Xilin with menthol and eucalyptus (Spray) Instructions for Use

Marketing Authorization Holder

Pharmtekhnologiya LLC (Republic of Belarus)

ATC Code

R01AA07 (Xylometazoline)

Active Substance

Xylometazoline (Rec.INN registered by WHO)

Dosage Form

Xilin with menthol and eucalyptus

Nasal spray 1 mg/ml

Dosage Form, Packaging, and Composition

Nasal spray

10 ml – bottles – carton packs – Over-the-Counter
15 ml – bottles – carton packs – Over-the-Counter

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestants and other nasal preparations for topical application

Pharmacological Action

Vasoconstrictor agent for topical use in ENT practice. Alpha-adrenomimetic. When applied to the mucous membranes, it causes constriction of the blood vessels of the nasal mucosa, thereby eliminating swelling and hyperemia of the nasal mucosa, and restores the patency of the nasal passages. In rhinitis, it facilitates nasal breathing.

Pharmacokinetics

When applied topically, 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 recommended dosage based on patient age and the specific product formulation.

For adults and children aged 12 years and older, administer one spray into each nostril. Repeat this dose up to three times daily as needed for nasal congestion relief.

Do not exceed three applications per 24-hour period. The maximum duration of continuous use is 7 days.

For children aged 6 to 11 years, administer one spray into each nostril. This dose may be repeated, but not more than twice in 24 hours.

This product is not recommended for use in children under 6 years of age without explicit medical direction.

Before initial use, prime the pump by pressing the actuator several times until a fine mist is produced. If the product has not been used for several days, re-prime the pump.

To administer, hold the bottle with the nozzle between your fingers. Tilt your head slightly forward. Insert the tip into a nostril, pointing away from the nasal septum. Press the actuator firmly while breathing in gently through the nose. Repeat for the other nostril.

Wipe the nozzle clean after each use. Strictly adhere to the prescribed frequency and duration of treatment to avoid rebound congestion (medicinal rhinitis).

Adverse Reactions

Immune system disorders uncommon – hypersensitivity reactions (angioedema, skin rash, itching).

Gastrointestinal system disorders rare – nausea, vomiting.

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

Eye disorders very rare – blurred vision.

Cardiovascular system disorders 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 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 labels for xylometazoline regarding contraindications for use in children of different ages for specific dosage forms of xylometazoline. 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 (medicinal rhinitis), and ultimately even to atrophy of the nasal mucosa (ozena). In milder cases, to improve the patient’s condition, one can initially stop the administration of the sympathomimetic into one nostril, and after the complaints decrease, continue to administer it into the other nostril 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 operate machinery

During 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.