Xanterdes

Xanthan gum 0.2%, desonide sodium phosphate 0.025%, monobasic sodium phosphate monohydrate, disodium phosphate dodecahydrate, sodium citrate, purified water.

20 single-dose containers, 0.3 ml each and 1 leaflet

XANTERDES is indicated to relieve eye discomfort and irritation due to environmental conditions such as dust, heat, smoke, wind, air conditioning, allergens.
XANTERDES also contains, as ancillary substance, a very low concentration of a corticosteroid, desonide sodium phosphate, which can be useful in case of redness of the ocular surface, as for example in ocular dryness.

XANTERDES gently provides hydrating and lubricating action to the eye surface due to the presence of a natural polymer, xanthan gum.
XANTERDES, after application into the conjunctival sac, it integrates with the tear restoring the normal lubrication of the ocular surface.
The presence of desonide sodium phosphate is to be considered ancillary to the main lubricant action of XANTERDES and helps to reduce ocular redness that may occur during mild eye inflammatory processes.
XANTERDES is preservative-free.

It is recommended to instill 1 drop of XANTERDES in the conjunctival fornix, three times a day, unless otherwise indicated by a doctor.

1. Make sure that the single-dose container is intact before use.
2. Tear one single-dose container from the strip.
3. Hold the single-dose container upright (with the cap pointing upwards) and twist off the cap, without pulling it.
4. Instill XANTERDES into the eye(s). Do not let the open-end of the single-dose container touch your eye or anything else.

Hypersensitivity to the products’ components; ocular hypertension and glaucoma, eye infections (such as Herpes Simplex, corneal virus infections, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, stye); lesions or corneal abrasions; diseases related to corneal thinning.

The product contains low concentrations of corticosteroids therefore should not be used chronically, unless otherwise indicated by the doctor.
Cases of corneal calcification have been very rarely reported in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
The use, especially if prolonged, of corticosteroids may cause an increase of the intraocular pressure. It is therefore advisable to monitor intraocular pressure if corticosteroids are used for more than two weeks. Since corticosteroids also favor the onset of cataracts, it is advisable not to use them for long periods of time.

In childhood and in pregnancy, the product should be administered in cases of real need and only under medical supervision.

The use of the product may occasionally cause mild burning after instillation.

Product interactions with the administration of other ophthalmic drugs are unknown. However, it is advised not to administer other drugs or medical devices for ocular use within 10 minutes from the instillation of XANTERDES. It is not necessary to remove the contact lenses before the administration of XANTERDES since the product does not alter the physical characteristics, including the transparency, of the most common soft, semirigid and rigid contact lenses.

Do not use XANTERDES if single-dose container is opened or damaged.

Avoid touching the eye or any surface with the tip of the opened container and do not allow the tip of the container to touch the eye.Each single-dose container must be used immediately after opening.
Any residual product should not be re-used, since XANTERDES does not contain preservative and the remaining product may become contaminated.
After the opening of each aluminum sachet, the remaining single-dose containers must be kept inside the sachet to protect the product from light. After aluminum sachet opening, the single-dose containers should be used within 28 days.
Do not store above 25 °C.
Do not use XANTERDES after the expiry date.
Do not dispose the product in the environment after use. It would be advisable to eliminate the vial and any residual product as special waste. For the correct disposal of the product, please follow the national or local regulations.
The administration of XANTERDES to children or people with limited skills should be supervised by a responsible adult.

FOR TOPICAL OCULAR USE ONLY
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

The product must be used under medical advice.

Any adverse reactions should be reported to the local Vigilance Authorities or to:

SIFI S.p.A.
Via Ercole Patti, 36
95025 Aci Sant’Antonio (CT) Italy
e-mail: vigilance@sifigroup.com

The Summary of safety and clinical performance (SSCP) of XANTERDES is available at the following URL: https://ec.europa.eu/tools/eudamed.

SIFI S.p.A.
Via Ercole Patti, 36
95025 Aci S. Antonio (CT)
ITALY