TANTUM VERDE B 120ML22.5+7,5MG

TANTUM VERDE BOCCA 22.5MG/15 ML + 7.5MG/15 ML COLLUTORIA

active ingredients

100 ml contain: active ingredients: benzidamine hydrochloride 0.15 g (equal to benzidamin 0.134 g) and chloride cetilpyrinium 0.05 g (equal to cetilpyrinium 0.0425 g). Excipients with known effects: Hydrogenated castor oil 40 polyxyethylene, ethanol 96%. For the full list of excipients see paragraph 6.1.

Excellent

Glicerolo, Ethanol (96%), Saccarina, Hydrogenated castor oil 40 polyxyethylene, Sodium bicarbonate, Aroma mint, Yellow chinolina (E 104), Blue Patent V (E 131), Purified Water

Therapeutic indications

Antiseptic, anti-inflammatory and analgesic treatment in mouth irritations, gums; in the gums and stomatitis. Indicated even before and after tooth extractions.

Contraindications

Hypersensitivity to benzidamine, cetilpiridinium or any of the excipients listed in the paragraph 6.1.

Population

Sciacqui with 15 ml of collutory, 2-3 times a day, using the appropriate dosing glass. The product can be used, if necessary, at any time of the day. Use for a maximum period of 5-7 days. For longer use consult your doctor.

Conservation

Store in the original packaging to protect the medicine from light and moisture.

Warnings

The use, especially if prolonged preparations for oropharyngeal use, could give rise to awareness-raising phenomena. In this case, stop the treatment and consult your doctor to establish suitable therapy.

Interactions

No interaction studies have been carried out. However, contemporary use of other antiseptics should be avoided.

Effects

The table below shows the side effects, by organic systemic classification MedDRA. The side effects are listed using the following frequency scales: very common (≥1/10); common (≥1/100, CLASSIFICATION FOR SYSTEMS AND ORGANI FACILITIES Gastrointestinal diseases Notable: light sense of mouth numbness1 Systemic pathologies and conditions for administration Notable: phenomena of intolerance to the drug, which manifest with mild and transitory burning or irritation in application2 ⁽¹⁾ associated with local anaesthetic activity of benzidamina ⁽²⁾ observable phenomena with cetilpiridinium, which do not require changes in treatment Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The toxic manifestations of overdose of benzidamine by systemic means consist of excitement, convulsions, sweating, ataxia, tremors and vomiting. Benzida Intoxication is expected only in case of accidental ingestion of high quantities of benzidamine (>300 mg). Symptoms associated with overdose by ingestion of benzidamine are mainly of gastrointestinal nature and dependent on the central nervous system. The most frequent gastrointestinal symptoms are nausea, vomiting, abdominal pain and esophageal irritation. Symptoms to the central nervous system include dizziness, hallucinations, agitation, anxiety and irritability. In case of acute overdose, only symptomatic treatment can be performed. Patients should be kept under close observation, and should receive support treatment. An adequate hydration must be maintained. Cetilpiridi Symptoms resulting from ingestion of significant amounts of quaternary ammonia compounds include nausea, vomiting, dispnea, asphyxiation cyanosis, SNC depression, hypotension and coma. However, such toxic doses of chloride cetilpyrine cannot be achieved even with the intake of more than 10 packs of products. Treatment of overdose from cetilpiridinium is symptomatic.

There are no contraindications to the topical use of benzidamine and cetilpiridinium during pregnancy or during breastfeeding.

Source: Farmadati