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 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;

-periodontosis.

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

Pharmacological effect

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug

ATX code: A01AD02

Pharmacological properties

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 an amount insufficient to obtain systemic effects. Excretion of the drug occurs mainly by the kidneys in the form of inactive metabolites.

Special instructions

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

If there is an ulcerative lesion of the oropharyngeal mucosa, the patient should consult a doctor if 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.

The drug Tantum® Verde Forte 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® Verde Forte contains methyl parahydroxybenzoate, which can cause allergic reactions.

Impact on the ability to drive vehicles and operate machinery

The drug does not affect the ability to drive vehicles or other activities that require increased attention.

Active ingredient

Benzydamine

Composition

Spray for topical use dosed 0.51 mg/dose.

per 100 ml spray for topical use dosed 0.51 mg/dose:

Active ingredient:

benzydamine hydrochloride 0.30 g.

Auxiliary components:

glycerol 5.0 g, ethanol 96% 8.0 g,

macrogol,

glyceryl hydroxystearate 1.5 g,

menthol flavoring (flavoring additive) 0.5 g,

methyl parahydroxybenzoate 0.1 g,

sodium saccharinate 0.07 g,

purified water up to 100 ml.

With one press of the pump, approximately 0.17 g of the drug is released, which corresponds to 0.51 mg of benzydamine hydrochloride.

Contraindications

Hypersensitivity to benzydamine or other components of the drug.

Children under 18 years of age.

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.

Local reactions: rarely – dryness, burning in the mouth; frequency unknown – feeling of numbness in the mouth.

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 are aggravated, or other side effects not listed in the instructions are noted, you should immediately inform your doctor.

Interaction

No clinically significant interaction of the drug Tantum ® Verde Forte with other drugs has been established.

Overdose

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

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. No antidote is known. In case of overdose, gastric lavage and symptomatic treatment are recommended.

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