TANTUM VERDE COLLUT 120ML0,15%

TANTUM VERDE 0.15% COLLUTORIA

active ingredients

100 ml contain: active ingredient: benzidamine hydrochloride 0.15 g (equal to 0.134 g benzidamine). Excipient with known effects: methyl parahydroxybenzoate. For the full list of excipients see paragraph 6.1.

Excellent

Glicerol, ethanol (96%), saccharin, methyl parahydroxybenzoate, sodium bicarbonate, aroma mint, polysorbed 20, yellow chinolina (E 104), blue patent V (E 131), 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 listed in paragraph 6.1.

Population

Pour in the dispenser cup 15 ml of Tantum Verde collutory to be used, 2–3 times a day, in pure or diluted form (in this case add in the dispenser cup 15 ml of water). 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 collutory 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 collutory contains parahydroxybenzoates that can cause allergic reactions (also delayed). For sportsmen: the use of medicines containing ethyl alcohol can determine positivity to antidoping tests in relation to the limits of alcohol concentration indicated by some sports federations.

Interactions

Interaction studies have not been carried out.

Effects

The table below shows the unwanted effects classified by systems and organs according to MedDRA. The side effects are listed using the following frequency scales: very common (≥1/10); common (≥1/100, CLASSIFICATION FOR SYSTEMS AND ORGANI FACILITIES Immune system disorders Rare : reaction of hypersensitivity Notable : anaphylactic reaction Respiratory pathologies, thoracic, mediastinic Very rare : laryngeospasmo Gastrointestinal diseases Rare : burning in the mouth, dry mouth. Pathologies of skin and subcutaneous tissue Not common : photosensitivity Very rare : angioedema Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

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