Eucazolin®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT EUCASOLINE® (EUCAZOLIN®)

Composition:

Active substances: 1 ml of solution contains 1 mg of xylometazoline calculated as 100% substance, 0.1 mg of eucalyptus oil;

Excipient: medium-chain triglycerides.

Pharmaceutical form. Nasal drops.

Main physico-chemical properties: clear yellowish oily liquid.

Pharmacotherapeutic group.

Agents used in diseases of the nasal cavity. Sympathomimetics in combination with other agents, excluding corticosteroids.

ATC code R01A B06.

Pharmacological properties.

Pharmacodynamics.

The drug exerts an α-adrenomimetic effect, constricting peripheral blood vessels. When applied to the mucous membrane, due to its vasoconstrictive action, it reduces mucosal edema, hyperemia, and exudation, thus facilitating nasal breathing.

Eucalyptus oil contained in the drug eliminates dryness of the mucous membrane and provides anti-inflammatory and antiseptic effects.

Pharmacokinetics.

When used at therapeutic doses, the drug acts predominantly locally. The effect begins 3–4 minutes after administration and lasts for several hours.

Clinical characteristics.

Indications.

Symptomatic treatment of nasal congestion due to colds, hay fever, allergic rhinitis, and sinusitis.

For facilitating drainage of secretions in diseases of the nasal sinuses.

Adjunctive therapy in otitis media (to reduce swelling of the mucous membranes of the nasal cavities).

For diagnostic procedures (rhinoscopy).

Contraindications.

Hypersensitivity to any component of the drug, acute coronary diseases, coronary asthma, hyperthyroidism, closed-angle glaucoma, transsphenoidal hypophysectomy, or history of transnasal/transoral surgical interventions exposing the dura mater, dry rhinitis (rhinitis sicca) or atrophic rhinitis. Concurrent use of monoamine oxidase inhibitors (MAOIs), as well as use within 2 weeks after discontinuation of such therapy.

Interaction with other medicinal products and other forms of interaction.

Monoamine oxidase inhibitors (MAOIs): xylometazoline may potentiate the effect of monoamine oxidase inhibitors and induce a hypertensive crisis. Do not use xylometazoline in patients taking or who have taken MAOIs within the last two weeks.

Tricyclic and tetracyclic antidepressants: concomitant use of tricyclic or tetracyclic antidepressants and sympathomimetic agents may enhance the sympathomimetic effect of xylometazoline; therefore, concomitant use of these agents is not recommended.

Concomitant use with β-blockers may cause bronchospasm or decreased blood pressure.

Special precautions for use.

The product should not be used for longer than 10 consecutive days. Prolonged or excessive use may lead to rebound nasal congestion and/or atrophy of the nasal mucosa.

The recommended dose of the product should not be exceeded, especially when treating children and elderly patients.

The product should be prescribed with caution to patients who experience strong reactions to adrenergic agents, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

The product should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, patients with prostatic hyperplasia, patients with phaeochromocytoma, and should not be used in patients receiving treatment with monoamine oxidase inhibitors (MAOIs), as well as within 2 weeks after discontinuation of such treatment.

Each package of drops should be used by only one person to avoid infection.

Use during pregnancy or breast-feeding.

The product should not be used during pregnancy due to its potential vasoconstrictive effects.

There is no evidence of any adverse effect on the infant. It is unknown whether xylometazoline is excreted in breast milk; therefore, caution is required, and the product should be used during breast-feeding only under medical supervision.

Fertility.

There are no adequate data regarding the effect of Eukazolin® on fertility. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.

Ability to affect reaction speed when driving or operating machinery.

The product usually has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

Dosage and Administration

Before use, hold the bottle in the palm of the hand to warm the solution to body temperature. Remove the cap and, by gently pressing the rubber dropper insert, instill the prescribed dose into each nostril. After use, close the bottle with the cap.

For adults and children aged 12 years and older: administer 1–2 drops of the solution 2–3 times daily into each nostril.

The duration of treatment depends on the course of the disease; usually, the drug should be used for 10 days.

Children. The drug is not recommended for children under 12 years of age.

Overdose.

Excessive local use of xylometazoline hydrochloride or accidental ingestion may lead to pronounced dizziness, sweating, significant decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma, and convulsions. Elevated arterial pressure may be followed by decreased pressure. Young children are more sensitive to the toxic effects than adults.

All patients suspected of overdose should receive appropriate supportive measures and, if necessary, immediate symptomatic treatment under medical supervision. Medical care should include monitoring of the patient for several hours. In cases of severe overdose accompanied by cardiac arrest, resuscitation efforts should continue for at least 1 hour.

Side effects.

Immune system:

Rare (< 1/10,000): hypersensitivity reaction, including angioneurotic edema, rash, itching.

Nervous system:

Common (≥ 1/100, < 1/10): headache.

Eye disorders:

Rare (< 1/10,000): temporary visual disturbance.

Cardiovascular system:

Rare (< 1/10,000): irregular or rapid heartbeat.

Respiratory, thoracic and mediastinal disorders:

Common (≥ 1/100, < 1/10): dryness or discomfort of the nasal mucosa;

Uncommon (≥ 1/1,000 – < 1/100): epistaxis.

Gastrointestinal disorders:

Common (≥ 1/100, < 1/10): nausea.

General disorders and administration site conditions:

Common (≥ 1/100, < 1/10): burning sensation at the application site.

Shelf life.

1 year.

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

Storage conditions.

Store in a light-protected place at a temperature between 8 °C and 15 °C.

Keep out of reach of children.

Packaging. 10 ml in a bottle with a rubber dosing insert-dropper. 1 bottle per carton.

Pharmaceutical category. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's name and address.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.