TANTUM VERDE * NEBUL FL 15ML 0.3%

TANTUM VERDE * NEBUL FL 15ML 0.3%

Therapeutic indications

Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.

Dosage and method of use

Adults: 2–4 sprays 2–6 times a day (each spray equals 0.17 ml of solution). Do not exceed the recommended dose.

Contraindications

Hypersensitivity to benzydamine or to any of the excipients.

Side effects

Within each frequency class, undesirable effects are reported in descending order of severity. The following scales of values were used: very common (≥1 / 10); Common (≥1 / 100, Gastrointestinal disorders - Rare : burning and dry mouth. Immune system disorders - Rare : hypersensitivity reactions - Not known : anaphylactic reactions. Respiratory, thoracic, mediastinal disorders - Very rare : laryngospasm. Skin disorders and subcutaneous tissue - Uncommon : photosensitivity - Very rare : angioedema.

Special warnings

The use of the product, especially if prolonged, can give rise to sensitization phenomena. In this case, stop the treatment and consult your doctor to establish a suitable therapy. In a limited number of patients, oro-pharyngeal ulcerations can be a sign of more serious pathologies. Therefore, if symptoms persist for more than three days, the patient should contact their doctor or dentist as needed. The use of benzydamine is not recommended in patients with hypersensitivity to acetylsalicylic acid or to other NSAIDs. Tantum Verde solution for oral mucosa should be administered with caution in subjects who have had episodes of bronchial asthma in the past, as bronchospasm phenomena may occur in this type of patient. Tantum Verde contains parahydroxybenzoates which can cause allergic reactions (including delayed). For those who carry out sports activities: the use of medicines containing ethyl alcohol can determine positivity to doping tests in relation to the alcohol concentration limits indicated by some sports federations.

Pregnancy and breastfeeding

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

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Interaction studies with other drugs have not been conducted.

Overdose

Symptoms of overdose in children, such as excitation, convulsions, sweating, ataxia, tremor and vomiting, have been reported very rarely after oral administration of benzydamine at a dosage approximately 100 times that of the 3 mg tablets. In case of acute overdose, only symptomatic treatment can be carried out; empty the stomach by inducing vomiting or gastric lavage and keep the patient under observation by giving supportive treatment and maintaining adequate hydration.

Active principles

100 ml contain: active ingredient: benzydamine hydrochloride 0.30 g (equal to 0.268 g of benzydamine). Excipients: methyl parahydroxybenzoate, castor oil 40 hydrogenated polyhydroxy. For the full list of excipients see section 6.1.

Excipients

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