Active substanceBenzidamineBenzidamine
Dosage form: & nbsp

spray for topical use

Composition:

One dose of the spray contains:

active ingredient: benzidamine hydrochloride 0.27 mg;

auxiliary substances: sodium saccharinate dihydrate 0.0432 mg, ethanol 96% 14.4 mg, methyl parahydroxybenzoate 0.18 mg, glycerol 9 mg, polysorbate 20 0.0099 mg, mint flavor 0.4483 mg, water to 0.18 ml.

Description:

A clear, colorless solution with the smell of mint.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug
ATX: & nbsp

A.01.A.D.02   Benzidamine

G.02.C.C.03   Benzidamine

Pharmacodynamics:

Benzydamine is a non-steroidal anti-inflammatory drug, belongs to the group of indazoles. Has anti-inflammatory and local anesthetic effect, has antibacterial, antifungal and antiseptic effect. The mechanism of action of the drug is associated with stabilization cell membranes and inhibition of synthesis prostaglandins.

Benzydamine has antibacterial and antifungal effects due to the rapid penetration of microorganisms through the cell membranes, followed by damage to cellular structures, violation metabolic processes and lysosomes of microorganism cells.

Benzydamine has an antifungal effect against Candida albicans. It causes structural modifications of the cell wall of fungi and their metabolic chains and, thus, prevents their reproduction, which was the basis for the use of benzidamine in inflammatory processes in the oral cavity, including infectious etiology.

Pharmacokinetics:

When applied locally, the drug is well absorbed through the mucous membranes and penetrates into inflamed tissues.

Excretion of the drug occurs mainly by the kidneys in the form of metabolites and through the intestine.

Indications:Symptomatic therapy of pain syndrome of inflammatory diseases of the oral cavity and ENT organs:

- gingivitis, glossitis, stomatitis (including after radiation chemotherapy);

- pharyngitis, laryngitis, tonsillitis;

- Candidiasis of the oral mucosa (as part of combination therapy);

- calculous inflammation of the salivary glands;

- after surgical interventions and traumas (tonsillectomy, jaw fractures);

- after treatment or removal of teeth;

- Parodontosis.

With infectious and inflammatory diseases requiring systemic treatment, it is necessary to use the drug as part of a combination therapy.

Contraindications:

Hypersensitivity to any component of the drug; children under 3 years.

Pregnancy and lactation:

In connection with the lack of sufficient data, the use of the drug during pregnancy and during breastfeeding is possible only according to the doctor's prescription.

Dosing and Administration:

Locally.

Adults and elderly patients are prescribed 4-8 doses every 1.5-3 hours.

Children aged 3-6 years - 1-4 doses (maximum - 4 doses) every 1.5-3 hours.

Children aged 6-12 years - 4 doses every 1.5-3 hours.

A course of treatment:

- with inflammatory diseases of the oral cavity and ENT organs (different etiology): from 4 to 15 days;

- with odonto-stomatologic pathology: from 6 to 25 days;

- after surgical interventions and traumas (tonsillectomy, jaw fractures): from 4 to 7 days.

When using the drug for long periods (more than 7 days), a doctor's consultation is necessary.

Side effects:

From the respiratory system: Very rarely (<0.01%) is laryngospasm.

Local reactions: dry mouth, numbness, burning in the mouth.

Allergic reactions: skin rash.

Overdose:

No cases of overdose have been reported.

Interaction:

There is no clinically significant interaction of the Bronflex drug with other drugs.

Special instructions:

Avoid contact with the eyes.

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to drive vehicles and mechanisms.

Form release / dosage:Spray for topical use dosed with 0.27 mg / dose.

Packaging:

For 30 ml (135 doses) in bottles of dark glass with a plastic nozzle dosing type and a plastic lid. For 1 bottle with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of reach of children in the original packaging.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe
Registration number:LP-002173
Date of registration:06.08.2013 / 23.08.2017
Expiration Date:Unlimited
The owner of the registration certificate:Sanofi-aventis groupSanofi-aventis group France
Manufacturer: & nbsp
Representation: & nbspSanofi Aventis GroupSanofi Aventis Group
Information update date: & nbsp17.01.2018
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