Tyzine^® Classic (Spray) Instructions for Use

Marketing Authorization Holder

J&JTL, LLC (Russia)

Manufactured By

Delpharm Orleans (France)

Contact Information

J&JTL LLC (Russia)

ATC Code

R01AA07 (Xylometazoline)

Active Substance

Xylometazoline (Rec.INN registered by WHO)

Dosage Forms

	Tyzine® Classic	Dosed nasal spray 0.1%: 10 ml bottle (60 doses) with dosing device
		Dosed nasal spray 0.05%: 10 ml bottle (115 doses) with dosing device

Dosage Form, Packaging, and Composition

Dosed nasal spray 0.05% in the form of a clear, colorless solution without odor or with a faint characteristic odor.

Excipients : benzalkonium chloride solution 50%, sorbitol 70%, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, disodium edetate, purified water.

10 ml (at least 115 doses) – brown glass bottles (class III) (1) with a dosing device and a removable polyethylene cap – cardboard packs.

Dosed nasal spray 0.1% in the form of a clear, colorless solution without odor or with a faint characteristic odor.

Excipients : benzalkonium chloride solution 50%, sorbitol 70%, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, disodium edetate, purified water.

10 ml (at least 60 doses) – brown glass bottles (class III) (1) with a dosing device and a removable polyethylene cap – cardboard packs.

Clinical-Pharmacological Group

Decongestant – vasoconstrictor (alpha-adrenergic agonist)

Pharmacotherapeutic Group

Decongestant – vasoconstrictor (alpha-adrenomimetic)

Pharmacological Action

Pharmacodynamics

Xylometazoline belongs to the group of topical vasoconstrictors (decongestants) with alpha-adrenomimetic action. It causes constriction of the blood vessels of the nasal mucosa, eliminating swelling and hyperemia of the nasopharyngeal mucosa.

Xylometazoline also reduces the accompanying hypersecretion of mucus and facilitates the drainage of nasal passages blocked by secretions, and thus improves nasal breathing in case of nasal congestion.

Xylometazoline is well tolerated by patients with sensitive mucosa, and its action does not impede the discharge of mucus. Xylometazoline has a balanced pH value characteristic of the nasal cavity.

In therapeutic concentrations, the drug does not irritate the mucosa and does not cause hyperemia.

The action begins within 2 minutes after application and lasts for 12 hours (for example, throughout the night).

In vitro studies have shown that Xylometazoline suppresses the infectious activity of human rhinovirus, which causes the “common cold”.

Pharmacokinetics

When applied topically, Xylometazoline is practically not absorbed; its plasma concentrations are so low that they cannot be determined by modern analytical methods.

Indications

• Acute respiratory diseases with symptoms of rhinitis (runny nose):
  • Acute allergic rhinitis, hay fever, sinusitis;
  • Eustachitis, otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa);
• Preparation of the patient for diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Intranasally.

Tyzine^® Classic in the form of 0.1% nasal spray is prescribed to adults and children over 6 years of age, 1 spray into each nostril 2-3 times/day.

Tyzine^® Classic in the form of 0.05% nasal spray is prescribed to children aged 2 to 6 years, 1 spray into each nostril 1-3 times/day.

It is not recommended to use the drug more than 3 times/day.

It is not recommended to use the drug for more than 5-7 days.

The drug in children should be used under adult supervision. The duration of use of the drug in children is determined by the doctor.

General recommendations for drug administration

Remove the protective cap.

Before first use, press the spray nozzle several times (fig. 1) until a uniform cloud of “mist” appears. The bottle is ready for further use.

When applying, press once (fig. 2). Inhale the drug through the nose.

If possible, hold the spray bottle vertically. Do not spray horizontally or downwards.

After use, close the bottle with the cap.

Adverse Reactions

Classification of the frequency of adverse reactions: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000).

Immune system disorders very rare – hypersensitivity reactions (angioedema, rash, itching).

Nervous system disorders common – headache.

Psychiatric disorders rare – insomnia, depression (with long-term use in high doses).

Eye disorders very rare – blurred vision.

Cardiac disorders rare – palpitations; very rare – tachycardia, arrhythmia.

Vascular disorders rare – increased blood pressure.

Respiratory, thoracic and mediastinal disorders: common – irritation and/or dryness of the nasal mucosa, burning, tingling, sneezing, hypersecretion of the nasopharyngeal mucosa, medicinal rhinitis.

Gastrointestinal disorders common – nausea; rare – vomiting.

General disorders and administration site conditions common – burning at the application site.

If any of the adverse reactions listed in the instructions worsen, or if any other adverse reactions not listed in the instructions are noted, it is necessary to inform the doctor.

Contraindications

• Hypersensitivity to xylometazoline or any of the excipients of the drug;
• Arterial hypertension;
• Tachycardia;
• Severe atherosclerosis;
• Hyperthyroidism;
• Glaucoma;
• Atrophic rhinitis;
• Inflammatory diseases of the skin or mucous membrane of the nasal vestibule;
• Surgical interventions on the meninges (in history);
• Condition after transsphenoidal hypophysectomy;
• Use of monoamine oxidase inhibitors (MAOIs) (including 14 days after their withdrawal), tricyclic or tetracyclic antidepressants;
• Pregnancy;
• Children under 6 years of age (for 0.1% solution);
• Children under 2 years of age (for 0.05% solution).

With caution

Diabetes mellitus, severe cardiovascular diseases (including coronary artery disease, angina pectoris); prostatic hyperplasia; pheochromocytoma; porphyria; breastfeeding period; patients with hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure; patients with long QT syndrome.

Use in Pregnancy and Lactation

Pregnancy

During pregnancy, the use of the drug is contraindicated.

Breastfeeding period

It is unknown whether Xylometazoline or its metabolites pass into breast milk, so the drug should not be used during breastfeeding.

If it is necessary to use the drug during pregnancy and breastfeeding, you should consult a doctor.

Pediatric Use

0.1% nasal spray is contraindicated in children under 6 years of age, 0.05% nasal spray is contraindicated in children under 2 years of age.

Special Precautions

Long-term use and overdose of sympathomimetics with decongestant action can lead to reactive hyperemia of the nasal mucosa and a “rebound” effect.

The “rebound” effect can cause airway obstruction, which leads to the patient reusing the drug or even using it constantly. This can lead to chronic swelling (medicinal rhinitis), and ultimately even to atrophy of the nasal mucosa and ozena.

The duration of use of the drug in children is determined after consultation with a doctor. In case of chronic rhinitis, the drug can be used only under medical supervision, taking into account the risk of atrophy of the nasal mucosa.

Patients with long QT syndrome taking Xylometazoline may be at increased risk of developing serious ventricular arrhythmias.

If the severity of symptoms persists or increases, or if new symptoms appear, it is necessary to stop using the drug and consult a doctor.

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

The drug should not be used in the presence of hypersensitivity to benzalkonium chloride, which is part of the drug as a preservative. Benzalkonium chloride can cause irritation of the nasal mucosa.

Effect on ability to drive vehicles and machinery

With long-term treatment or when using the drug in doses exceeding the recommended ones, the possibility of a systemic effect on the cardiovascular system cannot be excluded, which may impair the ability to drive vehicles and operate machinery.

Drug disposal rules

If the drug has deteriorated or the expiration date has expired, it should not be thrown into sewers or onto the street. It is necessary to place the drug in a bag and put it in a trash container. These measures will help protect the environment.

Overdose

Overdose or accidental ingestion of the drug may lead to the following symptoms: dilated pupils, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, cardiac arrhythmias, collapse, cardiac arrest, increased blood pressure, pulmonary edema, respiratory depression, mental disorders, headache, dizziness, convulsions, increased sweating. In addition, the following symptoms may be observed: depression of CNS function, accompanied by drowsiness, decreased body temperature, bradycardia, shock-like decrease in blood pressure, apnea and coma.

If any overdose is suspected, seek medical attention immediately.

Treatment if any overdose is suspected, seek medical attention immediately. Treatment is symptomatic, under medical supervision. In case of accidental ingestion of the drug – administration of activated charcoal, gastric lavage. In case of severe overdose, intensive therapy in a hospital. Non-selective alpha-blockers may be used to reduce blood pressure, as well as antipyretics, anticonvulsants, intubation and artificial lung ventilation. In case of severe poisoning with cardiac arrest, resuscitation measures should continue for at least 1 hour.

Drug Interactions

Concomitant use of xylometazoline with monoamine oxidase inhibitors (MAOIs), tricyclic or tetracyclic antidepressants is contraindicated.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is available without a prescription.

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.