Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Sodium fluoride
Colgate-Palmolive A/S
A01AA; A01AA01
Sodium fluoride
5000 ppm
Toothpaste
Product subject to prescription which may be renewed (B)
Caries prophylactic agents; sodium fluoride
Marketed
2003-07-25
CONFIDENTIAL 1.3.1 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER DURAPHAT® 5000PPM FLUORIDE TOOTHPASTE Fluoride (as Sodium Fluoride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE - BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your dentist or pharmacist has 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 dentist 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. 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. WHAT YOU NEED TO KNOW 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. WARNINGS AND PRECAUTIONS - 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, pharmacist or oral hygienist concerning this matter. - Duraphat® Toothpaste is not intended for use in adolescents and children under 16 years of age. IN THIS LEAFLET: 1. What Duraphat® Toothpaste is and what it is used for 2. What you need to know before you use Duraphat® Toothpaste 3. How to use Duraphat® Toothpaste 4. Possible side effects 5. How to store Duraphat® Toot Lire le document complet
Health Products Regulatory Authority 31 January 2023 CRN00CPYR Page 1 of 4 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. Excipients with known effects: 1 g of toothpaste contains 5 mg of sodium benzoate (E211). 1 g of toothpaste contains 10 mg of spearmint flavouring with allergens. 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). For use by persons aged 16 years of age and over only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. Spit out the excess foam. 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_ Health Products Regulatory Authority 31 January 2023 CRN00CPYR Page 2 of 4 This toothpaste has a high fluoride content. Therefore, the opinion of a qualified healthcare professional, such as dentist, pharmacist, oral hygienist should be sought before the product is used. An increased number of potential fluoride sources may lead to fluorosis. Before using fluoride medicines such as Duraphat, an assessment of overall fluor intake (i.e. drinking water, fluori Lire le document complet