Euca spray turbo

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EUCASPRAY TURBO (EUCASPRAY TURBO)

Composition:

Active substance: xylometazoline hydrochloride;

1 ml of solution contains 1.0 mg of xylometazoline hydrochloride;

Excipients: benzalkonium chloride; polyoxyl hydrogenated castor oil; sodium hydrogen phosphate, dodecahydrate; sodium dihydrogen phosphate, monohydrate; eucalyptus oil; disodium edetate; sodium chloride; sorbitol (E 420); purified water.

Pharmaceutical form. Nasal spray, metered.

Main physicochemical characteristics: opalescent solution, colorless to whitish, with a characteristic eucalyptol odor.

Pharmacotherapeutic group. Medicinal products used in nasal disorders. Decongestants and other locally acting drugs for nasal disorders. Simple sympathomimetics. 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, clears 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 test results have shown that xylometazoline reduces the infectious activity of human rhinovirus associated with the common cold.

The preparation contains a cooling aromatic volatile substance – eucalyptol.

Pharmacokinetics.

When applied locally, the drug is practically not absorbed, and the concentration of xylometazoline in blood plasma is so low that it is practically undetectable (plasma concentration is close to the limit of detection).

Xylometazoline has no mutagenic properties. Also, animal studies have not revealed any teratogenic effects of xylometazoline.

Clinical characteristics.

Indications.

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

Facilitation of secretion drainage in diseases of the nasal sinuses.

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

Facilitation of rhinoscopy.

Contraindications.

Hypersensitivity to xylometazoline, any other component of the medicinal product, or to other sympathomimetic amines; closed-angle glaucoma; transsphenoidal hypophysectomy; transnasal or transoral surgical procedures involving exposure of the meninges or history thereof; atrophic rhinitis (rhinitis sicca) or atrophic rhinitis. Patients receiving concomitant treatment with monoamine oxidase inhibitors (see section "Interaction with other medicinal products and other forms of interaction").

Interaction with other medicinal products and other forms of interaction.

Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline may potentiate the effect of MAO inhibitors and may cause a hypertensive crisis. Xylometazoline must 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, concomitant use of these medicinal products is not recommended.

Concomitant use with beta-blockers may cause bronchospasm or reduced blood pressure.

Special precautions for use.

The medicinal product should not be used for longer than 5 consecutive days.

Prolonged or excessive treatment with xylometazoline may cause secondary swelling of the nasal mucosa, with a risk of chronic rhinitis and/or atrophy of the nasal mucosa.

The 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 product should not be exceeded, especially when treating children and elderly patients.

The product should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma, or benign prostatic hyperplasia, and should not be used in patients who have received concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 2 weeks after discontinuation of such treatment.

Patients with long QT syndrome who receive xylometazoline may be at increased risk of serious ventricular arrhythmias. As first-line therapy, nasal irrigation with physiological saline is recommended. Eucaspray Turbo may be used as a second-line medicinal product.

The medicinal product contains benzalkonium chloride (0.007 mg of benzalkonium chloride per 0.14 mL dose, equivalent to 0.05 mg/mL), which may cause irritation of the nasal mucosa, especially with prolonged use.

Rare cases of posterior reversible encephalopathy syndrome (PRES) / reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of sympathomimetic agents. Reported symptoms include sudden severe headache, nausea, vomiting, and visual disturbances. In most cases, symptoms resolve or improve within several days after appropriate treatment. The product 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.

Pregnancy and breastfeeding

The medicinal product 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 necessary, and the product should be used during breastfeeding only under medical supervision. Breastfeeding mothers should avoid prolonged use 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 Eucaspray Turbo on fertility. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is very small.

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 or operate machinery. However, with excessively prolonged use or use at high doses, an effect on the cardiovascular system cannot be excluded.

Method of Administration and Dosage

The medication should be administered to adults and children aged 12 years and older at a dose of 1 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 illness and should not exceed 5 consecutive days.

Do not cut off the spray nozzle. The nasal spray is dosed and ready for immediate use.

The dosed 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 the first use, prime the spray pump by pressing it 4 times. After this, the spray pump will be ready for use throughout the entire treatment period. If the spray does not dispense when the pump is pressed, or if the medication has not been used for more than 7 days, re-prime the spray pump by actuating it 4 times into the air.

The spray should be used as follows:

• thoroughly clear the nasal passages before applying the medication;
• hold the bottle vertically, supporting the bottom with the thumb and positioning the nozzle between two fingers;
• slightly tilt the bottle and insert the nozzle into the nostril;
• administer the spray while simultaneously taking a gentle nasal inhalation;
• after use, before replacing the cap, clean and dry the nozzle;
• to prevent infection, each medication bottle should be used by only one person.

The last application is recommended to be performed immediately before bedtime.

Children.

Eucaspray Turbo is indicated for children aged 12 years and older.

Overdose.

Excessive local application of xylometazoline hydrochloride or accidental ingestion may lead to pronounced dizziness, sweating, significant decrease in body temperature, headache, bradycardia, less commonly tachycardia, arterial hypertension, respiratory depression, coma, and seizures. Elevated arterial pressure may be followed by a drop in pressure. Impaired consciousness may indicate severe intoxication. Younger children are more sensitive to the toxic effects than adults. At home, activated charcoal may be administered as an emergency measure prior to hospitalization.

In cases of severe intoxication, the patient should be hospitalized and receive immediate symptomatic treatment under medical supervision. Medical care should include monitoring of the patient's condition for several hours. In cases of severe overdose accompanied by cardiac arrest, resuscitation efforts should continue for at least 1 hour.

Side effects.

Side effects are classified by frequency of occurrence into the following categories: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1/10,000 to <1/1000), very rare (< 1/10,000).

Reporting of suspected adverse reactions. Reporting of adverse reactions after drug registration is highly important. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life.

3 years.

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

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging.

10 ml in a polyethylene container with a pump spray dispenser, in a carton.

Availability.

Over-the-counter (without prescription).

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer's address and site of operations.

21027, Vinnytsia, vul. 600-Richchia, 25, Ukraine.

Tel.: +38 (0432) 52-30-36. E-mail: [email protected]

www.sperco.ua