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BIFLUORID 12 SUSPENSION 60MG/G

Active substance(s): CALCIUM FLUORIDE / SODIUM FLUORIDE / CALCIUM FLUORIDE / SODIUM FLUORIDE / CALCIUM FLUORIDE / SODIUM FLUORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Bifluorid 12 Suspension
Active substances: sodium fluoride 60 mg/g (6.0 % w/w), calcium fluoride 60 mg/g
(6.0 % w/w)
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 doctor 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 doctor or pharmacist.
In this leaflet:

1. What Bifluorid 12 is and what it is
used for
2. Before you use Bifluorid 12
3. How to use Bifluorid 12

4. Possible side effects
5. How to store Bifluorid 12
6. Further information

1. WHAT BIFLUORID 12 IS AND WHAT IT IS USED FOR
Bifluorid 12 is a liquid suspension for application to the teeth surfaces.
Bifluorid 12 is used:
- for treatment of sensitive teeth
- for prevention of cavities and caries
- to make teeth, necks of teeth and crown edges less sensitive following dental
treatment
2. BEFORE YOU USE BIFLUORID 12
DO NOT use Bifluorid 12
- if you are allergic (hypersensitive) to sodium fluoride, calcium fluoride or any of the other
ingredients of Bifluorid 12.
- if you have mottled teeth (spots on the enamel; dental fluorosis) due to a high intake of
fluoride.
Take special care with Bifluorid 12
If the Bifluorid 12 Suspension gets into the eyes by mistake, wash them immediately with
plenty of water.
Please note: After the treatment you must avoid tooth brushing until 24 hours after
application.
For the cleaning of instruments a solvent is delivered together with Bifluorid 12. This
solvent is flammable and has to be kept away from hot surfaces and ignition sources.
The cap of bottle has to be tightened after use.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. There are no known
interactions with other medicines.
Using Bifluorid 12 with food and drink
There are no known interactions with other products, such as alcohol, tobacco and food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. There are no
restrictions for the use of Bifluorid 12 during pregnancy and breast-feeding, although
safety in pregnancy and breast-feeding has not been established.
Driving and using machines
Biflourid 12 is not known to have any influence on the ability to drive vehicles or to
operate machinery.
3. HOW TO USE BIFLUORID 12
The treatment with Bifluorid 12 will be carried out by your dentist or by the dental
assistant.
For cavities and caries prevention painting a whole set of teeth, your dentist will use:
- for milk teeth approximately 0.2 ml Bifluorid 12 Suspension
- for permanent teeth approximately 0.3 ml Bifluorid 12 Suspension for cavities and
caries prevention after fillings have been inserted and for treatment of sensitive teeth:
- approximately 0.02 ml per tooth
Method of administration
1 Your dentist will prepare the teeth for treatment by cleaning them to remove plaque
and thoroughly drying them with air.
2 The Bifluorid 12 Suspension must be shaken well before use so that any solid
particles are well dispersed. Two loose metal balls are inside the container to assist
this. After shaking the suspension must be liquid in a way that it easily runs out of the
dropper.
3 Your doctor will put drops of the Bifluorid 12 Suspension onto a brush, cotton tip or
special foam pellet (“Pele Tim”) and thinly paint the teeth surfaces to be treated.
4 The suspension is adsorbed within10-20 seconds and then dried with air.
Please note: After the treatment you must avoid tooth brushing until 24 hours after
application.
Duration of usage
For most cases of sensitive teeth a single application is enough. In cases of intense
sensitivity, when you still have problems after the first application, the treatment should
be repeated two or three times at weekly intervals.
A single application is given to prevent cavities and caries after fillings have been
inserted.
For a general cavities and caries prevention Bifluorid 12 should be applied twice a year.
If you use more Bifluorid 12 than you should
In case of overdosage, sensitive patients may occasionally react with nausea, tickle of

the throat or irritation of the mucous membrane of the mouth (reddening of the mouth
cavity, tongue, gums and lips).
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Bifluorid 12 can cause side effects, although not everybody gets
them.
Known side effects are itching or irritating sensations.
The application of Bifluorid 12 may result in a momentary tooth pain sensation triggered
by evaporating organic solvent. This effect has no clinical significance and fades as soon
as the varnish coat has dried. A similar effect is a temporary “itching” sensation on the
gums or mucosa if Bifluorid 12 inadvertently contacted oral soft tissues upon application.
Moreover, sensitive patients may experience evaporating solvent fumes as irritating or
nauseating. This perception fades quickly and has no clinical relevance.
Prevalence: Unknown. Insufficient data available
If you are prone to allergies you could react to Bifluorid 12 with irritation of the mucous
membrane of the mouth (reddening of the mouth cavity, tongue, gums and lips).
Prevalence: Unknown. Insufficient data available
If you get any side effects, please talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
5. HOW TO STORE BIFLUORID 12
Keep out of the reach and sight of children.
Store at room temperature not exceeding 25°C. Do not expose to direct sunlight.
Do not use Bifluorid 12 after the expiry date which is stated on the label. The expiry date
refers to the last day of that month.
6. FURTHER INFORMATION
What Bifluorid 12 contains
The active substances are:
sodium fluoride 60 mg/g (6.0 % w/w)
calcium fluoride 60 mg/g (6.0 % w/w)
The other ingredients are:
Ethylacetate, Pyroxylin, Fumed silica, Clove oil, Isoamylpropionate (no
E-number-classification for these compounds)
What Bifluorid 12 looks like and contents of the pack
Bifluorid 12 is a solvent-based opaque suspension of low viscosity.
The suspension may separate upon storage and then turns into a clear solution with a white
sediment. Bifluorid 12 always has to be resuspended prior to use.
Original pack with 4 g Bifluorid 12 and 10 ml solvent for the cleaning of instruments.

Clinical pack with 10 g content.
Giant pack (3 x 10 g incl. 10 ml solvent).
Marketing Authorisation Holder and Manufacturer
VOCO
Phone +49 (4721) 719-0
Fax +49 (4721) 719-140
P.O. Box 767
27457 Cuxhaven
Germany
e-mail: marketing@voco.com
www.voco.com
This leaflet was approved in 05/2016

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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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