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1. Duraphat 50 Mg/Ml Dental Suspension
2. Duraphat 50 Mg/Ml Dental Suspension

10148751_10148751 9/10/14 19:01 Pagel

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.

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.

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).

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.

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.

Information for the user

Duraphat 50 mg/ml Dental Suspension Sodium fluoride

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

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

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 liguids 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 plague 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.