Eucafilipt® xylo

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EUCAPHYLIPT XYLO (EUCAPHYLIPT XYLO)

Composition:

Active substance: xylometazoline hydrochloride;

1 ml of solution contains xylometazoline hydrochloride 1 mg;

Excipients: sodium dihydrogen phosphate dihydrate; sodium hydrogen phosphate, dodecahydrate; sodium chloride; benzalkonium chloride solution; disodium edetate; menthol (levomenthol); eucalyptus oil; sorbitol (E 420); polyoxylated hydrogenated castor oil; purified water.

Pharmaceutical form. Nasal spray, metered.

Main physicochemical properties: clear or opalescent solution, colourless to white, with the odour of menthol or menthol and eucalyptus.

Pharmacotherapeutic group.

Agents used in diseases of the nasal cavity. Decongestants and other agents for local use in nasal diseases.

Sympathomimetics, simple preparations. ATC code R01A A07.

Pharmacological properties.

Pharmacodynamics.

Xylometazoline is a sympathomimetic agent acting on α-adrenergic receptors.

When applied intranasally, xylometazoline causes vasoconstriction of the blood vessels in the nasal mucosa and adjacent areas of the nasopharynx, thereby reducing swelling and hyperemia of the nasal and nasopharyngeal mucosa. It also decreases associated excessive mucus secretion, facilitates removal of blocked nasal secretions, promotes clearance of the nasal passages, and improves nasal breathing.

The effect of the drug begins within 2 minutes after administration and lasts up to 12 hours.

The drug is well tolerated, including by patients with sensitive mucosa, and does not impair mucociliary function. Laboratory analyses have shown that xylometazoline reduces the infectious activity of human rhinovirus associated with the common cold.

Due to the moisturizing component sorbitol, the medicinal product Eucafillipt® Ksilo, nasal spray, helps relieve dryness and irritation of the nasal mucosa. The product has a balanced pH value within the physiological range typical for the nasal cavity.

Pharmacokinetics.

When applied locally, the drug is minimally absorbed. Plasma concentrations of xylometazoline are so low that they are nearly undetectable (plasma concentration is close to the limit of detection).

Xylometazoline has no mutagenic properties. In animal studies, no teratogenic effects of xylometazoline were observed.

Clinical characteristics.

Indications.

For symptomatic treatment of nasal congestion due to colds, hay fever, other allergic rhinitis, and sinusitis.

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

For adjunctive therapy in cases of otitis media (to relieve mucosal swelling).

For facilitating rhinoscopy.

Contraindications.

Hypersensitivity to xylometazoline, to any other component of the medicinal product or to other sympathomimetic amines, acute coronary diseases, coronary asthma, hyperthyroidism, closed-angle glaucoma, transsphenoidal hypophysectomy and neurosurgical procedures with exposure of the meninges in medical history, atrophic rhinitis (rhinitis sicca) or dry rhinitis. Concomitant use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of such treatment.

Interaction with other medicinal products and other forms of interaction.

Monoamine oxidase inhibitors (MAOIs): xylometazoline may potentiate the effect of MAOIs and induce hypertensive crisis. Do not use xylometazoline in patients receiving or who have received MAOIs within the previous 2 weeks.

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

Concomitant use of xylometazoline with β-blockers may cause bronchospasm or reduction in blood pressure.

Special precautions for use.

The duration of treatment should not exceed 5 consecutive days. Prolonged use or excessive doses of xylometazoline may cause secondary swelling of the nasal mucosa, with a risk of chronic rhinitis and/or atrophy of the nasal mucosa.

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

The recommended dose of the drug should not be exceeded, especially in children and elderly patients.

The drug should be used with caution in patients with cardiovascular diseases, arterial hypertension, diabetes mellitus, pheochromocytoma, or benign prostatic hyperplasia. Do not use in patients receiving or who have received concomitant treatment with MAO inhibitors within the previous 2 weeks.

Patients with prolonged QT interval syndrome who have used xylometazoline are at increased risk of serious ventricular arrhythmias.

The medicinal product contains benzalkonium chloride, which may cause irritation of the nasal mucosa.

The medicinal product contains hydrogenated polyethoxylated castor oil, which may cause skin reactions.

Rare cases of posterior reversible encephalopathy syndrome / reversible cerebral vasoconstriction syndrome have been reported with the use of sympathomimetic drugs. Symptoms include sudden severe headache, nausea, vomiting, and visual disturbances. In most cases, symptoms resolve or improve within a few days after appropriate treatment. The drug should be discontinued immediately and medical advice sought if signs or symptoms of posterior reversible encephalopathy syndrome / reversible cerebral vasoconstriction syndrome develop.

Use during pregnancy or breastfeeding.

The drug 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. During breastfeeding, the drug should be used only on medical advice and prolonged treatment should be avoided due to the risk of adverse effects in the infant (tachycardia, excitation, increased blood pressure).

Fertility.

There are no adequate data on the effect of the medicinal product Eukaphyllipt® Ksilo on fertility. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is also very low.

Ability to influence reaction speed when driving or operating machinery.

Generally, the medicinal product has no or negligible influence on the ability to drive or operate machinery.

Dosage and Administration

The medicinal product should be administered to adults and children aged 12 years and older as one spray into each nostril, up to 3 times daily. Do not exceed 3 applications into each nostril per day. The interval between administrations should be at least 8–10 hours. The duration of treatment depends on the course of the disease and should not exceed 5 consecutive days.

The metered-dose spray ensures accurate dosing and proper distribution of the solution over the nasal mucosal surface. Each spray delivers 0.14 mL of solution, corresponding to 0.14 mg of xylometazoline.

Before use, prime the spray pump by pressing it several times until a fine mist is released into the air. After priming, the spray bottle will be ready for use.

To use the spray:

• Thoroughly clear the nose before administration;
• Hold the bottle vertically, supporting the bottom with the thumb and positioning the spray nozzle between two fingers;
• Slightly tilt the bottle and insert the nozzle into the nostril;
• Administer the spray while simultaneously inhaling gently through the nose;
• After use, clean and dry the nozzle before replacing the cap;
• To prevent contamination, the bottle should be used by only one patient.

The last dose should be administered immediately before bedtime.

Children

This medicinal product should not be administered to children under 12 years of age.

Overdose

Excessive local use of xylometazoline hydrochloride or accidental ingestion may lead to pronounced dizziness, increased sweating, significant decrease in body temperature, headache, bradycardia, and less frequently, tachycardia, arterial hypertension, respiratory depression, coma, and convulsions. Elevated blood pressure may later be replaced by hypotension. Impaired consciousness may indicate severe intoxication. Younger 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 management should include monitoring the patient for several hours. In cases of severe overdose accompanied by cardiac arrest, resuscitation efforts should continue for at least 1 hour.

As an emergency measure prior to hospitalization, activated charcoal may be administered.

Side effects.

Immune system disorders:

Very rare (< 1/10,000): hypersensitivity reactions, including angioneurotic edema, rash, itching.

Nervous system disorders:

Common (≥ 1/100, < 1/10): headache;

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

Eye disorders:

Very rare (< 1/10,000): temporary visual disturbances.

Cardiac disorders:

Very 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;

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

General disorders and administration site conditions:

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

Reporting of side effects after marketing authorization is highly important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Do not use 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 glass bottle with a nasal spray pump or in a polymer bottle with a nasal spray pump. One bottle per cardboard box.

Supply category. Over-the-counter.

Manufacturer.

PJSC "CHEMFARMPLANT "CHERVONA ZIRKA".

Manufacturer's address and place of business.

1, Gordienkivska Street, Kharkiv, Kharkiv Oblast, 61010, Ukraine.