Nosolin^®-balsam (Drops) Instructions for Use

Marketing Authorization Holder

Firn M, LLC (Russia)

ATC Code

R01AA07 (Xylometazoline)

Active Substance

Xylometazoline (Rec.INN registered by WHO)

Dosage Form

Nosolin®-balsam

Nasal drops 0.1%: bottle 10 ml with dropper dispenser

Dosage Form, Packaging, and Composition

Nasal drops colorless or with a yellowish tint, with slight opalescence and a specific smell of menthol and essential oils.

Excipients: sorbitol – 50 mg, benzalkonium chloride – 0.1 mg, racemic menthol – 1 mg, tea tree oil – 1 mg, eucalyptus leaf oil – 1 mg, disodium edetate dihydrate – 0.4 mg, povidone 8000 – 5 mg, macrogol glycerides – 15 mg, macrogol glycerol hydroxystearate – 15 mg, macrogol 4000 – 100 mg, macrogol 400 – 10 mg, purified water – up to 1 ml.

10 ml – plastic bottles (1) with a dropper dispenser – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant – alpha-adrenomimetic

Pharmacological Action

A vasoconstrictor agent for topical use in ENT practice. An alpha-adrenomimetic.

When applied to the mucous membranes, it causes constriction of the blood vessels of the nasal mucosa, thereby eliminating edema and hyperemia of the nasal mucosa, and restores the patency of the nasal passages.

In rhinitis, it facilitates nasal breathing.

Pharmacokinetics

With topical application, it is practically not absorbed; plasma concentrations are so low that they cannot be determined by modern analytical methods.

Indications

To reduce swelling of the nasopharyngeal mucosa and discharge in acute allergic rhinitis, acute respiratory infections with symptoms of rhinitis, sinusitis, hay fever, otitis media; preparation of the patient for diagnostic procedures in the nasal passages.

ICD codes

Dosage Regimen

Administer intranasally only. Use the 0.1% solution for adults and children aged 6 years and older.

For adults and children over 6 years, instill 1-2 drops into each nostril. Do not use more than three times per day.

Prior to application, clear the nasal passages. Tilt the head back slightly during instillation.

Limit the duration of treatment to a maximum of 3-5 days for acute conditions. Do not use continuously for more than 7 days.

Strictly adhere to the recommended dosage frequency. Exceeding the dose or frequency increases the risk of systemic adverse effects and medication-induced rhinitis.

For preparatory diagnostic procedures, use a single dose as directed by a physician.

This formulation is contraindicated for children under 6 years of age. Use an age-appropriate concentration for younger pediatric patients.

If symptoms persist beyond 5 days, discontinue use and consult a physician.

Adverse Reactions

From the immune system uncommon – hypersensitivity reactions (angioedema, skin rash, itching).

From the digestive system rare – nausea, vomiting.

From the nervous system: rare – headache; very rare – insomnia, anxiety, fatigue, hallucinations and convulsions (mainly in children).

From the organ of vision very rare – blurred vision.

From the cardiovascular system rare – palpitations, increased blood pressure, tachycardia; very rare – arrhythmia.

Local reactions common – irritation and/or dryness of the nasopharyngeal mucosa, burning and paresthesia of the nasal mucosa, sneezing, hypersecretion of the nasal mucosa; uncommon – swelling of the nasal mucosa, nosebleeds, withdrawal syndrome. Increased swelling of the nasal mucosa (reactive hyperemia) is possible.

Contraindications

Hypersensitivity to xylometazoline; atrophic rhinitis, thyrotoxicosis; inflammatory diseases of the skin or mucous membrane of the nasal vestibule; condition after transsphenoidal hypophysectomy; patients with severe cardiovascular diseases (e.g., coronary artery disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis); patients with a history of surgical interventions on the meninges; patients receiving MAO inhibitors or other drugs that can cause increased blood pressure; patients with increased intraocular pressure, especially with angle-closure glaucoma; during therapy with tricyclic and tetracyclic antidepressants, other topical vasoconstrictors (decongestants); pregnancy; pediatric age – depending on the dosage form.

With caution patients with hypersensitivity to adrenomimetics, accompanied by symptoms of insomnia, dizziness, arrhythmia, tremor, increased blood pressure; patients with pheochromocytoma, porphyria; patients with endocrine diseases (e.g., hyperthyroidism, diabetes mellitus); patients with prostatic hyperplasia; during lactation (breastfeeding).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy. During lactation, use is possible only as prescribed by a doctor, after a thorough assessment of the benefit-risk ratio for the mother and the potential risk to the child. Exceeding the recommended doses is not allowed.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the drug leaflets for xylometazoline regarding contraindications for the use of specific dosage forms of xylometazoline in children of different ages. The recommended doses in children should not be exceeded.

Geriatric Use

The recommended doses in elderly patients should not be exceeded.

Special Precautions

Long-term use (more than 7 days) and overdose of sympathomimetics with a decongestant effect can lead to reactive hyperemia of the nasal mucosa.

As a result, nasal breathing difficulty occurs, which leads to the patient starting to use xylometazoline repeatedly or even constantly.

This can lead to chronic swelling (medication-induced rhinitis), and ultimately even to atrophy of the nasal mucosa (ozena).

In milder cases, to improve the patient’s condition, it is initially possible to stop the administration of the sympathomimetic into one nostril, and after the complaints decrease, continue to administer it into the other nostril, in order to at least partially ensure nasal breathing.

The recommended doses should not be exceeded, especially in children and elderly patients.

Effect on the ability to drive vehicles and mechanisms

With long-term treatment or when using xylometazoline in higher doses, the possibility of its systemic action cannot be excluded.

If systemic side effects develop, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Enhancement of the systemic action of xylometazoline is possible with simultaneous use of MAO inhibitors and tricyclic antidepressants. Simultaneous use of xylometazoline with tetracyclic antidepressants, other topical vasoconstrictors (decongestants), as well as other drugs that increase blood pressure is incompatible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.