Tantum Verde Nebulizer Bottle 15ml 0.3%

Active ingredients

100 ml contain: active ingredient: benzidamine hydrochloride 0.30 g (equivalent to 0.268 g of benzidamine). Excipients: methyl parahydroxybenzoate, hydrogenated castor oil 40 polyoxyethylated. For the complete list of excipients see paragraph 6.1.

Excipients

Glycerol, Ethanol (96 percent), Sodium saccharin, Methyl parahydroxybenzoate, Mint flavor, Hydrogenated castor oil 40 polyoxyethylated, Purified water.

Therapeutic indications

Symptomatic treatment of irritative-inflammatory states also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extraction dental therapy.

Contraindications/Side effects

Hypersensitivity to benzidamine or to any of the excipients.

Dosage

Adults: 2 - 4 nebulizations 2 - 6 times a day (each nebulization is equivalent to 0.17 ml of solution). Do not exceed the recommended doses.

Storage

This medicine does not require any particular storage conditions.

Warnings

The use of the product, especially if prolonged, may lead to sensitization phenomena. In this case, discontinue treatment and consult a doctor to establish appropriate therapy. In a limited number of patients, oropharyngeal ulcerations may be a sign of more serious conditions. Therefore, if symptoms persist for more than three days, the patient should consult their doctor or dentist as needed. The use of benzidamine is not recommended in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs. Tantum Verde oral mucosa solution should be administered with caution in individuals who have previously had episodes of bronchial asthma, as bronchospasm phenomena may occur in these patients. Tantum Verde contains parahydroxybenzoates that may cause allergic reactions (including delayed). For those engaged in sports activities: the use of medicines containing ethyl alcohol may result in positive doping tests in relation to the blood alcohol concentration limits indicated by some sports federations.

Interactions

No interaction studies with other drugs have been conducted.

Side effects

Within each frequency class, side effects are listed in descending order of severity. The following scales have been used: very common (≥1/10); common (≥1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1000); very rare (<1/10,000); not known (frequency cannot be defined based on available data). Gastrointestinal disorders - Rare: burning and dryness of the mouth. Immune system disorders - Rare: hypersensitivity reactions - Not known: anaphylactic reactions. Respiratory, thoracic, mediastinal disorders - Very rare: laryngospasm. Skin and subcutaneous tissue disorders - Uncommon: photosensitivity - Very rare: angioedema.

Overdose

Very rarely, symptoms of overdose have been reported in children, such as excitement, convulsions, sweating, ataxia, tremors, and vomiting, after oral administration of benzidamine at a dosage of about 100 times higher than that of the 3 mg tablets. In the case of acute overdose, only symptomatic treatment can be performed; empty the stomach by inducing vomiting or with gastric lavage and monitor the patient providing supportive treatment and maintaining adequate hydration.

Pregnancy and breastfeeding

There are no data regarding the use of benzidamine during pregnancy or breastfeeding. The excretion of the product in breast milk has not been studied. Studies conducted on animals regarding the effects during pregnancy and breastfeeding are insufficient (see paragraph 5.3) and therefore the potential risk to humans cannot be assessed. During pregnancy and breastfeeding, Tantum Verde should not be used.

Adulti: 2-4 nebulizzazioni 2-6 volte al di' (ogni nebulizzazione equiv ale a 0,17 ml di soluzione). Non superare le dosi consigliate.

100 ml contengono: principio attivo: benzidamina cloridrato 0,30 g (pa ri a 0,268 g di benzidamina). Eccipienti con effetti noti: metile para idrossibenzoato, olio di ricino 40 poliossidrato idrogenato, aroma men ta (alcol benzilico, citronellolo, d-limonene, eugenolo, geraniolo e l inalolo). Per l'elenco completo degli eccipienti vedere paragrafo 6.1.