Pharmazolin® n
Ukraine
Table of Contents
INSTRUCTIONS for medical use of the medicinal product FARMASOLIN® H (FARMAZOLINEN)
Composition:
Active substance: xylometazoline hydrochloride;
1 ml of the preparation contains xylometazoline hydrochloride, calculated as 100% substance, 1 mg;
Excipients: benzalkonium chloride; sodium chloride; sodium dihydrogen phosphate, dihydrate; sodium hydrogen phosphate, dodecahydrate; water for injections.
Pharmaceutical form. Nasal spray.
Main physicochemical properties: clear, colorless liquid.
Pharmacotherapeutic group.
Anti-edematous and other agents for local use in nasal cavity disorders. Simple sympathomimetics. ATC code R01A A07.
Pharmacological Properties
Pharmacodynamics
Xylometazoline is a sympathomimetic agent acting on α-adrenergic receptors.
Farmazolin® N causes constriction of nasal blood vessels, reducing swelling and hyperemia of the nasal mucosa and its paranasal sinuses, thereby improving nasal breathing in nasal and paranasal sinus congestion.
The effect of the drug begins within a few minutes after application and lasts up to 12 hours (for example, throughout the night).
The drug is well tolerated, including by patients with sensitive mucosa. The drug does not impair mucociliary function. Farmazolin® N has a balanced pH value within the physiological range of the nasal cavity.
In vitro studies have shown that xylometazoline reduces the infectivity of human rhinovirus associated with the common cold.
Pharmacokinetics
After topical application, plasma concentrations of xylometazoline are so low that they cannot be detected by current analytical methods.
Clinical characteristics.
Indications.
Symptomatic treatment of nasal congestion due to colds, hay fever, allergic rhinitis, and sinusitis.
For facilitating drainage of secretions in diseases of the nasal accessory sinuses.
Adjunctive therapy in cases of otitis media (to reduce mucosal swelling).
For facilitating rhinoscopy.
Contraindications.
Hypersensitivity to the components of the drug; acute coronary diseases, coronary asthma, hyperthyroidism, closed-angle glaucoma, dry rhinitis (rhinitis sicca) or atrophic rhinitis, surgical interventions involving exposure of the dura mater or transsphenoidal hypophysectomy. Concomitant use of monoamine oxidase inhibitors (MAO inhibitors) and within 2 weeks after discontinuation of such therapy.
Interaction with other medicinal products and other forms of interaction.
Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline may potentiate the effect of monoamine oxidase inhibitors, potentially causing a hypertensive crisis. Xylometazoline is not recommended for patients who are taking or have taken 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, simultaneous use of these agents is not recommended.
Concomitant use with β-blockers may cause bronchospasm or reduced blood pressure.
Special precautions for use.
The product should not be used for longer than 10 consecutive days. Prolonged or excessive use may lead to rebound nasal congestion and/or atrophy of the nasal mucosa.
The recommended dose of the product should not be exceeded, especially when treating children and elderly individuals.
The product should be used with caution in patients with cardiovascular disorders, high blood pressure, diabetes mellitus, prostate hyperplasia, or pheochromocytoma due to possible systemic sympathomimetic effects. As with other sympathomimetics, the product should be administered cautiously in patients who exhibit strong reactions to adrenergic agents, such as sleep disturbances, dizziness, tremor, cardiac arrhythmia, or increased blood pressure. The product contains benzalkonium chloride, which may cause irritation of the skin and mucous membranes.
Patients with long QT syndrome who receive xylometazoline may have an increased risk of serious ventricular arrhythmias.
Use during pregnancy or breastfeeding.
The product must not be used during pregnancy due to its potential vasoconstrictive effects.
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.
Fertility.
There are no adequate data regarding the effect of the product 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.
Generally, the product has no or negligible influence on the ability to drive or operate machinery.
Method of Administration and Dosage
For adults and children aged 12 years and older
Administer 1 spray into each nostril 3 times daily.
Maximum daily dose – 3 sprays.
The duration of treatment depends on the course of the disease and must not exceed 10 consecutive days.
Method of Administration
- Thoroughly clean the nose before using the medication. Immediately before use, hold the bottle in the palm of the hand to warm it to body temperature. During administration, hold the bottle vertically with the spray nozzle pointing upwards.
- Before use, remove the protective cap from the bottle.
- Insert the nozzle into the nasal passage, press the bottle firmly with a quick, sharp motion, then withdraw the nozzle from the nose and release the pressure. A gentle inhalation through the nose is recommended during spraying.
- After using the medication, replace the protective cap on the bottle and store as recommended in the instructions. To prevent infection, each bottle must be used by only one person.
Children. The medication may be used in 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, arterial hypertension, respiratory depression, coma, and seizures. Elevated arterial pressure may be followed by 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 monitoring of the patient for several hours. In cases of severe overdose accompanied by cardiac arrest, resuscitation efforts should continue for at least 1 hour.
Side effects.
Immune system disorders: hypersensitivity reactions, including angioedema, rash, itching.
Nervous system disorders: headache.
Eye disorders: temporary visual disturbances.
Cardiovascular disorders: irregular or rapid heartbeat.
Respiratory, thoracic and mediastinal disorders: dryness or discomfort of the nasal mucosa, epistaxis.
Gastrointestinal disorders: nausea.
General disorders and administration site conditions: burning sensation at the application site.
Reporting of suspected side effects
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report any 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 in a light-protected place at a temperature not exceeding 25 °C. Keep out of reach and sight of children.
Packaging. 15 ml or 20 ml in polyethylene bottles equipped with a dosing nozzle and protective cap. 1 bottle per cardboard box.
Supply category. Over-the-counter.
Manufacturer. JSC "Farmak".
Manufacturer's name and address of the place of business.
74, Kyrylivska Street, Kyiv, 04080, Ukraine.