Pharmazolin® with mint and eucalyptus

INSTRUCTIONS FOR MEDICINAL USE OF FARMASOLINE® WITH MINT AND EUCALYPTUS (FARMAZOLINE® MINT AND EUCALYPTUS)

Composition:

Active substance: xylometazoline hydrochloride;

1 ml of the preparation contains xylometazoline hydrochloride equivalent to 100% anhydrous substance 1 mg;

Excipients: eucalyptus oil; peppermint oil; benzalkonium chloride; disodium edetate; propylene glycol; polyethylene glycol 1500; povidone; hypromellose; polysorbate 20; sodium hydrogen phosphate, dodecahydrate; potassium dihydrogen phosphate; sorbitol (E 420); water for injections.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical properties: clear, slightly yellowish to yellowish-green liquid.

Pharmacotherapeutic group.

Agents used in nasal cavity 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 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 mucous membranes. It also decreases associated excessive mucus secretion and facilitates clearance of blocked nasal secretions, resulting in the opening of nasal passages and improved 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 mucous membranes, and does not impair mucociliary function. Laboratory test results have shown that xylometazoline reduces the infective activity of human rhinovirus associated with the common cold.

Due to its moisturizing components (sorbitol, hypromellose), FarmaZolin® with mint and eucalyptus 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.

Xylometazoline has no mutagenic properties. In animal studies, xylometazoline showed no teratogenic effects.

Pharmacokinetics.

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

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 accessory sinuses.

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

Facilitation of rhinoscopy.

Contraindications.

Hypersensitivity to xylometazoline or any other component of the medicinal product, closed-angle glaucoma, transsphenoidal hypophysectomy, and transnasal or transoral surgical interventions with exposure of the meninges in medical history, atrophic rhinitis or dry rhinitis (rhinitis sicca).

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 induce a hypertensive crisis. Do not use xylometazoline in patients who are taking or have taken MAO inhibitors within the last 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 agents is not recommended.

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

Special precautions for use.

The drug should not be used for longer than 7 consecutive days. Prolonged or excessive use may lead to the development of drug-induced rhinitis, characterized by recurrence of nasal congestion, i.e. symptoms similar to those of a common cold, and/or atrophy of the nasal mucosa.

As with other sympathomimetics, this drug should be used with caution in patients who exhibit strong reactions to adrenergic agents, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

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

The drug should be used with caution in patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma, or benign prostatic hyperplasia, and should not be used concomitantly with MAO inhibitors or within 2 weeks after discontinuation of such therapy.

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

The drug contains benzalkonium chloride, which may cause irritation and skin reactions.

The drug contains propylene glycol, which may cause skin irritation.

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 on the effect of Pharmazolin® with mint and eucalyptus on fertility. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely small.

Ability to influence reaction rate while driving or operating machinery.

The drug usually has no effect or only a negligible effect on the ability to drive vehicles or operate machinery. However, with 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 as one spray into each nostril up to three times daily. Do not use more than three times per day into each nostril. The duration of treatment depends on the course of the disease and should not exceed 7 consecutive days.

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

Before first use, prime the dosing device by performing several spray actuations until the spray is released into the air. After priming, the device will be ready for immediate use.

The spray should be used as follows:

• thoroughly clear the nose 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 a spray while simultaneously taking a gentle breath in through the nose;
• after use, before covering the nozzle with the cap, clean and dry the nozzle thoroughly;
• to prevent infection, each bottle of medication should be used by only one person.

The last administration is recommended immediately before bedtime.

Children.

The medication should not be used in children under 12 years of age.

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 hypotension. 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 care should include observation 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:

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

Nervous system side effects:

Common (≥1/100, <1/10): headache.

Eye-related side effects:

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

Cardiovascular system side effects:

Rare (<1/10,000): irregular or rapid heartbeat, arterial hypertension, arrhythmia.

Respiratory, thoracic and mediastinal side effects:

Common (≥1/100, <1/10): dryness or discomfort of the nasal mucosa, burning sensation, drug-induced rhinitis;

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

Gastrointestinal side effects:

Common (≥1/100, <1/10): nausea.

General disorders and administration site reactions:

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

Shelf life. 2 years.

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

Storage conditions. Store in the original packaging at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging. 10 ml in a bottle. 1 bottle per pack.

Supply classification. Over-the-counter (without prescription).

Manufacturer. JSC "Farmak".

Manufacturer's name and address of the place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.