Tantimvert

INSTRUCTIONS for medical use of the medicinal product TANTIVERT (TANTIVERT)

Composition:

Active substance: benzidamine hydrochloride;

1 tablet contains benzidamine hydrochloride (calculated as 100% dry substance) 3 mg;

ORANGE-FLAVORED TABLETS:

Excipients: mannitol (E 421), hypromellose, sodium saccharin, orange flavor, magnesium stearate;

MINT-FLAVORED TABLETS:

Excipients: mannitol (E 421), hypromellose, sodium saccharin, mint flavor, magnesium stearate;

EUCALYPTUS-FLAVORED TABLETS:

Excipients: mannitol (E 421), hypromellose, sodium saccharin, eucalyptus flavor, magnesium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: round, biconvex tablets of white or almost white color, with orange, mint, or eucalyptus flavor and taste.

Pharmacotherapeutic group. Agents for use in dentistry. Other agents for local use 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. The drug's action is directed towards stabilization of the cell membrane and inhibition of prostaglandin synthesis. The drug exerts anti-inflammatory and local analgesic effects.

Pharmacokinetics.

After oral administration, benzydamine is rapidly absorbed from the gastrointestinal tract. Peak plasma concentration is reached within 2–4 hours after dose administration. Benzydamine accumulates in the area of inflammation. Approximately half of the administered dose is excreted unchanged by the kidneys. About 10% of the administered dose is excreted within the first 24 hours after drug intake. The remaining portion undergoes metabolism, primarily to the N-oxide.

Clinical characteristics.

Indications.

Symptomatic treatment of irritation and inflammation 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.

Special precautions.

If there is no improvement after short-term use of the drug, medical advice is necessary. Prolonged use of the medicinal product may lead to the development of allergy.

Interaction with other medicinal products and other forms of interaction.

No interactions with other medicinal products have been reported.

Special precautions for use

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

In patients with bronchial asthma, including a history of it, the drug may provoke bronchospasm. Therefore, the medicinal product should be used with caution in such patients.

In some patients, oral mucosal ulcers may be caused by serious underlying pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other new symptoms, should seek medical advice (from a dentist).

Use during pregnancy or breastfeeding

There are no clinical data on the use of the 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. Toward the end of pregnancy, prolonged bleeding time may occur in both the mother and the newborn, and labor onset may be delayed.

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

Therefore, the medicinal product should not be used during pregnancy except when clinically justified. If used, the dose should be as low as possible and the duration of treatment kept to a minimum.

Clinical studies on the use of the drug during breastfeeding have not been conducted; therefore, the use of the medicinal product is not recommended during this period.

Ability to influence reaction rate when driving vehicles or operating machinery

The use of benzydamine at recommended doses does not affect or has negligible influence on the ability to drive vehicles or operate machinery.

Dosage and Administration.

The tablets should be sucked. Do not chew or swallow the tablets.

For adults and children aged 6 years and older: 1 tablet 3 times a day.

The medicinal product is recommended for use no longer than 7 days.

Children. The medicinal product is indicated for children aged 6 years and older.

Overdose .

Overdose is unlikely with use of this medicinal product. Ingestion of a large number of tablets may cause nausea, excitement, convulsions, tremor, increased sweating, ataxia, and vomiting. Such acute overdose requires immediate gastric lavage, treatment of water-electrolyte imbalances, symptomatic therapy, and adequate hydration.

Side effects.

Gastrointestinal disorders: burning sensation in the mouth, dry mouth, oral hypoaesthesia, nausea, vomiting, swelling and discoloration of the tongue, taste alteration.

Immune system disorders: hypersensitivity reactions, anaphylactic reactions.

Respiratory system disorders: laryngospasm, bronchospasm.

Skin and subcutaneous tissue disorders: photosensitivity reactions, angioneurotic edema, rash, itching, urticaria.

Nervous system disorders: dizziness, headache.

If any adverse reactions occur, administration of the drug should be discontinued and medical advice should be sought regarding further treatment.

Reporting of side effects.

Reporting suspected adverse reactions after marketing authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

**Shelf life. **3 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

10 tablets per blister; 2 blisters per carton.

Supply category. Over-the-counter.

Manufacturer.

Limited Liability Company "Pharmaceutical Company "Vertex".

Manufacturer's address and location of manufacturing activities.

33, Astronomichna Street, lit. "B-1", Kharkiv, Kharkiv region, 61085, Ukraine (primary and secondary packaging, batch release)

33, Astronomichna Street, lit. "H-2" (first floor), Kharkiv, Kharkiv region, 61085, Ukraine (all stages of the manufacturing cycle except quality control, primary and secondary packaging)