Tantum Verde, spray 30 ml

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 the use of 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 and is found in blood plasma in amounts insufficient to produce systemic effects.

The drug is excreted mainly by the kidneys, as 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;

oral mucosal candidiasis (in combination therapy);

calculous inflammation of the salivary glands;

after surgical interventions and trauma (tonsillectomy, jaw fractures);

After treatment and extraction of teeth;

Tantum® Verde should be used as part of combination therapy for infectious and inflammatory diseases that require systemic treatment.

Active ingredient

Composition

Active ingredient: benzidamine hydrochloride 0.255 mg;

Auxiliary substances: 96% ethanol, glycerol, methyl parahydroxybenzoate, menthol flavoring (flavor additive), saccharin, sodium hydrogen carbonate, polysorbate 20, purified water.

How to take, the dosage

Topically, after meals. One dose (one injection) corresponds to 0.255 mg of benzidamine.

Adults (including elderly patients) and children over 12 years – 4-8 injections 2-6 times a day.

In children from 6 to 12 years of age – 4 injections 2-6 times a day.

In children 3 to 6 years of age – 1 injection for each 4 kg of body weight, but not more than 4 injections (maximum single dose) 2 to 6 times a day.

Do not exceed the recommended dose.

1. Turn the cannula (white tube) to the “upright to the vial” position.

2. Insert the cannula into your mouth and point at the inflamed areas in your mouth or throat.

3. Press the dosing pump on the top of the bottle as many times as the prescribed doses. One press corresponds to one dose. Hold your breath while injecting.

Please note: Before first use, press the cap several times to activate the atomizer.

The duration of treatment should not exceed 7 days. If after 7 days of treatment, there is no improvement or new symptoms appear, you should consult a physician. Use the drug only according to the route of administration and in the dosage indicated in the instructions. If necessary, please talk to your doctor before using the medicine.

Interaction

Special Instructions

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

In a limited number of patients, the presence of ulcers in the throat and mouth may indicate more serious disease. 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.

Impact on the ability to operate vehicles, machinery
Does not affect the ability to operate vehicles and machinery.

Synopsis

Contraindications

Hypersensitivity to benzidamine or other components of the drug;

children under 3 years of age.

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

Side effects

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

very common – ≥ 1/10;
common – ≥ 1/100 to < 1 /10;
infrequent – ≥ 1/1000 to < 1/100;
rare – ≥ 1/10000 to < 1/1000;
very rare – < 1/10000;
frequency unknown – cannot be estimated based on available data.
In each group, adverse effects are presented in decreasing order of severity.

Local reactions: rare – dry mouth, burning sensation in the oral cavity; frequency unknown – numbness sensation 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 any other side effects not listed in the instructions are noted, you should inform your doctor 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; clear the stomach by inducing vomiting or gastric lavage using a gastric tube (under medical supervision); provide medical supervision, supportive therapy, and adequate hydration. No known antidote

Is not known.

Pregnancy use

Similarities