DEFLUXA EYE DROPS 15 SINGLE-DOSE CONTAINERS OF 0.4 ML

Descriptive sheet

Defluxa

Sterile eye drops
based on Palmitoylethanolamide
and Hydrophilic and hydrating polymers

Without preservatives

INSTRUCTIONS FOR USE
COMPOSITION
Palmitoylethanolamide (PEA), Hyaluronic acid sodium salt (NaHA), Polyvinyl alcohol (PVA), Methyl-B cyclodextrin (MBCD), Potassium citrate tribasic monohydrate, Sodium chloride, Glycerol, Citric acid monohydrate, Sodium phosphate dibasic dodecahydrate, Sodium phosphate monobasic dihydrate, Purified water, in isotonic ophthalmic solution at physiological pH.

PACKAGING
DEFLUXA 15 single-dose containers of 0.4 ml of sterile eye drops, presented in a box containing 3 strips of 5 ml each, each strip inserted in an aluminium pouch.

CHARACTERISTICS AND MECHANISM OF ACTION
DEFLUXA is a sterile, isotonic ophthalmic solution at physiological pH consisting of palmitoylethanolamide (a lipid molecule), hydrophilic and hydrating polymers (hyaluronic acid sac, polyvinyl alcohol and cyclodextrin), glycerol (a molecule with a humectant and osmoprotective action) and mineral salts.
DEFLUXA is able to rebalance the homeostasis of the ocular surface and reconstruct the tear film in all cases of qualitative and quantitative alterations resulting from chronic treatments with topical ocular medications with hypotensive action. Specifically, DEFLUXA stabilizes the tear film and maintains lubrication of the ocular surface by replenishing the three layers of the tear film: lipid, aqueous, and mucin.
PEA, a natural lipid molecule, integrates the lipid layer of the tear film (the outermost layer), prevents hyperevaporation of water, and helps maintain a protective tear layer on the ocular surface. The hydrophilic and hydrating polymers present in DEFLUXA (hyaluronic acid, polyvinyl alcohol, cyclodextrin) retain water and replenish the aqueous layer of the tear film. Hyaluronic acid also has mucomimetic and mucoadhesive properties; it is therefore able to interact with the mucin layer and stabilize it. Glycerol has a humectant and osmoprotective action, and the minerals (sodium, potassium, chloride, citrate, phosphate) have a nourishing function on the ocular surface as well as regulating pH and osmolarity.

DIRECTIONS
DEFLUXA stabilizes the tear film, hydrates, lubricates and protects the ocular surface in all cases of qualitative and quantitative alterations of the tear film, including those resulting from chronic treatments with topical ocular drugs with hypotensive action.

DOSAGE AND HOW TO USE
Hold the single-dose container upright above the eye and gently pull down the lower eyelid.
Fig. 1 Detach a single-dose container from the strip by holding it from the bottom opposite the label.
Fig. 2 Tap the single-dose container lightly for a few seconds (like a clinical thermometer) until all the preparation reaches the neck of the container.
Fig. 3 Rotate the top of the single-dose container.
Fig. 4 Hold the single-dose container upright above the eye to instill the preparation.
Instill 1 or 2 drops into the eye up to 5 times a day, as directed by your doctor, gently squeezing the single-dose container. It is recommended to hold the single-dose container upright (as shown in Fig. 4 ) during instillation.

STORAGE METHODS AND VALIDITY
- Do not use the product after the expiry date indicated on the carton. This period refers to the product stored at room temperature (≤25°C).
- Keep the product away from light, storing the single-dose containers in the aluminum bag.
- DEFLUXA does not contain preservatives. Therefore, the single-dose container and any unused portion must be discarded after opening and use. Once the single-dose container is opened, sterility requirements are no longer guaranteed.

PRECAUTIONS/WARNINGS
- Wash hands before use.
- Keep out of the reach and sight of children.
- Do not use in case of specific hypersensitivity to one of the components of the product.
- Do not swallow the solution.
- Do not instill into the eye at the same time as other ophthalmic products as it may alter their effects. An interval of at least 15 minutes should be observed between one instillation and the next.
- Not intended for use with contact lenses.
- Do not use in children under 3 years.

Cod. 9011