Ország: Örményország
Nyelv: angol
Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
benzydamine (benzydamine hydrochloride)
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
R02AX03
benzydamine (benzydamine hydrochloride)
3mg
lozenges
(20/2x10/), in pack
OTC
Registered
2020-12-26
SUMMARY OF PRODUCT CHARACTERISTIC 1. NAME OF THE MEDICINAL PRODUCT Tantum Verde, 3 mg lozenges, mint taste. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains: Active substance: 3 mg of benzydamine hydrochloride equivalent to 2.68 mg benzydamine. Excipients with known effects: each lozenge contains 3183 mg of Isomalt (E 953) and 3.5 mg of Aspartame (E 951). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Lozenge. Green square-shaped lozenges, with a central cavity. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of pain and irritation of the oral cavity and throat 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children over 6 years of age: one lozenge 3 times a day. Treatment duration must not exceed 7 days. _Paediatric population _ Children 6-11 years of age: The medicinal product should be administered under adult supervision. Children below 6 years of age: Due to the type of the pharmaceutical form, the administration should be restricted to children of more than 6 years of age. Method of administration For oropharingeal use. Lozenge should be dissolved slowly in the mouth. Do not swallow. Do not chew. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in the section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Benzydamine use is not advisable in patient with hypersensitivity to salicylic acid or other NSAIDs. Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma. Caution should be exercised in these patients. In a minority of patients, buccal/pharyngeal ulceration may be caused by serious disease processes. Patients whose symptoms worsen or do not improve within 3 days, or who appear feverish or have other symptoms, must therefore seek the advice of their doctor or dentist as appropriate. This medicinal product contains: - ASPARTAME: aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hy Olvassa el a teljes dokumentumot