Tyzine^® Expert (Spray) Instructions for Use

Marketing Authorization Holder

J&JTL, LLC (Russia)

Manufactured By

Famar Health Care Services Madrid, S.A.U. (Spain)

Contact Information

J&JTL LLC (Russia)

ATC Code

R01AA07 (Xylometazoline)

Active Substance

Xylometazoline (Rec.INN registered by WHO)

Dosage Forms

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

Dosage Form, Packaging, and Composition

Dosed nasal spray 0.05% is a transparent or slightly opalescent solution, colorless or slightly yellowish in color.

Excipients: glycerol – 8.5 mg, sorbitol – 5 mg, sodium dihydrogen phosphate dihydrate – 4 mg, sodium chloride – 3 mg, disodium phosphate dihydrate – 0.628 mg, sodium hyaluronate – 0.2 mg, water for injections – up to 1 ml.

10 ml (115 doses) – high-density polyethylene bottles (1) with a dosing device and a polyethylene cap – cardboard packs.

Dosed nasal spray 0.1% is a transparent or slightly opalescent solution, colorless or slightly yellowish in color.

Excipients: glycerol – 8.5 mg, sorbitol – 5 mg, sodium dihydrogen phosphate dihydrate – 4 mg, sodium chloride – 3 mg, disodium phosphate dihydrate – 0.628 mg, sodium hyaluronate – 0.2 mg, water for injections – up to 1 ml.

10 ml (60 doses) – high-density polyethylene bottles (1) with a dosing device and a polyethylene cap – cardboard packs.

Clinical-Pharmacological Group

Decongestant – vasoconstrictor (alpha-adrenergic agonist)

Pharmacotherapeutic Group

Decongestant – vasoconstrictor

Pharmacological Action

Xylometazoline (an imidazole derivative) is an alpha-adrenergic agonist that constricts the blood vessels of the nasal mucosa, eliminating swelling and hyperemia of the mucous membrane. It facilitates nasal breathing in rhinitis.

The preparation contains inactive components – hyaluronic acid (in the form of sodium hyaluronate), glycerol, and sorbitol, which are moisturizers that allow the preparation to reduce the symptoms of irritation and dryness of the nasal mucosa.

The effect begins 2 minutes after application and lasts for 12 hours.

Pharmacokinetics

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

Pharmacokinetic studies have not been conducted in humans.

Indications

• Reduction of swelling of the nasal mucosa in rhinitis, including allergic rhinitis, acute respiratory infections with symptoms of rhinitis, hay fever;
• Facilitation of discharge from the nose in paranasal sinusitis and inflammation of the middle ear caused by a cold;
• Preparation of patients for diagnostic manipulations in the nasal passages.

The dosed nasal spray 0.05% is intended for children aged 2 to 6 years.

The dosed nasal spray 0.1% is intended for adults and children over 6 years of age.

ICD codes

Dosage Regimen

Adults and children over 6 years of age are prescribed the dosed nasal spray 0.1%, 1 dose in each nasal passage up to 3 times/day. The dose depends on the individual sensitivity of the patient and the clinical effect.

Children aged 2-6 years are prescribed the dosed nasal spray 0.05%, 1 dose in each nasal passage 1-2 times/day.

The preparation should not be used for more than 5-7 days unless the doctor recommends a different duration of treatment. After completion of therapy, the preparation can be prescribed again only after a few days.

The duration of use of the preparation in children is determined by the doctor.

In chronic rhinitis, the preparation can be used only under medical supervision, taking into account the risk of developing atrophy of the nasal mucosa.

Method of application of the preparation

Remove the protective cap. Before the first use, press the spray nozzle several times until a uniform cloud of “mist” appears. The bottle is ready for further use.

When applying, press once. Inhale the preparation 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

Local reactions: transient mild irritation of the nose (burning) in susceptible individuals, sneezing. Frequently (>1%, <10%), after the effect of the preparation wears off, increased swelling of the nasal mucosa (reactive hyperemia) may be observed. Prolonged or too frequent use of xylometazoline, or its use in high doses, can lead to burning in the nose or dryness of the mucous membrane, as well as reactive nasal congestion, with the development of drug-induced rhinitis, paresthesia, sneezing, hypersecretion (this effect can be observed even 5-7 days after completion of treatment, and with prolonged use can be the cause of chronic inflammation of the mucous membrane with the formation of crusts (dry rhinitis)).

From the nervous system: rarely (>0.01%, <1%) - headache, insomnia, visual impairment, fatigue and depression (with long-term use in high doses).

From the cardiovascular system: in isolated cases (0.1%, <1%), local intranasal use of sympathomimetics may be accompanied by systemic effects, such as palpitations, tachycardia, arrhythmia and increased blood pressure.

Contraindications

• Hypersensitivity to any of the components of the preparation;
• Atrophic rhinitis;
• Thyrotoxicosis;
• Severe cardiovascular diseases (e.g., coronary artery disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis);
• Increased intraocular pressure, especially angle-closure glaucoma;
• Condition after transsphenoidal hypophysectomy;
• History of surgical interventions on the meninges;
• Patients receiving MAO inhibitors or other drugs that can cause an increase in blood pressure;
• Newborns and children under 2 years of age (for dosed nasal spray 0.05%);
• Children under 6 years of age (for dosed nasal spray 0.1%).

With caution

In the following cases, Tyzine^® Expert can be used only after carefully weighing the benefits and risks of treatment

• Hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure;
• Pheochromocytoma;
• Endocrine diseases (e.g., hyperthyroidism, diabetes mellitus);
• Prostatic hyperplasia;
• Porphyria.

Use in Pregnancy and Lactation

Xylometazoline should not be used during pregnancy, as the effect on the fetus has not been studied in clinical trials.

The preparation should not be used during breastfeeding, as it is not known whether the active substance is excreted in breast milk.

Pediatric Use

The use of the preparation is contraindicated in newborns and children under 2 years of age (dosed nasal spray 0.05%), in children under 6 years of age (dosed nasal spray 0.1%).

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, difficulty in nasal breathing occurs, which leads to the patient starting to use the preparation again or even constantly. This can lead to chronic swelling (drug-induced rhinitis), and sometimes even to atrophy of the nasal mucosa (ozena).

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

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

It is not recommended to use the preparation continuously for more than 7 days.

If the medicinal product has deteriorated or the expiration date has passed, it should not be disposed of in sewage or on the street. It is necessary to place the medicinal product in a bag and put it in a trash container. These measures will help protect the environment.

Effect on the ability to drive vehicles and machinery

With long-term treatment or use of the preparation in higher doses, the possibility of its systemic effect on the cardiovascular system cannot be excluded. In such cases, the ability to drive and operate machinery may be impaired.

Overdose

Overdose or accidental ingestion of the preparation may lead to the following symptoms: dilated pupils, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, arrhythmia, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory distress, mental disorders. In addition, the following symptoms may be observed: suppression of CNS function, accompanied by drowsiness, decreased body temperature, bradycardia, hypotension, apnea and coma.

Treatment: use of activated charcoal, gastric lavage, artificial respiration with oxygen administration. To reduce blood pressure, phentolamine 5 mg (in saline) is administered intravenously slowly or 100 mg orally. Vasopressors are contraindicated. If necessary, antipyretics and anticonvulsants are used.

Drug Interactions

Concomitant use of MAO inhibitors such as tranylcypromine or tricyclic antidepressants may lead to an increase in blood pressure due to the cardiovascular effects of these substances.

Storage Conditions

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

Shelf Life

The shelf life is 2 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The preparation is dispensed 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.