VIAL® LIGHT

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VIAL® LIGHT (VIAL LIGHT)

Composition:

Active substance: tetryzoline;

1 ml of the preparation contains tetrahydrozoline hydrochloride, calculated as 100% dry substance – 0.5 mg;

Excipients: benzalkonium chloride, boric acid, sodium tetraborate, sodium chloride, disodium edetate, water for injections.

Pharmaceutical form. Eye drops.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Agents used in ophthalmology. Anti-edematous and antiallergic agents. Sympathomimetics used as anti-edematous agents. ATC code S01G A02.

Pharmacological properties.

Pharmacodynamics.

Tetrahydrozoline is a sympathomimetic agent belonging to the group of imidazoline decongestants. It directly stimulates alpha-adrenergic receptors of the sympathetic nervous system with minimal or no effect on beta-adrenergic receptors. When applied topically to the conjunctival mucosa, the drug exerts a temporary vasoconstrictor effect on small blood vessels, thereby reducing vasodilation and conjunctival edema.

Pharmacokinetics.

In a study involving 10 healthy volunteers, tetrahydrozoline was detected in blood serum and urine after therapeutic ocular administration. The mean elimination half-life of tetrahydrozoline in serum was approximately 6 hours. Systemic absorption varied among patients, with maximum serum concentrations ranging from 0.068 to 0.380 ng/mL. Twenty-four hours after administration, tetrahydrozoline was detected in the urine of all patients.

Clinical Characteristics.

Indications.

Symptomatic, temporary relief of secondary ocular hyperemia due to mild irritative influences and allergic conjunctivitis.

Contraindications.

Hypersensitivity to the components of the drug, closed-angle glaucoma.

Interaction with other medicinal products and other forms of interaction.

No significant interactions with other medicinal products are known. Consult a physician before use with other ophthalmic medications.

Special precautions for use.

The use of the medicinal product may cause mydriasis.

The patient should discontinue use and consult a physician if there is no improvement within 72 hours, or if irritation or hyperemia persists or worsens, or if eye pain or visual disturbances occur.

The excipient benzalkonium chloride may cause irritation. Contact with soft contact lenses should be avoided (remove contact lenses before using the product and reinsert them 15 minutes after administration). The product may discolor soft contact lenses.

To avoid contamination, do not touch the tip of the container to any surface. Close the bottle with the cap after use. Discard the product if the solution changes color or becomes cloudy.

Use with caution in children aged 2 to 6 years. Patients with severe cardiovascular disorders such as ischemic heart disease, arterial hypertension, pheochromocytoma, or metabolic disorders (hyperthyroidism, diabetes mellitus), as well as patients receiving monoamine oxidase inhibitors or other agents capable of increasing blood pressure, should use Vial® Light eye drops only if, in the opinion of the physician, the potential benefit outweighs the potential risk. Frequent use may cause eye redness.

Vial® Light should be used only in cases of mild eye irritation. The patient should be aware:

• if the condition does not improve within 48 hours, or if irritation or redness persists or increases, use of the product should be discontinued;
• if irritation or redness is associated with serious eye conditions (such as infection, foreign body, or chemical injury to the cornea), medical advice is recommended;
• if severe eye pain, headache, sudden vision loss, sudden appearance of floating spots ("floaters") in the visual field, eye redness, pain upon exposure to light, or double vision occurs, immediate medical attention is required.

Prolonged use and overdosage should be avoided, especially in children.

Vial® Light eye drops should not be used in patients with epithelial-epidermal corneal dystrophy.

Use during pregnancy or breastfeeding.

Adequate and well-controlled studies on the effects of tetrahydrozoline hydrochloride on the fetus have not been conducted. There are no data on the excretion of the drug in breast milk.

Although the product is not intended for systemic exposure, consultation with a physician is recommended before use in pregnant women or women who are breastfeeding, in order to assess potential risks.

Ability to influence reaction rate while driving or operating machinery.

The use of eye drops may cause temporary blurred vision.

Method of Administration and Dosage

Before starting to use, do not tightly screw the cap onto the bottle!

Before the first use, tightly screw the bottle cap until the spike on its inner side pierces the opening in the bottle.

Immediately before administration, hold the bottle in the palm of your hand to warm it to body temperature.

Unscrew the cap, remove it, and gently press on the body of the bottle to instill the solution into the eye (conjunctival sac).

To prevent leakage of the solution during storage, after instillation, tightly screw the cap back on, ensuring that the spike on the inner side of the cap seals the opening in the bottle. Store the medication according to the recommendations provided in the section "Storage Conditions" (in an upright position).

For topical use in ophthalmology only.

The solution may be used for more than 72 hours only under medical supervision.

Adults and children ≥ 6 years of age

Instill 1–2 drops of the solution into the affected eye(s) up to 4 times daily.

Children aged 2 to 6 years

The solution may be used in children under 6 years of age only under medical supervision.

Children

Use in children aged 2 to 6 years should be under medical supervision. There is no experience with the use of the drug in children under 2 years of age.

Overdose

Overdose is unlikely when the drug is used as recommended.

With overdose of the drug, increasing hyperemia or reactive hyperemia may occur.

Symptoms

Symptoms that may occur with ingestion or excessive use of the drug: bradycardia, drowsiness, decreased blood pressure, apathy, and reduced body temperature. Additional symptoms that may occur only with ingestion of the drug include apnea, central nervous system depression, coma, respiratory depression, and possible development of cardiovascular reactions.

Treatment

In case of ingestion of the drug, treatment includes administration of activated charcoal and gastric lavage. Further treatment should be symptomatic and supportive.

Side effects.

Very rare (<0.01%) adverse reactions associated with the use of tetrahydrozoline hydrochloride have been observed in the post-marketing period:

Local site reactions (including burning sensation in the eyes and periorbital area, eye mucous membrane irritation, eye pain, itching, erythema, eye stinging, mydriasis (pupil dilation), reactive ocular hyperemia ("rebound" hyperemia of the eye)).

Systemic sympathomimetic effects may occasionally occur.

Hypersensitivity reactions may occur in patients with increased sensitivity to components of the drug.

Shelf life. 3 years.

Shelf life of the product after opening the bottle – 28 days.

Do not use the product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 ml in a bottle. 1 bottle in a carton.

Supply category. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's location and address of the place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.