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DURAPHAT 5000 PPM FLUORIDE TOOTHPASTE

Active substance(s): SODIUM FLUORIDE

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50559-15_50559-15 7/10/14 11:41 Page1

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.
Package Leaflet: Information for the User
®

Duraphat

5000 ppm Fluoride Toothpaste

Fluoride (as Sodium Fluoride)
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.

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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or dentist.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via:

50559-15_50559-15 7/10/14 11:41 Page2

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL-Dublin 2
Tel: + 353 1 6764971
Fax: + 351 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE DURAPHAT® TOOTHPASTE
Keep out of the reach and sight 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.
6. FURTHER INFORMATION
What Duraphat® Toothpaste contains
- The active substance is fluoride (as sodium fluoride).
1 g of toothpaste contains 5 mg 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 contents of the pack
Duraphat® Toothpaste is a blue coloured toothpaste.
It is supplied in a 51g tube, enclosed in an outer carton.
Pack sizes: 1 x 51g tube or 3 x 51g tubes.
Marketing Authorisation Holder
Colgate-Palmolive (UK) Limited
Guildford Business Park
Middleton Road
Guildford
Surrey GU2 8JZ
United Kingdom
Manufacturer
Colgate-Palmolive Manufacturing (Poland) Sp. z o.o.
Al. Colgate 2
58-100 Swidnica
Poland
This leaflet was last revised in December 2014.

50559-15 - 07 OCT. 2014

50559-15_50559-15 7/10/14 11:41 Page3

BLACK

Duraphat 5000 TP - Leaflet 51g - UK / Ireland
Dim: 170mm x 190mm
Font size: 9/9pts
(50559-15)

10148641_10148641 17/10/14 15:33 Page1

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.
Package Leaflet: Information for the User
®

Duraphat

5000 ppm Fluoride Toothpaste

Fluoride (as Sodium Fluoride)
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.

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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or dentist.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via:

10148641_10148641 17/10/14 15:33 Page2

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL-Dublin 2
Tel: + 353 1 6764971
Fax: + 351 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE DURAPHAT® TOOTHPASTE
Keep out of the reach and sight 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.
6. FURTHER INFORMATION
What Duraphat® Toothpaste contains
- The active substance is fluoride (as sodium fluoride).
1 g of toothpaste contains 5 mg 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 contents of the pack
Duraphat® Toothpaste is a blue coloured toothpaste.
It is supplied in a 51g tube, enclosed in an outer carton.
Pack sizes: 1 x 51g tube or 3 x 51g tubes.
Marketing Authorisation Holder
Colgate-Palmolive (UK) Limited
Guildford Business Park
Middleton Road
Guildford
Surrey GU2 8JZ
United Kingdom
Manufacturer
Thepenier Pharma Industrie S.A.S.,
Route d’Alençon,
Saint-Langis-Lès-Mortagne,
61400 Mortagne,
France
This leaflet was last revised in December 2014.
10148641 - 214991601 - 06 OCT. 2014

10148641_10148641 17/10/14 15:33 Page3

BLACK

Duraphat 5000 TP - Leaflet 51/153g - UK / Ireland
Dim: 170mm x 190mm
Font size: 9/9pts
(50559-14)

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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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