Flunoxil

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FLONOXIL (FLONOXIL)

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 properties: opalescent solution, from colorless to whitish, with a characteristic eucalyptol odor.

Pharmacotherapeutic group. Preparations used in nasal disorders. Decongestants and other agents for local treatment in nasal disorders. Sympathomimetics, simple preparations.

ATC code R01A A07.

Pharmacological properties.

Pharmacodynamics.

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

When administered 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 the 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 test results have shown that xylometazoline reduces the infectious activity of human rhinovirus associated with the common cold.

The medicinal product contains eucalyptol—a cooling aromatic substance that evaporates.

Pharmacokinetics.

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

Xylometazoline has no mutagenic properties. In addition, 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 rhinitides, and sinusitis.

Facilitation of secretion drainage in diseases of the nasal accessory sinuses.

Adjunctive therapy in cases of otitis media (to reduce 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 interventions involving exposure of the meninges, or history thereof; atrophic rhinitis or dry rhinitis (rhinitis sicca). Patients receiving concomitant treatment with monoamine oxidase inhibitors (MAO inhibitors) (see section "Interaction with other medicinal products and other types of interactions").

Interaction with other medicinal products and other types of interactions.

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 taking or who have taken MAO inhibitors within the preceding two weeks.

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

Concomitant use with beta-adrenoreceptor blockers may cause bronchospasm or reduction in blood pressure.

Special precautions for use

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

Prolonged or excessive use of xylometazoline may cause secondary swelling of the nasal mucosa, with 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 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. It should not be used in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 2 weeks after discontinuation of such treatment.

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

The medicinal product contains: polyethylene glycol hydrogenated castor oil, which may cause skin reactions; benzalkonium chloride (0.007 mg benzalkonium chloride per 0.14 mL dose, equivalent to 0.05 mg/mL), which may cause irritation of the nasal mucosa, particularly 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 improved or resolved within a few days after appropriate treatment. The medicinal 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 required. During breastfeeding, the medicinal product should be used only on medical advice. Prolonged use should be avoided during breastfeeding due to the risk of adverse effects in the infant (tachycardia, excitability, increased blood pressure).

Fertility

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

Ability to affect reaction speed when driving or operating machinery

The medicinal 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 medicinal product should be administered to adults and children aged 12 years and older with one spray into each nostril up to 3 times daily. Do not administer more than 3 times 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.

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

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, equivalent to 0.14 mg of xylometazoline.

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

The spray should be used as follows:

• thoroughly clean the nose before administration;
• 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 a spray while simultaneously taking a gentle nasal inhalation;
• after use, before covering the nozzle with the cap, clean and dry the nozzle;
• to prevent infection, the bottle with the medicinal product should be used by only one person.

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

Children.

Flonoxil is indicated for children aged 12 years and older.

Overdose.

Excessive local use of xylometazoline hydrochloride or its accidental ingestion may lead to pronounced dizziness, excessive sweating, significant decrease in body temperature, headache, bradycardia, less commonly tachycardia, arterial hypertension, respiratory depression, coma, and seizures. Elevated arterial blood pressure may be followed by a decrease. Impaired consciousness may indicate severe overt intoxication. Younger children are more sensitive to 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 measures 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 the medicinal product has been registered is of great importance. 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, should report all suspected adverse reactions and lack of efficacy of the medicinal product through 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 spray pump, in a cardboard box.

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

Manufacturer. Ukrainian-Spanish joint venture "Sperko Ukraine".

Manufacturer's address and place of business.
21027, Ukraine, Vinnytsia, 600-richchya St., 25.