Eukabal® drops for children

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EUKABAL® DROPS FOR CHILDREN

Composition:

Active substance: xylometazoline hydrochloride;

1 ml of solution contains xylometazoline hydrochloride 0.5 mg;

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

Pharmaceutical form. Drops.

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

Pharmacotherapeutic group.

Medicinal products used in nasal cavity disorders. Decongestants and other agents for local treatment of 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 that of the paranasal sinuses, thus improving nasal breathing in nasal and paranasal sinus congestion.

Pharmacokinetics.

When applied locally, the drug is practically not absorbed, and plasma concentrations of xylometazoline are so low that they cannot be determined by modern analytical methods.

Clinical characteristics.

Indications.

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

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

As an adjunctive therapy in cases of otitis media (to reduce swelling of the mucous membrane).

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 with exposure of the meninges in medical history. Concomitant use of monoamine oxidase inhibitors (MAO inhibitors) and within 2 weeks after discontinuation of such treatment.

Interaction with medicinal products and other types of interactions.

Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline may potentiate the effect of monoamine oxidase inhibitors and induce a hypertensive crisis. Xylometazoline should not be used in patients receiving or who have received MAO inhibitors within the previous two weeks.

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

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

Special precautions for use.

Do not use the medication in children under 2 years of age.

Use in children aged 2 to 11 years is recommended only under adult supervision.

The medication should not be used for longer than 7 consecutive days. Prolonged or excessive use may lead to rebound nasal congestion and/or atrophy of the nasal mucosa.

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

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

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

The medication should be prescribed with caution in patients with cardiovascular disorders, 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 drops should be used by only one person to avoid infection.

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

Use during pregnancy or breastfeeding. The medication 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 advised, and the medication should be used during breastfeeding only under medical supervision.

Fertility.

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

Ability to influence reaction rate while driving or operating machinery. The medication usually has no or minimal effect on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

For children aged 2 to 5 years (under adult supervision): administer 1–2 drops into each nostril 1–2 times daily (every 8–10 hours), but not more than 3 times per day into each nostril.

For children aged 6 to 11 years (under adult supervision): administer 2–4 drops into each nostril 2–3 times daily. Do not exceed 3 times per day into each nostril.

The duration of treatment depends on the course of the disease and must not exceed 7 consecutive days. One drop of the preparation contains 0.0125 mg of xylometazoline hydrochloride.

Children

Do not administer the drug to children under 2 years of age.

Use in children aged 2 to 11 years is recommended only under adult supervision.

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 seizures. Elevated arterial pressure may be followed by a drop in pressure. 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 patient observation 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 disorders: hypersensitivity reactions, including angioneurotic edema, rash, itching.

Nervous system disorders: headache.

Eye disorders: transient visual disturbances.

Cardiac disorders: irregular or rapid heartbeat.

Respiratory, thoracic and mediastinal disorders: dryness or discomfort of the nasal mucosa, burning sensation, epistaxis.

Gastrointestinal disorders: nausea.

General disorders and administration site conditions: 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 for up to 6 months.

Storage conditions.

Store at a temperature not exceeding 25°C.

Keep out of reach and sight of children.

Packaging.

10 ml drops in a bottle with a screw cap-pipette, 1 bottle in a cardboard box.

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

Manufacturer.

Pharma Vernigehrode GmbH, Germany.

Manufacturer's address.

Dornberger Weg 35, 38855 Wernigerode, Germany.

Marketing authorization holder.

Esparma GmbH, Germany.

Address of the marketing authorization holder.

Bielefelder Strasse 1, 39171 Schöningen, Germany.