OFTALACRIM

Eye drops based on 0.4% hyaluronic acid and distilled witch hazel water, preservative-free, 10 ml (ml)

INDICATIONS

OFTALACRIM is a medical device for ophthalmic use consisting of a sterile, viscous, slightly hypotonic saline solution with physiological pH, free of preservatives and phosphates, based on hyaluronic acid and distilled witch hazel water.

The high concentration of hyaluronic acid provides enhanced eye hydration and, in case of tear film imbalance, helps restore its balance.

OFTALACRIM is intended to protect and moisturize the surface of the eye in cases of redness, burning, and eye fatigue caused by:

• dry eye syndrome;

• exposure to external factors (dust, allergens, smoke, air conditioners, air pollution);

• visual strain due to prolonged use of electronic devices (computers, televisions, monitors);

• intensive studying or driving.

OFTALACRIM is a refreshing solution intended for people suffering from occasional dry eyes or insufficient tear production. It provides quick relief and daily comfort. OFTALACRIM can be instilled before or during the use of contact lenses to improve application and comfort.

INSTRUCTIONS FOR USE:

1. Break the protective seal on the bottle.

2. Wash your hands thoroughly before use.

3. Remove the protective cap.

4. Gently press the bottle and instill 1–2 drops into each eye.

5. After instillation, close the bottle, store it in the original packaging, and reuse the remaining solution within 3 months.

6. The product is intended for a single patient to avoid possible infection.

7. The product can be used with contact lenses.

FREQUENCY OF USE:

Instill 1–2 drops into the eye 2–3 times a day or as directed by a doctor.

COMPOSITION:

Hyaluronic acid 0.4%, distilled witch hazel water, sodium chloride, trisodium citrate dihydrate, citric acid monohydrate, purified water.

PACKAGING

The box contains a 10 ml (ml) preservative-free bottle. The bottle is suitable for resealing.

WARNINGS:

• The product is intended for ophthalmic use only. Do not swallow or use for unintended purposes.

• After opening, the bottle can be resealed, and the remaining solution should be used within 3 months to avoid possible contamination.

• Before instillation, check the dropper opening; if there are residues, clean it with a damp wipe and squeeze out one drop before use.

• Keep out of reach of children.

• During instillation, do not touch the eye or other surfaces with the tip of the bottle.

• Do not use in case of known intolerance to any of the components.

• If necessary, consult a specialist regarding compatibility of eye drops with contact lenses.

• In case of adverse reactions, discontinue use and consult a doctor or pharmacist.

• Consult a doctor regarding use during pregnancy, lactation, and in children.

• Treatment with ophthalmic medicinal products or other ophthalmic medical devices should be carried out under medical supervision to assess possible interactions.

• In case of damage to the ocular surface or cornea, consult a doctor.

• Do not use the product after the expiration date indicated on the packaging.

• In case of serious complaints or incidents related to the medical device, notify the manufacturer and the competent authority of the country where the user is registered to provide additional safety information.

SHELF LIFE: 36 months in unopened packaging.

MANUFACTURER: Enable Innovations S.r.l., Via Claudio

Tolomeo No. 26, 41012, Carpi (MO), Italy

Authorized representative in Ukraine:

LLC “VISUS PHARM”, 5-B Budindustrii St.,

Kyiv, 01013, Ukraine. Tel.: +38 (044) 281 24 06

Email: info@visuspharm.com