Rinofluimucil nasal spray. (vial of dark glass) 10ml per set with spray # 1

Release form, composition and packaging

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Nasal spray in the form of an almost colorless transparent liquid with a characteristic mint slightly sulfurous odor.

1 ml

acetylcysteine ​​10 mg

tuaminoheptane sulfate 5 mg

benzalkonium chloride, hypromellose, disodium edetate, sodium dihydrogen phosphate, sodium hydrogen phosphate dodecahydrate, dithiothreitol, sorbitol 70%, mint flavor, ethanol 96%, sodium hydroxide, purified water.

10 ml - dark glass vials (1) complete with a spray nozzle - cardboard packs.

pharmachologic effect

A drug with a mucolytic and vasoconstrictor effect for use in ENT practice.

Acetylcysteine ​​liquefies mucous and purulent-mucous secretions by breaking disulfide bonds of mucus glycoproteins.

It also has anti-inflammatory (due to inhibition of leukocyte chemotaxis) and antioxidant effect.

Tuaminoheptane sulfate is a sympathomimetic amine that, when applied topically, has a vasoconstrictor effect.

Eliminates swelling and hyperemia of the nasal mucosa.

Pharmacokinetics

When applied topically in recommended doses, the drug is not absorbed.

Indications for use

- acute and subacute coryza with thick purulent-mucous secretion

- chronic rhinitis

- vasomotor rhinitis

- sinusitis.

Contraindications for use

- angle-closure glaucoma

- thyrotoxicosis

- simultaneous use of MAO inhibitors and a period of up to 14 days after their cancellation

- simultaneous use of tricyclic antidepressants and a period of up to 14 days after their cancellation

- hypersensitivity to drug components.

The drug is prescribed with caution to children under the age of 3 years, patients with bronchial asthma, arterial hypertension, angina pectoris of III-IV functional classes, frequent extrasystole (treatment should be carried out under medical supervision).

Dosage regimen

The drug is injected into the nasal cavity in the form of an aerosol using a special nebulizer.

Adults are injected with 2 doses of aerosol (2 pressing the valve) into each nasal passage 3-4 times / day.

For children, the drug is prescribed 1 dose of aerosol (1 press on the valve) in each nasal passage 3-4 times / day.

The duration of therapy should not exceed 7 days.

Do not exceed the recommended dose and course of treatment without consulting your doctor.

Rules for using the drug 1. Remove the cap from the solution bottle.

2. Remove the cap from the spray gun.

3. Remove the cap from the spray gun.

4. Activate the nebulizer by pressing again.

Overdose

Symptoms: it is possible to develop systemic side effects due to the tuaminoheptane, which is part of the drug (tachycardia, tremor, anxiety, increased blood pressure, addiction).

Treatment: if necessary, symptomatic therapy is performed.

Side effect

From the side of the cardiovascular system: palpitations, tachycardia, arterial hypertension.

From the side of the central nervous system: rarely - agitation, tremor.

Local reactions: dryness of the mucous membrane of the nasal cavity, mouth and pharynx.

Others: rarely - allergic reactions, urinary retention, inflammation of the sebaceous glands.

With prolonged use of vasoconstrictors, it is possible to change the normal function of the mucous membrane of the nasal cavity and sinuses, as well as the development of addiction to the drug.

Drug interactions

When Rinofluimucil is used together with MAO inhibitors and tricyclic antidepressants, the likelihood of systemic side effects caused by tuaminoheptane increases (since these drugs potentiate the effect of sympathomimetic drugs).

With the simultaneous use of Rinofluimucil® can weaken the effect of antihypertensive drugs.

Application during pregnancy and lactation

The use of the drug during pregnancy and lactation is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus and child.

Special instructions The drug is intended only for and

Name ENG

RINOFLUIMUCIL

Clinical and pharmacological group

A drug with mucolytic and vasoconstrictor action for topical use in ENT practice

ATX code

Tuaminoheptane in combination with other drugs

Dosage

1g + 500mg x 10ml

Structure

Active ingredients: acetylcysteine ​​1 g

tuaminoheptane sulfate 0.5 g. Excipients: benzalkonium chloride, methyl hydroxypropyl cellulose, disodium edetate, sodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, dithiotreitol, sorbitol 70%, mint flavor, purified ethanol 96%, sodium hydroxide.

Indications

Acute and subacute rhinitis with thick purulent-mucous secretion

chronic rhinitis

vasomotor rhinitis

sinusitis.

Storage conditions and periods

At a temperature of 15-25 degrees.

Expiration date: 2.5 years

INN / Active ingredient

Acetylcysteine, Tuaminoheptane Sulfate

Contraindications

Hypersensitivity to drug components

angle-closure glaucoma

thyrotoxicosis

the simultaneous use of tricyclic antidepressants and MAO inhibitors and a period up to 14 days after their cancellation.

With care: children under 3 years of age

with bronchial asthma

with arterial hypertension

with angina pectoris III-IV functional classes

with frequent extrasystole (treatment should be carried out under medical supervision).

Specifications

Category

Runny nose

Scope of the drug

Ear, Throat, Nose

Release form

Spray

Manufacturer country

Italy

Package quantity, pcs

one

Minimum age from

1 year

Way of introduction

Through the respiratory tract

Vacation conditions

Without recipe

Volume, ml.

10 ml

Brand name

Zambon

Components

spray nozzle

The amount of the dosage form in the primary package

10 ml

Primary packaging type

Dark glass bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Decongestant

Anatomical and therapeutic characteristics

R01AB08 Tuaminoheptane, in combination with other drugs

Dosage form

Nasal spray

The target audience

Children

Expiration date in days

912

Dosage (volume) of the substance in the preparation

Acetylcysteine ​​1 g

tuaminoheptane sulfate 0.5 g

Package weight, g

80

Mode of application

:

The drug is injected into the nasal cavity in the form of an aerosol using a special nebulizer.

< br> Adults: inject 2 doses of aerosol (2 pressings on the valve) into each nostril 3-4 times / day. < br> Children: the drug is prescribed 1 dose (1 press on the valve) 3-4 times / day. < br> The duration of therapy should not exceed 7 days.

Shelf life after opening

:

After opening the bottle, the contents can be used within 20 days.

Information on technical characteristics, delivery set, country of manufacture