elmex Duraphat

Leaflet attached to the packaging: patient information

elmex DURAPHAT, 1.1% w/w, toothpaste
Sodium fluoride

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

This medicine should always be used exactly as described in this patient leaflet or according to the dentist's or pharmacist's instructions.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a dentist or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is elmex DURAPHAT and what is it used for
• 2. Important information before using elmex DURAPHAT
• 3. How to use elmex DURAPHAT
• 4. Possible side effects
• 5. How to store elmex DURAPHAT
• 6. Package contents and other information

1. What is elmex DURAPHAT and what is it used for

elmex DURAPHAT is used for the prevention of dental caries (tooth decay) in adolescents over 16 years of age and adult patients, especially those at high risk of caries. The toothpaste contains fluoride in the form of sodium salt, which belongs to a group of medicines called anti-caries agents.

2. Important information before using elmex DURAPHAT

When not to use elmex DURAPHAT

• if the patient is allergic (hypersensitive) to sodium fluoride or any of the other ingredients of elmex DURAPHAT (listed in section 6).

Warnings and precautions

elmex DURAPHAT has a high fluoride content. When using elmex DURAPHAT, the patient should avoid taking tablets, drops, chewing gum, gels, or varnishes containing fluoride, as well as fluoridated water or salt. To prevent fluoride accumulation in the body, the total amount of fluoride ingested should be assessed before starting treatment with a fluoride-containing paste. For more information, the patient should consult their dentist, pharmacist, or dental hygienist.
elmex DURAPHAT is not intended for use in children and adolescents under 16 years of age.

elmex DURAPHAT and other medicines

No interactions with other medicines are known. The patient should inform their doctor or dentist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

elmex DURAPHAT with food, drink, and alcohol

When using this toothpaste, the patient should avoid fluoridated water or salt.
If food or drinks are consumed by the patient immediately after brushing their teeth, it may have an inhibitory effect on tooth remineralization. Therefore, the patient should brush their teeth with elmex Duraphat after meals.

Pregnancy, breastfeeding, and fertility

There are no data on the use of elmex DURAPHAT in pregnant women. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, dentist, or pharmacist before using this medicine.
elmex DURAPHAT contains 5 mg of sodium benzoate (E211) per gram of toothpaste. Sodium benzoate (E211) may cause local irritation.
This medicine also contains peppermint flavor with limonene, linalool, citral, geraniol, and citronellol, which may cause allergic reactions.

3. How to use elmex DURAPHAT

elmex DURAPHAT is intended for use only in individuals over 16 years of age.
This medicine should always be used exactly as described in this patient leaflet or according to the dentist's or pharmacist's instructions. In case of doubt, the patient should consult their dentist or pharmacist.
elmex DURAPHAT for tooth brushing should be used 3 times a day as follows:

• each time, before each tooth brushing, apply about 2 cm of paste to the toothbrush (2 cm of paste squeezed from the tube contains 3-5 mg of fluoride).
• brush teeth after each meal.
• perform vertical movements with the toothbrush, from the gums to the end of the teeth.
• spit out excess foam and do not swallow. The brushing time is approximately 3 minutes.

Using a higher dose than recommended or swallowing elmex DURAPHAT

If a significant amount of paste is accidentally swallowed and the following symptoms occur: vomiting, diarrhea, and abdominal pain - the patient should immediately contact their doctor, as treatment may be necessary. The patient should bring the leaflet with them.
elmex Duraphat contains menthol, which, if accidentally swallowed in excess, may cause seizures, especially in infants and children.
If the patient has swallowed too much toothpaste over several months or years, they may develop dental fluorosis (spots or discoloration visible on the tooth enamel or brittle enamel) or skeletal fluorosis (bone hardening: increased bone density).

Missing a dose of elmex DURAPHAT

The patient should use the paste as soon as possible, but should not use a double dose to make up for the missed dose. After the next meal, the patient should continue treatment as before.
In case of doubts about using the medicine, the patient should consult their dentist or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In some rare cases (i.e., less than 1 in 1000 treated patients), allergic reactions (hypersensitivity) may occur, such as: rash, itching, swelling, and redness.
Burning sensation in the mouth (frequency not known) has also been reported.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store elmex Duraphat

The medicine should be stored out of sight and reach of children.
The patient should not use elmex DURAPHAT after the expiry date stated on the tube and outer packaging after "Expiry date". The expiry date refers to the last day of the stated month.
The medicine should not be stored at a temperature above 25°C.

6. Package contents and other information

What elmex DURAPHAT contains

• The active substance is fluoride in the form of sodium fluoride. 1 g of toothpaste contains 5 mg of fluoride, which corresponds to 5000 ppm of fluoride.
• The other ingredients are: liquid sorbitol (non-crystallizing), dental silica, precipitated silica, macrogol 600, potassium pyrophosphate, xanthan gum, sodium benzoate (E211), sodium lauryl sulfate, peppermint flavor (contains peppermint oil, carvone, spearmint oil, menthol, anethole, lemon oil) [excipients with known effects are listed in section 2],

sodium saccharin, brilliant blue FCF (E133), purified water.

What elmex DURAPHAT looks like and what the package contains

elmex DURAPHAT is a blue toothpaste. The toothpaste is available in tubes of 51 g, packaged in cardboard boxes.
Packaging: 1 tube containing 51 g or 3 tubes of 51 g.
Not all packaging sizes may be marketed.

Marketing authorization holder:

CP GABA GmbH,
Alsterufer 1-3
20354 Hamburg
Germany
Phone: 801 11 66 11

Manufacturer:

Thepenier Pharma & Cosmetics.
Route Departmentale 912
Saint-Langis-Lès-Mortagne
F-61400 Mortagne
France
This medicine is authorized in the Member States of the European Economic Area under the following names:
France:
Duraphat 500mg/100g toothpaste
Germany:
medelmex Duraphat Fluorid 5mg/g toothpaste
Portugal:
Duraphat 5000, toothpaste
Sweden:
Duraphat 5 mg/g toothpaste
Denmark:
Duraphat 5 mg/g toothpaste
Greece:
Duraphat 5000 toothpaste
Poland:
elmex Duraphat
United Kingdom:
Duraphat 5000ppm Fluoride toothpaste
Ireland:
Duraphat 5000ppm Fluoride toothpaste
Norway:
Duraphat 500mg/100g toothpaste
Finland:
Duraphat 500mg/100g toothpaste with fluoride
Iceland:
Duraphat 500mg/100g toothpaste
Netherlands:
Duraphat 5000 ppm toothpaste
Date of leaflet approval:July 2024