Vial

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VIAL® (VIAL)

Composition:

Active substance: tetryzoline;

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

Excipients: benzalkonium chloride; sodium dihydrogen phosphate dihydrate; sodium hydrogen phosphate dodecahydrate; sodium chloride; disodium edetate; water for injections.

Pharmaceutical form. Eye drops.

Main physicochemical characteristics: transparent, colorless, odorless liquid.

Pharmacotherapeutic group. Agents used in ophthalmology. Anti-edematous and anti-allergic agents. Sympathomimetics used as anti-edematous agents. Tetryzoline. 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 vasoconstrictive effect on small blood vessels, thereby reducing vasodilation and conjunctival edema.

Pharmacokinetics.

After therapeutic ocular administration, tetrahydrozoline was detected in blood serum and urine. The mean elimination half-life of tetrahydrozoline from blood serum was approximately 6 hours. Systemic absorption varied among patients, with peak serum concentrations ranging from 0.068 to 0.380 ng/mL. Tetrahydrozoline was detected in the urine of all patients within 24 hours.

Clinical characteristics.

Indications.

Symptomatic temporary relief of secondary ocular hyperemia due to mild irritative influences.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

No known significant interactions with other medicinal products. Consult your doctor before use with other ophthalmic medications.

Special precautions for use.

The use of the medicinal product may cause mydriasis.

The medicinal product should be discontinued and medical advice sought if there is no improvement within 72 hours, 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 use). The product may discolor soft contact lenses.

To avoid contamination, do not let the tip of the dropper bottle touch any surfaces. Replace the cap on the bottle after use. Discard the product if the solution changes color or becomes cloudy.

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

Vial® is recommended only for mild eye irritation. The patient should be aware:

• if symptoms do not improve within 48 hours, or if irritation or redness persists or worsens, 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 should be sought;
• if severe eye pain, headache, rapid vision loss, sudden appearance of floating spots ("floaters") in the visual field, eye redness, photophobia (pain when exposed to light), or diplopia (double vision) occur, immediate medical attention is required.

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

Vial® 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 human 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 affect reaction speed while driving or operating machinery.

The use of eye drops may cause temporary blurred vision.

Method of administration and dosage.

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

Before the first use of the drops, 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 the hand to warm it to body temperature.

Unscrew and remove the cap; gently press the bottle body to instill the solution into the eye (conjunctival sac).

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

Vial® is intended for topical ophthalmic use only.

The medication may be used for longer 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 administered to children under 6 years of age only under medical supervision.

Children.

Use in children aged 2 to 6 years should be under medical prescription. Experience with use in children under 2 years of age is lacking.

Overdose.

Overdose is unlikely when the medication is used as recommended.

With overdose, increasing hyperemia or reactive hyperemia may occur.

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

Treatment. In case of ingestion, 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 eyes and periorbital area, eye mucous membrane irritation, eye pain, itching, erythema, eye stinging, pupil dilation (mydriasis), reactive ocular hyperemia ("rebound" hyperemia of the eye)).

Systemic sympathomimetic effects may occasionally occur.

Hypersensitivity reactions are possible in patients with increased sensitivity to the components of the medicinal product.

Shelf life. 3 years.

The shelf life of the product after opening the bottle is 28 days.

Do not use the medicinal 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 name and address of the place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.