Tantum^® Verde (Tablets, Solution, Spray) Instructions for Use

ATC Code

A01AD02 (Benzydamine)

Active Substance

Benzydamine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical NSAID for use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs used in dentistry; other drugs for the local treatment of oral diseases

Pharmacological Action

Topical NSAID belonging to the indazole group. It has anti-inflammatory and local analgesic effects and possesses antiseptic activity against a wide range of microorganisms.

The mechanism of action is associated with the stabilization of cell membranes and inhibition of prostaglandin synthesis.

Benzydamine has an antibacterial effect due to rapid penetration through the membranes of microorganisms with subsequent damage to cellular structures, disruption of metabolic processes, and cell lysis.

It has an antifungal effect against Candida albicans. It causes structural modifications of the fungal cell wall and metabolic chains of mycelia and thus prevents their reproduction. This property is the basis for the use of benzydamine in inflammatory processes in the oral cavity, including those of infectious etiology.

Pharmacokinetics

When applied topically, it is well absorbed through the mucous membranes and penetrates into inflamed tissues; it is detected in the blood plasma in an amount insufficient to produce systemic effects.

Benzydamine is excreted mainly by the kidneys in the form of inactive metabolites or conjugation products.

Indications

Symptomatic therapy of pain syndrome in 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 dental treatment and tooth extraction;
• Periodontitis.

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

ICD codes

Dosage Regimen

Spray

Apply topically, after meals.

1 dose (1 spray) corresponds to 0.255 mg of benzydamine.

Adults (including elderly patients) and children over 12 years are prescribed 4-8 sprays 2-6 times/day; children aged 6 to 12 years – 4 sprays 2-6 times/day; children aged 3 to 6 years – 1 spray for every 4 kg of body weight, but not more than 4 sprays (maximum single dose) 2-6 times/day. The recommended dose should not be exceeded.

The duration of treatment should not exceed 7 days. If after 7 days of treatment there is no improvement or new symptoms appear, the patient should consult a doctor.

Tablets, Solution

Applied topically. The dose is set individually depending on the patient’s age and indications for use.

Adverse Reactions

Classification of the frequency of side effects according to WHO: very common (≥1/10); common (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10,000 to <1/1000); very rare (<1/10,000); frequency unknown (cannot be estimated from the available data).

In each group, adverse effects are presented in order of decreasing severity.

Local reactions rarely – dry mouth, burning sensation in the oral cavity; frequency unknown – numbness in the oral cavity.

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

Contraindications

• Children under 3 years of age;
• Hypersensitivity to benzydamine.

With caution in case of hypersensitivity to acetylsalicylic acid or other NSAIDs; bronchial asthma (including history).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 3 years of age.

Special Precautions

The development of hypersensitivity reactions is possible. In this case, it is recommended to discontinue treatment and consult a doctor for appropriate therapy.

In a limited number of patients, the presence of ulcers in the throat and oral cavity may indicate the presence of a more serious pathology. If symptoms do not resolve within more than 3 days, the patient should consult a doctor.

It is not recommended for use in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.

Use with caution in patients with a history of bronchial asthma, as bronchospasm may develop while taking the drug.

Effect on ability to drive vehicles and operate machinery

Benzydamine does not affect the ability to drive vehicles or operate machinery.

Drug Interactions

Interaction studies with other medicinal products have not been conducted.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.