Duraphat

B. PATIENT INFORMATION LEAFLET

Leaflet enclosed with the packaging: information for the user

Duraphat

50 mg/ml, suspension for dental application

Sodium fluoride

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a dentist or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, you should tell your dentist or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Duraphat and what is it used for
• 2. Important information before using Duraphat
• 3. How to use Duraphat
• 4. Possible side effects
• 5. How to store Duraphat
• 6. Contents of the packaging and other information

1. What is Duraphat and what is it used for

Duraphat contains sodium fluoride and is used to prevent tooth decay and treat tooth sensitivity.

2. Important information before using Duraphat

When not to use Duraphat:

• -if you are allergic to sodium fluoride or any of the other ingredients of this medicine (listed in section 6),
• in patients with ulcerative gingivitis,
• in patients with oral mucositis,
• in patients with asthma.

Warnings and precautions

Application of the medicine to the entire dentition should not be performed on an empty stomach. If you are using other fluoride products (e.g. fluoride gels, fluoride tablets, or fluoridated salts), you should stop taking them for a few days after the treatment to avoid excessive fluoride intake.

Duraphat and other medicines

You should tell your doctor about all the medicines you have taken recently, including those that are available without a prescription.

Using Duraphat with food and drink

Do not chew food for 4 hours after applying the medicine. You can consume light meals and drinks.

Pregnancy and breastfeeding

Before using any medicine, you should consult a doctor or pharmacist. Duraphat contains 33.8% v/v ethanol (each dose contains up to 0.2 g of alcohol) and therefore, it is recommended to avoid using the medicine in pregnant and breastfeeding women.

Driving and using machines

No studies have been conducted on the effect of the product on the ability to drive and use machines.

Duraphat contains ethanol and a flavoring agent

Ethanol

This medicine contains 0.279 g of alcohol (ethanol) in each 1 ml, which is equivalent to 27.9 g in 100 ml of suspension.

Flavoring agent

This medicine contains a flavoring agent - raspberry flavor, with allergens: geraniol, citronellol, citral, benzyl benzoate, linalool, and benzyl alcohol. These compounds may cause an allergic reaction. Benzyl alcohol may cause mild local irritation.

3. How to use Duraphat

Duraphat should always be used according to the dentist's recommendations. If you have any doubts, you should consult your dentist or pharmacist again. If your doctor does not recommend a different dosage for you, the recommendations for using Duraphat are as follows. You should follow the recommendations, otherwise, Duraphat will not work properly.

How often and in what dose to use Duraphat

In the case of average susceptibility to tooth decay, it is recommended to repeat the treatment every 6 months. This can be combined with a routine dental check-up. In patients with a high risk of tooth decay, it is recommended to perform the treatment every 3 months. This applies primarily to selective coating of thin layers of the medicine on parts of the dentition that are particularly exposed to the risk, e.g. primary teeth and erupting molars. In the case of treating tooth sensitivity, improvement is achieved after 2-3 applications of the medicine with a few-day interval between treatments. In the case of single applications, do not exceed the following doses of the medicine: For primary teeth - up to 0.25 ml of suspension (= 5.65 mg of fluoride) For mixed dentition - up to 0.4 ml of suspension (= 9.04 mg of fluoride) For permanent dentition - up to 0.75 ml of suspension (= 16.95 mg of fluoride) These amounts should not be exceeded if Duraphat is applied in a thin layer to teeth at risk of tooth decay. Note that during application using cotton and instruments, some amount of the medicine remains on them.

How and when to use Duraphat

You should remove dental plaque and dry the teeth using cotton or air. Then, you should apply the suspension to the teeth. The patient should not apply Duraphat themselves.Duraphat is applied from a tube in a thin layer, using cotton swabs, a spatula, or a brush. Then, you should proceed in the same way with the next teeth. It is recommended to start applying the suspension from the lower jaw, before too much saliva accumulates there. It is not necessary to apply the medicine to the surface of the teeth from the tongue side, as it is more resistant to tooth decay. Duraphat should be applied to the surfaces most exposed to tooth decay. Application of the medicine using a syringe is particularly useful in the case of selective application of a small dose of the medicine. A blunt syringe with a bent tip facilitates application to the contact and distal surfaces of the teeth. To apply the suspension to the interdental surfaces, the syringe is inserted between the teeth to apply a small amount of Duraphat. The suspension should be applied to both sides of the interdental space and to the entire occlusal surface. Grooving: apply a drop of Duraphat, drawing the syringe along the tooth grooves. Sensitivity of the edges of fillings, crowns, and tooth necks can be treated in the same way. Smooth surfaces of the teeth should be treated only in the case of increased tooth decay activity, especially in the case of early signs of demineralization (decalcification). For this purpose, the syringe should be placed in contact and in this position, Duraphat can be spread on the surface with the bent tip of the syringe. Duraphat can be used to treat areas around orthodontic appliances using a syringe.

Using a higher dose of Duraphat than recommended

Depending on the dose and route of administration, in extreme cases, a larger amount of fluoride may be administered to the oral cavity. In the case of swallowing the medicine, nausea and diarrhea may occur, especially in patients with sensitive stomachs. If during tooth development, the dose of 2 mg of fluoride per day is repeatedly exceeded (administered locally or generally), it may lead to disturbances in enamel mineralization. This condition, called fluorosis, is characterized by the occurrence of spots on the enamel.

Missing a dose of Duraphat

You should not take a double dose to make up for a missed dose. Duraphat should always be used according to the dentist's recommendations.

Stopping the use of Duraphat

You should not stop the treatment without consulting a doctor. If you have any further doubts about using the medicine, you should consult a dentist or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Duraphat can cause side effects, although not everybody gets them. Very rare cases of allergic reactions have been reported in patients with a tendency to allergies, manifested by swelling of the oral mucosa, especially after applying the medicine to a large surface. Ulcerative gingivitis and oral mucositis have been reported very rarely by sensitive patients. Rarely, during the administration of the medicine in patients with asthma, an asthma attack may be triggered. In patients with gastrointestinal sensitivity, nausea may occur after using a high dose and on a large surface. If symptoms of intolerance to the medicine occur, the layer of suspension can be easily removed at any time by thoroughly brushing the teeth and rinsing the mouth several times.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. HOW TO STORE DURAPHAT

Store in a temperature below 25°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label, tube, or carton. The expiry date refers to the last day of the month stated. Tubes containing 10 ml and 30 ml: use within 3 months of opening the packaging. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Duraphat contains

• -The active substance of Duraphat is sodium fluoride. 1 ml of suspension contains 50 mg of sodium fluoride, which corresponds to 22.6 mg of fluoride ions.
• Other ingredients of the medicine are: ethanol 96%, white wax (E 901), shellac (E 904), colophony, mastic, saccharin (E 954), raspberry flavor (ethyl maltol, geraniol, iris rhizome, isoamyl acetate, jasmine absolute, propylene glycol, and vanillin). The medicine contains a flavoring agent - raspberry flavor, with allergens: geraniol, citronellol, citral, benzyl benzoate, linalool, and benzyl alcohol.

What Duraphat looks like and what the packaging contains

Yellowish suspension for dental application. The packaging contains: 5 ampoules of 1.6 ml or 1 tube of 10 ml or 30 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder: CP GABA GmbH, Beim Strohhause 17, 20097 Hamburg, Germany Manufacturer: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany For more detailed information about this medicine, you should contact the representative of the marketing authorization holder: Colgate-Palmolive Poland, Sp. z o.o. ul. Wybrzeże Gdyńskie 6D 01-531 Warsaw Tel: 801 11 66 11

Date of last revision of the leaflet: -------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals:

Notes Instructions for using the medicine

Cleaning the teeth before the fluoridation treatment: a) you should remove dental calculus, but it is not necessary to completely remove dental plaque; b) in a dental office, it is recommended to apply the suspension directly after professional tooth cleaning; c) during fluoridation of large groups of patients (e.g. in pediatric dental care), it is allowed for patients to thoroughly brush their teeth themselves using a toothbrush. Application: First, you should remove excess saliva from one or two quadrants of the dentition, using air or by clenching the teeth on a spatula wrapped in lignin, and immediately apply the suspension. Application of the suspension can be performed using an aspirator and a blunt syringe (in the case of Duraphat in ampoules) or a cotton swab, brush, or special applicator (Duraphat in a tube). When using a cotton swab or similar material, you should apply Duraphat in thin layers, repeating the movements, applying and removing the swab. Application of the suspension should be started from the lower jaw, before too much saliva accumulates there. Duraphat should be applied selectively and only to the surfaces at risk of tooth decay. The tongue surface of the teeth usually does not require coating with the suspension, as it is generally sufficiently resistant to tooth decay. The treatment of applying the suspension to all teeth should not be performed on an empty stomach. The yellowish color of Duraphat facilitates its application. Administration of the medicine using a syringe is particularly useful in the case of a patient with a fixed orthodontic appliance. In this way, fluoridation can be effectively applied to the edges of clamps and other areas exposed to tooth decay. The teeth after the treatment do not need to be kept dry; the suspension does not need to be dried. The patient can close their mouth immediately after applying Duraphat. Duraphat hardens by itself under the influence of saliva. The special effect of Duraphat is related to the concentration of fluoride and its prolonged release. The patient should refrain from eating and chewing gum for about 2 to 4 hours after the treatment. The suspension can be easily removed at any time by brushing the teeth. Additional notes Dental instruments, clothing, etc. that have been contaminated with Duraphat can be cleaned with alcohol.