Tantum Verde, 120 ml solution

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drug

ATX code: A01AD02

Pharmacological properties

Pharmacodynamics

Benzidamine is a non-steroidal anti-inflammatory drug, belongs to the group of indazoles. It has anti-inflammatory and local analgesic effect, has antiseptic action against a wide range of microorganisms.

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

Benzidamine has antibacterial and specific antimicrobial action due to rapid penetration through the membranes of microorganisms with subsequent damage of cell structures, disruption of metabolic processes and cell lysosomes.

It has antifungal action against Candida albicans.

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

Pharmacokinetics

When used topically, the drug is well absorbed through mucous membranes and penetrates inflamed tissues, being detected in blood plasma in amounts 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 (different etiology):

Gingivitis, glossitis, stomatitis (including. After radiation and chemotherapy);

-pharyngitis, laryngitis, tonsillitis;

-candidosis of the oral mucosa (in combination therapy);

-calculous inflammation of the salivary glands;

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

-after dental treatment and extraction;

Parodontosis;

In infectious and inflammatory diseases requiring systemic treatment, Tantum® Verde should be used as part of combination therapy.

Active ingredient

Composition

The solution for topical use is 0.15%.

For 100 ml of 0.15% topical solution:

Active ingredient: benzidamine hydrochloride – 0.15 g

Excipients:

Ethanol 96% 8.00 g,

Glycerin (glycerol) 5.00 g,

methyl parahydroxybenzoate 0.100 g,

menthol flavoring 0.030 g,

saccharin 0.024 g,

p> sodium bicarbonate 0.011 g,

polysorbate 20 0.005 g,

quinoline yellow dye 70% (E104) 0.0016 g,

/p>

Patent blue dye 85% (E131) 0.00033 g,

purified water q.s. up to 100 ml.

How to take, the dosage

Topically, after meals. Adults (including elderly patients) and children from 12 years of age use 15 ml of the drug to rinse the throat or mouth (measuring cup is included) 2-3 times a day.

After rinsing the solution should be spat out. If the undiluted solution causes a burning sensation, the solution should be diluted (add 15 ml of water to the measuring cup to dilute it). Do not exceed the recommended dose.

The duration of treatment should not exceed 7 days. If after 7 days of treatment, there is no improvement or new symptoms develop, you should consult a physician.

The drug should only be used according to the route of administration and in the doses mentioned in the instructions. If necessary, please talk to your doctor before using this medicine.

Interaction

There have been no studies of interactions with other medicinal products.

Special Instructions

If a burning sensation occurs when using the solution, the solution should be pre-diluted with water by doubling the water level to the risk in the graduated cup.

A hypersensitivity reaction may occur during use of Tantum® Verde. In this case, it is recommended to discontinue treatment and consult a physician for prescribing appropriate therapy.

In a limited number of patients, the presence of sore throat and mouth may indicate a more serious condition. If symptoms persist for more than 3 days, you should consult a physician.

The use of Tantum® Verde is not recommended in patients who are hypersensitive to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

Tantum® Verde should be used with caution in patients with a history of bronchial asthma because of the possibility of bronchospasm associated with the drug.

Tantum® Verde contains parahydroxybenzoates that may cause allergic reactions.

Sports patients: When using products that contain ethanol, the blood ethanol tolerance limits set by some sports federations may be tested positive. Drivers should be aware that this drug contains ethanol (one dose of this drug (15 ml) contains 1.2 grams of 96% alcohol).

Impact on the ability to drive vehicles, operate machinery

It does not affect the ability to drive vehicles and operate machinery.

Contraindications

– hypersensitivity to benzidamine or other components of the drug;

– children under 12 years of age

With caution

/p>

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

Side effects

World Health Organization (WHO) Classification of the frequency of side effects:

very common – ≥1/10;

frequent – ≥1/100 to infrequent – ≥1/1000 to rare – ≥1/10000 to very rare –

frequency unknown – cannot be estimated based on available data.Within each group, adverse effects are presented in decreasing order of severity.

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

Allergic reactions: infrequent – photosensitization; rare – hypersensitivity reactions, skin rash, itching; very rare – angioedema, laryngospasm; frequency unknown – anaphylactic reactions.

If any of the side effects listed in the instructions worsen, or if any other side effects not listed in the instructions are noted, the physician should be informed immediately.

Overdose

Tantum® Verde has not currently been reported as an overdose.

Symptoms: If the drug is used according to the instructions for use, overdose is unlikely. If the drug is accidentally swallowed, the following symptoms may occur: vomiting, abdominal cramps, restlessness, fear, hallucinations, seizures, ataxia, fever, tachycardia, respiratory depression.

Treatment: symptomatic; empty stomach by inducing vomiting or gastric lavage, using a gastric tube (under medical supervision); provide medical supervision, supportive therapy, and adequate hydration. An antidote is not known.

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