Tizin Classic spray 0.05%, 10ml

• To reduce swelling of the nasopharyngeal mucosa and discharge in acute allergic rhinitis,

• ARI with symptoms of rhinitis,

• sinusitis

• hay fever,

• otitis media;

• preparation of the patient for diagnostic manipulations in the nasal passages.

TizinЃ Classic in the form of a nasal spray 0.05% is prescribed for children aged 2 to 6 years, 1 dose in each nasal passage 1-2 times / day.

TizinЃ Classic in the form of a nasal spray 0.1% is prescribed for adults and children over 6 years of age, 1 dose in each nasal passage 3 times / day.

The dose depends on the individual sensitivity of the patient and the clinical response. You should not use the drug for more than 5-7 days without a doctor's recommendation. After completion of therapy, the drug can be re-prescribed only after a few days.

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

Recommendations for the use of the drug

Remove the protective cap.

Before the first use, press the spray nozzle several times until an even cloud of 'fog' appears.

The bottle is ready to use.

When applying, press 1 time.

Inhale the drug through the nose.

If possible, keep the spray bottle upright.

Do not spray horizontally or downward.

After use, the bottle should be closed with a cap.

Dosed nasal spray in the form of a clear, colorless solution, odorless or with a weak characteristic odor.

xylometazoline hydrochloride

Excipients: benzalkonium chloride - 0.2 mg, sorbitol 70% - 20 mg, sodium chloride - 4.16 mg, sodium dihydrogen phosphate dihydrate - 3.38 mg, disodium hydrogen phosphate dihydrate - 2.08 mg, disodium edetate - 1.0 mg, purified water - a sufficient amount.

• Hypersensitivity to xylometazoline or any of the components of the drug;

• concomitant use of MAO inhibitors, tricyclic and tetracyclic antidepressants or other drugs that can cause an increase in blood pressure;

• arterial hypertension;

• tachycardia;

• severe atherosclerosis;

• glaucoma;

• atrophic rhinitis;

• surgical interventions on the meninges (in history);

• condition after transsphenoidal hypophysectomy;

• inflammatory diseases of the skin or mucous membrane of the vestibule of the nose;

• children under 6 years of age (for nasal spray 0.1%);

• children under 2 years of age (for nasal spray 0.05%).

• With care: diseases of the cardiovascular system, incl. Ischemic heart disease (angina pectoris); hyperplasia of the prostate; thyrotoxicosis; diabetes; pheochromocytoma; porphyria; in patients with hypersensitivity to adrenergic agonists, accompanied by insomnia, dizziness, arrhythmia, tremor and increased blood pressure.

pharmachologic effect

Xylometazoline (imidazole derivative) is a sympathomimetic drug with alpha-adrenergic activity. Has a vasoconstrictor effect and reduces swelling of the mucous membrane. The drug facilitates nasal breathing by reducing swelling and hyperemia of the mucous membrane, and also improves the discharge of secretions. The effect occurs within 2 minutes after application.

Pharmacokinetics

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

Side effect

Local reactions: possible transient slight irritation of the nose (burning), paresthesia, sneezing and hypersecretion in susceptible people; in some cases, there may be increased swelling of the nasal mucosa (reactive hyperemia); long-term or frequent use of xylometazoline or the use of the drug in high doses can lead to a burning sensation in the nose or dryness of the mucous membrane, as well as reactive congestion with the development of drug-induced rhinitis (this effect can be observed even 5-7 days after completion of treatment, and with prolonged use can cause irreversible damage to the mucous membrane with the formation of crusts (dry rhinitis)).

From the nervous system: very rarely - headache, insomnia or fatigue, depression (with prolonged use in high doses).

Systemic reactions: in isolated cases - palpitations, tachycardia, arrhythmias, increased blood pressure, visual impairment.

Application during pregnancy and lactation

Pregnancy

There have not been carefully controlled and appropriate studies in pregnant women. The drug should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the potential risk to the developing fetus.

Breastfeeding period

It is not known whether xylometazoline or its metabolites pass into breast milk, so the drug should not be used during breastfeeding. If you need to use the drug during pregnancy and breastfeeding, you should consult your doctor.

Application in children

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

special instructions

Long-term use and overdose of sympathomimetics, which have a decongestant effect, can lead to reactive hyperemia of the nasal mucosa and the 'rebound' effect. The 'rebound' effect can cause airway obstruction, which leads to the patient using the drug repeatedly or even continuously. This can lead to chronic swelling (rhinitis medicamentosa) and sometimes even to atrophy of the nasal mucosa (ozena). If the severity of symptoms persists or increases, or new symptoms appear, the patient should stop using the drug and consult a doctor. In chronic rhinitis, TizinЃ Classic 0.05% and 0.1% can be used only under medical supervision, given the risk of atrophy of the nasal mucosa.TizinЃ Classic should not be used in the presence of hypersensitivity to benzalkonium chloride, which is part of the drug as a preservative. The recommended doses should not be exceeded, especially in children and elderly patients.

Influence on the ability to drive vehicles and use mechanisms

With prolonged treatment or with the use of 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 control equipment.

Overdose

ѕередозировка или случайный прием препарата внутрь может привести к следующим симптомам: расширение зрачков, тошнота, рвота, цианоз, лихорадка, спазмы, тахикарди¤, сердечные аритмии, коллапс, остановка сердца, повышение ј?, отек легких, нарушение дыхани¤, психические нарушени¤, головна¤ боль, головокружение, судороги.  роме того, могут наблюдатьс¤ следующие симптомы: подавление функции ?Ќ—, сопровождающеес¤ сонливостью, снижением температуры тела, брадикардией, шокоподобным понижением ј?, апноэ и комой. Ћечение: применение активированного угл¤, промывание желудка, искусственное дыхание с введением кислорода; дл¤ снижени¤ ј? примен¤ют фентоламин (растворенный в физиологическом растворе) в/в медленно в дозе 5 мг или внутрь в дозе 100 мг. ¬азопрессорные средства противопоказаны. ѕри необходимости примен¤ют жаропонижающие и противосудорожные средства. ѕри проглатывании препарата ребенком необходимо незамедлительно обратитьс¤ за медицинской помощью.

Drug interactions

With the simultaneous use of the drug with MAO inhibitors such as tranylcypromine and tricyclic antidepressants, an increase in blood pressure is possible due to the cardiovascular effects of these substances.