TANTUM VERTER

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TANTIVERT (TANTIVERT)

Composition:

Active substance: benzidamine hydrochloride;

1 ml of solution contains benzidamine hydrochloride (calculated as 100 % dry substance) 1.5 mg;

Excipients: ethanol 96 %, glycerol, methylparahydroxybenzoate (E 218), flavoring agent "Menthol", sodium saccharin, sodium hydrogencarbonate, polysorbate 20, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear, colorless solution with a characteristic mint taste.

Pharmacotherapeutic group.

Agents for use in dentistry. Other agents for local application in the oral cavity.

ATC code A01AD02.

Pharmacological properties.

Pharmacodynamics.

Benzydamine is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-exudative properties.

Benzydamine has been shown to be effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzydamine exerts anti-inflammatory and local analgesic action, producing a local anesthetic effect on the mucous membrane of the oral cavity.

Pharmacokinetics.

Absorption through the mucous membrane of the oral cavity and pharynx has been demonstrated by the presence of measurable amounts of benzydamine in human plasma. However, this is insufficient to produce any systemic pharmacological effect. Excretion occurs primarily via the urine, mainly as inactive metabolites or conjugated compounds.

It has been shown that with local application, an effective concentration of benzydamine accumulates in inflamed tissues due to its ability to penetrate through the mucous membrane.

Clinical characteristics.

Indications.

Symptomatic treatment of irritations and inflammations of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in dentistry after tooth extraction or for prophylactic purposes.

Contraindications.

Hypersensitivity to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interactions.

Interaction studies have not been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and a physician should be consulted for appropriate management.

In some patients, ulcers of the buccal mucosa/throat may be caused by serious underlying pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days of using the product, or who develop fever or other new symptoms, should consult a physician or dentist, as appropriate.

Benzidamine should not be used in patients with hypersensitivity to acetylsalicylic acid or to other nonsteroidal anti-inflammatory drugs (NSAIDs).

The use of this drug may cause bronchospasm in patients with bronchial asthma or in those with a history of bronchial asthma. Such patients must be warned accordingly.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

For athletes: The use of medicinal products containing ethyl alcohol may result in a positive anti-doping test, depending on the thresholds established by certain sports federations.

Use during pregnancy or breastfeeding

Animal studies are insufficient to allow conclusions regarding the effects of this agent when used during pregnancy or breastfeeding. The potential risk to humans is unknown.

There are no clinical data on the use of this medicinal product during pregnancy.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may cause cardiovascular and renal toxicity in the fetus. Towards the end of pregnancy, prolonged bleeding time may occur in both mother and newborn, and onset of labor may be delayed.

It is unknown whether systemic exposure to the drug following topical application could be harmful to the embryo/fetus.

Therefore, this medicinal product should not be used during pregnancy unless its use is considered clinically necessary. If used, the dose should be as low as possible and the duration of treatment kept to a minimum.

Currently, there are no adequate data available on the use of benzidamine in breastfeeding women. The ability of this agent to pass into breast milk has not been studied.

The medicinal product should not be used during breastfeeding.

Ability to influence reaction speed when driving or operating machinery

When used at recommended doses, this medicinal product has no effect on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

Pressing the spray pump generates an aerosol containing 1 dose of spray – 0.17 mL, corresponding to 0.255 mg of benzydamine hydrochloride.

Dosing

Adults: 4–8 sprays 2–6 times daily.

Children 6–12 years: 4 sprays 2–6 times daily.

Children 4–6 years: 1 spray per 4 kg of body weight, up to a maximum dose equivalent to 4 sprays 2–6 times daily.

Do not exceed the recommended dosage.

Children

The drug may be used in children aged 4 years and older.

Overdose

No cases of overdose with benzydamine have been reported following topical administration.

However, accidental ingestion of a large amount of benzydamine (> 300 mg), particularly in children, may lead to poisoning. Characteristic signs of overdose after oral ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (such as dizziness, hallucinations, excitement, convulsions, tremor, excessive sweating, ataxia, anxiety, and irritability).

Such acute overdose requires immediate gastric lavage, correction of fluid and electrolyte imbalances, symptomatic treatment, and adequate hydration.

Adverse Reactions

Within each frequency group, adverse effects are listed in order of decreasing severity.

Adverse reactions are classified by frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); frequency not known (cannot be estimated based on available data).

Gastrointestinal disorders:
Rare – burning sensation in the mouth, dry mouth;
Frequency not known – oral hypaesthesia, nausea, vomiting, swelling and discoloration of the tongue, taste alteration.

Immune system disorders:
Rare – hypersensitivity reaction;
Frequency not known – anaphylactic reaction.

Respiratory, thoracic and mediastinal disorders:
Very rare – laryngospasm;
Frequency not known – bronchospasm.

Skin and subcutaneous tissue disorders:
Uncommon – photosensitivity;
Very rare – angioneurotic edema;
Frequency not known – rash, itching, urticaria.

Nervous system disorders:
Frequency not known – dizziness, headache.

The medicinal product contains methylparahydroxybenzoate, which may cause allergic reactions (possibly delayed).

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Packaging.

30 ml in a glass or plastic bottle, 1 bottle with spray dispenser in a carton.

Availability classification.

Over-the-counter.

Manufacturer.

Limited Liability Company "Pharmaceutical Company "Vertex".

Manufacturer's address and location of business activities.

Ukraine, 61085, Kharkiv region, city of Kharkiv, Astronomichna Street, building 33, lit. "V-1".

(batch release)

Ukraine, 61085, Kharkiv region, city of Kharkiv, Astronomichna Street, building 33, lit. "N-2" (first floor).

(all stages of the production cycle except quality control)