ELMEX DENTAL GEL TUBE 25 G

Name
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 a product for oral hygiene and contains 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 above for:
- prevention (prophylaxis) of dental caries, particularly in predisposed subjects;
- reduce tooth sensitivity, prevent calcium loss from tooth enamel, caused by dental prosthetics (e.g. dentures) or orthodontic appliances (e.g. bite);
- protect tooth enamel by applying fluoride locally to the enamel (topical fluoridation of tooth enamel).

Talk to your doctor if you do not feel better or if you feel worse.


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


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

For people whose control of the swallowing reflex is compromised or not yet fully developed, it is preferable to use alternative pharmaceutical forms with a precise dosage, such as fluoride tablets.

Due to the menthol flavour 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 may cause skin irritation;
- a flavoring containing 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 dosage forms with precise dosing, such as fluoride tablets.

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

Do not ingest. In case of accidental ingestion, it is recommended to take substances containing calcium (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)
- Mouth irritation (inflammation/redness, discomfort/burning, numbness, swelling, itching, taste alteration, dry mouth, inflammation of the gums)
- Nausea or vomiting
- Hypersensitivity
- Intolerance
- Allergic reactions

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.