of trehalose, sodium hyaluronate and carbomer, THEALOZ GEL offers long-term protection, hydration and lubrication of the eye surface.
THEALOZ GEL is gentle on the eyes because it is preservative-free. The absence of preservatives protects ocular tissue and does not cause reactions in users sensitive to preservatives.
Sterile, phosphate-free, hypotonic and pH-neutral gel.
How to use
Dosage: 1 drop in each eye, 1 to 4 times daily.
Particularly suitable for evening use, just before going to bed.
No special training is required to use THEALOZ GEL.
For contact lens wearers: Remove contact lenses before using THEALOZ GEL. After use, wait at least 30 minutes before putting your lenses back in.
Wash your hands thoroughly before use. Open the foil pouch and separate a single-dose container from the strip. Return the remaining strip to the pouch. Do not use any tools to open the container.
Invert the container and tap until the gel runs out. Open the container by twisting the top tab. To avoid contamination, do not touch the tip of the container with anything. Squeeze until a drop appears. Apply one drop to the hollow of the eyelid, gently pulling down the lower eyelid and looking up. Gently close the eye after application.
Discard the disposable container, even if there is some gel left. Do not store.
Components
Trehalose (3%), sodium hyaluronate (0.15%), carbomer (Carbopol 974P, 0.25%), sorbitol, sodium hydroxide and water for injections.
Warnings
For ophthalmic use only.
Keep out of the sight and reach of children.
After use, do not drive or operate machinery. If your vision is blurred, wait a few minutes for it to clear.
Wait at least 15 minutes between using two different ophthalmic products.
Check that the packaging is intact before first use: use only if the sachets and disposable containers are unopened.
To avoid contamination, do not touch the tip of the container to anything.
Do not reuse the container, because once opened the contents are not protected from microbial contamination.
You should contact a healthcare provider if your symptoms worsen or do not improve.
The following side effects have been reported: rare possibility of mild eye irritation and eye redness.
When using an eye gel, you may experience unpleasant symptoms, such as burning sensation, stinging sensation, foreign body sensation in the eye, and blurred vision for a short time.
If you notice any side effects or unusual sensations after using this product, contact a healthcare professional and report the information to your local distributor, manufacturer, or local health authority.
Do not inject or ingest.
Do not use THEALOZ GEL if you are allergic to any of its ingredients.
Conservation
Store between 8°C and 30°C. Do not expose to direct light or moisture.
Do not use after the expiration date shown on the single-dose container and outer carton. The expiration date refers to the last day of that month, provided the package is intact and has been stored properly.
Shelf life when packaging is intact: 18 months.
Format
30 single-dose containers of 0.4 g