Relins Active (Ophthalmic product) Instructions for Use

Marketing Authorization Holder

Doctor Klaus, LLC (Republic of Belarus)

Contact Information

DOCTOR KLAUS LLC (Russia)

Dosage Form

Relins Active

Ophthalmic moisturizing product: fl. 10 ml

Dosage Form, Packaging, and Product Composition

Ophthalmic moisturizing product in the form of a sterile, isotonic borate buffer solution, odorless, transparent, colorless or yellowish, without visible mechanical inclusions.

Composition: sodium hyaluronate (0.41%), boric acid, sodium chloride, sodium borate, edetate disodium dihydrate, polyquaternium-7, PHMG, purified water.

There are about 25 drops in 1 ml of the product.
The product is sterilized by membrane filtration.

10 ml – polymer bottles (1) – cardboard packs.

Therapeutic Category

Medical device for moisturizing the mucous membrane of the eye

Properties

The ophthalmic moisturizing product RELINS ACTIVE is intended for moisturizing, lubricating, and protecting the anterior surface of the eyes.

Description and principle of action

The moisturizing, lubricating, and protective properties of RELINS ACTIVE are due to the hyaluronic acid (in the form of its sodium salt) included in its composition.

RELINS ACTIVE contains sodium hyaluronate, which has a smaller molecular size compared to hyaluronic acid, allowing the substance to penetrate tissues more easily and spread evenly over the corneal surface.

Sodium hyaluronate is a polysaccharide with a pronounced ability to retain water, which provides a high degree of moisturizing and lubrication of the corneal surface. Hyaluronic acid is a component of tears and is also a structural component of the vitreous body, conjunctiva, and lacrimal gland, where it retains moisture, maintaining the stability of the tear film and protecting the eyes from drying out.

When RELINS ACTIVE is instilled, a uniform thin film forms on the anterior surface of the cornea, protecting the eye from drying out, relieving the sensation of discomfort, dryness, fatigue, pain, and eye irritation for a long time, which is not washed away by blinking and does not cause a decrease in visual acuity. Due to the high content of hyaluronic acid (0.41%), RELINS ACTIVE provides a longer moisturizing and protective effect from use.

Main causes of “dry eye” syndrome

• Reduced tear production or increased evaporation of moisture from the eye surface;
• Wearing all types of contact lenses;
• Hormonal changes in women (during pregnancy, breastfeeding, as well as during menstruation, menopause, and postmenopause);
• Aging (“dry eye” syndrome is most often observed in women after 40 years, after 60 years – in approximately 75% of people);
• Exposure to climatic factors (wind, cold, intense solar radiation, polluted air, etc.);
• Exposure to external factors when using air conditioners and heaters, as well as when working in rooms with dry air, in dusty or smoky (including cigarette smoke) areas, when working with chemicals, etc.;
• Long-term driving;
• Prolonged work at a computer or watching television;
• Work of beauty industry masters, jewelers, or other meticulous activities associated with high visual load and the need for concentration;
• Mechanical damage to the eyes or consequences of surgical intervention;
• Taking certain medications, such as contraceptives, antihistamines, beta-blockers, antispasmodics, etc.;
• Past infectious, inflammatory, and other eye diseases;
• Various chronic diseases, such as rheumatoid arthritis, diabetes, thyroid diseases, asthma, etc.

Scope of Application

Of the product Relins Active

RELINS ACTIVE is indicated for use for intensive and prolonged moisturizing, preventing the loss of natural tear fluid, reducing symptoms of dry eyes, as well as

• For “dry eye” syndrome with symptoms of dryness, irritation, itching, burning, redness, discomfort, feeling of “gritty eyes” or a foreign body;
• To relieve eye fatigue during intense visual load;
• When wearing all types of contact lenses to relieve discomfort;
• For comfortable insertion of rigid contact lenses.

RELINS ACTIVE may be prescribed or recommended by an ophthalmologist or contact lens specialist for moisturizing, lubricating, and protecting the anterior surface of the eyes, including when wearing all types of contact lenses. The device is intended for personal individual use both at home and in medical institutions, following the instructions for use and precautions.

ICD codes

Dosage Regimen

There are about 25 drops in 1 ml of the product.

1. It is recommended to use RELINS ACTIVE, 1-2 drops in each eye, 3 times a day or as needed.
2. RELINS ACTIVE should be instilled into clean eyes, without contact lenses and, if possible, without makeup.
3. Before using RELINS ACTIVE, you should thoroughly wash your hands with soap.
4. Remove the protective cap from the bottle, do not touch the open tip of the bottle dropper insert.
5. Tilt your head back, pull the lower eyelid down, look up, and instill 1-2 drops of RELINS ACTIVE into the space formed between the eyelid and the eyeball (into the middle of the conjunctival cavity).
6. Blink several times and slowly close your eyes so that RELINS ACTIVE is distributed evenly over the entire surface of the eye.
7. It is recommended not to use other ophthalmic products and not to put on contact lenses for 15 minutes.

The frequency of instillation is set individually depending on sensations and/or according to the recommendations of an ophthalmologist or contact lens specialist. There are no restrictions regarding the duration of use of RELINS ACTIVE.

In case of using RELINS ACTIVE for comfortable insertion of rigid contact lenses, instill 1 drop into each lens and put on the lens according to the instructions from the manufacturer of the rigid contact lenses.

Side effects

No side effects have been detected.

Possible: allergic reactions, irritation, itching in case of individual intolerance or non-compliance with the instructions for use.

Contraindications

• Hypersensitivity to the components of the product;
• Allergic reaction to any component of the product;
• Simultaneous use of therapeutic ophthalmic drugs during inflammatory processes and acute phases of eye diseases, with damaged mucous membranes and cornea of the eye, immediately after ophthalmic surgeries.

Use during pregnancy and lactation

Data on the experience of using RELINS ACTIVE by women during pregnancy and lactation are absent; prescription is possible only after consultation with a doctor.

Special instructions

Children under 14 years of age should consult a doctor before using RELINS ACTIVE.

Do not use RELINS ACTIVE if unpleasant sensations in the eyes are observed within 15 minutes after instillation; if unpleasant sensations persist after discontinuation of use, you should consult an ophthalmologist.

If it is necessary to use simultaneously with medicinal eye drops or care products, you should consult a doctor.

In case of combined use with ophthalmic drugs, it is recommended to maintain a pause of at least 15 minutes between the instillation of RELINS ACTIVE and other products.

RELINS ACTIVE is supplied sterile and does not require additional disinfection or treatment.

It is not allowed to use RELINS ACTIVE from one bottle by several persons.

RELINS ACTIVE should be stored out of the reach of children.

Effect on the ability to drive vehicles and mechanisms

RELINS ACTIVE does not have a negative effect on the ability to perform potentially hazardous activities that require special attention and quick reactions, for example, driving a car and other vehicles, working with moving mechanisms, work of a dispatcher and operator, etc.

Immediately after instillation of RELINS ACTIVE, “blurred” vision is possible, which passes within 5-15 seconds. In this case, you should wait for the distribution of RELINS ACTIVE over the surface of the eye and stabilization of vision.

Dispensing Status

Dispensed without a prescription.

Storage Conditions

RELINS ACTIVE should be stored in a tightly closed bottle in a place protected from direct sunlight, at a temperature from +1°C (33.8°F) to +25°C (77°F), at a relative air humidity of not more than 80% (at +25°C (77°F)).

Shelf Life

The shelf life is 2 years from the date of manufacture. Use RELINS ACTIVE before the expiration date indicated on the box and bottle.

The shelf life after opening the bottle is 90 days.

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.