Duraphat 5000 ppm Fluoride Toothpaste

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Sodium fluoride

Предлага се от:

Colgate-Palmolive A/S

АТС код:

A01AA; A01AA01

INN (Международно Name):

Sodium fluoride

дозиране:

5000 ppm

Лекарствена форма:

Toothpaste

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

Caries prophylactic agents; sodium fluoride

Статус Оторизация:

Marketed

Дата Оторизация:

2003-07-25

Листовка

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

Данни за продукта

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