Pharmazolin®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FARMASOLINE® (FARMASOLINE®)

Composition:

Active substance: xylometazoline;

1 ml of solution contains xylometazoline hydrochloride equivalent to 100% substance 0.5 mg or 1 mg;

Excipients: sodium hydrogen phosphate, dodecahydrate; sodium dihydrogen phosphate, dihydrate; sorbitol (E 420); benzalkonium chloride; disodium edetate; water for injections.

Pharmaceutical form. Nasal drops.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group.

Agents used in nasal disorders. Anti-edematous 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.

Farmazolin® causes constriction of nasal blood vessels, reducing swelling of the nasal mucosa and mucosa of the paranasal sinuses, thereby improving nasal breathing during nasal and sinus congestion. The product is well tolerated, including by patients with sensitive mucous membranes. The drug does not impair mucociliary function. Due to the moisturizing component (sorbitol), the product helps relieve dryness and irritation of the nasal mucosa. Farmazolin® nasal drops have a balanced pH value corresponding to that of the nasal cavity.

Pharmacokinetics.

The effect of the drug begins within a few minutes after application and lasts up to 12 hours. When applied locally, the drug is practically not absorbed, and concentrations of xylometazoline in blood plasma are so low that they cannot be detected 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 nasal accessory sinuses.

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

For facilitating rhinoscopy.

Contraindications.

Hypersensitivity to xylometazoline or to any other component of the medicinal product, acute coronary diseases, cor pulmonale, hyperthyroidism, closed-angle glaucoma, transsphenoidal hypophysectomy, and surgical interventions involving exposure of meninges in medical history, dry rhinitis (rhinitis sicca) or atrophic rhinitis. Concomitant use of monoamine oxidase inhibitors (MAO inhibitors) and within 2 weeks after discontinuation of their use.

Interaction with other 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 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, simultaneous use of these agents is not recommended.

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

Special precautions for use.

Pharmazoline®, 0.05% nasal drops should not be used in children under 1 year of age.

Use in children aged 1 to 11 years is recommended only under adult supervision.

The drug should not be used in children for longer than 7–10 consecutive days.

Pharmazoline®, 0.1% nasal drops should not be used in 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.

As with other sympathomimetics, this drug should be prescribed with caution to patients who exhibit strong reactions to adrenergic agents, such 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 prescribed with caution in patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, thyroid disorders, pheochromocytoma, or benign prostatic hyperplasia. It should not be used in patients receiving concomitant treatment with MAO inhibitors or within 2 weeks after discontinuation of such therapy. Patients with long QT syndrome who receive xylometazoline may be at increased risk of serious ventricular arrhythmias.

To prevent infection, each container should be used by only one person.

The product contains benzalkonium chloride, prolonged use of which may cause swelling 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 Pharmazoline® on fertility. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.

Ability to affect reaction speed when driving or operating machinery.

The drug usually has no effect or has a negligible effect on the ability to drive or operate machinery.

Administration and Dosage

Before administration, the nasal cavity should be thoroughly cleaned.

When using a polyethylene bottle, before the first use, the cap should be screwed on tightly so that the spike on the inner side of the cap pierces the opening.

When using a polyethylene bottle closed with a tamper-evident cap (with first-opening control), the cap should be twisted to break the seal.

Immediately before use, the bottle should be held in the hand to warm it to body temperature.

Administration method of drops:

1. Unscrew and remove the cap/closure.
2. Turn the bottle upside down and gently press on the bottle body to instill the required number of drops into each nostril.
3. After use, close the bottle with the cap/closure.

Pharmazolin®, nasal drops 0.05%, is indicated for children aged 1 to 11 years.

Pharmazolin®, nasal drops 0.1%, is indicated for adults and children aged 12 years and older.

Nasal drops 0.05%:

For children aged 1 to 5 years (under adult supervision): 1–2 drops in each nostril 1–2 times daily, but not more than 3 times daily;

For children aged 6 to 11 years (under adult supervision): 2–4 drops in each nostril 2–3 times daily.

Do not use more than 3 times daily.

Duration of treatment depends on the course of the disease and should not exceed 7 days unless otherwise prescribed by a physician.

Nasal drops 0.1%:

For adults and children aged 12 years and older: 2–4 drops in each nostril 3 times daily.

Do not use more than 3 times daily.

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

Children.

Pharmazolin®, 0.05% drops, is contraindicated in children under 1 year of age.

Pharmazolin®, 0.05% drops, should be used in children aged 1 to 11 years under adult supervision.

Pharmazolin®, nasal drops 0.1%, is contraindicated 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 subsequently shift to 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 patient monitoring 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.

Respiratory, thoracic and mediastinal side effects:

Common (≥1/100, <1/10): dryness or discomfort of the nasal mucosa;

Uncommon (≥1/1,000 – <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. 3 years.

After opening the bottle, the preparation is suitable for use for 28 days.

Do not use the medicine after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 ml in a polyethylene bottle stoppered with a cap, or in a polyethylene bottle with a dispenser stoppered with a tamper-evident cap (first opening indicator), or 10 ml in a polyethylene bottle stoppered with a dropper plug and cap.

1 bottle per carton.

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

Manufacturer.

JSC "Farmak".

Manufacturer's address and location of its business activities.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.