Galazolin®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GАLAZOLIN® (GALAZOLIN®)

Composition:

active substance: 1 ml of solution contains 0.5 mg or 1 mg of xylometazoline hydrochloride;

excipients: sodium chloride, sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, disodium edetate, benzalkonium chloride, sorbitol (E 420), purified water.

Pharmaceutical form. Nasal drops, solution.

Main physico-chemical properties: colorless or almost colorless, clear liquid.

Pharmacotherapeutic group. Preparations used in nasal disorders. Simple sympathomimetics. ATC code R01A A07.

Pharmacological properties.

Pharmacodynamics.

Xylometazoline is an imidazoline derivative with sympathomimetic action. It is a direct agonist of alpha-adrenergic receptors.

The drug causes vasoconstriction of the mucosal blood vessels, reduces swelling, alleviates hyperemia of the nasal and pharyngeal mucosa, and decreases the amount of exudate.

Pharmacokinetics.

The drug begins to act within 5–10 minutes; its effect lasts up to 10 hours. When applied to the nasal mucosa, the drug produces local vasoconstriction. It is generally not absorbed in clinically significant amounts and does not produce systemic effects.

Clinical characteristics.

Indications.

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

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

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

Facilitation of rhinoscopy.

Contraindications.

• Hypersensitivity to any component of the medicinal product.
• Should not be used in patients after hypophysectomy or following other surgical interventions involving incision of the dura mater.
• Atrophic rhinitis.
• Acute coronary diseases, coronary asthma, hyperthyroidism, closed-angle glaucoma.
• Concomitant use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of such treatment.

Interaction with other medicinal products and other forms of interaction.

Cases of interaction between xylometazoline and tricyclic antidepressants or MAO inhibitors are known. Halazoline® should not be used during treatment with these medicinal products.

Concomitant use of xylometazoline with other sympathomimetic agents (e.g., ephedrine, pseudoephedrine) should be avoided due to their additive effects.

Xylometazoline may influence the effects of certain antihypertensive agents, such as β-adrenoblockers, and certain antidepressants, such as tricyclic or tetracyclic antidepressants. Concomitant use with β-adrenoblockers may cause bronchospasm or reduction in blood pressure.

Special precautions for use

GALAZOLINE® 0.05% should not be used in children under 1 year of age.

GALAZOLINE® 0.1% should not be used in children under 12 years of age.

GALAZOLINE®, like other sympathomimetics, should be used with caution in patients with hypersensitivity to adrenomimetics, the symptoms of which include insomnia, dizziness, tremor, cardiac arrhythmias, and arterial hypertension.

The drug should not be used in patients with chronic or vasomotor rhinitis, as they may use it for longer than 5 days.

Prolonged use beyond the recommended duration may lead to secondary dilation of blood vessels and, as a result, to secondary drug-induced rhinitis (rhinitis medicamentosa).

This condition is likely caused by inhibition of norepinephrine release from nerve endings due to stimulation of presynaptic alpha-2 receptors.

The drug should be used with caution in patients with arterial hypertension and other cardiovascular disorders, diabetes mellitus, prostate hyperplasia, urinary retention, or thyroid disorders.

Doses higher than recommended should not be used, especially in children and elderly patients.

GALAZOLINE® should not be used during treatment with monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (see "Interaction with other medicinal products and other forms of interaction").

Due to the presence of benzalkonium chloride, the product may irritate the nasal mucosa.

The drug should be used with caution in patients with porphyria or existing pheochromocytoma due to the potential for systemic sympathomimetic effects.

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

Use during pregnancy or breastfeeding

GALAZOLINE® should not be used during pregnancy due to its potential vasoconstrictive effects. There is no evidence of adverse effects on the infant.

There are no data indicating that xylometazoline passes into breast milk. Therefore, caution is advised, and the medicinal product should be used during breastfeeding only under medical supervision.

Fertility. Adequate data on the effect of the drug on fertility are lacking. 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 medicinal product usually has no effect or has a minimal effect on the ability to drive or operate machinery.

Method of Administration and Dosage

The medication is intended for nasal use. Before administration, the nasal cavity should be thoroughly cleaned. The last dose is recommended to be administered immediately before bedtime.

HALAZOLINE® 0.05% Nasal Drops are indicated for children aged 1 year and older.

Children aged 1 to 5 years (under adult supervision): 1–2 drops into each nostril 1–2 times daily (every 8–10 hours), but no more than 3 times per nasal passage per day.

Children aged 6 to 11 years (under adult supervision): 2–4 drops into each nasal passage 2–3 times daily. Do not administer more than 3 times per nasal passage per day.

The duration of treatment depends on the course of the illness and should not exceed 7 consecutive days.

HALAZOLINE® 0.1% Nasal Drops are indicated for adults and children aged 12 years and older.

Adults and children aged 12 years and older: 2–4 drops into each nasal passage up to 3 times daily.

Do not administer more than 3 times per nasal passage per day.

The duration of treatment depends on the course of the illness and should not exceed 10 consecutive days.

For hygienic reasons, the medication package should be used by only one patient.

Children.

HALAZOLINE® 0.05% 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.

HALAZOLINE® 0.1% should not be used in children under 12 years of age.

Overdose.

Excessive local use or accidental ingestion of the medication may lead to pronounced dizziness, sweating, significant drop in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma, and seizures. After an initial rise in blood pressure, a subsequent drop may occur. Younger children are more sensitive to the toxic effects than adults.

Administration of more than 0.2 mg/kg may result in fatigue, tachycardia, and elevated arterial blood pressure. Very rarely, in cases of severe overdose—especially in children (e.g., accidental ingestion of high doses)—alternating phases of stimulation and depression of the central nervous and cardiovascular systems may occur. Symptoms of central nervous system stimulation may include restlessness, agitation, hallucinations, and, in severe cases, seizures. Symptoms of central nervous system depression may include hypothermia, lethargy, drowsiness, and, in the most severe cases, coma.

Other possible symptoms include pupillary constriction or dilation, sweating, pallor, cyanosis, nausea, tachycardia, bradycardia, arrhythmia, asystole, hypotension, circulatory disturbances, pulmonary edema, respiratory disturbances, and apnea.

Overdose, particularly in children, may significantly affect the central nervous system, including seizures, coma, bradycardia, apnea, and elevated arterial blood pressure, which may later shift to hypotension.

Treatment. 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.

Treatment of severe overdose (>1 mg/kg, which for a 20 kg child corresponds to the contents of 4 vials of the medication) should ideally begin within 1 hour of ingestion. For seizure management, anticonvulsant agents such as benzodiazepines should be used. For blood pressure reduction, non-selective α-blockers (e.g., doxazosin, terazosin) are recommended. Vasoconstrictors are contraindicated. Atropine should be administered only in cases of clinically significant bradycardia associated with low blood pressure.

Adverse Reactions

Below are the undesirable effects associated with the use of xylometazoline.

Immune system disorders: Hypersensitivity reactions, including angioedema, rash, and pruritus.

Cardiovascular system disorders: Palpitations, tachycardia, arrhythmia, arterial hypertension (especially in individuals with cardiovascular diseases).

Nervous system disorders: Headache, drowsiness, restlessness, insomnia, fatigue, hallucinations, convulsions (especially in children).

Respiratory, thoracic and mediastinal disorders: Sneezing, dryness or discomfort of the nasal mucosa.

Use of the product for longer than recommended and/or in doses exceeding the recommended may lead to secondary drug-induced inflammation of the nasal mucosa.

General disorders and administration site conditions: Nausea, fatigue, feeling of weakness, increased nasal mucosa swelling after discontinuation of the drug effect, epistaxis.

Irritation of the nasal mucosa, burning sensation in the nose and throat may occur.

Eye disorders: Transient visual disturbances.

Shelf life

4 years.

The shelf life after first opening the bottle is 12 weeks.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Incompatibilities Not known.

Packaging

10 ml of 0.05% or 0.1% in polyethylene dropper bottles with tamper-evident seal, pack of 1 in a cardboard box.

Availability

Over-the-counter (without prescription).

Manufacturer

Pharmaceutical Works “POLPHARMA” S.A. / Pharmaceutical Works POLPHARMA S.A.

Manufacturer's address and place of business

Medana Branch in Sieradz, 10 Wladyslawa Lokietka Str., 98-200 Sieradz, Poland / Medana Branch in Sieradz, 10, Wladyslawa Lokietka Str., 98-200 Sieradz, Poland