Страна: Малта
Език: английски
Източник: Medicines Authority
BENZYDAMINE HYDROCHLORIDE
A. C. R. A. F. SpA (Aziende Chimiche Riunite Angelini Francesco) Viale Amelia 70, Rome 00181, Italy
R02AX03
BENZYDAMINE HYDROCHLORIDE 3 mg
LOZENGE
BENZYDAMINE HYDROCHLORIDE 3 mg
OTC
THROAT PREPARATIONS
Authorised
2006-03-15
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER TANTUM VERDE P 3 MG LOZENGES, MINT TASTE Benzydamine Hydrochloride WHAT IS IN THIS LEAFLET 1. What Tantum Verde P is and what is used for 2. What you need to know before you take Tantum Verde P 3. How to take Tantum Verde P 4. Possible side effects 5. How to store Tantum Verde P 6. Contents of the pack and other information 1. WHAT TANTUM VERDE P IS AND WHAT IS USED FOR Tantum Verde P contains benzydamine, which 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANTUM VERDE P DO NOT TAKE TANTUM VERDE P: - If you are allergic to benzydamine hydrochloride or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, or pharmacist before taking Tantum Verde P 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 has 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 or nurse. This includes any possible side effects not listed in this leaflet. You must talk to a doctor if you don’t feel better or if you feel worse after 3 days Page 2 of 4 - 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 in your mouth or throat gets worse or does not improve within 3 days, or you appear feverish or have other symptoms, you should speak to your doctor or dentist. OTHER M Прочетете целия документ
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tantum Verde P 3 mg Lozenges, mint taste. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 3 mg benzydamine hydrochloride (equivalent to 2.68 mg benzydamine). Excipients: each lozenge contains 3183 mg Isomalt (E 953), 3,5 mg Aspartame (E 951). Tantum Verde mint taste contains fragrances with Benzyl Alcohol, Citronellol, d- Limonene, Eugenol, Geraniol, Linalool, Citral, Butylated hydroxyanisole. For the full list of excipients, see 6.1 3. PHARMACEUTICAL FORM Lozenge. Green square-shaped lozenges, with a central cavity. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tantum Verde P is indicated in adults and children over 6 years of age, for symptomatic treatment for the relief of pain and irritation of mouth and throat. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over six years of age: one lozenge 3 times a day. The treatment must not exceed 7 days. 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. Oropharingeal use. Lozenge should be dissolved slowly in the mouth. Do not swallow. Do not chew. Page 2 of 5 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Benzydamine use is not advisable in patients 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 do not improve within three days, or who appear feverish or have other symptoms, must therefore seek the advice of their doctor or dentist as appropriate. The medici Прочетете целия документ