THEALOZ DUO GEL for moisturizing the eye x 30
INSTRUCTIONS FOR USE
THEALOZ® DUO GEL
This product is a medical device. Please read the instructions before use.
Keep this leaflet. You may need to read it again.
INDICATIONS
THEALOZ DUO GEL is indicated to protect, moisturize and lubricate the eye in the treatment of moderate to severe Dry Eye Syndrome.
For ocular use only.
APPROPRIATE FOR
- Adults,
- Children: Parents or caregivers must place the product,
- Pregnant or lactating women, based on current knowledge.
CONTRAINDICATIONS
Do not inject or swallow.
Do not use THEALOZ DUO GEL if you are allergic to any of its ingredients (see Product Description).
PRODUCT DESCRIPTION
THEALOZ DUO GEL is an ophthalmic gel containing trehalose (3%), sodium hyaluronate (0.15%), carbomer (Carbopol 974P, 0.25%), sorbitol, sodium hydroxide and water for injections.
THEALOZ DUO GEL is a sterile, phosphate-free, hypotonic and pH neutral liquid gel.
THEALOZ DUO GEL is gentle on the eyes as it contains no preservatives. The absence of preservatives allows the protection of eye tissues and also does not cause reactions on the part of users who are sensitive to preservatives.
BENEFIT, PRESENTATION AND MECHANISM OF ACTION
THEALOZ DUO GEL is recommended in case of discomfort, "pinching", foreign body or eye irritation. These symptoms can be triggered by external factors such as wind, tobacco smoke, pollution, dust, sun or cold, dry heat, air conditioning, travel and prolonged standing in front of a computer screen and eye surgery, such as
refractive surgery and cataract surgery.
THEALOZ DUO GEL provides eye comfort, long-lasting relief
dry eye symptoms as described above.
The main ingredients of THEALOZ DUO GEL are trehalose, sodium hyaluronate and carbomer (Carbopol 974P).
Trehalose is a natural substance present in many plants and animals and can exist in extremely dry conditions. It has protective and hydrating (moisturizing) properties.
Sodium hyaluronate, found naturally in the human eye, holds water to hydrate and lubricate the surface of the eye. It holds the solution on the surface of the eye, providing long-lasting relief and shortening the healing time of the ocular surface.
Carbomer allows THEALOZ DUO GEL to stay longer on the ocular surface, providing long-lasting relief from the signs and symptoms of dry eye.
The special combination of trehalose, sodium hyaluronate and carbomer in THEALOZ DUO GEL provides particularly long-lasting protection, moisturizing and lubrication of the eye surface.
GENERAL APPLICATION RECOMMENDATIONS
Dosage : 1 drop in each eye, 1 to 4 times a day.
However, due to the fact that it is a gel, THEALOZ DUO GEL is particularly suitable for application in the evening, immediately before going to bed.
No special training is required before applying THEALOZ DUO GEL.
If you wear contact lenses: you must remove them before applying THEALOZ DUO GEL.
After using the gel, you should wait at least 30 minutes before putting your contact lenses back in.
Wash your hands thoroughly before use.
Open the aluminum sachet and separate one single-use vial from the strip.
Put the rest of the strip back into the sachet.
Do not use any tools to open the vial.
Turn it upside down, gently shake and tap the vial until the gel comes off.
Open the vial by twisting the top.
To prevent contamination, do not touch the tip of the vial to anything.
Squeeze until a drop appears.
Place one drop in the eyelid pocket by gently pulling the lower eyelid down and looking up. Close the eye slightly after application.
Throw away the single-use vial, even if there is some gel left in it, do not keep it.
PRECAUTIONS FOR USE
Check that the packaging is not damaged before the first use: use only if the sachets or single-use vials are whole (unopened).
To avoid contamination, do not touch the tip of the vial to anything.
Do not reuse the vial, as once opened the contents are not protected from microbial contamination.
You should seek medical attention if your symptoms worsen or do not improve.
WARNINGS
Keep out of the reach of children.
You should not drive or operate machinery if your vision is blurred after use: wait five minutes for your vision to recover (clear).
Wait at least 15 minutes between applying another eye product. THEALOZ DUO GEL should be applied last.
UNWANTED REACTIONS
The following side effects have been reported: rare cases of mild irritation and redness of the eyes.
When applying the eye gel, you may experience some symptoms of discomfort, such as a burning sensation, "pinching", feeling of a foreign body in the eye and blurred vision for a short period of time.
If you notice any side effects or unusual sensation after using this product, please consult your doctor and report this information to the local distributor, manufacturer or your local health authority (see contact information at the end of the instructions for use).
STORAGE AND DISPOSAL CONDITIONS
Store between 8°C and 30°C.
Do not expose your product to direct sunlight or moisture.
Discard the single-use vial immediately after use, even though there may be some gel left in it.
Store unopened vials in their sachet to protect from light.
Unopened single-use vials can be used up to one month after first opening the sachet.
Do not use after the expiry date stated on the single-use vial and carton.
The expiration date corresponds to the last day of the specified month, in case the packaging has not been opened and stored properly.
Dispose of the product responsibly according to local regulations (the single-use vial and sachet must be disposed of in the household waste container, the carton and leaflet can be recycled).
Date of issue and version of the instructions for use: Ver. 6 11/2020
0459
Manufacturer :
Laboratoires Théa
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2 France
«Contact Information»
Bulgaria:
Distributor : Tea Pharma OOD, Sofia 1113, Shipchenski Prohod Blvd. 18, Galaxy Shopping Center, Office 110, Bulgaria
Health authority : Executive Agency for Medicines, Sofia 1303, 8 "Damyan Gruev" St., Bulgaria
