Tantum Verde forte, spray 15 ml

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drug

ATX code: A01AD02

Pharmacological properties

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 related to 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. The drug is excreted mainly by the kidneys in the form of inactive metabolites.

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;

Phandrosis of the oral mucosa (in combination therapy);

-calculous inflammation of the salivary glands;

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

-after dental treatment and extraction;

Parodontosis.

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

Active ingredient

Composition

Topical spray dosed 0.51 mg/dose.

per 100 ml of 0.51 mg/dose topical application spray:

The active ingredient:

benzidamine hydrochloride 0.30 g.

Auxiliary components:

Glycerol 5.0 g, 96% ethanol 8.0 g,

Macrogol,

glyceryl hydroxystearate 1.5 g,

Menthol flavoring (flavor additive) 0.5 g,

methyl parahydroxybenzoate 0.1 g,

sodium saccharinate 0.07 g,

purified water to 100 ml.

One press of the pump releases approximately 0.17 g of the drug, which corresponds to 0.51 mg of benzidamine hydrochloride.

How to take, the dosage

Topical Dose Spray 0.51 mg/dose: Adults administer 2-4 doses 2-6 times daily.

To use the spray: Lift the cannula, insert it into the oral cavity and point it into the area of inflammation; press the cap (arrowed).

Benzidamine adheres to the mucosa and therefore has a long-lasting effect. Because of this, the drug should be used after meals.

If you need to use the drug for more than 7 days, a physician should be consulted.

If after treatment, there is no improvement or if new symptoms develop, you should talk to your doctor.

Please only use 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

No clinically significant interaction of Tantum® Verde Forte with other medicinal products has been established.

Special Instructions

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

In case of ulcerative lesions of the oropharyngeal mucosa, the patient should consult a physician if the symptoms persist for more than three days.

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

Tantum® Verde Forte should be used with caution in patients with a history of bronchial asthma due to the possible development of bronchospasm during drug administration.

Tantum® Verde Forte contains methyl parahydroxybenzoate, which may cause allergic reactions.

Impact on ability to drive and operate machinery

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

Contraindications

Hypersensitivity to benzidamine or other ingredients of the drug.

Children under 18 years of age.

With caution

Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, bronchial asthma (including 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 infrequent – ≥1/10000 to very rare –

frequency unknown – cannot be estimated based on available data.

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

Allergic reactions:

infrequent – photosensitization;

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

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

Overdose

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

If the drug is used according to the instructions for use, overdose is unlikely.

Inadvertent ingestion may cause the following symptoms: vomiting, abdominal cramps, restlessness, fear, hallucinations, seizures, ataxia, fever, tachycardia, respiratory depression. An antidote is not known. In case of overdose, gastric lavage and symptomatic treatment are recommended.

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