Tearfid® - Fidia Farmaceutici S.p.A.

TEARFID®
TEARFID® SPRAY

LIPOSOME BASED SOLUTION FOR STABILIZING THE LIPID LAYER OF THE TEAR FILM

DESCRIPTION

Tearfid® and Tearfid® spray stabilize the lipid layer of the tear film, regulate and correct lubrication of the ocular surface. They are sterile ophthalmic solutions containing vitamins A and E, liposomes and amino acids, preservatives free. Vitamins A and E, known for their soothing and softening properties, provide a practical support for the lipid component present in the palpebral fissure when combined with liposomes; they also contribute to alleviating ocular and periocular symptoms associated with inflammatory conditions due to allergies and/or infections.

The amino acids L-proline, L-glycine, L-lysine, chlorhydrate and L-leucine, contained in the product, increase the ocular surface lubrication and may contribute to enhanced protection of the epithelia, subject to different kinds of stress. Furthermore, the lipid component of the tear film is essential for the containment of tear fluid and for controlling its evaporation. The use of Tearfid® assists the functioning of the lipid secretions of the ocular appendage glands (Meibomian, Zeiss and Moll Glands), helping to stabilize the lipid component of the tear film.

INDICATION

Tearfid® and Tearfid® spray are indicated in case of subjective disorders associated with dry eye syndrome, such as foreign body sensation, eye burning and itching sensation, dry eye syndrome caused by poor quality of the lipid layer of the tear film.

COMPOSITION

Retinyl palmitate (vitamin A), α-tocopherol (vitamin E), Hydrogenated phospholipids, L-proline, L-glycine, L-lysine chlorhydrate, L-leucine.

AVAILABLE
FORMULATION

10 ml OSD, 8 ml spray and 15 single-doses (0.35 ml).

DOSING,
ADMINISTRATION
AND INSTRUCTION FOR USE

Tearfid®/Tearfid®monodose is applied directly on the eye surface according to the following dosage diagram: apply 1-2 drops in the conjunctival sac 4 times a day or as needed or advised by your doctor.

Tearfid® Spray
Apply 1 to 2 sprays of Tearfid® Spray to the eye, preferably keeping the eyelids closed. It is recommended to apply Tearfid Spray 3 to 4 times a day. For severe symptoms, Tearfid® Spray may even be applied more often. If rheum and thick discharges are present, clean the ocular and periocular area of the eye using sterile disposable medicated gauze before applying 1 to 2 sprays of Tearfid® Spray. Spray the product from a distance of 10 cm. Tearfid® Spray may also be used when wearing cosmetics. In that case, apply just one spray from a greater distance (approximately 20 cm). Upon first use, pump repeatedly until the first spray comes out. Keep the bottle in vertical position during the usage.

PRECAUTIONS AND WARNINGS

Tearfid® spray

  • Keep out of the reach of children;
  • In case of concomitant administration of other topic ophthalmic drug consult the physician;
  • Do not use if the bottle is damaged;
  • Do not use the product after the expiring date reported on the bottle;
  • The product is for external ophthalmic use only;
  • Store at a temperature between 4°C and 25°C;
  • Avoid any contact between the spray pump and the eye;
  • Small amounts of swallowed product will not create any problem.

Tearfid®/Tearfid®monodose

  • Keep the preparation away from children’s reach;
  • When administered at the same time as topical ophthalmic drugs, seek the advice of your physician;
  • Do not use if the bottle/single-dose vial is damaged;
  • When the solution in the bottle is running out, you will need to squeeze harder for the drop to come out;
  • To eliminate the risk of contaminating the solution, avoid the dropper/ single-dose container from coming into contact with the eye or with any objects;
  • Close the bottle well after use.
  • After the administration, discard the single-dose container with its remaining contents as the product is preservatives free;
  • Do not use the product after the expiration date printed on the bottle/vial;
  • The product is for ophthalmic external use only;
  • Store at temperature between 4 and 25°C;

REFERENCES
Tearfid®, Tearfid® monodose and Tearfid® Spray Package Insert.