DURAPHAT 5000 Toothpaste

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM FLUORIDE

Available from:

LTT Pharma Limited

INN (International Name):

SODIUM FLUORIDE

Dosage:

5000

Pharmaceutical form:

Toothpaste

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

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

Summary of Product characteristics

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