Tantum® Verde (Tantum® Verde)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBenzidamineBenzidamine
Dosage form: & nbspSolution for topical application.
Composition:

Hand 100 ml of topical solution 0.15%:

Active ingredient - benzidamine hydrochloride - 0.15 g

Excipients: ethanol 96%, glycerol (glycerol), methyl parahydroxybenzoate, menthol flavorant, saccharin,sodium hydrogen carbonate, polysorbate 20, quinoline yellow dye 70% (E 104), dye blue patented 85% (E 131), purified water.

Description:Transparent liquid of green color 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;

- children's age till 12 years (for application of a solution of 0,15%);

- phenylketonuria (for the use of tablets).

Carefully:

- hypersensitivity to any of the components of the drug;

- children's age till 12 years;

Pregnancy and lactation:

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

Dosing and Administration:

ATadults, elderly patients and children from the age of 12 prescribe for gargling or mouth cavity, use 15 ml of the drug (a measuring cup is attached) 2-3 times a day.

- undiluted solution is used for rinsing in inflammatory processes;

- diluted solution (15 ml of the preparation and 15 ml of water mixed in a measuring cup) should be used daily for hygienic mouth and throat rinses.

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:

If a burning sensation occurs when applying the solution, the solution should be diluted twice with water, by bringing the water level to the risks in a graduated cup.

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:Solution for topical application.
Packaging:

120 ml of the solution in a vial of colorless transparent glass, closed with a screw cap of polyethylene with a sealing ring made of polyethylene.

- a glass of polypropylene, having a calibration of 15 and 30 ml, is attached to the vial.

- The bottle together with the graduated cup and instruction 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 / 03
Date of registration:22.12.2008
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: & nbsp22.12.2008
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