22.6 mg / ml dental suspension 
fluoride

Read all of this leaflet carefully before you start taking this medicine.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to 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 doctor.

In this leaflet you will find information about: 
1. What Duraphat is and what it is used for 
2. Before using Duraphat 
3. How to use Duraphat 
4. Possible side effects 
5. How to store Duraphat 
6. Other information 

1. WHAT DURAPHAT IS AND WHAT IT IS USED FOR

Duraphat, which contains the active substance fluoride, is medicine for caries(cavities) in the teeth.

Duraphat is used to prevent tooth decay.

2. BEFORE YOU USE DURAPHAT

Do not use Duraphat:

  • if you are allergic (hypersensitive) to fluoride or to any of the other ingredients of Duraphat (see section 6)
  • if you have sores in your mouth or inflammation of the gums
  • if you have inflammation of the mouth ( stomatitis ).

Take special care with Duraphat

Application of Duraphat to the entire set of teeth should not be done on an empty stomach.

Tubes: The material in the medicine packaging contains latex. May cause severe allergic reactions.

Use of other medicines

Tell your dentist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Do not use the high dose fluoride preparations, such as gels you on the day of Duraphat applied. The use of fluoride tablets should be discontinued for a few days after the application of Duraphat.

Use of Duraphat with food and drink

  • Make sure you / your child has eaten before Duraphat is applied, especially if the preparation is applied to the entire set of teeth.
  • For the four hours immediately following the application of Duraphat, you should not eat solid foods.

Pregnancy and breastfeeding

Consult a doctor or dentist before taking any medicine.

Due to insufficient information, the use of Duraphat during pregnancy and lactation is not recommended.

Driving and using machines

Duraphat has no known effect on the ability to drive or use machines.

3. HOW TO USE DURAPHAT

Your dentist applies Duraphat to your teeth. Dose one is adapted to your type of teeth (eg baby teeth or permanent teeth) and the cause of the treatment.

Recommended single doses

  • milk teeth: not more than 0.3 ml
  • when the patient has both deciduous and permanent teeth: not more than 0.4 ml
  • permanent teeth: not more than 1.0 ml.

To prevent caries, the application is usually repeated every six months, but if necessary, the application can be done more often (every three months).

Do not brush or eat food within four hours of treatment.

If you have any further questions on the use of this product, ask your dentist or doctor.

If you use more Duraphat than you should

It is very unlikely that you would get too large a dose of Duraphat because the dentist applying the preparation.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Duraphat can cause side effects, although not everybody gets them.

Contact a dentist or doctor immediately and remove the suspension by brushing your teeth and rinsing if you get any of the following symptoms ( angioedema ) after treatment with Duraphat:

  • swelling of the face, tongue, mouth, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

The following side effects have been reported.

Very rare side effects (may affect up to 1 in 10,000 people):

  • swelling in the mouth
  • inflammation of the oral mucosa
  • inflammation and ulcers in the gums
  • nausea, nausea
  • skin irritation, angioedema with symptoms such as swelling of the face, lips, tongue, mouth, or throat, sometimes with difficulty breathing or swallowing
  • asthma attack.

Has been reported (occurs in an unknown number of users):

  • hypersensitivity ( allergy )

5. HOW TO STORE DURAPHAT

Keep out of sight and reach 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 carton. The expiration date is the last day of the specified month. The dentist checks that the product has not passed this date. The contents of the tube should be used within three months after opening.

The medicine 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

Content declaration

  • The active substance is fluoride. One ml of suspension contains sodium fluoride corresponding to 22.6 mg of fluoride.
  • The other ingredients are 96% ethanol, white wax (E901), shellac (E904), rosin, mastic, saccharin sodium (E954), raspberry essence.

What the medicine looks like and the contents of the pack

Duraphat dental suspension is a brown/yellow opaque suspension.

Package sizes 
1 x 10 mL tubes 
5 x 1.6 ml in vial s

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Colgate-Palmolive A / S, Bredevej 2, 2830 Virum, Denmark

Manufacturer

Pharbil Waltrop GmbH, Im Wirrigen 25, D-45731 Waltrop, Germany

Muhammad Nadeem

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