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FLUORIDE 5000 PPM TOOTHPASTE

Active substance(s): SODIUM FLUORIDE

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Patient Information Leaflet: Information for the User

Duraphat® 5000 ppm Fluoride Toothpaste
(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.
• The name of your medicine is Duraphat® 5000 ppm Fluoride
Toothpaste but will be referred to as Duraphat Toothpaste throughout
the remainder of this leaflet.

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.

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

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.

4) POSSIBLE SIDE EFFECTS

5) HOW TO STORE DURAPHAT TOOTHPASTE
• Keep 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 becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6) FURTHER INFORMATION
What Duraphat Toothpaste contains
1g of toothpaste contains 5mg fluoride (as sodium fluoride),
corresponding to 5000 ppm fluoride.
Also contains: Liquid Sorbitol (Non-crystallising), Dental Type Silica,
Dental Type Silica (Precipitated), Macrogol 600,Tetrapotassium
Pyrophosphate, Xanthan Gum, Sodium Benzoate (E211), Sodium
Laurilsulphate, 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 the contents of the pack
Duraphat Toothpaste is a blue coloured toothpaste.
It is supplied in a 51g tube, enclosed in an outer carton.

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.

Manufacturer
Thepenier Pharma Industrie S.A.S., Route d’Alencon,
Saint-Langis-Les-Mortagne, F-61400 Mortagne, France.

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.

Repackaged by: MPT Pharma Ltd.

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.

It is procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER. UK
PL: 33532/0521 Duraphat® 5000 ppm Fluoride Toothpaste
Leaflet dated 02 April 2015
Leaflet coded XXXXXXXXXX

POM

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

Patient Information Leaflet: Information for the User

Fluoride 5000 ppm Toothpaste
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.
• The name of your medicine is Fluoride 5000 ppm Toothpaste but will
be referred to as Fluoride Toothpaste throughout the remainder of this
leaflet.

Like all medicines, Fluoride 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.

In this leaflet:
1) What Fluoride Toothpaste is and what it is used for
2) Before you use Fluoride Toothpaste
3) How to use Fluoride Toothpaste
4) Possible side effects
5) How to store Fluoride Toothpaste
6) Further information

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

1) WHAT FLUORIDE TOOTHPASTE IS AND WHAT IT IS USED
FOR
Fluoride 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 FLUORIDE TOOTHPASTE
Do not use Fluoride Toothpaste
• if you are allergic (hypersensitive) to Sodium Fluoride or any of the
other ingredients of Fluoride Toothpaste.
Take special care with Fluoride Toothpaste
• Fluoride 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 Fluoride 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.
• Fluoride 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 Fluoride 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 Fluoride Toothpaste after meals.
Pregnancy and breast-feeding
There is no experience from the use of Fluoride 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 Fluoride
Toothpaste
This toothpaste contains Sodium Benzoate. Sodium Benzoate is a mild
irritant to the skin, eyes and mucous membrane.
3) HOW TO USE FLUORIDE TOOTHPASTE
Fluoride Toothpaste is for use by persons aged 16 years and above.
Always use Fluoride Toothpaste exactly as your dentist or pharmacist
has told you. You should check with your dentist or pharmacist if you are
not sure. Use Fluoride 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 Fluoride 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.
Fluoride Toothpaste 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 Fluoride 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

5) HOW TO STORE FLUORIDE TOOTHPASTE
• Keep out of the sight and reach of children.
• Do not use Fluoride 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 becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6) FURTHER INFORMATION
What Fluoride Toothpaste contains
1g of toothpaste contains 5mg fluoride (as sodium fluoride),
corresponding to 5000 ppm fluoride.
Also contains: Liquid Sorbitol (Non-crystallising), Dental Type Silica,
Dental Type Silica (Precipitated), Macrogol 600,Tetrapotassium
Pyrophosphate, Xanthan Gum, Sodium Benzoate (E211), Sodium
Laurilsulphate, Spearmint flavouring (containing Peppermint Oil,
Carvone, Spearmint Oil, Menthol, Anethol and Lemon Oil), Saccharin
Sodium, Brilliant Blue FCF (E133) and Purified Water.
What Fluoride Toothpaste looks like and the contents of the pack
Fluoride Toothpaste is a blue coloured toothpaste.
It is supplied in a 51g tube, enclosed in an outer carton.
Manufacturer
Thepenier Pharma Industrie S.A.S., Route d’Alencon,
Saint-Langis-Les-Mortagne, F-61400 Mortagne, France.
It is procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER. UK
Repackaged by: MPT Pharma Ltd.
PL: 33532/0521 Fluoride 5000 ppm Toothpaste
Leaflet dated 02 April 2015
Leaflet coded XXXXXXXXXX

POM

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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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