Tantum verde

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, quinoline yellow (E 104), patent blue V (E 131), purified water.

Pharmaceutical form. Oral solution.

Main physicochemical characteristics: green clear 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 is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzydamine exerts anti-inflammatory and local analgesic effects, producing a local anesthetic action on the mucous membranes of the oral cavity.

Pharmacokinetics.

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

It has been shown that topical application leads to accumulation of an effective concentration of benzydamine 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 interaction.

Interaction studies have not been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and medical advice should be sought to determine appropriate therapy.

In some patients, oral/pharyngeal mucosal ulcers 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.

The use of this medicinal product may cause bronchospasm in patients with bronchial asthma or 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/ml.

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

Use during pregnancy or breastfeeding

Animal studies are insufficient to allow any conclusions regarding the effects of this product 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 the systemic exposure to the drug resulting from 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 kept as low as possible and the duration of treatment as short as possible.

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

The product should not be used during breastfeeding.

Ability to affect reaction speed when driving or operating machinery

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

Method of Administration and Dosage

For oral rinse use only. Do not exceed the recommended dose.

Adults and children aged 12 years and older should rinse the mouth for 20–30 seconds using one measuring cup (15 ml) of the rinse solution, then spit out the liquid without swallowing it. The rinsing dose (15 ml) may be diluted with an equal amount of water if necessary.

Repeat the procedure 2–3 times with intervals of 3–4 hours, unless otherwise directed by a physician. If needed, the number of rinses may be increased up to 5 times daily.

The duration of treatment should be determined individually by a physician. It is recommended not to use the medication for more than 7 days without consulting a doctor.

Children

Do not use the medication in children under 12 years of age due to the risk of accidentally swallowing the solution during mouth rinsing.

Overdose

Overdose with benzidamine following topical application has not been reported.

In case of accidental ingestion of a large amount of benzidamine (> 300 mg), poisoning may occur. Typical signs of overdose after ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system effects (dizziness, hallucinations, excitement, anxiety, and irritability).

Very rarely, ingestion of high doses of benzidamine by children (hundreds of times higher than the recommended doses for this dosage form) has been associated with excitement, convulsions, tremor, nausea, excessive sweating, ataxia, and vomiting. Such acute overdose requires immediate gastric lavage, treatment of fluid and electrolyte imbalances, symptomatic therapy, and adequate hydration.

Side effects

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

Adverse reactions are classified by frequency of occurrence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); 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 hypoaesthesia, 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, pruritus, urticaria.

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

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

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

120 ml in a bottle made of transparent colorless glass or plastic. One bottle with a measuring cup in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Limited liability company "Pharmaceutical Company "Vertex".

Manufacturer's address and location of business operations.

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

(primary and secondary packaging, batch release)

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

(all stages of the production cycle except quality control, primary and secondary packaging)