ELMEX 25 G Żel dentystyczny

Treść ulotki

1. ELMEX 30.32 mg/g / 2.87 mg/g / 22.1 mg/g dental gel
   1. What is ELMEX and what is it 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
2. ELMEX 30.32 mg/g / 2.87 mg/g / 22.1 mg/g dental gel
   1. What is ELMEX and what is it 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

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

Read this 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 you use 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 is ELMEX and what is it 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 starting from 6 years of age for:

• the prevention (prophylaxis) of tooth decay, particularly in predisposed individuals.
• reducing tooth sensitivity, preventing the loss of calcium from tooth enamel, caused by dental prostheses (e.g. dentures) or orthodontic appliances (e.g. bite).
• protecting tooth enamel, applying fluorine locally to the enamel (topical fluoridation of tooth enamel). If you do not feel better or if you feel worse, please consult your doctor.

2. What you need to know before using ELMEX

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 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 stains on the tooth enamel (skeletal and/or 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
Consult your doctor, dentist or pharmacist before using ELMEX.
For people whose swallowing reflex control 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 peppermint and spearmint oil 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 flavouringwhich in turn contains benzyl alcohol, limonene, linalool, eugenol, benzyl benzoate, citronellol and geraniol. Benzyl alcohol, limonene, linalool, eugenol, benzyl benzoate, citronellol and geraniol can cause allergic reactions
• 0.002232 mg of benzyl alcoholper each g of product. Benzyl alcohol can cause mild local irritation.

Children
For children under 6 years of age, it is recommended to use alternative pharmaceutical forms with a precise dosage, such as fluoride tablets.
It is recommended that children under 8 years of age use ELMEX under the supervision of their parents.
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 a doctor.

Other medicines and ELMEX
Tell 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 fluoride administration should be suspended for a few days after application of ELMEX.
• products capable of forming foam (anionic surfactants or other large anionic molecules, 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 drink
Ingestion of calcium (e.g. with the consumption of milk) can reduce the effects of fluorides.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor, dentist or pharmacist for advice before using this medicine.
Pregnancy
If you are pregnant, you can use ELMEX only if strictly necessary.
Breastfeeding
ELMEX should be used with caution in breastfeeding women, as fluorides pass into breast milk.

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

3. How to use ELMEX

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

Home use:
Once a week, apply approximately 1-2 cm of ELMEX (approx. 0.5 g of dental gel corresponding to

• 6.25 mg of fluoride) to your toothbrush and brush your teeth thoroughly. It is sufficient to use ELMEX with a normal toothbrush for a duration of 2-3 minutes, rinsing normally. The total application time (brushing time) should 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 have accidentally used more ELMEX than you should, consult your doctor, dentist or pharmacist immediately.
Acute overdose
In case of acute overdose, local irritation of the oral mucosa is possible.
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 you regularly exceed a total daily dose of 2 mg of fluoride during tooth development and up to
approximately 8 years of age, disturbances in enamel mineralization (discoloration) may occur, which manifest as spots on the enamel. This condition,
known as dental fluorosis, no longer occurs after this age, even at high daily doses of fluoride.

Overdose treatment
Acute
With mild symptoms of intoxication (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.
With severe symptoms of intoxication (more than 150 mg of fluoride, corresponding to more than 12 g of ELMEX),
supplemental administration of activated charcoal is recommended.
If you have any doubts about the use of this medicine, ask your doctor, dentist or pharmacist.

4. 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 person in 10,000)

• Irritation of the mouth (inflammation/redness, discomfort/burning, numbness, swelling, itching, altered taste, dry mouth, inflammation of the gums)
• Nausea or vomiting
• Hypersensitivity
• Intolerance
• Allergic reactions Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 which is stated on the packaging. The expiry date refers to
the last day of that month.
This medicinal product does not require special storage conditions.
Do not dispose of any medicine in 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 ingredients 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, green peppermint oil, peppermint aroma, apple aroma, menthone aroma, 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.
Packs: 1 x 25 g.

Marketing Authorisation Holder
Colgate-Palmolive Commerciale S.r.l. – Viale Eiffel, 15 - 00148 ROMA

Manufacturer
Thépenier Pharma & Cosmetics – Saint-Langis-Les-Mortagne - (France)

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

Read this 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 is ELMEX and what is it 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 from 6 years of age for:

• the prevention (prophylaxis) of tooth decay, particularly in individuals predisposed to it.
• reducing tooth sensitivity, avoiding calcium loss from tooth enamel, caused by dental prostheses (e.g. dentures) or orthodontic appliances (e.g. bite).
• protecting tooth enamel by applying fluorine locally 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 ingredients (bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-octadecylamine dihydrofluoride, octadecylamine hydrofluoride, 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 exfoliating changes of the oral mucosa).
• If you have stains on the tooth enamel (bone and/or 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 precautionsConsult your doctor, dentist or pharmacist before using ELMEX.

For people whose swallowing reflex control is impaired or not yet fully developed, it is preferable to use alternative pharmaceutical forms with a precise dosage, such as fluoride tablets.
In rare cases, following repeated application of the gel with a mouth tray at short intervals, alterations (exfoliation), superficial erosions and ulcerations (lesions) of the oral mucosa have been reported (see section 4 “Possible side effects”).
Due to the peppermint and spearmint oil 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
• an aromawhich in turn contains benzyl alcohol, limonene, linalool, eugenol, benzyl benzoate, citronellol and geraniol. Benzyl alcohol, limonene, linalool, eugenol, benzyl benzoate, citronellol and geraniol may cause allergic reactions
• 0.002232 mg of benzyl alcoholper gram of product. Benzyl alcohol may cause mild local irritation.

Children
For children under 6 years of age, the use of alternative pharmaceutical forms with a precise dosage, such as fluoride tablets, is recommended.
It is recommended that children under 8 years of age use ELMEX under the supervision of their parents.
Due to the risk of overdose and subsequent poisoning, the application of ELMEX with a mouth tray is not recommended in children under 8 years of age.
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 pack), consult a doctor.

Other medicines and ELMEX
Tell 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). The systemic administration of fluoride should be suspended for a few days after the application of ELMEX.
• products capable of forming foam (anionic surfactants or other large anionic molecules, e.g. detergents).
• calcium (e.g. contained in milk), magnesium and aluminium (contained in medicines for the treatment of gastric disorders: antacids). Ingesting these substances immediately after treatment with ELMEX may reduce the effects of fluorine.

ELMEX with food and drink
Ingestion of calcium (e.g. with the consumption of milk) may reduce the effects of fluorides.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor, dentist or pharmacist for advice before using this medicine.
Pregnancy
If you are pregnant, you can use ELMEX only if strictly necessary.
Breastfeeding
ELMEX should be used with caution in breastfeeding women, as fluorides pass into breast milk.

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

3. How to use ELMEX

Use this medicine following exactly as described in this leaflet or as instructed by your doctor, dentist or pharmacist. If you have any doubts, ask your doctor, dentist or pharmacist.

For dentist use only:
ELMEX can be applied to the teeth using a rotating toothbrush, or with a cotton swab.
Particularly effective and long-lasting is the application using a tray made of plastic or wax material. An adequate contact time of the dental gel with the teeth must be maintained (at least
2-4 minutes). However, do not exceed 5 minutes. Rinse your mouth after use.

• Using the blunt cannula of a disposable syringe filled with gel, apply the product directly to the chewing surfaces and in the interdental spaces (0.5 to 1 g of ELMEX, corresponding to an amount of fluoride between 6.25 and 12.5 mg).
• With 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 intoxication, the 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 you should, consult your doctor, dentist or pharmacist immediately.
Acute overdose
In case of acute overdose, local irritation of the oral mucosa is possible.
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 dose of more than 2 mg of fluoride is regularly exceeded during tooth development and up to approximately 8 years of age, enamel mineralization disorders (discoloration) may occur, which manifest as spots on the enamel. This condition, known as dental fluorosis, no longer occurs after this age, even at high daily doses of fluoride.

Overdose treatment
Acute
With mild symptoms of intoxication (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.
With severe symptoms of intoxication (more than 150 mg of fluoride, corresponding to more than 12 g of ELMEX), supplementary administration of activated charcoal is recommended.
If you have any doubts about the use of this medicine, ask your doctor, dentist or pharmacist.

4. 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)

• Changes to the oral mucosa (desquamative changes of the oral mucosa)
• Irritation of the mouth (inflammation/redness, discomfort/burning, numbness, swelling, itching, altered taste, dry mouth, gum inflammation)
• Superficial lesions and ulcerations of the oral mucosa (ulcers, sores, blisters)
• Nausea or vomiting
• Hypersensitivity
• Intolerance
• Allergic reactions Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging. The expiry date refers to the last day of that month.
This medicinal product does not require special storage conditions.
Do not dispose of any medicine in waste water 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 ingredients 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 ingredients are: propylene glycol, hydroxyethylcellulose, saccharin, green peppermint oil, peppermint aroma, apple aroma, menthone aroma, purified water.

Description of the appearance of ELMEX and contents of the pack
ELMEX is a transparent gel.
It is packaged in a 215 g tube.
Packs: 1 x 215 g.

Marketing Authorisation Holder
Colgate-Palmolive Commerciale S.r.l. – Viale Eiffel, 15 - 00148 ROMA

Manufacturer
Thépenier Pharma & Cosmetics – Saint-Langis-Les-Mortagne - (France)