Tantum Verde solution for external use, 120ml

Composition

Solution for topical application of 0.15%.

Per 100 ml of topical solution 0.15%:

Active ingredient: Benzydamine hydrochloride-0.15 g

Auxiliary substances:

ethanol 96% of 8.00 g of

glycerin (glycerol) 5.00 g,

methyl parahydroxybenzoate 0,100 g,

menthol flavor 0.030 g,

saccharin 0,024 g,

sodium bicarbonate is 0.011 g,

Polysorbate 20 0.005 g,

dye quinoline yellow 70% (E 104) 0.0016 inch g,

dye blue patented 85% (E 131) 0,00033 g,

purified water q. s. to 100 ml.

Pharmacological properties

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug

ATX code: A 01AD02

Pharmacological properties

Pharmacodynamics

Benzydamine is a nonsteroidal anti-inflammatory drug that belongs to the indazole group. It has an anti-inflammatory and local analgesic effect, has an antiseptic effect against a wide range of microorganisms.

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

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

It has an antifungal effect against Candida albicans.

It causes structural modifications of the cell wall of fungi and their metabolic chains, thus preventing their reproduction, which was the basis for the use of benzydamine in inflammatory processes in the oral cavity, including infectious etiology.

Pharmacokinetics

When applied topically, the drug is well absorbed through the mucous membranes and penetrates into inflamed tissues, it is found in the blood plasma in an amount insufficient to produce systemic effects. Excretion of the drug occurs mainly by the kidneys, in the form of inactive metabolites or conjugation products.

Indications

Symptomatic therapy of pain syndrome of inflammatory diseases of the oral cavity and ENT organs (of various etiologies):

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

– pharyngitis, laryngitis, tonsillitis;

– candidiasis of the oral mucosa (as part of combination therapy);

– calculous inflammation of the salivary glands;

– after surgical interventions and injuries (tonsillectomy, jaw fractures)

-after treatment and extraction of teeth;

– periodontal disease;

For infectious and inflammatory diseases requiring systemic treatment, Tantum®should be used. Verde in combination therapy.

Contraindications

-hypersensitivity to benzydamine or other components of the drug;

– children under 12 years of age

With caution

Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, bronchial asthma (including in the anamnesis).

Side effects

World Health Organization (WHO)classification of the incidence of side effects:

very common – ≥1/10;

common – ≥ 1/100 donechasto – ≥1/1000 to rare —≥1/10000 to very rare —

frequency unknown-cannot be estimated based on available data. In each group, undesirable effects are presented in decreasing order of severity.

Local reactions: rarely-dry mouth, burning sensation in the oral cavity; frequency unknown-feeling of numbness in the oral cavity.

Allergic reactions: infrequently-photosensitization; rarely-hypersensitivity reactions, skin rash, pruritus; very rarely-angioedema, laryngospasm; frequency unknown – anaphylactic reactions.

If any of the side effects listed in the instructions get worse, or any other side effects that are not listed in the instructions are noted, you should immediately inform your doctor.

Interaction

Interaction studies with other drugs have not been conducted.

How to take, course of use and dosage

Locally, after a meal. Adults (including elderly patients) and children from 12 years of age for gargling or mouthwash use 15 ml of the drug (measuring cup attached) 2-3 times a day.

After rinsing, the solution must be spat out. If a burning sensation occurs when using an undiluted solution, the solution should be diluted (for dilution, add 15 ml of water to a measuring cup). Do not exceed the recommended dose.

The duration of treatment should not exceed 7 days. If there is no improvement after treatment within 7 days or new symptoms appear, you should consult your doctor.

Use the drug only according to the method of use and in the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.

Overdose

Currently, cases of overdose of Tantum®have been reported Verde was not informed.

Symptoms: if the drug is used in accordance with the instructions for use, overdose is unlikely. If the drug is accidentally swallowed, the following symptoms may occur: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression.

Treatment: symptomatic; clear the stomach by inducing vomiting or flush the stomach using a gastric tube (under the supervision of a doctor); provide medical supervision, supportive therapy and necessary hydration. The antidote is not known.

Special instructions

If a burning sensation occurs when applying the solution, the solution should be pre-diluted with water 2 times by bringing the water level to the level in a graduated cup.

When using the drug Tantum® Verde may develop hypersensitivity reactions. In this case, it is recommended to stop treatment and consult a doctor to prescribe appropriate therapy.

In a limited number of patients, the presence of ulcers in the throat and oral cavity may indicate

the presence of a more serious pathology. If symptoms persist for more than 3 days, you should consult your doctor.

Application of the drug Tantum® Verde is not recommended in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

Tantum®preparation Verde should be used with caution in patients with a history of bronchial asthma due to the possibility of developing bronchospasm while taking the drug.

Tantum®preparation Verde contains parahydroxybenzoates, which can cause allergic reactions.

Sports patients: when using drugs containing ethanol, the results of anti-doping tests for the maximum permissible level of ethanol in the blood according to the standards established by some sports federations may be positive. Drivers driving vehicles should keep in mind that the drug contains ethanol (one dose of the drug (15 ml) contains 1.2 g of 96% alcohol).

Influence on the ability to drive vehicles and mechanisms

It does not affect the ability to drive vehicles or work with mechanisms.

Form of production

Solution for topical application

Storage conditions

In a dark place, at a temperature not exceeding 25 °C.

Shelf

life is 4 years.

Active ingredient

Benzydamine