Elmex

Leaflet attached to the packaging: information for the user

Elmex, 12.5 mg fluoride/g, gel

Olaflur + Dectaflur + Sodium fluoride
You should carefully read the contents of the leaflet 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 as directed by your
doctor, dentist, or pharmacist.

• You should keep this leaflet, so you can read it again if you need to
• If you need advice or additional information, you should consult your doctor, dentist, or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, dentist, or pharmacist. See section 4.
• If you need advice or additional information, you should consult your doctor or pharmacist.

Table of contents of the leaflet

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

1. What is Elmex and what is it used for

Gel for application to the teeth.
Elmex with aminofluorides is intended for use:

• prophylactically: o for intensive prevention of caries, especially in children, adolescents, and people particularly exposed to caries o for patients with orthodontic appliances, bridges, or partial dentures,
• therapeutically: o for the remineralization of early carious changes, o for the treatment of hypersensitivity of tooth necks.

If there is no improvement or if symptoms worsen, you should contact your doctor

2. Important information before using Elmex

When not to use Elmex:

• if the patient is allergic to Olaflur, Dectaflur, Sodium fluoride, or any of the other ingredients of the medicine (listed in section 6),
• in the case of pathological changes in the mucous membrane of the oral cavity,
• in patients with bone and/or enamel fluorosis,
• in people who do not control the swallowing reflex (preschool children - under 6 years old, people with disabilities).

Warnings and precautions

Before starting to use Elmex, you should discuss it with your doctor, dentist, or pharmacist.
Since the medicine contains peppermint flavor and peppermint oil, people with asthma and other respiratory disorders should consult their doctor or dentist before using the medicine.
After applying Elmex, you should stop systemic fluoride administration (e.g., fluoride tablets) for one day before and one day after using the medicine.

Children

Children between 6 and 8 years old should use Elmex only under adult supervision.

Elmex and other medicines

You should tell your doctor, dentist, or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Elmex may interact with:
o medicines containing fluoride (e.g., fluoride tablets). You should stop taking fluoride internally for one day before and one day after using Elmex;
o products that can create foam (anionic surfactants or other large anionic molecules, e.g., detergents);
o calcium (e.g., in milk), magnesium, and aluminum (contained in medicines used for stomach disorders to neutralize stomach acid, called antacids). If these substances are taken immediately after using Elmex, it may reduce the effectiveness of fluorides.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor, dentist, or pharmacist before using this medicine.
Pregnancy:
There is no evidence of fetal risk due to fluoride intake. If necessary, the use of Elmex can be considered during pregnancy.
Breastfeeding
Studies have shown that fluorides pass into breast milk. The risk to the child cannot be excluded. After consulting your doctor, you should decide whether to stop breastfeeding or stop using Elmex.

Driving and using machines

Elmex does not affect the ability to drive vehicles or operate machinery.

Elmex contains propylene glycol

Propylene glycol may cause skin irritation.
This medicine contains flavors with benzyl alcohol, limonene, linalool, eugenol, benzyl benzoate, citronellol, and geraniol.
Limonene, linalool, eugenol, benzyl benzoate, citronellol, and geraniol may cause allergic reactions.
This medicine contains 0.002232 mg of benzyl alcohol per 1 gram of medicine.
Benzyl alcohol may cause mild local irritation.

3. How to use Elmex

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, dentist, or pharmacist. If you are unsure, you should consult your doctor, dentist, or pharmacist.
Using Elmex at home

• In the prevention of caries and treatment of early carious changes in adults and children over
• 6 years old, Elmex is used once a week, preferably in the evening before bedtime. You should apply 1 cm of gel (approximately 0.5 g, which corresponds to 6.25 mg of fluoride) to the toothbrush, then brush your teeth for 2-3 minutes, and finally spit and rinse your mouth. Children between 6 and 8 years old should use Elmex only under adult supervision. They should avoid swallowing the gel during application and spit and rinse their mouth after brushing. Elmex should not be used before mastering the ability to spit (in preschool children - under 6 years old).
• In the treatment of hypersensitivity of tooth necks, Elmex should be gently applied with a finger or a soft toothbrush to the aching surfaces.

In the case of increased risk of caries and in the treatment of hypersensitivity of tooth necks, the frequency of using the preparation can be increased. This applies especially to the use of the preparation in patients wearing orthodontic appliances.
The total time of use (brushing and leaving the medicine in the mouth) should not exceed 5 minutes.
Using Elmex in a dental office
Elmex can be administered using special individual plastic trays and application spoons, or it can be applied directly to the chewing surfaces and interdental spaces using a blunt needle with a filled single-dose syringe. You should ensure that the teeth are in contact with the gel for 2-4 minutes, but not longer than 5 minutes. After the procedure, you should rinse your mouth.
The recommended frequency of this type of application is about twice a year. In patients who are particularly exposed to caries, this method of application can be used more frequently. Application of the gel using spoons is recommended from the age of 8.

Using a higher dose of Elmex than recommended

Acute overdose
In the case of acute overdose, local irritation of the mucous membrane is possible. Depending on the dose and method of administration (e.g., application in a dental office using a spoon), in extreme cases, up to 37.5 mg of fluoride can be introduced into the mouth, which corresponds to 3 g of Elmex. Swallowing this amount can cause nausea, vomiting, and diarrhea.
Symptoms usually occur within the first hour after administration and subside after about 3 to 6 hours.
Actions to be taken in case of acute overdose
If you have taken a higher dose of Elmex than recommended, you should immediately consult your doctor or pharmacist.
In the case of symptoms of mild poisoning (less than 150 mg of fluoride, which corresponds to an amount of less than 12 g of Elmex), to bind fluoride, you should take calcium-containing drinks (milk, calcium in the form of effervescent tablets).
In the case of symptoms of severe poisoning (more than 150 mg of fluoride, which corresponds to an amount of more than 12 g of Elmex), it is also recommended to administer activated charcoal. If necessary, calcium can also be administered intravenously, forced diuresis can be induced, and the urine can be alkalized. You should carefully monitor the pulse, blood clotting, electrolyte balance, and acid-base balance.
Chronic overdose
In the case of regular exceeding of the total daily fluoride dose of 2 mg during the formation and development of teeth, i.e., up to about 8 years old, disturbances of the enamel matrix and abnormalities in its mineralization, called enamel fluorosis, may occur. This disorder does not occur at a later age, even with higher daily doses.

Missing a dose of Elmex

You should not use a double dose to make up for a missed dose. Elmex can be used again at any time, but after use, you should wait for the recommended period before the next application.

4. Possible side effects

Like all medicines, Elmex can cause side effects, although they may not occur in everyone.
The frequency of side effects is described as follows:
Very common: may occur in more than 1 in 10 people,
Common: may occur in no more than 1 in 10 people,
Uncommon: may occur in no more than 1 in 100 people,
Rare: may occur in no more than 1 in 1000 people,
Very rare: may occur in no more than 1 in 10,000 people,
Frequency not known: the frequency cannot be determined based on available data.

Gastrointestinal disorders

Very rare

• shedding of the oral mucosa
• superficial ulcers of the oral mucosa or oral ulcers (ulcers, sores, blisters) Frequency not known
• irritation of the oral mucosa (inflammation or redness of the oral mucosa, discomfort or burning in the mouth, numbness, swelling or puffiness, inflammation, itching of the mouth, changes in taste, feeling of dryness in the mouth, gingivitis)
• nausea or vomiting

Immune system disorders

Very rare

• hypersensitivity (allergic reactions)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, dentist, or pharmacist. Side effects can also 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 Elmex

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
You should pay attention to the shelf life after opening the tube. After opening, the medicine is stable for 20 months, but no longer than the expiry date.
You should not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. 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 Elmex contains

• The active substances in 1 g of gel contain a total of 12.5 mg of fluoride (30.32 mg of Olaflur aminofluoride, 2.87 mg of Dectaflur aminofluoride, and 22.1 mg of sodium fluoride).
• The other ingredients are propylene glycol, hydroxyethylcellulose, saccharin, apple flavor, menthol flavor with limonene and linalool, peppermint flavor with limonene, linalool, and benzyl alcohol, citronellol, eugenol, and geraniol, spearmint flavor with limonene, eugenol, benzyl alcohol, linalool, benzyl benzoate, and purified water.

1 cm of Elmex gel (approximately 0.5 g of gel) corresponds to 6.25 mg of fluoride.

What Elmex looks like and what the packaging contains

Elmex is available without a prescription in tubes containing: 25 g, 38 g, or 215 g.
This is a clear, homogeneous, pale yellow, aqueous gel.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer:

Thépenier Pharma & Cosmetics
Route Départementale 912
61400 Saint-Langis-Lès-Mortagne
France
Phone: +33 2 33 85 22 22

Date of last update of the leaflet: