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 treatment 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 tooth extraction;

– periodontal disease;

For infectious and inflammatory diseases requiring systemic treatment, it is necessary to use Tantum® Verde as part of combination therapy.

Pharmacological effect

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug

ATX code: A01AD02

Pharmacological properties

Pharmacodynamics

Benzidamine is a non-steroidal anti-inflammatory drug that belongs to the indazoles group. It has an anti-inflammatory and local analgesic effect, and 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.

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

Has antifungal effect 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 the use of benzydamine for 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 quantities insufficient to obtain systemic effects. Excretion of the drug occurs mainly by the kidneys, in the form of inactive metabolites or conjugation products.

Special instructions

If a burning sensation occurs when using the solution, the solution should first be diluted with water 2 times by bringing the water level to the mark in a graduated glass.

When using the drug Tantum® Verde, hypersensitivity reactions may develop. 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 mouth may indicate

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

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

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

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

Patients involved in sports: 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).

Impact on the ability to drive vehicles and machinery

Does not affect the ability to drive vehicles and operate machinery.

Active ingredient

Benzydamine

Composition

Solution for topical use 0.15%.

Per 100 ml of solution for topical use 0.15%:

Active ingredient: benzydamine 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,

sodium bicarbonate 0.011 g,

polysorbate 20 0.005 g,

quinoline yellow dye 70% (E104) 0.0016 g,

patented blue dye 85% (E131) 0.00033 g,

purified water q.s. up to 100 ml.

Contraindications

– hypersensitivity to benzydamine or other components of the drug;

– children’s age up to 12 years

With caution

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

Side Effects

World Health Organization (WHO) side effect frequency classification:

very often – ≥1/10;

often – from ≥ 1/100 to infrequently – from ≥1/1000 to rarely – from ≥1/10000 to very rarely –

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

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

Allergic reactions: uncommon – photosensitivity; rarely – hypersensitivity reactions, skin rash, itching; very rarely – angioedema, laryngospasm; frequency unknown – anaphylactic reactions.

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

Interaction

No interaction studies have been conducted with other drugs.

Overdose

Currently, no cases of overdose of Tantum® Verde have been reported.

Symptoms: when using the drug in accordance with the instructions for use, an overdose is unlikely. If the drug is accidentally ingested, the following symptoms are possible: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression.

Treatment: symptomatic; cleanse the stomach by inducing vomiting or flushing the stomach using a gastric tube (under medical supervision); provide medical supervision, supportive care and necessary hydration. No antidote is known.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C.

Shelf life

4 years.

Manufacturer

Aziende Chimique Riunite Angelini Francesco A.C.R.A., Italy