Package leaflet: Information for the patient

elmex DURAPHAT, 1.1% w/w, toothpaste
Sodium fluoride
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet, or as directed
by the dentist or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your dentist or pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Contents of the leaflet:

What elmex DURAPHAT is and what it is used for
Important information before using elmex DURAPHAT
How to use elmex DURAPHAT
Possible side effects
How to store elmex DURAPHAT
Contents of the pack and other information

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

elmex DURAPHAT toothpaste is used for caries prophylaxis (dental caries) in adolescents over 16 years of age and adult patients, particularly those at high risk of high-intensity 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 contains a high concentration of fluoride. During treatment with elmex Duraphat, avoid taking tablets, drops, chewing gum, gels or varnishes containing fluoride, as well as fluoridated water or salt. To prevent accumulation of fluoride in the body, the total daily intake of fluoride should be assessed before starting treatment with fluoride-containing toothpaste. For further information, consult your dentist, pharmacist or dental hygienist. elmex Duraphat is not intended for use in adolescents and children under 16 years of age.

elmex Duraphat and other medicines

No interactions with other medicinal products are known. Inform your doctor or dentist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.

Food, drink and alcohol with elmex Duraphat

During treatment with this toothpaste, avoid fluoridated water or salt.
If food or drinks are consumed immediately after tooth brushing, this may impair the remineralization of teeth. Therefore, teeth should be brushed with elmex Duraphat after meals.

Pregnancy, breastfeeding and fertility

There are no data available on the use of elmex Duraphat in pregnant women. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 green mint flavour containing limonene, linalool, citral, geraniol and citronellol, which may cause allergic reactions.

3. How to use elmex DURAPHAT

The medicine elmex DURAPHAT is intended for use only in individuals aged above 16 years.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
dentist or pharmacist. If in doubt, consult your dentist or pharmacist.
To clean teeth, use elmex DURAPHAT 3 times daily as follows:

Each time, before brushing, apply approximately 2 cm of toothpaste onto the toothbrush (2 cm of toothpaste squeezed from the tube contains between 3 mg and 5 mg of fluoride).
Brush teeth after each meal.
Use vertical brushing motions, moving from the gums toward the ends of the teeth.
Spit out excess foam and do not swallow. Thorough brushing should take about 3 minutes.

Use of more than the recommended dose or swallowing of elmex DURAPHAT
If a significant amount of toothpaste has been accidentally swallowed and the following symptoms occur: vomiting, diarrhoea, and abdominal pain – contact a doctor immediately, as treatment may be necessary. Bring the medicine leaflet with you.
elmex Duraphat contains menthol, which, if accidentally swallowed in excessive amounts, may cause seizures, particularly in infants and children.

If a patient has swallowed too much toothpaste over several months or years, dental fluorosis (spots or discolorations visible on tooth enamel or enamel fragility) or skeletal fluorosis (bone hardening: increased bone density) may occur.

Missed use of elmex DURAPHAT
Apply the toothpaste as soon as possible, but do not use a double amount to make up for a missed application. After the next meal, continue treatment as before.
If you have any doubts regarding the use of this medicine, consult your dentist or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
In some rare cases (i.e. in less than 1 in 1,000 treated individuals), allergic reactions (hypersensitivity) may occur, for example: rash, itching, swelling and redness.
A burning sensation in the mouth has also been reported (frequency not known).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the responsible entity.

5. How to store the medicinal product elmex Duraphat

The medicinal product should be stored out of sight and reach of children.
Do not use elmex Duraphat after the expiry date stated on the tube and
outer packaging following "Expiry date". The expiry date refers to the last day of the stated month.
Do not store above 25 °C.

6. Contents of the pack 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, corresponding to 5000 ppm fluoride.
The other ingredients are: sorbitol liquid (non-crystallising), silica for dental use, silica for dental use (precipitated), macrogol 600, potassium pyrophosphate, xanthan gum, sodium benzoate (E211), sodium lauryl sulphate, peppermint flavour (containing peppermint oil, carvone, green mint 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 contents of the pack

elmex DURAPHAT is a blue-coloured toothpaste. The toothpaste is contained in tubes of 51 g, packed in cardboard boxes.
Pack sizes: 1 tube containing 51 g or 3 tubes of 51 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
CP GABA GmbH,
Alsterufer 1-3
20354 Hamburg
Germany
Tel: 801 11 66 11

Manufacturer:
Thepenier Pharma & Cosmetics.
Route Departmentale 912
Saint-Langis-Lès-Mortagne
F-61400 Mortagne
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: Duraphat 500mg/100g pâte dentifrice
Germany: medelmex Duraphat Fluorid 5mg/g Zahnpaste
Portugal: Duraphat 5000, Pasta dentifrica
Sweden: Duraphat 5 mg/g Tandkräm
Denmark: Duraphat 5 mg/g Tandpasta
Greece: Duraphat 5000 Toothpaste
Poland: elmex Duraphat
United Kingdom: Duraphat 5000ppm Fluoride Toothpaste
Ireland: Duraphat 5000ppm Fluoride Toothpaste
Norway: Duraphat 500mg/100g Tannkrem
Finland: Duraphat 500mg/100g Hammastahna Fluori
Iceland: Duraphat 500mg/100g Tannpasta
Netherlands: Duraphat 5000 ppm Tandpasta