ELMEX*DENTAL GEL 25G

ELMEX 30.32 mg/g / 2.87 mg/g / 22.1 mg/g dental gel
Bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-octadecylamine dihydrofluoride / octadecylamine hydrofluoride / sodium fluoride

What it is and what it is used for
ELMEX is an oral hygiene product containing three active substances (bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-octadecylamine dihydrofluoride, octadecylamine hydrofluoride, sodium fluoride) in a dental gel.

ELMEX is used in adults and children aged 6 years and older for:
- prevention (prophylaxis) of dental caries, especially in predisposed individuals;
- reducing tooth sensitivity, preventing calcium loss from dental enamel caused by dental prostheses (e.g., dentures) or orthodontic appliances (e.g., braces);
- protecting tooth enamel by local application of fluoride to the enamel (topical fluoridation of dental enamel).

Consult your doctor if your condition does not improve or worsens.

What you need to know before taking the medicine
Do not use ELMEX:
- if you are allergic to the active ingredients (bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-octadecylamine dihydrofluoride, octadecylamine hydrofluoride, sodium fluoride) or any of the other ingredients of this medicine (listed in section 6);
- if you have lesions of the oral mucosa (pathological desquamative changes of the oral mucosa);
- if you have spots on your tooth enamel (bone fluorosis and/or dental fluorosis);
- in cases where swallowing control is impaired or not yet fully developed;
- in children under 6 years of age (see section Children).

Warnings and precautions
Consult your doctor, dentist or pharmacist before using ELMEX.

For individuals in whom the swallowing reflex control is impaired or not yet fully developed, it is preferable to use alternative pharmaceutical forms with precise dosage, such as fluoride tablets.

Due to the menthol taste contained in the gel, patients with bronchial asthma or other airway disorders should consult their doctor/dentist before using ELMEX.

Elmex gel contains:
- propylene glycol. Propylene glycol can cause skin irritation;
- a flavouring which in turn contains limonene, linalool and geraniol. Limonene, linalool and geraniol can cause allergic reactions.

Children
For children under 6 years of age, it is recommended to use alternative pharmaceutical forms with precise dosage, such as fluoride tablets.

It is recommended that children under 8 years of age use ELMEX under parental supervision.

Do not swallow. In case of accidental ingestion, it is recommended to take calcium-containing substances (e.g., milk), or in case of ingestion of large quantities (more than one package), consult your doctor.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the following frequency:

Very rare side effects (may affect up to 1 in 10,000 people)
- Oral irritation (inflammation/redness, discomfort/burning, numbness, swelling, itching, altered taste, dry mouth, gum inflammation)
- Nausea or vomiting
- Hypersensitivity
- Intolerance
- Allergic reactions

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.