Vizoptic

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VIZOPTIC (VIZOPTIC)

Composition:

Active substance: tetryzoline hydrochloride;

1 ml of the preparation contains tetryzoline hydrochloride 0.5 mg;

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

Pharmaceutical form. Eye drops, solution.

Main physico-chemical properties: colorless or slightly yellow transparent liquid, odorless or almost odorless.

Pharmacotherapeutic group.

Medicinal products used in ophthalmology. Anti-edematous and anti-allergic agents. Sympathomimetics used as anti-edematous agents. ATC code S01GA02.

Pharmacological properties.

Pharmacodynamics.

The drug is a sympathomimetic agent that directly stimulates alpha-adrenergic receptors of the sympathetic nervous system, with no effect or minimal effect on beta-adrenergic receptors. When applied locally, tetrahydrozoline instilled into the conjunctival sac causes vasoconstriction of blood vessel walls, leading to a reduction in conjunctival hyperemia and edema.

Pharmacokinetics.

Tetrahydrozoline may be absorbed in amounts sufficient to produce systemic effects following local application.

There are no adequate data available on distribution and elimination of the drug following local administration. Vasoconstrictor effects on small blood vessels begin within a few minutes and last for at least 4 hours.

Clinical characteristics.

Indications.

Symptomatic temporary relief of secondary ocular hyperemia due to mild irritation and allergic conjunctivitis.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Concomitant use of tetriazole with monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants, guanethidine, or reserpine (for systemic use) may lead to increased blood pressure.

When used concomitantly with anesthetics, insulin, atropine sulfate, or propranolol, the effects of these drugs on the circulatory system may be potentiated.

If used simultaneously with other eye drops, a 15-minute interval between instillations should be observed.

Special precautions for use.

The use of the medicinal product may cause mydriasis.

The patient should discontinue use and consult a physician if improvement is not observed within 72 hours, or if irritation or hyperemia persists or worsens, or if eye pain or visual disturbances occur.

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

Use of the drops in children aged 2 to 6 years should be carried out with caution and only under medical supervision. Patients with severe cardiovascular disorders such as ischemic heart disease, arterial hypertension, pheochromocytoma, and metabolic disorders (hyperthyroidism, diabetes mellitus), as well as patients receiving monoamine oxidase inhibitors (MAOIs) or other agents capable of increasing blood pressure, should use VIZOPTIK eye drops only when the potential benefit outweighs the potential risk. Very frequent use may cause eye redness.

VIZOPTIK 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 disorders (such as infection, foreign body, or chemical corneal injury), medical advice should be sought;
• if intense eye pain, headache, rapid vision loss, sudden appearance of floating spots in front of the eyes, eye redness, photophobia, or diplopia occur, immediate medical attention is required.

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

VIZOPTIK eye drops should not be used in patients with epithelial-epidermal corneal dystrophy.

The medicinal product contains 0.1 mg of benzalkonium chloride per 1 ml.

Limited data are available regarding whether the safety profile is the same in children and adults. However, children's eyes generally react more strongly to benzalkonium chloride than adult eyes. Irritation may affect treatment compliance in children. Benzalkonium chloride has been reported to cause eye irritation, dry eye syndrome, and may affect the tear film and corneal surface. Therefore, the product should be used with caution in patients with dry eye syndrome and in patients with corneal disorders.

Patients should be monitored during prolonged use.

Benzalkonium chloride may be absorbed by contact lenses and may alter their color. Contact lenses should be removed before instilling the eye drops and reinserted 15 minutes after administration.

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 into breast milk.

The product should be used during pregnancy and breastfeeding only when the expected benefit to the mother outweighs the potential risk to the child.

Ability to affect reaction speed when driving or operating machinery.

The effect is unlikely, but immediately after administration of the product, patients should wait until vision clears before driving or operating machinery.

Method of Administration and Dosage

For topical ophthalmic use only.

The solution should not be used for more than 72 hours without 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 use of the solution in children under 6 years of age should only be carried out under medical supervision.

Children

The use of the solution in children aged 2 to 6 years should only be administered under a physician's prescription. There is no clinical experience with the use of this medication in children under 2 years of age.

Overdose

Overdose is unlikely when the drug is used as directed.

With overdose, increasing hyperemia or reactive hyperemia may occur.

Symptoms

Symptoms that may occur following 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, and coma.

Treatment

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

Adverse reactions

The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); frequency not known (cannot be estimated from available data).

Eye disorders

Common: reactive ocular hyperemia (rebound hyperemia of the eye), burning and dryness sensation in the eyes, irritation of the ocular mucosa. Blurred vision and conjunctival irritation may also occur.

Rare: mydriasis (pupil dilation), eye pain, eye redness, eye stinging.

Systemic sympathomimetic effects may occasionally occur.

Very rare: excessive conjunctival keratosis with closure of lacrimal puncta and excessive lacrimation.

Systemic effects such as palpitations, headache, tremor, weakness, excessive sweating, and increased blood pressure are possible.

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

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse reactions.

Shelf life: 2 years.

Shelf life after first opening: 28 days.

Storage conditions

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

Keep out of reach and sight of children.

An opened bottle should be stored at a temperature not exceeding 25 °C.

Packaging

5 ml in a bottle with dropper and cap with tamper-evident ring. 2 bottles per cardboard box.

Availability
Over-the-counter (without prescription)

Manufacturer

JADRAN GALENSKI LABORATORIJ d.d.
JADRAN GALENSKI LABORATORIJ d.d.,

Manufacturer's address and place of business

Svilno 20, Rijeka, 51000, Croatia