Properties
What is it?
International Nonproprietary Name (Active Substance) - benzydamine hydrochloride ATC Classification Code - A01AD02 Clinical-Pharmacological Group - Non-steroidal anti-inflammatory drugs (in otorhinolaryngology) Composition and Dosage Form - 3 mg lozenges, 20 tablets - 0.15% spray in a 30ml bottle - 0.15% solution in a 120ml bottle - Per 1 lozenge: active ingredient - benzydamine hydrochloride - 3 mg Excipients: isomaltose, menthol, aspartame, citric acid monohydrate, mint flavoring, lemon flavoring, quinoline yellow (E 104), indigotine (E 132). - Per 100 ml of 0.15% metered spray: active ingredient - benzydamine hydrochloride – 0.15 g Excipients: ethanol, glycerol, methyl p-hydroxybenzoate, menthol flavoring, saccharin, sodium bicarbonate, polysorbate 20, purified water. - 100 ml of solution for local use contains: active ingredient: benzydamine hydrochloride - 0.15 g Excipients: ethanol, glycerol, methyl p-hydroxybenzoate, menthol flavoring, saccharin, sodium bicarbonate, polysorbate 20, quinoline yellow (E 104), patent blue V (E-131), purified water. See blog: Tantum Verde — for symptomatic relief of oral and throat infections Pharmacological Properties Benzydamine is a non-steroidal anti-inflammatory drug. It belongs to the indazole group. It has anti-inflammatory and local analgesic effects. The mechanism of action is related to the stabilization of cell membranes and inhibition of prostaglandin synthesis. When used locally, the drug is well absorbed by the mucous membrane and reaches inflamed tissues. Benzydamine is excreted by the kidneys and gastrointestinal tract. Indications Inflammatory diseases of the throat and oral cavity: - Gingivitis, glossitis, stomatitis (including post-radiation and post-chemotherapy periods); - Angina, pharyngitis, laryngitis, tonsillitis; - Candidiasis (as part of combination therapy); - Calculous inflammation of the salivary glands. - After surgical interventions and trauma (tonsillectomy, jaw fracture, etc.); - After dental treatment or extraction; - Periodontosis; In infectious-inflammatory diseases, it is necessary to use Tantum Verde as part of combination therapy. Dosage and Administration Lozenges: 1 lozenge 3-4 times/day. The lozenge should be kept in the mouth until completely dissolved (for maximum effect, it is desirable to keep it for as long as possible). Solution for local use: Use 15 ml (1 tablespoon) of the preparation for gargling the throat or rinsing the oral cavity every 1.5-3 hours to relieve pain. After rinsing, the solution should be expectorated. 0.15% Metered Spray for Local Use: For adults and elderly patients, 4-8 doses ("sprays") are administered every 1.5-3 hours. For children aged 6-12 years - 4 doses, for children under 6 years - 1 dose per 4 kg of body weight (maximum - 4 doses) every 1.5-3 hours. To use the spray: prepare the device, insert it into the oral cavity and aim at the inflamed area; press the cap (marked with an arrow). Side Effects Local reactions: dry mouth, numbness and/or burning sensation in the oral cavity. Allergic reactions: skin rash. Very rarely: laryngospasm. Contraindications - Hypersensitivity to any component of the preparation; - Children under 12 years of age (for solution); - Phenylketonuria (for lozenges). Pregnancy and Lactation It is possible to use the solution and spray form of the preparation during pregnancy and lactation (breastfeeding). In other cases, consult your doctor. Special Instructions If a burning sensation is observed when using the solution, it is necessary to dilute it with double the amount of water beforehand. Avoid getting the spray into the eyes. Effect on Driving and Operating Machinery: External use of the preparation does not affect the ability to drive or perform other activities requiring concentration. Overdose Currently, there is no information on cases of Tantum Verde overdose. Drug Interactions No clinically significant interactions of Tantum Verde with other drugs have been identified. Storage Conditions and Expiry Dates Lozenges - temperature not exceeding 25ºC, protected from light. Solution for local use - temperature not exceeding 25ºC, protected from light. Metered spray for local use - temperature not exceeding 25ºC, protected from light. Keep out of reach of children! Lozenges - 4 years; Solution for local use - 4 years; 0.15% metered spray for local use - 4 years; Dispensing from Pharmacy Over-the-counter Manufacturer, Country Aziende Chimiche Riunite Angelini Francesco, Italy
