THEALOZ DUO eye drops 10ml
INSTRUCTIONS FOR USE
THEALOZ® DUO
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 is indicated for the protection, moistening and lubrication of the eye in the treatment of moderate to severe Dry Eye Syndrome.
For ocular use only.
SUITABLE FOR
- Adults,
- Children: Parents or caregivers should place the product,
- Pregnant or breastfeeding women, based on current knowledge,
- Wearing all types of contact lenses.
CONTRAINDICATIONS
Do not inject or swallow.
Do not use THEALOZ DUO if you are allergic to any of its ingredients (see Product Description).
PRODUCT DESCRIPTION
THEALOZ DUO is a solution for ophthalmic administration containing trehalose (3%), sodium hyaluronate (0.15%), sodium chloride, trometamol, hydrochloric acid and water for injections.
THEALOZ DUO is a sterile, phosphate-free, hypotonic and pH neutral solution.
The solution is available in an ABAK® multidose bottle. This innovative and patented device allows the application of the eye drops through a 0.2 µm filter, protecting the solution from bacterial contamination, without the presence of any preservatives.
Therefore, THEALOZ DUO is gentle on the eyes as it does not contain preservatives. The absence of preservatives allows for the protection of eye tissues and also does not cause reactions in users who are sensitive to preservatives.
BENEFITS, PRESENTATION AND MECHANISM OF ACTION
THEALOZ DUO is recommended in case of discomfort, “stinging”, foreign body or irritation of the eye. These symptoms can be caused 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 provides immediate comfort throughout the day, relieving the symptoms of dry eyes, as described above.
THEALOZ DUO is well tolerated by the ocular surface and can be used by people wearing all types of contact lenses.
The main ingredients of THEALOZ DUO are trehalose and sodium hyaluronate.
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, 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 reducing the healing time of the ocular surface.
The unique combination of trehalose and sodium hyaluronate in THEALOZ DUO provides long-lasting protection, moisturizing and lubrication of the ocular surface.
GENERAL RECOMMENDATIONS FOR APPLICATION
Dosage: 1 drop in each eye, 4 to 6 times daily.
No special training is required before applying THEALOZ DUO.
Wash your hands thoroughly before use.
Do not use any tools to open the bottle.
When you use THEALOZ DUO for the first time, you will notice that it takes longer for the first drop to separate due to the unique filtration system in the bottle (see Product Description).
Place one drop into the eyelid pocket by gently pulling the lower eyelid down and looking up. Close the eye gently after placing the drop.
After use, put the cap back on the bottle.
PRECAUTIONS FOR USE
The product is intended for multiple use by a single patient.
Do not share the bottle with other people to prevent cross-contamination.
Check that the packaging is not damaged before using this product for the first time.
Check that the safety ring on the bottle is intact before using it for the first time.
To avoid contamination, do not touch the tip of the bottle to any surface.
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 until your vision clears.
Wait at least 10 minutes between applying another eye product.
Never dilute THEALOZ DUO or mix it with other solutions.
After first use, if exposed to low atmospheric pressure, the bottle may leak.
ADVERSE REACTIONS
The following side effects have been reported: rare cases of mild irritation and redness of the eyes.
In these cases, contact lens wearers should remove them.
When using eye drops, you may experience some symptoms of discomfort, such as a burning sensation, "stinging", a feeling of a foreign body in the eye, and blurred vision for a short period of time.
If you notice any adverse reactions or unusual sensations after using this product, please consult your doctor and report this information to the local distributor, the 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.
Do not use after the expiry date stated on the bottle and carton.
The expiry date corresponds to the last day of the month indicated, provided that the packaging has not been opened and has been stored correctly.
The product can be used for up to 6 months after first opening. After this period, dispose of any remaining product as required.
Dispose of the product responsibly, according to local regulations (the bottle should be disposed of in the household waste container, the cardboard packaging and leaflet can be recycled).
Release date and version of the instruction manual: Ver.5 11/2020
Manufacturer:
Laboratoires Théa
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2 France
www.laboratoires-thea.com
«Contact information»
Bulgaria:
Distributor: Tea Pharma Ltd., Sofia 1113, 18 Shipchenski Prohod Blvd., Galaxy Shopping Center, office 110, Bulgaria
Health Authority: Bulgarian Medicines Executive Agency, Sofia 1303, 8 Damyan Gruev Str., Bulgaria
MEANING OF THE PICTOGRAMS ON THE PACKAGING
Manufacturer
Manufacturer Medical Device
Medical device
Batch number
Batch Consult instruction for use
Read the instructions for use
Date of manufacture
Date of manufacture Single patient – Multiple use
Single patient-Multiple use
Use-by date
Best before
Do not use if package is damaged
Do not use if packaging is damaged.
Temperature limits
Storage temperature conditions
Caution
Attention
Sterilized using aseptic processing techniques
Sterilized using aseptic techniques
