BRUDYAL PLUS MULTI

BRUDYAL PLUS MULTI is a sterile, physiologically‑balanced ocular moisturizing and lubricating solution, based on sodium hyaluronate, supplied in a multidose container.

Sodium hyaluronate provides a hydrating and lubricating effect that counteracts ocular dryness and creates a protective film over the corneal epithelium against external environmental factors. The formulation also contains Sodium Chloride and phosphate buffers — disodium phosphate heptahydrate and monosodium phosphate dihydrate — to ensure a physiological solution, as well as distilled water from Chamomile and Cornflower to reinforce the moisturizing action.

BRUDYAL PLUS MULTI is intended for use in adults (18 to 64 years) and older adults (65 years and above).

INTENDED USE: BRUDYAL PLUS MULTI is indicated for ocular dryness or discomfort of the ocular mucosa due to:

• Environmental factors (air conditioning, excessive sunlight, wind, smoke, pollution, swimming in seawater or pool water).

• Ocular dryness caused by excessive fatigue after long hours of computer work, studying, or due to dry eye syndrome.

• Prolonged daily use of contact lenses.

10 ml bottle of sterile, preservative‑free solution.

INSTRUCTIONS FOR USE:

• Wash and dry your hands thoroughly before use.

• Remove the safety seal before the first administration.

• Remove the protective cap.

• Press the container and instill 2 or 3 drops of BRUDYAL PLUS MULTI into the eye.

• Release pressure on the container and wait a few seconds after administering each drop. This allows sufficient air to enter the system and prevents difficulty in dispensing the drops.

• As the container gradually empties, it may be necessary to apply greater pressure to allow the product to be dispensed. This is due to the properties of the closure system, which preserves sterility and the physical and chemical characteristics of preservative‑free solutions. A small amount of product will always remain inside the container.

• Remove any remaining drop of product from the tip of the dispenser after use.

• Close the container immediately with the cap.

• Do not place the protective cap while pressing the container.

• Avoid touching the tip of the applicator with the ocular surface or with your fingers.

• The product may be used for up to 3 months after first opening.

• BRUDYAL PLUS MULTI may be used several times a day according to the user’s needs or following medical advice.

• BRUDYAL PLUS MULTI may be used by contact lens wearers.

Text revised: 01/11/2023. The update will take effect in the next shipment.

BRUDYAL PLUS MULTI 10 ml

CN 195092.5

CNP 6543454

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WARNINGS AND PRECAUTIONS:

• This product is for ocular use only.

• The product is intended for use by a single patient.

• Do not use the product if the container is damaged or if it is not perfectly sealed when opened for the first time.

• Do not use it if you observe particles and/or changes in the colour of the solution.

• During application, avoid touching the eye or any other surface with the tip of the dispenser.

• Do not use the product after the expiry date indicated on the box.

• Do not use in case of known intolerance to any of the ingredients, or if you are allergic to Asteraceae plants.

• If you suffer from a severe injury to the transparent surface of the eye (the cornea), phosphates may, in very rare cases during treatment, facilitate the appearance of whitish spots on the cornea due to calcium deposits.

• No interactions with medicines or other artificial tears have been described; however, wait 15 minutes before administering other eye drops.

• If you experience any side effects during use, discontinue treatment and consult your doctor.

• Dispose of the product according to local regulations.

• Keep out of the reach and sight of children.

• Consult your doctor before using this product if you are pregnant or breastfeeding.

• For external use only; do not swallow.

• Do not attempt to manipulate or dismantle the dispenser.

• Any serious incident related to the device must be reported to the manufacturer and to the Competent Authority of the Member State where you reside.

• It is recommended to consult your doctor in case of use in children.

SIDE EFFECTS: No undesirable side effects are known to date.