Medelmex duraphat

Patient Information Leaflet: Information for the User

medelmex Duraphat
50 mg/ml, oral suspension for topical use on teeth
Sodium fluoride
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please ask your dentist or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, tell your dentist or pharmacist. See section 4.

Table of Contents

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

1. What medelmex Duraphat is and what it is used for

medelmex Duraphat contains sodium fluoride and is used for the prevention of dental caries and the treatment of tooth hypersensitivity.

2. Information before using medelmex Duraphat

When not to use medelmex Duraphat:

• if the patient is 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 bronchial asthma.

Warnings and precautions
Application of the product to the entire dentition should not be performed on an empty stomach.
If the patient is using other fluoride-containing products (e.g. fluoride gels, fluoride tablets, or
fluoridated salts), their use should be discontinued for several days after the procedure to avoid
fluoride overdose.

medelmex Duraphat with other medicines
Inform your doctor about all medicines you have recently taken, including those obtained without a prescription.

Taking medelmex Duraphat with food and drink
Do not chew food for 4 hours after application of the product. Light food and drinks may be consumed.

Pregnancy and breastfeeding
Consult a doctor or pharmacist before using any medicine.
medelmex Duraphat contains 33.8% v/v ethanol (each dose contains up to 0.2 g of alcohol), therefore use of this product is not recommended in pregnant and breastfeeding women.

Driving and operating machinery
No studies have been conducted on the effects of this product on the ability to drive or operate machinery.

medelmex Duraphat contains ethanol and a flavouring agent

Ethanol
This medicine contains 0.279 g of alcohol (ethanol) per 1 ml, equivalent to 27.9 g per 100 ml of suspension.

Flavouring agent
This medicine contains a flavouring agent – raspberry essence, with allergens: geraniol, citronellol, citral, benzyl benzoate, linalool, and benzyl alcohol. These substances may cause allergic reactions. Benzyl alcohol may cause mild local irritation.

3. How to use medelmex Duraphat

medelmex Duraphat should always be used as directed by your dentist.
If you have any doubts, you should contact your dentist or pharmacist again.
Unless your dentist has advised a different dosage for a specific patient, the recommendations for using medelmex Duraphat are as stated below. You must follow these instructions; otherwise, medelmex Duraphat may not work properly.

How often and in what dose to use medelmex Duraphat
For average caries susceptibility, the procedure is recommended every 6 months. This may coincide with routine dental check-ups. For patients at increased risk of developing caries, treatment every 3 months is recommended. This particularly applies to selective application of a thin layer of the product to tooth areas especially at risk, e.g. primary (deciduous) teeth and erupting molars.

For treatment of tooth hypersensitivity, improvement is achieved with 2 to 3 applications, with several-day intervals between treatments.

For single applications, the following doses of the product must not be exceeded:
For primary (deciduous) teeth – up to 0.25 ml of suspension (= 5.65 mg fluoride)
For mixed dentition – up to 0.4 ml of suspension (= 9.04 mg fluoride)
For permanent dentition – up to 0.75 ml of suspension (= 16.95 mg fluoride)

The above amounts should not be exceeded when medelmex Duraphat is applied as a thin layer to teeth at risk of caries. Note that during application using cotton and instruments, some of the product remains on them. When applying via syringe, the exact amount of product can be read from the scale on the surface of the ampoule.

How and when to use medelmex Duraphat
Dental plaque should be removed and teeth dried using cotton or air. Then apply the suspension to the teeth. The patient must not apply medelmex Duraphat by themselves.

medelmex Duraphat is applied from the tube as a thin layer, using cotton swabs, probes, or a brush. The same procedure should then be repeated for the remaining teeth. It is advisable to begin application from the lower jaw before excessive saliva accumulates.

Application of the product to the lingual (tongue-side) surfaces of teeth is not necessary, as these surfaces are more resistant to caries.

medelmex Duraphat should be applied to the surfaces most susceptible to caries attack.

Application of medelmex Duraphat from a syringe is especially suitable for selective application of a small dose of the product. A blunt syringe with a bent tip facilitates application to interproximal and distal tooth surfaces.

To apply the suspension to interdental surfaces, insert the syringe between the teeth to deliver a small amount of medelmex Duraphat. The suspension should be applied to both sides of the interdental space, as well as to the entire occlusal surface.

Fissure application: apply a drop of medelmex Duraphat by drawing the syringe along the dental grooves.

Hypersensitivity of filling margins, crowns, and tooth necks may be treated in the same manner.

Smooth tooth surfaces should only be treated in cases of increased caries activity, especially in the presence of early signs of demineralization (decalcification). For this purpose, the syringe should be placed adjacent to the surface, allowing medelmex Duraphat to be spread over the surface using the bent tip of the syringe.

medelmex Duraphat may be used to treat areas around orthodontic appliances using the syringe.

Use of a higher than recommended dose of medelmex Duraphat
Depending on the dose and route of administration, excessive amounts of fluoride may be introduced into the oral cavity in extreme cases. If the product is swallowed, vomiting and diarrhoea may occur, especially in patients with sensitive stomachs.

If the daily dose of 2 mg fluoride is repeatedly exceeded during tooth development (administered either locally or systemically), this may lead to disturbances in enamel mineralization. This condition, known as fluorosis, is characterized by the appearance of spots on the enamel.

Missed application of medelmex Duraphat
Do not use a double dose to make up for a missed application. medelmex Duraphat should always be used as directed by your dentist.

Discontinuation of treatment with medelmex Duraphat
Do not discontinue treatment without consulting your dentist.

If you have any further questions about the use of this medicine, please consult your dentist or pharmacist.

4. POSSIBLE UNDESIRABLE EFFECTS

Like any medicine, this medicine can cause undesirable effects, although they do not occur in everyone.
Very rarely, cases of allergic reactions have been reported in patients with a tendency to allergies, manifesting as mucosal swelling of the oral cavity, especially after application of the medicine over a large surface area.
Ulcerative inflammation of the gums and oral mucosa has been reported very rarely in sensitive patients.
Rarely, during administration of the medicine, an asthmatic attack may be triggered in patients with bronchial asthma.
In patients with intestinal sensitivity, nausea may occur after administration of a high dose and over a large surface area.
If symptoms of intolerance to the medicine occur, the layer of suspension can always be easily removed by thoroughly brushing the teeth and rinsing the oral cavity several times.
Reporting of undesirable effects
If any undesirable symptoms occur, including any undesirable effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Undesirable effects can be reported directly to the
Department of Monitoring Adverse Drug Reactions 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
Undesirable effects can also be reported to the marketing authorization holder.
By reporting undesirable effects, additional information on the safety of the medicine use can be collected.

5. HOW TO STORE MEDELMEX DURAPHAT

Store below 25°C.
Keep the medicine out of the 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 stated month.
Tubes containing 10 ml and 30 ml: use within 3 months after opening the container.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What the medicine contains medelmex Duraphat

• The active substance is sodium fluoride. 1 ml of the suspension contains 50 mg of sodium fluoride, corresponding to 22.6 mg of fluoride ions.
• Other components of the medicine are: ethanol 96%, white wax (E 901), shellac (E 904), rosin, mastic, saccharin (E 954), and raspberry flavouring (ethyl butyrate, geraniol, iris rhizome, isoamyl acetate, jasmine absolute, propylene glycol, and vanillin). The medicine contains a flavouring substance – raspberry essence, with allergens: geraniol, citronellol, citral, benzyl benzoate, linalool, and benzyl alcohol.

What medelmex Duraphat looks like and contents of the pack
Yellowish suspension for topical application to the teeth.
Packaging contains: 5 ampoules of 1.6 ml each, or 1 tube of 10 ml, or 1 tube of 30 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
CP GABA GmbH, Alsterufer 1-3, 20354 Hamburg, Germany
Manufacturer:
Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Colgate-Palmolive Poland Sp. z o.o.
Wybrzeże Gdyńskie 6D
01-531 Warsaw, Poland
Tel: 801 11 66 11

Information intended for medical professionals:

Notes
Instructions for use of the medicinal product

Cleaning teeth prior to fluoride application:
a) dental calculus should be removed, but complete removal of dental plaque is not necessary;
b) in a dental office, application is recommended immediately after professional teeth cleaning;
c) when performing fluoride treatment on large groups of patients (e.g. within pediatric dental care), patients may independently perform thorough tooth brushing using a toothbrush.

Application:
First, remove excess saliva from one or two dental quadrants using air or by having the patient bite down on a lignin-wrapped spatula, and immediately apply the suspension.
The suspension can be applied using an aspirator and a blunt syringe (in the case of medelmex Duraphat in ampoules) or using a cotton swab, brush, or special applicator (medelmex Duraphat in a tube). When using a cotton swab or similar material, apply medelmex Duraphat in thin layers, repeating motions of pressing and lifting the swab.

Application of the suspension should begin with the mandibular teeth before saliva accumulates in that area. medelmex Duraphat should be applied selectively and only to surfaces at risk of caries. The lingual surfaces of teeth generally do not require coverage with the suspension, as they are usually sufficiently resistant to caries.

The procedure of applying the suspension to all teeth should not be performed on an empty stomach.
The yellowish color of medelmex Duraphat facilitates its application.
Administering the product from a syringe is particularly beneficial when the patient wears a fixed orthodontic appliance. This allows effective fluoride application at the edges of brackets, clasps, and other caries-prone areas.

Teeth do not need to be kept dry after application; there is no need to dry the suspension. The patient may close their mouth immediately after application of medelmex Duraphat. medelmex Duraphat hardens spontaneously under the influence of saliva.

The special effect of medelmex Duraphat is related to the concentration of fluoride and its prolonged release. The patient should refrain from eating or chewing gum for approximately 2 to 4 hours after the procedure.
The suspension can be easily removed at any time by tooth brushing.

Additional notes
Dental instruments, clothing, etc., stained by medelmex Duraphat can be cleaned using alcohol.