Tantum Verde forte external spray, 15ml

Composition

Spray for topical application dosed 0.51 mg / dose.

per 100 ml of topical spray dosed at 0.51 mg / dose:

Active ingredient:

Benzydamine hydrochloride 0.30 g.

Auxiliary components:

glycerol 5.0 g, ethanol 96% 8.0 g,

macrogola,

glycerylhydroxystearate 1.5 g,

menthol flavor 0.5 g,

methyl parahydroxybenzoate 0.1 g,

sodium saccharinate 0.07 g,

purified water up to 100 ml.

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

Pharmacological action

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drug

ATX Code: A01AD02

Pharmacological Properties

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.

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 produce systemic effects. Excretion of the drug occurs 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 (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 removal of teeth;

– periodontal disease.

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

Contraindications

Hypersensitivity to benzydamine or other components of the drug.

Children under 18 years of age.

With caution

Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, bronchial asthma (including in the anamnesis).

Side effects

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

very common – ≥1/10;

common – ≥ 1/100 donechasto – ≥1/1000 to rare —≥1/10000 to very rare —

frequency unknown-cannot be estimated based on available data.

Local reactions: rarely-dryness, 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 indicated in the instructions are aggravated, or other side effects are noted that are not specified in the instructions, you should immediately inform your doctor.

Interaction

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

How to take, course of use and dosage

Spray for topical application dosed 0.51 mg / dose: adults are prescribed 2-4 doses 2-6 times a day.

To use the spray: lift the cannula, insert it into the oral cavity and point it at the area of inflammation; press the cap (marked with an arrow).

Benzydamine adheres to the mucous membrane and, due to this, gives a lasting effect. In this regard, the drug should be used after meals.

If you need to use the drug for more than 7 days, you should consult a doctor.

If there is no improvement after treatment or new symptoms appear, you should consult your doctor.

Use the drug only according to the method of use and in the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.

Overdose

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

When using the drug in accordance with the instructions for use, overdose is unlikely.

If the drug is accidentally swallowed, the following symptoms may occur: vomiting, abdominal cramps, anxiety, fear, hallucinations, convulsions, ataxia, fever, tachycardia, respiratory depression. The antidote is not known. In case of overdose, gastric lavage and symptomatic treatment are recommended.

Special instructions

When using the drug Tantum® Verde Forte may develop hypersensitivity reactions. 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.

Application of the drug Tantum® Verde Forte is not recommended in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

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

Influence on the ability to drive motor vehicles and manage mechanisms

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

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

4 years

Active ingredient

Benzydamine

Dosage Form

Oral spray