TANTUM VERDE P 20PASTL 3MEN

TANTUM VERDE P 3 MG PASTIGLIE GUSTO MENTA

active ingredients

Each pill contains benzidamine hydrochloride 3 mg (equal to 2.68 mg of benzidamine). Excipients: each pill contains 3183 mg of isomalto (E 953); 3.5 mg of aspartame (E 951). For the full list of excipients see paragraph 6.1.

Excellent

Isomalto (E 953), Aspartame (E 951), Levomentolo, Citric Acid monohydrate, Lemon Aroma, Peppermint Aroma (E 104), Indigotin (E 132).

Therapeutic indications

Tantum Verde P is indicated in adults and children over 6 years. Local symptom treatment of pain and irritation of the mouth and throat.

Contraindications

Hypersensitivity ascertained to benzidamine or any of the excipients.

Population

Adults and children over 6 years: a pill 3 times a day. Do not exceed 7 days of treatment. Children 6–11 years: the product must be taken under the supervision of an adult. Children under 6 years: for the type of pharmaceutical form the administration should be limited to children over 6 years. Use of oropharynx. Slowly rinse a pastel in the mouth. Don't swallow. Don't chew.

Conservation

Store in the original packaging to protect the medicine from moisture. Do not store at temperature above 25°C.

Warnings

The use of benzidamine is not recommended in patients with acetylsalicylic acid hypersensitivity or other NANS. Administer with caution in subjects who suffer or have suffered in the past episodes of bronchial asthma, as in this type of patients may intervene bronchospasm phenomena. In a limited number of patients, gold–faringeal ulcers can be a sign of more severe pathologies. Therefore, in case the symptoms worsen or not improve within three days, or have to intervene fever or other symptoms, the patient must contact his physician or dentist depending on the need. The product contains aspartame, a source of phenylalanine, therefore it can be harmful to those suffering from phenylchetonuria. The product contains isomalto, patients suffering from rare hereditary problems of fructose intolerance should not take this medicine.

Interactions

No interaction studies have been conducted.

Effects

Within each frequency class the unwanted effects are reported in decreasing order of gravity. The following values scales have been used: very common (≥1/10); common (≥1/100, gastrointestinal pathologies – Rari: burning and dry mouth, Notable: Oral hypoesthesia. Immune system disorders – Rare: hypersensitivity reactions – Notable: anaphylactic reactions. Respiratory pathologies, thoracic, mediastinic – Very rare: laryngospasm. Pathologies of skin and subcutaneous tissue – Not common: photosensitivity – Very rare: angioedema.

Overdosing

With the formulation tablets no case of overdose has been reported. However, symptoms of overdose in children have very rarely been reported, such as excitation, convulsions, sweating, ataxia, tremor and vomiting, after oral administration of benzidamine to a dosage of about 100 times higher than that of 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 adequate data regarding the use of benzidamine in pregnant or nursing women. The excretion of the product in breast milk has not been studied. Animal studies are insufficient to highlight the effects on pregnancy or breast-feeded children (see paragraph 5.3). The potential risk for human beings is not known. Tantum Verde P should not be used during pregnancy or during breastfeeding.

Source: Farmadati