Tizin Alerji nasal spray 50mcg / dose, 10 ml

Symptomatic therapy of seasonal and perennial allergic rhinitis.

Intranasal for adults and children over 6 years of age, 2 doses (100 mcg) each

nasal passage 2 times a day.

The use of the drug should be continued until the symptoms are eliminated.

In case of severity of symptoms, it can be used 3-4 times a day.

Patients should be warned about the need to clear the nasal passages.

before using the spray and inhale through the nose during administration.

Before the first use, remove the protective cap and press several times

spray nozzle until a cloud of 'fog' appears.

The bottle is ready for further use.

Shake the bottle before each use. Inhale the drug through the nose.

1 ml of the drug contains:

active substance:

levocabastine hydrochloride (0.54 mg) in terms of levocabastine 0.5 mg;

Excipients:

propylene glycol 48.26 ?l, sodium hydrogen phosphate 8.66 mg, sodium hydrogen phosphate

monohydrate 5.38 mg, hypromellose (2910 5 mPa.s) 2.50 mg, polysorbate 80 1.00 mg,

benzalkonium chloride 0.15 mg (in the form of a 50% solution 0.03 ml), disodium edetate 0.15

mg, water for injection up to 1.0 ml.

Hypersensitivity to any component of the drug.

Children under 6 years of age.

CAREFULLY

Patients with impaired renal function and the elderly.

Trade name: TizinЃ Allergy

International non-proprietary name: levocabastine.

Dosage form: dosed nasal spray.

Composition:

1 ml of the drug contains:

active substance:

levocabastine hydrochloride (0.54 mg) in terms of levocabastine 0.5 mg;

Excipients:

propylene glycol 48.26 ?l, sodium hydrogen phosphate 8.66 mg, sodium hydrogen phosphate

monohydrate 5.38 mg, hypromellose (2910 5 mPa.s) 2.50 mg, polysorbate 80 1.00 mg,

benzalkonium chloride 0.15 mg (in the form of a 50% solution 0.03 ml), disodium edetate 0.15

mg, water for injection up to 1.0 ml.

Description: white homogeneous suspension.

Pharmacotherapeutic group: antiallergic agent - H1-

a histamine receptor blocker.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Levocabastine is a selective blocker of H1-histamine receptors with

long-term action. The local effect occurs in 5 minutes, and

the action lasts for 12 hours. After intranasal administration

nasal spray 'TizinЃ Allergy' eliminates the symptoms of allergic

rhinitis: nasal discharge, sneezing, itching in the nasal cavity.

Pharmacokinetics

With each intranasal administration at the rate of 50 ?g / dose is absorbed

about 30-40 mcg of levocabastine, maximum concentration of levocabastine

in blood plasma is reached approximately 3 hours after nasal administration.

Levocabastine binds to blood plasma proteins by approximately

55%.

The main metabolite of levocabastine, acylglucuronide, is formed when

glucuronidation, which is the main metabolic pathway.

Levocabastine is excreted mainly in the urine unchanged

(about 70% of the absorbed amount). Half-life

levocabastine is about 35-40 hours.

INDICATIONS FOR USE

Symptomatic therapy of seasonal and perennial allergic rhinitis.

CONTRAINDICATIONS

Hypersensitivity to any component of the drug.

Children under 6 years of age.

CAREFULLY

Patients with impaired renal function and the elderly.

APPLICATION DURING PREGNANCY AND LACTATION

Reliable data on the use of the nasal spray 'TizinЃ Allergy' in

pregnant women are absent. Therefore, the nasal spray 'TizinЃ Allergy'

should not be used during pregnancy unless

when the intended benefit to the mother justifies the potential risk to

fetus.

Based on the determination of the concentration of levocabastine in saliva and chest

milk of lactating women who received a single oral dose of 0.5 mg

levocabastine, expected to be approximately 0.6% of the total intranasal dose

levocabastine can be passed on to the baby during breastfeeding.

Due to the limited number of clinical and experimental data

caution is advised when using the nasal spray

'TizinЃ Alergy' in lactating women. If necessary, appointments

the drug during lactation should stop breastfeeding.

DOSAGE AND APPLICATION

Intranasal for adults and children over 6 years of age, 2 doses (100 mcg) each

nasal passage 2 times a day.

The use of the drug should be continued until the symptoms are eliminated.

In case of severity of symptoms, it can be used 3-4 times a day.

Patients should be warned about the need to clear the nasal passages.

before using the spray and inhale through the nose during administration.

Before the first use, remove the protective cap and press several times

spray nozzle until a cloud of 'fog' appears.

The bottle is ready for further use.

Shake the bottle before each use. Inhale the drug through the nose.

SIDE EFFECT

Very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely

(> 1/10000, <1/1000), very rare (<1/10000, including individual messages),

frequency unknown (incidence cannot be estimated from

available data).

Adverse events that were observed in patients during clinical

research

Disturbances from the gastrointestinal tract: nausea (often).

General disorders and disorders at the injection site: fatigue, pain at the site

injection (often), irritation at the injection site, pain at the injection site, dryness

at the injection site, anxiety (infrequently), burning at the injection site, discomfort

at the injection site (rarely).

Infectious and parasitic diseases: sinusitis (often).

Nervous system disorders: headache (very common),

drowsiness, dizziness (often).

Disturbances from the respiratory system, chest organs and

mediastinum: pain in the pharynx and larynx, epistaxis (often), shortness of breath,

nasal congestion (uncommon), swelling of the nasal mucosa (rare),

bronchospasm, cough (frequency unknown).

Heart disorders: Palpitations (infrequent), tachycardia

(seldom).

Disturbances from the organ of vision: edema of the eyelids (frequency unknown).

Immune system disorders: hypersensitivity (infrequent),

anaphylactic reactions (frequency unknown).

Post-registration data

Heart disorders: palpitations, tachycardia (very

seldom).

Disturbances from the organ of vision: edema of the eyelids (very rare).

General disorders and disorders at the injection site: malaise (infrequently).

Immune system disorders: anaphylactic reactions,

hypersensitivity (very rare).

Disturbances from the respiratory system, chest organs and

mediastinum: bronchospasm, shortness of breath, swelling of the nasal mucosa (very

seldom).

OVERDOSE

Symptoms

There have been no reports of levocabastine overdose. When

accidental ingestion may lower blood pressure,

tachycardia, slight sedation.

Treatment

If taken orally, the patient should drink a large amount

fluids to accelerate the excretion of levocabastine through the kidneys.

INTERACTION WITH OTHER DRUGS

Interactions with alcohol have not been observed in clinical studies. Also

there was no increase in the effect of alcohol or diazepam when used

the usual dosages of the TizinЃ Allergy nasal spray.

Concomitant use of ketoconazole CYP3A4 isoenzyme inhibitors

or erythromycin did not affect the pharmacokinetics of levocabastine when administered nasally

administered.

Possible local interactions with other nasal medications

insufficiently studied, with the exception of interaction with oxymetazoline,

which can transiently reduce the absorption of levocabastine with nasal

administered.

SPECIAL INSTRUCTIONS

If the medicinal product has become unusable or the expiration date has expired, do not

throw it into wastewater or outside! Place the medicinal

the product in a bag and put in the trash can. These measures will help protect

environment!

INFLUENCE ON THE ABILITY TO DRIVE A VEHICLE AND

USE OF TECHNOLOGY

TizinЃ Allergy Nasal Spray in the recommended dose is usually not

has a clinically pronounced sedative effect and does not reduce the speed

reactions compared to placebo. If drowsiness occurs, do not

engage in potentially hazardous activities that require

increased attention and speed of psychomotor reactions.

RELEASE FORM

Dosed nasal spray 50 mcg / dose.

10 ml (100 doses) of the drug in a high density polyethylene bottle with

spray and low density polyethylene protective cap.

1 bottle with instructions for use in a cardboard box.

STORAGE CONDITIONS

Store at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

SHELF LIFE

2 years.

Do not use the drug after the expiry date indicated on the package.

TERMS OF RELEASE FROM PHARMACIES

Without recipe.

MANUFACTURER

Janssen Pharmaceuticals N.V., Belgium.

Legal address: Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340,

Beerse, Belgium / Janssen Pharmaceuticals N.V., Turnhoutseweg 30, 2340 Beerse,

Belgium.

Organization accepting claims: Johnson & Johnson LLC, Russia,

121614, Moscow, st. Krylatskaya, 17, bldg. 2, tel. (495) 726-55-55.