Eucabal® spray

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EUKABAL® SPRAY

Composition:

Active substance: xylometazoline hydrochloride;

1 ml of solution contains xylometazoline hydrochloride 1 mg;

Excipients: benzalkonium chloride, monohydrate of citric acid, sodium citrate 2H₂O, glycerol 85%, purified water.

Pharmaceutical form. Nasal solution.

Main physicochemical properties: clear, colorless solution with a faint odor.

Pharmacotherapeutic group.

Agents used in nasal disorders. Decongestants and other agents for local use in nasal disorders. Simple sympathomimetics.

ATC code R01A A07.

Pharmacological properties.

Pharmacodynamics.

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

The effect of the drug begins within several minutes after administration and lasts up to 12 hours. The drug causes constriction of nasal blood vessels, reducing swelling of the nasal mucosa and paranasal sinuses, thus improving nasal breathing in nasal congestion and sinus obstruction.

Pharmacokinetics.

When applied locally, the drug is hardly absorbed, and the concentration of xylometazoline in blood plasma is so low that it cannot be determined by modern analytical methods.

Clinical characteristics.

Indications.

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.

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

To facilitate rhinoscopy.

Contraindications.

Hypersensitivity to any component of the drug; dry inflammation of the nasal mucosa (dry rhinitis), acute coronary diseases, hyperthyroidism, closed-angle glaucoma, transsphenoidal hypophysectomy, and surgical interventions involving exposure of the meninges in medical history. Concomitant use of monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of such treatment.

Interaction with other medicinal products and other forms of interaction.

MAO inhibitors: xylometazoline may potentiate the effect of MAO inhibitors and induce a hypertensive crisis. Do not use xylometazoline in patients taking or who have taken MAO inhibitors within the previous 2 weeks.

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

When used concomitantly with β-blockers, the drug may cause bronchospasm or reduction in blood pressure.

Special precautions for use.

The drug is not administered to children under 12 years of age.

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

The drug 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.

Patients with prolonged QT syndrome receiving xylometazoline may be at increased risk of serious ventricular arrhythmias.

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

The drug should be prescribed with caution to patients with cardiovascular diseases, arterial hypertension, diabetes mellitus, thyroid disorders, pheochromocytoma, or benign prostatic hyperplasia. It should not be administered to patients who are receiving or have received treatment with monoamine oxidase inhibitors (MAOIs) within the previous 2 weeks.

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

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

Use during pregnancy or breastfeeding.

The drug should not be used during pregnancy due to its potential vasoconstrictive effect.

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 drug should be used during breastfeeding only under medical supervision.

Fertility.

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

Ability to affect reaction speed when driving or operating machinery.
The drug usually has no effect or only a minimal effect on the ability to drive or operate machinery.

Method of Administration and Dosage.

Before administering the medication, the nasal cavity should be thoroughly cleaned.

For adults and children aged 12 years and older: one spray into each nostril up to 3 times daily.

The duration of treatment depends on the course of the disease and should not exceed 10 consecutive days.

Children.

The medication should not be used for the treatment of children under 12 years of age.

Overdose.

Excessive local use of xylometazoline hydrochloride or its accidental ingestion may lead to pronounced dizziness, increased sweating, significant decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma, and seizures. Elevated arterial pressure may be followed by hypotension. Younger children are more sensitive to toxicity 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.

Adverse reactions.

Immune system side effects: hypersensitivity reactions, including angioneurotic edema, rash, itching.

Nervous system side effects: headache.

Eye disorders: transient visual disturbances.

Cardiac side effects: irregular or rapid heartbeat.

Respiratory, thoracic and mediastinal side effects: dryness or discomfort of the nasal mucosa, burning sensation, epistaxis (nasal bleeding).

Gastrointestinal side effects: nausea.

General disorders and administration site reactions: burning sensation at the application site.

If any adverse reactions occur, treatment should be discontinued and medical advice should be sought.

Shelf life. 3 years.

After opening the bottle, the product is suitable for use within 6 months.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

Nasal spray, 10 ml solution in a bottle with a dispenser, 1 bottle in a cardboard box.

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

Manufacturer.

Pharma Verwaltungs-GmbH, Germany.

Manufacturer's address.

Dornburger Weg 35, 38855 Wernigerode, Germany.

Marketing authorization holder.

Esparma GmbH, Germany.

Address of the marketing authorization holder.

Bielefelder Strasse 1, 39171 Schöningen, Germany.