Active substanceBenzidamineBenzidamine
Dosage form: & nbspSpray for topical use dosed.
Composition:

Hand 100 ml of spray for topical application of 0.255 mg / dose dosed:

Active ingredient - benzidamine hydrochloride - 0.15 g

Excipients: ethanol 96%, glycerol, methyl parahydroxybenzoate, flavoring menthol (flavor additive), saccharin, sodium hydrogen carbonate, polysorbate 20, purified water.

Description:

Colorless transparent liquid with a characteristic 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 pain medication action, has antiseptic action against a wide range of microorganisms.

The mechanism of action of the drug is associated with the stabilization of cell membranes and the inhibition of the synthesis of prostaglandins.

Benzydamine has an antibacterial and specific antimicrobial effect due to the rapid penetration of microorganisms through the membranes, followed by damage to cellular structures, metabolic disorders and cell lysis.

Has antifungal effect against Candida Albicans. Causes structural modifications of the cell wall of fungi and metabolic chains of mycetes, thus inhibiting 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 and through the intestine in the form of metabolites or conjugation products.

Medicinal forms for topical application do not have a systemic effect and do not penetrate into breast milk.

Indications:

Inflammatory diseases of the oral cavity and ENT organs (different etiology):

- Gingivitis, glossitis, stomatitis (including after radiation and chemotherapy);

- angina, 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;

For infectious and inflammatory diseases requiring systemic treatment, the use of Tantum® Verde in combination therapy is necessary.

Contraindications:

- hypersensitivity to any of the components of the drug;

- children under 3 years;

Pregnancy and lactation:

It is possible to use the drug during pregnancy and lactation (breastfeeding).

Dosing and Administration:

Adults and elderly patients are prescribed 4-8 doses every 1.5-3 h;

- children aged 3-6 years - 1 to 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 surgery and trauma (tonsillectomy, jaw fractures) when using a spray and a solution: 4 to 7 days.

When using the drug for long periods, it is necessary to consult a doctor.

Side effects:

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

Allergic reactions: skin rash.

Rarely: laryngospasm.

Overdose:At present, no cases of an overdose of Tantum® Verde have been reported.
Interaction:

There is no clinically significant interaction of the drug Tantum® Verde 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 other activities requiring increased attention.

Form release / dosage:

Spray for topical use dosed.

Packaging:- 30 ml (176 doses) of the solution in a white polyethylene bottle equipped with a pump and pressure device with a folding cannula.

-1 bottle together with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C, in a place protected from light.

Keep out of the reach of children!

Shelf life:

4 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe
Registration number:П N014279 / 01
Date of registration:27.11.2008
The owner of the registration certificate:Aziande Kimike Riounite Angelini Francesco AKR.A.A. SpAAziande Kimike Riounite Angelini Francesco AKR.A.A. SpA Italy
Manufacturer: & nbsp
Information update date: & nbsp27.11.2008
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