Optinol^® Soft recovery (Ophthalmic product) Instructions for Use

Marketing Authorization Holder

Jadran-Galenski Laboratorij, D.D. (Croatia)

Contact Information

JADRAN-GALENSKI LABORATORIJ A.O. (Croatia)

Dosage Form

Optinol® Soft recovery

Ophthalmic moisturizing product: fl. 10 ml

Dosage Form, Packaging, and Product Composition

Ophthalmic moisturizing product in the form of a transparent, colorless solution.

Excipients : purified water – up to 1 ml.

Does not contain preservatives.
Sterile.

10 ml (more than 350 drops) – bottles (1) with a dosing device – cardboard packs.

Therapeutic Category

Medical device for moisturizing the mucous membrane of the eye

Properties

The ophthalmic moisturizing product Optinol^® Soft recovery is a sterile isotonic solution containing hyaluronic acid in the form of sodium hyaluronate and Dexpanthenol.

Sodium hyaluronate is a salt of hyaluronic acid, which is a natural moisturizing substance. The sodium hyaluronate molecule has special physicochemical properties, namely a pronounced ability to bind water molecules and retain them on the surface of the eye. This feature allows the substance to form a uniform, stable, and durable protective layer on the cornea of the eye that does not affect visual acuity.

Dexpanthenol is a derivative of pantothenic acid (vitamin B₅), which is found in all living organisms and plants. Dexpanthenol additionally moisturizes, promotes healing and restoration of the eye surface, has caring and soothing properties, and enhances the moisture-retaining properties of sodium hyaluronate.

Performing the functions of a natural tear, the ophthalmic moisturizing product Optinol^® Soft recovery helps to accelerate the healing of eye injuries and wounds after trauma and surgical operations.

The ophthalmic moisturizing product Optinol^® Soft recovery effectively and quickly relieves symptoms of dry eye syndrome of varying severity: eliminates the sensation of a foreign body, burning, stinging in the eyes, helps relieve fatigue during intense visual load, eliminates discomfort when wearing all types of contact lenses, and supports healthy eye condition.

The absence of preservatives and the presence of components such as natural moisturizing substances (Hyaluronic acid in the form of a sodium salt and Dexpanthenol) ensure good tolerability of the ophthalmic moisturizing product Optinol^® Soft recovery even with long-term use.

Thanks to the specially designed bottle mechanism, the solution remains sterile for 180 days (6 months) after the first use, while containing no preservatives. The bottle’s multi-dispenser ensures dosing accuracy and ease of use of the ophthalmic moisturizing product Optinol^® Soft recovery. The bottle contains more than 350 drops.

The product is intended to eliminate problems of dry eyes of varying severity; to stabilize the tear film, lubricate the eye and protect its surface; to eliminate discomfort in case of mechanical irritation caused by wearing contact lenses or diagnostic intervention; to relieve eye fatigue during prolonged work at a computer.

Scope of Application

Of the product Optinol^® Soft recovery

• After ophthalmic surgical operations, as well as for corneal damage and injuries;
• When wearing all types of contact lenses to eliminate discomfort;
• For dry eye syndrome (with symptoms of discomfort, dryness, foreign body sensation – “sand in the eyes”, burning, irritation);
• To relieve eye fatigue during intense visual load.

ICD codes

Dosage Regimen

Apply 1-2 drops into each eye several times a day; more frequent use is possible if necessary. The duration of use is not limited.

Instructions for use

1. Remove the protective cap from the bottle. Try not to touch the open tip of the bottle dropper.
2. Place the index and middle fingers on the bottom of the bottle, and the thumb on the round plate at the top of the bottle.
3. Before first use of the bottle, turn it tip down and press the pressure plate with your thumb 2-3 times until the first drop appears.
4. Tilt your head back. With the index finger of your free hand, gently pull the lower eyelid downward, look upward. If possible, hold the bottle vertically.
5. To instill the product, press the bottle once. Thanks to the specially designed bottle mechanism, exactly 1 drop is released with each press. Close your eyes and slowly move your eyes in all directions so that the solution is evenly distributed over the surface of the eye.
6. Repeat the procedure for the second eye.

To prevent contamination of the bottle, avoid touching the tip of the bottle to the eye or lenses and do not touch it with your fingers.

After each use of the bottle, it is necessary to dry the tip of the dropper and close it with the protective cap.

Side effects

None identified.

Contraindications

• Hypersensitivity to the components of the medical device.

Use during pregnancy and breastfeeding

Use during pregnancy and breastfeeding is permitted.

Special instructions

When used concomitantly with ophthalmic drugs, it is recommended to maintain a pause of at least 15 minutes between the instillation of the ophthalmic moisturizing product Optinol^® Soft recovery and other eye drops.

Eye ointments/gels should be applied after instillation of the product Optinol^® Soft recovery.

When wearing all types of contact lenses, the ophthalmic moisturizing product Optinol^® Soft recovery can be instilled into the conjunctival sac without removing the lenses.

After application of the solution, a short-term decrease in visual acuity is possible, therefore it is recommended to refrain from driving vehicles until visual acuity is restored.

Effect on the ability to drive vehicles and operate machinery

Does not affect the speed of reaction when driving vehicles and working with other machinery.

Dispensing Status

Available without a prescription.

Storage Conditions

The product should be stored out of the reach of children at a temperature from 10°C (50°F) to 25°C (77°F), humidity 45-80% and pressure 84-106.7 kPa.

Shelf Life

Shelf life – 30 months. Do not use after the expiration date.

After opening the bottle, the product should be used within 6 months.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.