DURAPHAT 5000PPM FLUORIDE TOOTHPASTE

Active substance: SODIUM FLUORIDE

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Duraphat® 5000ppm Fluoride Toothpaste
0ppm
(sodium fluoride)
Your medicine is known by the above name, but will be referred to as
Duraphat Toothpaste throughout this:
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.
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 Toothpaste is not intended for use in adolescents and children
under 16 years of age.

Using other medicines
No interactions with other medicines are known. Please tell your dentist or
pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Using Duraphat Toothpaste with food and drink
Fluoridated water and salt should be avoided during the use of this
toothpaste. Food and drink, if taken immediately after brushing, may have an
inhibitory effect on the remineralisation of the teeth. Therefore brush your
teeth with Duraphat Toothpaste after meals.
Pregnancy and breast-feeding
There is no experience from the use of Duraphat in pregnant women. If you
are pregnant or breast-feeding, ask your doctor, dentist or pharmacist before
using this toothpaste as for any medicine.
Important information about some of the ingredients of Duraphat
Toothpaste
This toothpaste contains Sodium Benzoate. Sodium Benzoate is a mild
irritant to the skin, eyes and mucous membrane.
This toothpaste contains Sorbitol. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before using
this medicinal product.

3) How to use Duraphat Toothpaste
Duraphat Toothpaste is for use by persons aged 16 years and above. Always
use Duraphat Toothpaste exactly as your dentist or pharmacist has told you.
You should check with your dentist or pharmacist if you are not sure. Use
Duraphat Toothpaste 3 times a day for brushing your teeth
− apply a 2 cm ribbon onto your toothbrush for each brushing (2 cm
provides between 3 mg and 5 mg of fluoride).
− brush your teeth after each meal.
− vertically, from the gum to the tip of the tooth.
− spit out excess foam and do not swallow
Careful brushing takes approximately 3 minutes.

If you use more Duraphat Toothpaste than you should, or if you have
swallowed the toothpaste
If you swallowed a large amount of toothpaste by mistake, and if you
experience digestive problems such as: vomiting, diarrhoea, and abdominal
pain, you must tell a doctor immediately as treatment may be required.
Please take this leaflet with you.
Duraphat contains menthol which if accidentally ingested at excessive
amounts may cause convulsions, particularly in infants and children.
If you constantly swallow too much of the toothpaste over several months and
years, you may experience dental fluorosis (stained or speckled appearance
of the dental enamel and enamel fragility) or bone fluorosis (osteosclerosis;
increased density of your bones).
If you forget to use Duraphat Toothpaste
Simply use as soon as you remember, but do not use a double dose to make
up for the missed dose. Continue treatment as usual after the next meal.
If you have any further questions on the use of this product, ask your dentist
or pharmacist.

4) Possible side effects
Like all medicines, Duraphat Toothpaste can cause side effects, although not
everybody gets them. In some rare cases (i.e. less than 1 in 1000 people
treated) allergic (hypersensitivity) reactions can occur e.g. rash, itching
swelling and redness. Burning oral sensation has also been reported. 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.

6) Further information
What Duraphat Toothpaste contains:
− The active substance is fluoride (as sodium fluoride).
1 g of toothpaste contains 5 mg fluoride (as sodium fluoride),
corresponding to 5000ppm fluoride.
− The other ingredients are liquid sorbitol (non-crystallising),dental type
silica, dental type silica (precipitated),macrogol 600,tetrapotassium
pyrophosphate, xanthan gum, sodium benzoate (E211),sodium
laurilsulfate, spearmint flavouring (containing peppermint oil, carvone,
spearmint oil, menthol, anethol, and lemon oil), saccharin sodium, brilliant
blue FCF (E133) and purified water.
What Duraphat Toothpaste looks like and content of the pack
Duraphat Toothpaste is a blue coloured toothpaste, having the characteristic
mint smell and taste.
It is supplied in a 51g tube, enclosed in an outer carton.

PL 10383/2054

POM

Who makes and repackages your medicine
Your medicine is manufactured by Colgate-Palmolive (UK) Ltd., The Dental
Health Unit, Williams House, Lloyd Street North, Manchester M15 6SE,
United Kingdom, or GABA GmbH Berner Weg 7 D-79539 Lörrach Germany.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 07.05.2013

5) How to store Duraphat Toothpaste
• Keep all medicines out of the sight and reach of children.
• Do not use Duraphat Toothpaste after the expiry date which is stated on the
tube and carton after "Expiry date". The expiry date refers to the last day of
that month.
• Do not store above 25°C.
• If your toothpaste appears discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.

Duraphat® is a registered trademark of Colgate-Palmolive Company, NY,
USA.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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