Universal reference book for medicines
Product name: TANTUM ® VERDE (TANTUM VERDE)

Active substance: benzydamine

Type: NSAIDs for topical application in ENT practice and dentistry

Manufacturer: Aziende Chimiche Riunite Angelini Francesco ACRAF (Italy) manufactured by DISCH (Switzerland)
Composition, form of production and packaging
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Tablets for resorption of green, translucent, square, with a depression in the center, with a characteristic mint-lemon scent.
1 tab.

benzidamine hydrochloride 3 mg

[PRING] isomaltose, racemettol, aspartame, citric acid monohydrate, mint flavor, lemon flavor, dye quinoline yellow (E104), dye indigo carmine (E132).

1 PC.
- wax wrappers (10) - two-layer aluminum foil wrappers (2) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Benzydamine is a non-steroidal anti-inflammatory drug, belongs to the group of indazoles.
It has anti-inflammatory and local anesthetic effect, 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 an antifungal effect against Candida albicans.
It causes structural modifications of the cell wall of fungi and metabolic chains of mycetes, thus hindering 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.

DOSING MODE

Tablets for resorption of 3 mg: adults, elderly patients and children from 3 years, appoint 1 tablet 3-4 times a day.
The tablet should be kept in the mouth until it is completely resorbed (for longer effect, it is desirable to take as long as possible).
Solution for topical application 0.15%: adults, elderly patients and children from 12 years old are prescribed to rinse the throat or oral 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.

Spray for topical use 0.255 mg / dose: 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 h;

- 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 applying a spray and a solution: 4 to 7 days.

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

SIDE EFFECT

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

Allergic reactions: skin rash.

Very rarely: laryngospasm.

CONTRAINDICATIONS

- Hypersensitivity to any of the components of the drug;

- children's age till 3 years;

- Children's age under 12 years (for applying 0.15% solution);

- phenylketonuria (for the use of tablets).

PREGNANCY AND LACTATION

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

APPLICATION FOR CHILDREN

Contraindicated for children under 3 years.
A solution of 0.15% is contraindicated in children under 12 years of age.
APPLICATION IN ELDERLY PATIENTS

Assign according to the indications


SPECIAL INSTRUCTIONS

If a burning sensation occurs during application of the solution, the solution should be diluted twice with water, by adjusting the water level to the risks in the graduated cup.

Avoid contact with the eyes.

Impact on the ability to drive vehicles and manage mechanisms

The drug does not affect the ability to drive vehicles and other activities requiring increased attention.

OVERDOSE

At present, the
cases of an overdose of Tantum ® Verde were not reported.
DRUG INTERACTION

There is no clinically significant interaction of the drug Tantum ® Verde with other drugs.

TERMS OF RELEASE FROM PHARMACY

Without recipe.

TERMS AND CONDITIONS OF STORAGE

Tablets for resorption - at a temperature of no higher than 25 ° C, in a place protected from light.
The solution for topical application - at a temperature of no higher than 25 ° C, in a place protected from light. Spray for topical use dosed - at a temperature of no higher than 25 ° C, in a place protected from light. Keep out of the reach of children!
Shelf life

Tablets for resorption - 4 years.
Solution for topical application - 4 years. Spray for topical application dosed with 0.255 mg / dose - 4 years. Do not use after expiry date.
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