Elmex

PACKAGE LEAFLET

Package leaflet: information for use

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
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, dentist, or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

• 1. What ELMEX is and what it is used for
• 2. What you need to know before using ELMEX
• 3. How to use ELMEX
• 4. Possible side effects
• 5. How to store ELMEX
• 6. Contents of the pack and other information

1. What ELMEX 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, particularly in individuals who are predisposed.
• reducing tooth sensitivity and preventing calcium loss from tooth enamel caused by dental prostheses (e.g. dentures) or orthodontic appliances (e.g. mouthguards).
• protecting tooth enamel by means of local application of fluoride to the enamel (topical fluoridation of tooth enamel).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using ELMEX

Do not use ELMEX:

• If you are allergic to the active substances (dihydrofluoride of bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-octadecylamine, hydrofluoride of octadecylamine, sodium fluoride) or to any of the other ingredients of this medicine (listed in section 6).
• If you have lesions of the oral mucosa (pathological desquamative alterations of the oral mucosa).
• If you have spots on tooth enamel (skeletal fluorosis and/or dental enamel 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
Talk to your doctor, dentist, or pharmacist before using ELMEX.
For individuals in whom control of the swallowing reflex is impaired 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 flavour which in turn contains limonene, linalool, and geraniol. Limonene, linalool, and geraniol may cause allergic reactions.

Children
For children under 6 years of age, alternative pharmaceutical forms with a precise dosage, such as fluoride tablets, are recommended.
It is advisable that children under 8 years of age use ELMEX under parental supervision.
Do not swallow. In case of accidental ingestion, intake of calcium-containing substances (e.g. milk) is recommended; or, in case of ingestion of large quantities (more than one package), consult a doctor.

Other medicines and ELMEX
Inform your doctor, dentist, or pharmacist if you are taking, have recently taken, or might take any other medicines.
ELMEX may interact with:

• Medicines containing fluoride (e.g. fluoride tablets). Systemic administration of fluoride should be suspended for several days after application of ELMEX.
• Products capable of forming foam (anionic surfactants or other anionic macromolecules, e.g. detergents).
• Calcium (e.g. contained in milk), magnesium, and aluminium (contained in medicines for the treatment of gastric disorders: antacids). Ingestion of these substances immediately after treatment with ELMEX may reduce the effects of fluoride.

ELMEX with food and drinks
Ingestion of calcium (e.g. by consuming milk) may reduce the effects of fluoride.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor, dentist, or pharmacist for advice before using this medicine.

Pregnancy
You may use ELMEX during pregnancy only if strictly necessary.

Breastfeeding
ELMEX should be used with caution in breastfeeding women, as fluorides are excreted in breast milk.

Driving and using machines
ELMEX does not affect the ability to drive or operate machinery.

3. How to use ELMEX

Use this medicine exactly as stated in this leaflet or as directed by your doctor, dentist, or pharmacist. If you have any doubts, consult your doctor, dentist, or pharmacist.
Home use:
Once a week, apply approximately 1–2 cm of ELMEX (about 0.5 g of dental gel, corresponding to 6.25 mg of fluoride) onto the toothbrush and thoroughly brush the teeth. It is sufficient to use ELMEX with a regular toothbrush for 2–3 minutes, followed by normal rinsing. The total application time (brushing time) must not exceed 5 minutes.
Use in children:
Do not use ELMEX in children under 6 years of age.
If you use more ELMEX than you should
If you accidentally use more ELMEX than recommended, consult your doctor, dentist, or pharmacist immediately.
Acute overdose
In case of acute overdose, local irritation of the oral mucosa may occur.
Accidental ingestion of excessive amounts of ELMEX may cause nausea, vomiting, and diarrhoea. In most cases, these symptoms occur within the first hour after ingestion and resolve within 3–6 hours.
Chronic overdose
If a total daily dose of more than 2 mg of fluoride is regularly exceeded during tooth development and up to approximately 8 years of age, disturbances in dental enamel mineralization (discoloration) may occur, appearing as small spots on the enamel. This condition, known as dental fluorosis, does not occur beyond this age, even with high daily doses of fluoride.
Treatment of overdose
Acute
In case of mild intoxication symptoms (less than 150 mg of fluoride, corresponding to less than 12 g of ELMEX), drinks containing calcium (milk, soluble calcium tablets) should be taken to bind the fluoride.
In case of severe intoxication symptoms (more than 150 mg of fluoride, corresponding to more than 12 g of ELMEX), additional administration of activated charcoal is recommended.
If you have any questions about the use of this medicine, consult your doctor, dentist, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 sensation, numbness, swelling, itching, taste alteration, dry mouth, gum inflammation)
• Nausea or vomiting
• Hypersensitivity
• Intolerance
• Allergic reactions

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

5. How to store ELMEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ELMEX contains
The active substances are: bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-octadecylamine dihydrofluoride,
octadecylamine hydrofluoride, sodium fluoride.
100 g of ELMEX contain 3.032 g of bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-octadecylamine
dihydrofluoride, 0.287 g of octadecylamine hydrofluoride and 2.210 g of sodium fluoride (total fluoride content =
1.25%).
The other components are: propylene glycol, hydroxyethylcellulose, saccharin, Peach-Mint flavour (peach
flavour, menthol, eucalyptol, anethole), purified water.
Description of the appearance of ELMEX and contents of the pack
ELMEX is a transparent gel.
It is packaged in a 25 g tube.
Pack sizes: 1 x 25 g.
Marketing Authorization Holder
Colgate-Palmolive Commerciale S.r.l. – Via della Sierra Nevada, 60 – 00144 Rome
Manufacturer
Thépenier Pharma & Cosmetics – Saint-Langis-Les-Mortagne - (France)

PACKAGE LEAFLET

Package leaflet: information for use

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
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor, dentist or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

• 1. What ELMEX is and what it is used for
• 2. What you need to know before using ELMEX
• 3. How to use ELMEX
• 4. Possible side effects
• 5. How to store ELMEX
• 6. Package contents and other information

1. What ELMEX 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 from the age of 6 years for:

• prevention of dental caries, especially in individuals who are predisposed.
• reducing tooth sensitivity and preventing calcium loss from tooth enamel caused by dental prostheses (e.g. dentures) or orthodontic appliances (e.g. bite splints).
• protecting tooth enamel by local application of fluoride onto the enamel surface (topical fluoridation of tooth enamel).

Consult a physician if you do not feel better or if you feel worse.

2. What you need to know before using ELMEX

Do not use ELMEX:

• If you are allergic to the active substances (dihydrofluoride of bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-octadecylamine, hydrofluoride of octadecylamine, sodium fluoride) or to any of the other ingredients of this medicinal product (listed in section 6).
• If you have lesions of the oral mucosa (pathological desquamative changes of the oral mucosa).
• If you have spots on tooth enamel (skeletal fluorosis and/or dental enamel 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
Talk to your doctor, dentist or pharmacist before using ELMEX.

For individuals in whom control of the swallowing reflex is impaired or not yet fully developed, it is preferable to use alternative pharmaceutical forms with a precise dosage, such as fluoride tablets.
Rarely, repeated application of the gel using a tray at short intervals has been associated with mucosal changes (desquamation), superficial erosions and ulcerations (lesions) of the mouth (see section 4 “Possible side effects”).
Due to the presence of peppermint flavor 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 flavour containing limonene, linalool and geraniol: Limonene, linalool and geraniol may cause allergic reactions.

Children
For children under 6 years of age, alternative pharmaceutical forms with a precise dosage, such as fluoride tablets, are recommended.
It is advisable that children under 8 years of age use ELMEX under parental supervision.
Due to the risk of overdose and consequent poisoning, use of ELMEX with a tray is not recommended in children under 8 years of age.
Do not swallow. In case of accidental ingestion, intake of calcium-containing substances (e.g. milk) is advised. If large amounts are ingested (more than one package), consult your doctor.

Other medicines and ELMEX
Inform your doctor, dentist or pharmacist if you are taking, have recently taken, or might take any other medicines.
ELMEX may interact with:

• Medicines containing fluoride (e.g. fluoride tablets). Systemic administration of fluoride should be suspended for several days after application of ELMEX.
• Products that produce foam (anionic surfactants or other large anionic molecules, e.g. detergents).
• Calcium (e.g. present in milk), magnesium and aluminium (present in medicines used to treat gastric disorders: antacids). Ingestion of these substances immediately after ELMEX treatment may reduce the effects of fluoride.

ELMEX with food and drinks
Ingestion of calcium (e.g. by drinking milk) may reduce the effects of fluoride.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor, dentist or pharmacist for advice before using this medicine.

Pregnancy
You may use ELMEX during pregnancy only if strictly necessary.

Breastfeeding
ELMEX should be used with caution in breastfeeding women, as fluorides are excreted in breast milk.

Driving and using machines
ELMEX does not affect the ability to drive or operate machinery.

3. How to use ELMEX

Use this medicine exactly as stated in this leaflet or as directed by your doctor, dentist, or pharmacist. If you have any doubts, consult your doctor, dentist, or pharmacist.

Use reserved for dental professionals: ELMEX can be applied to the teeth using a rotating brush or a cotton swab.
Particularly effective and long-lasting application is achieved using a plastic or wax tray. An adequate contact time between the dental gel and the teeth must be maintained (at least 2–4 minutes). However, do not exceed 5 minutes. Rinse the mouth after use.

• Using the blunt cannula of a disposable syringe filled with gel, apply the product directly onto the chewing surfaces and into the interdental spaces (0.5 to 1 g of ELMEX, corresponding to a fluoride amount between 6.25 and 12.5 mg).
• When using a tray, apply approximately 6–8 g of ELMEX, corresponding to about 75–100 mg of fluoride.

Use in children: Do not use ELMEX in children under 6 years of age.
Due to the risk of overdose and subsequent poisoning, application of ELMEX with a tray is not recommended in children under 8 years of age.

If you use more ELMEX than you should

If you have accidentally used more ELMEX than recommended, contact your doctor, dentist, or pharmacist immediately.

Acute overdose
In case of acute overdose, local irritation of the oral mucosa may occur.
Accidental ingestion of excessive amounts of ELMEX may cause nausea, vomiting, and diarrhea.
In most cases, these symptoms occur within the first hour after ingestion and resolve within 3–6 hours.

Chronic overdose
If a total daily fluoride intake exceeding 2 mg is regularly exceeded during tooth development and up to approximately 8 years of age, disturbances in dental enamel mineralization (discoloration) may occur, appearing as small spots on the enamel. This condition, known as dental fluorosis, does not occur beyond this age, even with high daily fluoride doses.

Treatment of overdose

Acute
In cases of mild intoxication symptoms (less than 150 mg of fluoride, corresponding to less than 12 g of ELMEX), drinks containing calcium (such as milk or soluble calcium tablets) should be taken to bind the fluoride.
In cases of severe intoxication symptoms (more than 150 mg of fluoride, corresponding to more than 12 g of ELMEX), administration of activated charcoal is additionally recommended.

If you have any doubts about the use of this medicine, consult your doctor, dentist, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with the following frequency:
Very rare side effects (may affect up to 1 in 10,000 people)

• Changes in the mouth mucosa (desquamative changes of the oral mucosa)
• Mouth irritation (inflammation/redness, discomfort/burning, numbness, swelling, itching, altered taste, dry mouth, gum inflammation)
• Superficial lesions and ulcerations of the mouth mucosa (ulcers, aphthae, blisters)
• Nausea or vomiting
• Hypersensitivity
• Intolerance
• Allergic reactions

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

5. How to store ELMEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ELMEX contains
The active substances are: dihydrofluoride of bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-octadecylamine,
hydrofluoride of octadecylamine, sodium fluoride.
100 g of ELMEX contain 3.032 g of dihydrofluoride of bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-
octadecylamine, 0.287 g of hydrofluoride of octadecylamine and 2.210 g of sodium fluoride (total fluoride
content = 1.25%).
The other components are: propylene glycol, hydroxyethylcellulose, saccharin, Peach-Mint flavour (peach flavour, menthol, eucalyptol, anethole), purified water.
Description of the appearance of ELMEX and the contents of the pack
ELMEX is a transparent gel.
It is packaged in a 215 g tube.
Pack sizes: 1 x 215 g.
Marketing Authorization Holder
Colgate-Palmolive Commerciale S.r.l. – Via della Sierra Nevada, 60 – 00144 Rome, Italy
Manufacturer
Thépenier Pharma & Cosmetics – Saint-Langis-Les-Mortagne - (France)