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)

In this leaflet:

1.    What Bifluorid 12 is and what it is 4. Possible side effects used for

2. Before you use Bifluorid 12    5. How to store Bifluorid 12

3. How to use 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 breastfeeding, 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.

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).

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.

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 06/2008