VitA-POS^® (Ophthalmic product) Instructions for Use

Marketing Authorization Holder

Ursapharm Arzneimittel, GmbH (Germany)

Dosage Form

VitA-POS®

Ophthalmic lubricating product 250 IU/1 g: tube 5 g

Dosage Form, Packaging, and Composition

Excipients: white petrolatum, liquid paraffin, light liquid paraffin, lanolin.

5 g – aluminum tubes (1) with instructions for use – cardboard packs.

Properties

Medical device for use in ophthalmology – a sterile, oil-based product intended for insertion into the conjunctival sac, containing retinyl palmitate.

Retinyl palmitate is a natural component of the tear film and gives the product a gentle, oil-like consistency, which ensures its good mixing with the natural tear fluid.

Evenly distributing and remaining on the anterior surface of the eye (cornea and conjunctiva) for a long time, it helps to improve the condition of the tear film and, thereby, reliably protects the cornea from drying out.

The use of this product contributes to the rapid disappearance of subjective symptoms of discomfort: burning, “dryness”, feeling of a foreign body.

Scope of Application

To improve the condition of the tear film and protect the ocular surface, to eliminate discomfort in the sensation of “dryness”, feeling of a foreign body, burning in the eyes, including those arising under the influence of: climatic factors, such as air conditioning in a car or airplane, wind, cold, intense solar radiation, environmentally unhealthy air or cigarette smoke; intense visual load, for example, during prolonged work with a computer, camera, excessive time spent in front of the TV, the need to drive a car at night, prolonged wear of contact lenses.

Indications

This product is indicated for the management of ocular surface conditions and associated subjective symptoms of discomfort.

• Improve the condition of the tear film and protect the ocular surface.
• Relieve symptoms of dry eye syndrome, including sensations of dryness, burning, and foreign body.
• Provide protection against symptoms induced by environmental factors such as air conditioning, wind, cold, solar radiation, dry or polluted air, and cigarette smoke.
• Alleviate discomfort associated with intense visual load from prolonged computer use, driving at night, or extended wear of contact lenses.

ICD codes

Dosage Regimen

Apply a 1 cm strip of the product into the conjunctival sac of the affected eye(s).

Use from 1 to 3 times daily, adjusting the frequency based on individual symptom severity, lifestyle factors, and as directed by an ophthalmologist.

For maximum benefit, apply the product before nighttime sleep and after removing contact lenses.

Discontinue use and consult an ophthalmologist if discomfort or symptoms persist after several days of application.

Contraindications for Use Based on Hypersensitivity and Component Intolerance

Do not use this product under the following conditions.

• Known hypersensitivity to vitamin A palmitate or any of the excipients, including white petrolatum, liquid paraffin, light liquid paraffin, or lanolin.

Discontinue use immediately and seek medical advice if signs of an allergic reaction, such as redness, itching, or swelling, occur.

Drug Interactions with Other Ophthalmic Preparations and Concomitant Therapies

Avoid simultaneous application with other ophthalmic products, including eye drops, ointments, or gels.

The oil-based formulation may alter the absorption and therapeutic effect of concomitantly applied topical medications.

Administer other ophthalmic products at least 15-30 minutes before applying this product to prevent physical and chemical incompatibility.

Adverse Reactions

Immediately after application, temporary blurred vision is a common and expected effect due to the product’s consistency.

This may lead to a decrease in mental and physical reactivity, posing a risk when operating machinery or driving.

Local reactions, such as transient irritation, redness, or a burning sensation, may occur, particularly in individuals with sensitivity to the components.

Discontinue use and consult a physician if severe or persistent irritation, pain, or signs of an allergic reaction develop.

Overdose Management and Procedures for Accidental Excessive Application

In case of accidental application of an excessive amount, blurred vision will be more pronounced but is typically transient.

Wipe away any visible excess from the eyelids and lashes with a clean tissue.

Do not instill other products to rinse the eye, as this may exacerbate the situation.

Vision should clear spontaneously; if persistent severe visual impairment or ocular pain occurs, seek medical attention.

Special Instructions

Since immediately after application of this product, short-term blurred vision may occur, leading to a slowdown in mental and physical reactions, it is not recommended to use it immediately before working with machinery and driving vehicles.

In this regard, it is recommended to use the product before nighttime sleep, after removing lenses.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.