TANTUM VERDE NEBUL 30ML 0.15%

TANTUM VERDE 0.15% OFFICE FOR ORAL MUCOSA

active ingredients

100 ml contain: active ingredient: benzidamine hydrochloride 0.15 g (equal to 0.134 g benzidamine). Excipients: methyl parahydroxybenzoate, propile parahydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Glicerol; crystallized liquid sorbitol; sodium saccharin; potassium acesulfame; methyl parahydroxybenzoate; propile parahydroxybenzoate; mint aroma; polysorbed 20; purified water.

Therapeutic indications

Symptomatic treatment of irritative–inflammatory states also associated with pain of the oropharyngeal cable (e.g. gums, stomatitis, pharyngitis), also as a result of conservative or extractive dentaria therapy.

Contraindications

Hypersensitivity to benzidamine or any of the excipients.

Population

Nebulizations 2 to 6 times a day (each nebulization is 0.17 ml of solution). Adults: 4–8 nebulizations 2–6 times a day. Children (6–12 years): 4 nebulizations 2–6 times a day. Children (under 6 years): 1 nebulization for every 4 kg of body weight, up to a maximum of 4 nebulizations 2–6 times a day. Do not exceed the recommended doses.

Conservation

This medicine does not require any special condition of conservation.

Warnings

The use of the product, especially if prolonged, can give rise to awareness phenomena. In this case stop treatment and consult your doctor to establish suitable therapy. In a limited number of patients, gold–faringeal ulcers can be a sign of more severe pathologies. Therefore, in case the symptoms persist for more than three days, the patient must contact his physician or dentist depending on the need. The use of benzidamine is not recommended in patients with acetylsalicylic acid hypersensitivity or other NANS. Tantum Green solution for oral mucosa should be administered with caution in subjects that in the past have had bronchial asthma episodes, as in this type of patients may intervene bronchospasm phenomena. Tantum Green contains parahydroxybenzoates that can cause allergic reactions (also delayed).

Interactions

No interaction studies have been conducted with other drugs.

Effects

Within each frequency class the unwanted effects are reported in decreasing order of gravity. The following values scales have been used: very common (≥1/10); common (≥1/100, gastrointestinal pathologies – Rare: burning and dry mouth. Immune system disorders – Rare: hypersensitivity reactions – Notable: anaphylactic reactions. Respiratory pathologies, thoracic, mediastinic – Very rare: laryngospasm. Pathologies of skin and subcutaneous tissue – Not common: photosensitivity – Very rare: angioedema.

Overdosing

Very rarely have been reported symptoms of overdose in children, such as excitation, convulsions, sweating, ataxia, tremor and vomiting, after oral administration of benzidamine to a dosage of about 100 times greater than that of 3 mg tablets. In case of acute overdose, only a symptomatic treatment can be performed; drain the stomach causing vomiting or gastric lavender and keep the patient under observation giving a support treatment and maintaining an adequate hydration.

There is no data on the use of benzidamine during pregnancy or during breastfeeding. The excretion of the product in breast milk has not been studied. Animal studies with regard to pregnant effects and breastfeeding are insufficient (see paragraph 5.3) and therefore the potential risk for man cannot be assessed. During pregnancy and nursing Tantum Verde should not be used.

Source: Farmadati