TANTUM VERDE DENTURES AND DENTURES

TANTUM VERDE DENTAL 0.5% COUNTRIES

active ingredients

100 g toothpaste contain: Active ingredient: benzidamina hydrochloride 0.5 g (equal to benzidamina 0.447 g) Excipients with known effects: methyl parahydroxybenzoate; propile parahydroxybenzoa For the full list of excipients, see paragraph 6.1.

Excellent

Dihydrate dibasic phosphate calcium, Glicerolo, Sodium Carmellosa, Sodium laurilsolfato, Silice colloidal anidra, Saccarina sodica, Metile parahydroxybenzoate, Parahydroxybenzoate, Aroma minta, Yellow chinolina (E 104), Blue patent V (E131), Purified water.

Therapeutic indications

Anti-inflammatory and analgesic treatment in mouth and gum irritations.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Spread the Green Tantum Dental on the toothbrush, thoroughly massage the gums and teeth and, keeping the toothpaste in the mouth, rinse the oral cavity. Repeat applications three times a day, after meals. Do not exceed the recommended doses.

Conservation

This medicine does not require any special precaution of conservation

Warnings

The use, especially if prolonged, can give rise to awareness-raising phenomena. In this case, stop the treatment and take appropriate therapeutic measures. Gold-pharyngeal ulcers can be a sign of more serious pathologies that require thorough clinical examinations. In case symptoms persist for more than three days, reevaluate the clinical picture. The use of benzidamine is not recommended in patients with acetylsalicylic acid hypersensitivity or other NSAIDs. Tantum Green Dental should be given with caution in case of bronchial asthma anamnesi due to the risk of bronchospasm onset. Important information about some excipients Tantum Green Dental contains methyl parahydroxybenzoate and propile parahydroxybenzoate. They can cause allergic reactions (also delayed). Tantum Green Dental contains the mint aroma. Peppermint aroma contains alcohol of anise, benzyl alcohol, cinnamal, cinnamilic alcohol, citronellol, D-Limonene, eugenol, foliage, geraaniol, isoeugenol, linalol that can cause allergic reactions.

Interactions

No interactions with other drugs have been observed.

Effects

The undesirable effects are reported according to the 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 INDESIDER EFFECTS Immune system disorders Raro: reaction of hypersensitivity Notable: anaphylactic reaction Respiratory pathologies, chests, medianistic Very rare: laryngespasmo Gastrointestinal diseases Raro: burning to 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 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

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. Overdose symptoms have been reported in children, such as excitation, convulsions, sweating, ataxia, tremor and vomiting, after oral administration of benzidamine at a dosage of about 100 times greater than that of 3 mg tablets. 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.

There is no risk data available during pregnancy and breast-feeding. Tantum Green Dental during pregnancy and nursing with breast milk is not recommended. The use of must be taken into account only if the expected benefit for the mother exceeds the risk for the fetus or child.

Source: Farmadati