Tantum verde®

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

Composition:

Active substance: benzidamine hydrochloride;

100 ml of solution contain 0.15 g of benzidamine hydrochloride;

Excipients: ethanol 96%, glycerol, methylparahydroxybenzoate (E 218), flavoring agent (menthol), saccharin, sodium hydrogencarbonate, polysorbate 20, quinoline yellow (E 104), patent blue V (E 131), purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: transparent green liquid with a characteristic mint taste.

Pharmacotherapeutic group. Agents used 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 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 confirmed by the presence of measurable amounts of benzidamine in human plasma. However, these concentrations are insufficient to produce any systemic pharmacological effect. Excretion occurs primarily via urine, mainly in the form of inactive metabolites or conjugated compounds.

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

Studies on interaction 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, ulcers of the oral or pharyngeal mucosa 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 consult a physician or dentist, as appropriate.

Benzidamine is not recommended for patients with hypersensitivity to acetylsalicylic acid or 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 solution contains a flavouring agent (mint flavour) which includes benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol and D-limonene, which may cause allergic reactions.

Use during pregnancy or breast-feeding.

There are currently insufficient adequate data on the use of benzidamine in pregnant or breastfeeding women. It is not known whether this product is excreted in breast milk. Animal studies are insufficient to allow conclusions regarding the safety of this product during pregnancy or breastfeeding. The potential risk to humans is unknown.

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

Effect on ability to drive and use machines.

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

Method of administration and dosage.

Measure 15 ml of TANTUM VERDE**®** solution from the bottle using the measuring cup, either undiluted or diluted (the measured 15 ml of solution may be diluted with 15 ml of water). Use the solution to rinse the mouth. Rinsing should be performed 2–3 times daily. Do not exceed the recommended dose.

Children.

The preparation must not be used in children under 12 years of age due to the risk of swallowing the solution during mouth rinsing.

Overdose.

There have been no reports of overdose with benzydamine when used topically.

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

Very rarely, ingestion of a large dose of benzydamine by children (hundreds of times higher than the possible doses of this medicinal 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.

Adverse reactions.

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

Adverse reactions are classified according to the 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.

TANTUM VERDE**®** contains methylparaben, which may cause allergic reactions (including delayed-type reactions).

Shelf life. 4 years.

Storage conditions.

Store at temperatures not exceeding 25 °C. Keep out of reach of children.

Packaging. 120 ml of solution in a bottle with a measuring cup; 1 bottle per cardboard box.

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

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

Manufacturer's name and address: Via Vecchio del Pino, 22 – 60131 Ancona (AN), Italy.