Oftal

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT OFTAL

Composition:

Active substance: tetryzoline;

1 ml of solution contains 0.5 mg of tetryzoline hydrochloride;

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

Pharmaceutical form. Eye drops, solution.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group. Medicinal products used in ophthalmology. Anti-edematous and anti-allergic agents. Sympathomimetics used as anti-edematous agents.

ATC Code S01G A02.

Pharmacological properties.

Pharmacodynamics. The drug is a sympathomimetic agent belonging to the group of imidazoline decongestants. It directly stimulates α-adrenergic receptors of the sympathetic nervous system, with no effect or minimal effect on β-adrenergic receptors. When applied locally to the conjunctival mucosa, the drug exerts a temporary vasoconstrictive effect on small blood vessels, thereby reducing vasodilation and conjunctival edema.

Pharmacokinetics. It is known that after therapeutic ocular administration, tetryzoline is detected in blood serum and urine. The mean elimination half-life of tetryzoline from blood serum is approximately 6 hours. Systemic absorption varies among patients, with peak serum concentrations ranging from 0.068 to 0.380 ng/mL. Tetryzoline is excreted in urine within 24 hours.

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 known significant interactions with other medicinal products. Consult a physician before use with other ophthalmic medications.

Special precautions for use.

The use of the drug may cause mydriasis.

The drug should be discontinued and medical advice sought if no improvement is observed within 72 hours, or if irritation or hyperemia persists or worsens, or if eye pain or visual disturbances occur.

To avoid contamination, the tip of the container should not touch any surfaces. The bottle should be closed with the cap after use. The drug is not suitable for use if the solution changes color or becomes cloudy.

The use of eye drops in children aged 2 to 6 years should be performed with caution. 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 or other drugs capable of increasing blood pressure, should use the eye drops only when, in the physician's opinion, the expected benefit outweighs the potential risk. Very frequent use may cause eye redness.

The drug 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, the use of the drug should be discontinued;
• if irritation or redness is associated with serious eye disorders (such as infection, foreign body, or chemical injury to the cornea), medical advice should be sought;
• if intense eye pain, headache, rapid loss of vision, sudden appearance of floating spots in front of the eyes, eye redness, pain upon exposure to light, or double vision occur, immediate medical advice should be sought.

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

The drug should not be used in patients with epithelial–epidermal corneal dystrophy.

The drug contains benzalkonium chloride. Contact with soft contact lenses should be avoided (remove contact lenses before using the drug and reinsert them 15 minutes after use). The drug may discolor soft contact lenses.

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 drug is not intended for systemic exposure, consultation with a physician is recommended before use in pregnant women and women who are breastfeeding to assess potential risks.

Ability to affect reaction speed when driving or operating machinery. The use of eye drops may cause temporary blurred vision.

Method of administration and dosage.

For topical ophthalmic use 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 into the affected eye(s) up to 4 times daily.

Children aged 2 to 6 years: The drug may be used only under medical supervision.

Children. The use of the drug in children aged 2 to 6 years is allowed only as prescribed by a physician. Experience with the use of the drug in children under 2 years of age is lacking.

Overdose. Overdose is unlikely when the drug is used according to recommendations. In case of overdose, increasing hyperemia or reactive hyperemia may occur.

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, CNS depression and coma, respiratory depression, and possible development of cardiovascular reactions.

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

Adverse Reactions

. Local reactions at the site of application (including burning sensation in the eyes and periocular area, eye mucous membrane irritation, eye pain, itching, erythema, eye discomfort, conjunctival hyperemia, mydriasis (pupil dilation), reactive ocular hyperemia ("rebound" hyperemia)). Systemic sympathomimetic effects may occasionally occur.

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

Shelf life. 2 years. The product should not be used more than 4 weeks after opening the bottle.

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

Keep out of reach of children.

Packaging. 5 ml or 10 ml in a bottle with a dropper cap, in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Limited Liability Company "Experimental Plant "GNCLS".

Limited Liability Company "FARMEKS GROUP".

Manufacturer's address and place of business:

8 Vorobiova Street, Kharkiv, Kharkiv Region, Ukraine.

(Limited Liability Company "Experimental Plant "GNCLS")

100 Shevchenka Street, Boryspil, Kyiv Region, 08301, Ukraine.

(Limited Liability Company "FARMEKS GROUP")