Defluxa

Sterile eye drops
based on Palmitoylethanolamide
and hydrophilic and moisturizing polymers

Preservative-free

INSTRUCTIONS FOR USE
COMPOSITION
Palmitoylethanolamide (PEA), Hyaluronic acid sodium salt (NaHA), Polyvinyl alcohol (PVA), Methyl-B cyclodextrin (MBCD), Tripotassium citrate monohydrate, Sodium chloride, Glycerol, Citric acid monohydrate, Disodium phosphate dodecahydrate, Monosodium phosphate 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 single doses, each strip inserted in an aluminum pouch.

CHARACTERISTICS AND MECHANISM OF ACTION
DEFLUXA is a sterile, isotonic ophthalmic solution at physiological pH composed of palmitoylethanolamide (a lipid molecule), hydrophilic and moisturizing polymers (hyaluronic acid sodium salt, polyvinyl alcohol, and cyclodextrin), glycerol (a humectant and osmoprotective molecule), and mineral salts.
DEFLUXA is able to rebalance the homeostasis of the ocular surface and rebuild the tear film in all cases of qualitative-quantitative alterations, including those resulting from chronic treatments with topical ocular hypotensive drugs. In particular, DEFLUXA stabilizes the tear film and maintains the 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 water hyper-evaporation, and helps maintain a protective tear layer on the ocular surface. The hydrophilic and moisturizing 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 activity; it is therefore able to interact with the mucin layer and stabilize it. Glycerol has a humectant and osmoprotective action, and minerals (sodium, potassium, chloride, citrate, phosphate) have a nourishing function for the ocular surface as well as a function of regulating pH and osmolarity.

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

DOSAGE AND METHOD OF USE
Hold the single-dose container vertically above the eye and gently pull down the lower eyelid.
Fig. 1 Detach a single-dose container from the strip, holding it by the bottom opposite the label.
Fig. 2 Gently tap the single-dose container for a few seconds (like a clinical thermometer) until all the preparation reaches the neck of the container.
Fig. 3 Twist the top of the single-dose container.
Fig. 4 Hold the single-dose container vertically above the eye to instill the preparation.
Instill 1 or 2 drops into the eye up to 5 times a day, according to specialist advice, by gently squeezing the single-dose container. It is recommended to hold the single-dose container vertically (as shown in Fig. 4) during instillation.

STORAGE AND VALIDITY
- Do not use the product after the expiry date indicated on the box. 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 pouch.
- DEFLUXA does not contain preservatives. Therefore, the single-dose container and any unused residue must be discarded after opening and use. After opening the single-dose container, the sterility requirements are no longer guaranteed.

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

Cod.9011