Duraphat 22.6 mg/ml Dental Fluoride Suspension
1. What Is Duraphat And What It Is Used For
Duraphat, which contains the active substance fluoride, is medicine for caries(cavities) in the teeth. It is used to prevent tooth decay.
2. Before You Use Duraphat
Do Not Use:
- If you are allergic (hypersensitive) to fluoride or to any of the other Duraphat ingredients (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 medicine 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 high-dose fluoride preparations, such as the gels on the day of application. 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 the medicine 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 this medicine 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 it 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 about 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 it because the dentist applies 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 Duraphat 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 this medicine:
- Swelling of the face, tongue, mouth, or throat
- Difficulty swallowing
- Hives and difficulty breathing.
The following side effects have been reported.
Very rare Duraphat 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
- 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 Duraphat 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