Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
SODIUM FLUORIDE
Colgate-Palmolive (U.K.) Ltd
A01AA01
SODIUM FLUORIDE
5000 ppm
Toothpaste
Product subject to prescription which may be renewed (B)
Caries prophylactic agents
Authorised
2003-07-25
PACKAGE LEAFLET: INFORMATION FOR THE USER Fluoride (as Sodium Fluoride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your dentist or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your dentist or pharmacist. IN THIS LEAFLET: 1. What Duraphat ® Toothpaste is and what it is used for 2. Before you use Duraphat ® Toothpaste 3. How to use Duraphat ® Toothpaste 4. Possible side effects 5. How to store Duraphat ® Toothpaste 6. Further information 1. WHAT DURAPHAT ® TOOTHPASTE IS AND WHAT IT IS USED FOR Duraphat ® Toothpaste is used to help prevent dental caries (tooth decay) in adolescents aged 16 years and over and adults, particularly amongst patients at risk from multiple caries. This toothpaste contains fluoride as sodium salt, which belongs to a group of medicines called caries preventing agents. 2. BEFORE YOU USE DURAPHAT ® TOOTHPASTE Do not use Duraphat ® Toothpaste - if you are allergic (hypersensitive) to Sodium Fluoride or any of the other ingredients of Duraphat ® Toothpaste. TAKE SPECIAL CARE WITH DURAPHAT ® TOOTHPASTE - Duraphat ® Toothpaste has a high fluoride content. Fluoride tablets, drops, chewing gum, gels or varnishes, as well as fluoridated water or salt, should be avoided during the use of Duraphat ® Toothpaste. In order to prevent accumulation of fluoride, your total intake must be assessed before using this fluoride toothpaste. Ask your dentist or pharmacist concerning this matter. - Duraphat ® Toothp Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duraphat 5000 ppm Fluoride Toothpaste. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of toothpaste contains 5 mg fluoride (as sodium fluoride), corresponding to 5000 ppm fluoride. Excipient: 1 g of toothpaste contains 5 mg sodium benzoate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Toothpaste. Blue paste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of dental caries in adolescents and adults, particularly amongst patients at risk from multiple caries (coronal and/or root caries). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For use by persons aged 16 years of age and over only. Not to be swallowed. Brush carefully on a daily basis: • apply a 2 cm ribbon onto your toothbrush for each brushing. • 2 cm provides between 3 mg and 5 mg of fluoride. • 3 times daily, after each meal. • vertically, from the gum to the tip of the tooth. Careful brushing takes approximately 3 minutes. METHOD OF ADMINISTRATION: For dental use. 4.3 CONTRAINDICATIONS This medicinal product must not be used in cases of hypersensitivity to the active substance or to any of the excipients. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 16/04/2015_ _CRN 2158377_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Duraphat 500 mg/100 g Toothpaste is not intended for use in adolescents and children under 16 years of age, _see 4.2._ _Posology and method of adminisration._ This toothpaste has a high fluoride content. Therefore, the opinion of a dental specialist must be sought before the product is used. An increased number of potential fluoride sources may lead to fluorosis. Before u Leggi il documento completo