Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Benzydamine hydrochloride
Aziende Chimiche Riunite Angelini Francesco
A01AD; A01AD02
Benzydamine hydrochloride
3.0 milligram(s)
Lozenge
Product not subject to medical prescription
Other agents for local oral treatment; benzydamine
Not marketed
2000-09-01
PACKAGE LEAFLET: INFORMATION FOR THE USER Tantum Verde mint taste 3 mg lozenges Benzydamine Hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects , talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET: 1. What Tantum Verde is and what it is used for 2. What you need to know b you take Tantum Verde 3. How to take Tantum Verde 4. Possible side effects 5. How to store Tantum Verde 6. Contents of the pack and other information 1. WHAT TANTUM VERDE P IS AND WHAT IT IS USED FOR Tantum Verde contains the active substance benzydamine, which is a local anti-inflammatory agent. It belongs to the group of agent for oral local treatment. Tantum Verde is used in adults and children above 6 years of age, for symptomatic local treatment for the relief of pain and irritation of the mouth and throat. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE DO NOT TAKE TANTUM VERDE : - If you are allergic to benzydamine or any of the other ingredients of this medicine (listed in the section 6). WARNINGS AND PRECAUTION TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING TANTUM VERDE: - If you suffer from a condition known as phenylketonuria. - If you have a history of Asthma. - If you are allergic to acetylsalicylic acid or to other anti-inflammatory painkillers called NSAIDs. - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. - If after using the lozenges the pain Read the complete document
Health Products Regulatory Authority 22 May 2019 CRN008W94 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tantum Verde mint taste 3 mg lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 3 mg of benzydamine hydrochloride equivalent to 2.68 mg of 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 Tantum Verde is indicated in adults and children over 6 years of age, for symptomatic local treatment for the relief of pain and irritation of mouth and throat. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ Adults and children over 6 years of age: one lozenge 3 times a day. The treatment must not exceed 7 days. _Pediatric 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. Tantum Ver Read the complete document