Patient Information Leaflet: Information for the User

Elmex, 12.5 mg fluorine/g, gel
Olaflur + Dectaflur + Natrii fluoridum
Please read this 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 as directed by the physician, dentist, or pharmacist.

Keep this leaflet for future reference
If advice or further information is needed, consult your physician, dentist, or pharmacist
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the physician, dentist, or pharmacist. See section 4.
If advice or further information is needed, consult your physician or pharmacist.

Table of Contents

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

1. What Elmex is and what it is used for

Topical gel for application to the teeth.
Elmex with amine fluorides is intended for use:

Prophylactically: for intensive caries prevention, especially in children, adolescents, and individuals particularly susceptible to caries, as well as in patients with orthodontic appliances, bridges, or partial dentures
Therapeutically: for remineralization of early carious lesions, for treatment of dentin hypersensitivity.

If there is no improvement or if symptoms worsen, consult a physician.

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 case of pathological desquamative changes of the oral mucosa,
in patients with skeletal and/or dental fluorosis,
in individuals who cannot control the swallowing reflex (preschool children - under 6 years of age, disabled persons).

Warnings and precautions
Before starting to use Elmex, discuss this with your doctor, dentist, or pharmacist.
Since the product contains peppermint flavour and peppermint oil, patients with bronchial asthma and other respiratory disorders should consult their doctor or dentist before using the medicine.
After application of Elmex, systemic fluoride supplementation (e.g. fluoride tablets) should be discontinued for one day before and one day after application of the medicine.
Children
Children aged 6–8 years should use Elmex only under adult supervision.
Elmex and other medicines
Inform your doctor, dentist or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.
Elmex may interact with:
• medicines containing fluoride (e.g. fluoride tablets). The intake of fluoride compounds by mouth should be discontinued for one day before and one day after application of Elmex;
• products which may cause foaming (anionic surfactants or other large anionic molecules, e.g. detergents);
• calcium (e.g. in milk), magnesium and aluminium (contained in medicines used for gastrointestinal disorders to neutralize gastric acid, known as antacids). If these substances are ingested immediately after application of Elmex, the effectiveness of fluorides may be reduced.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, dentist or pharmacist before using this medicine.
Pregnancy:
There is no evidence of risk to the fetus from fluoride intake. If necessary, use of Elmex during pregnancy may be considered.
Breastfeeding:
Studies have shown that fluorides are excreted in breast milk. Risk to the infant cannot be excluded. After consultation with a doctor, a decision should be made whether to discontinue breastfeeding or to discontinue use of Elmex.
Driving and operating machinery
Elmex does not impair the ability to drive motor vehicles or operate mechanical equipment.
Elmex contains propylene glycol
Propylene glycol may cause skin irritation.
This medicine contains flavourings including 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 in each 1 gram of product.
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 advised by your
doctor, dentist, or pharmacist. If in doubt, consult your doctor, dentist, or pharmacist.

Home use of Elmex

For the prevention of dental caries and treatment of early carious lesions in adults and children over
6 years of age, Elmex should be used once a week, preferably in the evening before bedtime. Apply
1 cm of gel (approximately 0.5 g, corresponding to 6.25 mg of fluoride) onto the toothbrush, brush
teeth for 2–3 minutes, then spit out and rinse the mouth. Children aged 6–8 years should use Elmex
only under adult supervision. They should avoid swallowing the gel during application and should
spit out and rinse the mouth thoroughly after brushing. Elmex should not be used before the child
has learned how to spit (in preschool children – under 6 years of age).
For the treatment of dentin hypersensitivity, Elmex should be gently applied with a finger or a soft
toothbrush to the painful areas.

In cases of increased caries risk or for treatment of dentin hypersensitivity, the frequency of use
described above may be increased. This particularly applies to patients wearing orthodontic appliances.
The total duration of application (brushing and retention of the medicine in the oral cavity) must not
exceed 5 minutes.

Use of Elmex in the dental office
Elmex may be applied using special individual plastic trays or application syringes, or may be
applied directly to chewing surfaces and interdental spaces using a blunt needle from a disposable
syringe. Ensure contact between the gel and teeth for 2–4 minutes, but not longer than 5 minutes.
After the procedure, rinse the mouth thoroughly.
The recommended frequency of such applications is approximately twice a year. In patients
particularly susceptible to caries, this method of application may be used more frequently. Gel
application using trays is recommended from the age of 8 onwards.

Use of a higher than recommended dose of Elmex

Acute overdose
In case of acute overdose, local irritation of the mucous membranes may occur. Depending on the
dose and method of administration (e.g. application in the dental office using trays), up to 37.5 mg of
fluoride (equivalent to 3 g of Elmex) may be introduced into the oral cavity. Swallowing the entire
amount may cause nausea, vomiting, and diarrhea. These symptoms usually occur within the first
hour after administration and resolve after approximately 3 to 6 hours.

Actions to be taken in case of acute overdose
If a higher than recommended dose has been taken, seek immediate advice from a doctor or
pharmacist.
In cases of mild poisoning (below 150 mg fluoride, corresponding to less than 12 g of Elmex),
fluoride binding can be achieved by consuming calcium-containing drinks (milk, calcium in the form
of effervescent tablets).
In cases of severe poisoning (above 150 mg fluoride, corresponding to more than 12 g of Elmex),
activated charcoal is additionally recommended. If necessary, intravenous calcium may be
administered, forced diuresis and urinary alkalization may be initiated. Careful monitoring of pulse,
blood coagulation, electrolyte balance, and acid-base equilibrium is required.

Chronic overdose
If the total daily fluoride intake exceeds 2 mg regularly during tooth development and growth (up to
approximately 8 years of age), disturbances in enamel matrix formation and abnormalities in
mineralization, known as dental fluorosis, may occur. This condition does not occur at later ages, even
with higher daily doses.

Missed dose of Elmex
Do not use a double dose to make up for a missed dose. Elmex may be used again at any time, but
after administration, the recommended interval must be observed before the next application.

4. Possible adverse reactions

Like all medicines, Elmex may cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions is described as follows:
Very common: may affect more than 1 in 10 people,
Common: may affect up to 1 in 10 people,
Uncommon: may affect up to 1 in 100 people,
Rare: may affect up to 1 in 1,000 people,
Very rare: may affect up to 1 in 10,000 people,
Frequency not known: frequency cannot be estimated from the available data.

Gastrointestinal disorders
Very rare

desquamation of the oral mucosa
superficial erosions of the oral mucosa or oral ulceration (ulcers, sores, blisters) Frequency not known
irritation of the oral mucosa (inflammation or redness of the oral mucosa, discomfort or burning sensation in the mouth, numbness, swelling or puffiness, inflammatory condition, oral itching, taste disturbances, dry mouth sensation, gingivitis)
nausea or vomiting

Immune system disorders
Very rare

hypersensitivity (allergic reactions)

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, dentist, or pharmacist. Adverse reactions can also 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Elmex

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Pay attention to the shelf life after opening the tube. After opening, the medicine is stable for 20
months, but not beyond the expiry date indicated on the packaging.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Elmex contains

Active substances: 1 g of gel contains a total of 12.5 mg of fluoride (30.32 mg of olaflur, 2.87 mg of dectaflur and 22.1 mg of sodium fluoride).
Other ingredients: propylene glycol, hydroxyethylcellulose, saccharin, apple flavour, menthone flavour with limonene and linalool, peppermint flavour with limonene, linalool and benzyl alcohol, citronellol, eugenol and geraniol, garden mint flavour 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 contents of the pack
Elmex is available without prescription in tubes containing: 25 g, 38 g or 215 g.
It is a transparent, homogeneous, pale yellow, aqueous gel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CP GABA GmbH
Alsterufer 1-3
20354 Hamburg
Germany
Tel.: 801 11 66 11
Manufacturer:
Thépenier Pharma & Cosmetics
Route Départementale 912
61400 Saint-Langis-Lès-Mortagne
France
Tel.: +33 2 33 85 22 22