TANTUM VERDE COLLUTORIO 240ML 0.15%
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
Pour 15 ml of Tantum Verde mouthwash into the measuring cup to be used 2–3 times a day, in pure or diluted form (in this case add 15 ml of water to the measuring cup). Do not exceed the recommended dose.
Hypersensitivity to benzydamine or to any of the excipients listed in section 6.1.
The table below lists the undesirable effects classified by systems and organs according to MedDRA. Undesirable effects are listed using the following frequency scales: very common (≥1 / 10); common (≥1 / 100,
|CLASSIFICATION BY SYSTEMS AND ORGANS
||FREQUENCY: UNDESIRABLE EFFECTS
|Disorders of the immune system
|| Rare : hypersensitivity reaction
| Not known : anaphylactic reaction
|Respiratory, thoracic, mediastinal disorders
|| Very rare : laryngospasm
|| Rare : burning in the mouth, dry mouth.
|Skin and subcutaneous tissue disorders
|| Uncommon : photosensitivity
| Very rare : angioedema
Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
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 mouthwash 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 mouthwash contains parahydroxybenzoates which can cause allergic reactions (even delayed). For those who play sports: the use of medicines containing ethyl alcohol can determine a positive anti-doping test 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
No interaction studies have been performed.
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 performed; empty the stomach by inducing vomiting or gastric lavage and keep the patient under observation by giving supportive treatment and maintaining adequate hydration.
100 ml contain: active ingredient: 0.15 g benzydamine hydrochloride (equal to 0.134 g of benzydamine). Excipient with known effects: methyl parahydroxybenzoate. For the full list of excipients see section 6.1.
Glycerol, ethanol (96%), saccharin, methyl parahydroxybenzoate, sodium bicarbonate, mint flavor, polysorbate 20, quinoline yellow (E 104), patent blue V (E 131), purified water.