Tantum Verde solution for external use, 240ml

Composition

Per 100 ml of topical solution 0.15%: Active ingredient: benzydamine hydrochloride 0.15 g; excipients: ethanol 96%, glycerol (glycerin), methyl parahydroxybenzoate, menthol flavor, saccharin, sodium bicarbonate, polysorbate 20, quinoline yellow dye 70% (E 104), patent blue dye 85% (E 131), purified water.

Pharmacological action

Benzydamine is a nonsteroidal anti-inflammatory drug that belongs to the indazole group. It has an anti-inflammatory and local analgesic effect, 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. Benzydamine has an antibacterial and specific antimicrobial effect due to the rapid penetration of microorganisms through the membranes, followed by damage to cellular structures, disruption of metabolic processes and cell lysosomes. It has an antifungal effect against Candida albicans. It 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 in inflammatory processes in the oral cavity, including infectious etiology.

Clinical pharmacology

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 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 (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, Tantum®should be used. Verde in combination therapy.

Use during pregnancy and lactation

Tantum®preparation Verde should not be used during pregnancy and lactation.

Contraindications

• hypersensitivity to benzydamine or other components of the drug;
• children under 12 years of age

Side effects

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

• very common – ≥1/10;
• common – ≥1/100 to <1/10;
• uncommon – ≥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, undesirable effects are presented in decreasing order of severity. Local reactions: rarely-dry mouth, burning sensation in the oral cavity; frequency unknown-feeling of numbness in the oral cavity. Allergic reactions: infrequently-photosensitization; rarely-hypersensitivity reactions, skin rash, pruritus; very rarely-angioedema, laryngospasm; frequency unknown – anaphylactic reactions. If any of the side effects listed in the instructions get worse, or any other side effects that are not listed in the instructions are noted, you should immediately inform your doctor.

Interaction

Interaction studies with other drugs have not been conducted.

How to take, course of use and dosage

Locally, after a meal. Adults (including elderly patients) and children from 12 years of age for gargling or mouthwash use 15 ml of the drug (measuring cup attached) 2-3 times a day. After rinsing, the solution must be spat out. If a burning sensation occurs when using an undiluted solution, the solution should be diluted (for dilution, add 15 ml of water to a measuring cup). Do not exceed the recommended dose.

Overdose

Currently, cases of overdose of Tantum®have been reported Verde was not informed.

Description

Currently, cases of overdose of Tantum®have been reported Verde was not informed.

Storage conditions

It does not require special storage conditions. Keep out of reach of children.

Shelf

life is 4 years.

Active ingredient

Benzydamine

Dosage form

topical solution