国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
SODIUM FLUORIDE
LTT Pharma Limited
SODIUM FLUORIDE
5000
Toothpaste
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
DURAPHAT 5000PPM FLUORIDE TOOTHPASTE (fluoride) PATIENT INFORMATION LEAFLET 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. Your medicine is called Duraphat ® 5000ppm Fluoride Toothpaste, but will be refered to as Duraphat ® Toothpaste throughout this leaflet. IN THIS LEAFLET: What Duraphat ® Toothpaste is and what it is used for Before you use Duraphat ® Toothpaste How to use Duraphat ® Toothpaste Possible side effects How to store Duraphat ® Toothpaste Further information 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. 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 ® Toothpaste is not intended for use in adolescents and children under 16 years of age. USING OTHER MEDICINES No interactions w 阅读完整的文件
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. _Product imported from Germany:_ 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. 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 administration._ This toothpaste has a high fluoride content. Therefore, the opinion of a dental specialist must be sought before the HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 03/09/2014_ _CRN 2151601_ _page number: 1_ product is used. An increased number of potential fluoride sources 阅读完整的文件