Tantum verde®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TANTUM VERDE® (TANTUM VERDE®)

Composition:

Active ingredient: benzidamine hydrochloride;

100 ml of oral spray contains 0.15 g of benzidamine hydrochloride;

Excipients: ethanol 96%, glycerol, methylparahydroxybenzoate (E 218), flavor (mint), saccharin, sodium bicarbonate, polysorbate 20, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear, colorless liquid with a characteristic mint flavor.

Pharmacotherapeutic group.

Agents for use in dentistry. Other agents for local use in the oral cavity. ATC code A01AD02.

Pharmacological properties.

Pharmacodynamics.

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

Clinical studies have demonstrated that benzidamine is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzidamine exerts anti-inflammatory and local analgesic action, producing a local anesthetic effect on the mucous membranes of the oral cavity.

Pharmacokinetics.

Absorption through the mucous membranes of the oral cavity and pharynx has been confirmed by the presence of measurable amounts of benzidamine 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 with local application, an effective concentration of benzidamine 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 associated with 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 management.

In some patients, ulcers of the buccal or pharyngeal mucosa may be due to serious underlying pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other symptoms, should consult a physician or dentist, as appropriate.

Benzidamine is not recommended for patients with hypersensitivity to acetylsalicylic acid or to other nonsteroidal anti-inflammatory drugs (NSAIDs).

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 per dose.

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

Tantum Verde® oral spray contains a flavoring agent (mint flavor) which in turn contains benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol, and D-limonene, which may cause allergic reactions.

Use during pregnancy or breastfeeding

Pregnancy

There are no clinical data on the use of Tantum Verde® oral spray 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 labor onset may be delayed.

It is unknown whether systemic exposure to Tantum Verde® oral spray following local application could have adverse effects on the embryo/fetus.

Therefore, Tantum Verde® oral spray should not be used during pregnancy unless clearly needed and considered clinically justified. If used, the dose should be as low as possible and the duration of treatment kept to a minimum.

Breastfeeding

Currently, there are no adequate data available on the use of benzidamine in women who are breastfeeding. The ability of this product to pass into breast milk has not been studied. Animal studies are insufficient to draw conclusions regarding its use during breastfeeding. The potential risk to humans is unknown.

Tantum Verde**®** should not be used during breastfeeding.

Ability to affect reaction speed when driving or operating machinery

When used at recommended doses, this medicinal product does not impair the ability to drive or operate machinery.

Method of Administration and Dosage

Before use, the nebulizer must be assembled.

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

Dosage.

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 body weight, up to a maximum dose equivalent to 4 sprays, 2–6 times daily.

Do not exceed the recommended dosages.

Children.

The medication can be used in children aged 4 years and older.

Overdose.

There have been no reports of overdose with topical benzidamine application.

Following accidental ingestion of a large amount of benzidamine (> 300 mg), particularly in children, poisoning may occur. Characteristic signs of overdose after ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system effects (such as dizziness, hallucinations, excitation, seizures, tremor, excessive sweating, ataxia, anxiety, and irritability).

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

Adverse reactions.

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

Adverse reactions are classified according to 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 from 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 oedema; frequency not known – rash, pruritus, urticaria.

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

Tantum Verde**®** contains methylparaben, which may cause allergic reactions (possibly delayed).

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after 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, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life. 4 years.

Storage conditions.

No special storage conditions required.

Packaging.

30 ml of oral spray in a bottle with nebulizer in a cardboard box.

Availability. Over-the-counter.

Manufacturer. Azienide Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Manufacturer's name and address of the place of business.

Via Vecchio del Pignocco, 22 – 60131 Ancona (AN), Italy.