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DURAPHAT 50 MG/ML DENTAL SUSPENSION

Active substance(s): SODIUM FLUORIDE

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10148751_10148751 9/10/14 19:01 Page1

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

Information for the user
Duraphat 50 mg/ml Dental Suspension
Sodium fluoride

5. How to Store Duraphat Dental Suspension
Keep out of the reach and sight of children.
Do not store above 25°C. Do not use this medicine after the expiry date which is
stated on the tube and outer packaging. The expiry date refers to the last day of
that month. Your dentist will check that the product has not passed this date.
Once opened the contents of the Duraphat tube should be used within 3 months.
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.

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 doctor.
• 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your dentist or doctor.

6. Further Information

In this leaflet:
1. What Duraphat Dental Suspension is and what it is used for
2. Before you use Duraphat Dental Suspension
3. How to use Duraphat Dental Suspension
4. Possible side effects
5. How to store Duraphat Dental Suspension
6. Further Information

What Duraphat Dental Suspension contains
The active substance is sodium fluoride. 1 ml of this suspension contains 50 mg
of sodium fluoride equivalent to 22.6 mg of fluoride.
The other ingredients are: ethanol 96%; white wax (E901); shellac (E904);
colophony; mastic; saccharin (E954); raspberry essence (containing ethyl
butyrate, geraniol, iris resinoid, isoamyl acetate, jasmine absolute, vanillin and
propylene glycol).

1. What Duraphat Dental Suspension is and what it is used for

Marketing Authorisation Holder
Colgate-Palmolive (U.K.) Ltd., Guildford Business Park, Middleton Road, Guildford,
Surrey, GU2 8JZ, UK.
Manufacturer
Pharbil Waltrop GmbH, Im Wirrigen 25, D-45731 Waltrop, Germany.
For the product licence number PL00049/0042.
This leaflet was last revised in September 2014.

10148751 - 09 Oct. 2014

What Duraphat Dental Suspension looks like and the contents of the pack
Duraphat Dental Suspension is a brown/yellow opaque suspension. It is supplied
in tubes of 10 ml or 30 ml or cylinders of 1.6 ml.

The active ingredient of Duraphat Dental Suspension is sodium fluoride.
Duraphat Dental Suspension prevents tooth decay and is used to reduce the
sensitivity of very sensitive teeth. When Duraphat Dental Suspension is applied on
to the teeth, fluoride is released which penetrates deep into the tooth and
provides long-term protection against tooth decay.

2. Before you use Duraphat Dental Suspension
Do not use Duraphat Dental Suspension if:
• you are allergic (hypersensitive) to sodium fluoride, colophony or any of the
other ingredients in this medicine (see section 6)
• you have mouth ulcers or gum disease
• you have stomatitis (inflammation of the mouth)
• you have asthma.

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Take special care with Duraphat Dental Suspension
• Ensure you have eaten a meal before Duraphat Dental Suspension is used,
particularly if it is applied to all of your teeth.
• On the day when Duraphat has been applied, no high dose Fluoride
preparations, such as Fluoride gels, should be used. The administration of
Fluoride supplements should be suspended for several days after applying
Duraphat.
Tubes: The container of this medicinal product contains latex rubber. May cause
severe allergic reactions.
wUsing other medicines
Please tell your dentist or doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. In particular:
• fluoride supplements (e.g. drops or gels), do not use on the day of your
treatment with Duraphat Dental Suspension or for several days afterwards.
Using Duraphat Dental Suspension with food and drink
• Ensure you/your child has eaten a meal before Duraphat Dental Suspension is
used, particularly if it is applied to all of your teeth.
• Do not chew food for 4 hours after Duraphat Dental Suspension has been
applied to your teeth. You may drink liquids or eat soft foods during this time.
Pregnancy and breast-feeding
This medicine contains alcohol and should be avoided during pregnancy
and breast-feeding. Seek medical advice before taking/using any
medicine.

3. How to use Duraphat Dental Suspension
Duraphat Dental Suspension is intended for use in children and adults.
This medicine is applied on to your teeth by your dentist, who will decide
how much Duraphat Dental Suspension to use. The dosage will vary due to
the type of teeth (e.g. milk teeth or permanent teeth) and the reason for
treatment.
• the dentist will remove plaque by brushing your teeth; you may be asked to
brush your own teeth
• excess saliva will then be removed to ensure your teeth are dry
• the suspension is then painted on to the teeth using a brush, probe or swab
• all your teeth or only those susceptible to tooth decay may be painted.

The patient should not brush the teeth or chew food for 4 hours after treatment.
Recommended dosage for single applications
• for milk teeth, up to 0.25 ml to be applied
• for mixture of milk and permanent teeth, up to 0.40 ml to be applied
• for permanent teeth, up to 0.75 ml to be applied.
To prevent tooth decay
• The application is usually repeated every 6 months but more frequent
applications (every 3 months) may be made if required.
To reduce the sensitivity of very sensitive teeth
• treatment is repeated 2 or 3 times in a few days. Should be used alongside a
suitable toothpaste for sensitive teeth.
If you have any further questions about how this medicine is used please speak
to your dentist or doctor.
If too much Duraphat Dental Suspension is used
As Duraphat Dental Suspension is applied to your teeth by your dentist it is very
unlikely that too much of the product will be used.
If fluoride enters your bloodstream at very high dose, it may have a toxic effect. Doses
of several milligrams of fluoride per kg body weight may cause nausea (feeling
sick), vomiting, diarrhoea, muscular spasms, convulsions and heart problems.

4. Possible side effects
Like all medicines, Duraphat Dental Suspension can cause side effects, although
not everyone gets them. You are more likely to experience side effects if you are
allergic to any of the ingredients of Duraphat Dental Suspension. If necessary, the
varnish dental suspension can be removed by brushing the teeth and rinsing.
The following side effects have been reported by patients after using this medicine.
Very rare but serious side effects (occurs in fewer than 1 in 10,000 patients):
• If you think you may have any of the following side effects, see a doctor as
soon as possible : swelling of the face, lips, mouth or throat which may
cause difficulty in swallowing or breathing.
Other very rare side effects:
• irritation, inflammation and ulceration of the gums and mouth
• nausea (feeling sick) and retching
• asthma.

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Duraphat Varnish Light II - Leaflet - UK
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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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