elmex tooth gel

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elmex® Dental Gel is used for the fluoridation of tooth enamel through local application (e.g. by brushing with a toothbrush or by the dentist by applying it using a gel carrier).

Application

What is elmex® Dental Gel and what is it used for?

elmex® Dental Gel is used for the fluoridation of tooth enamel through local application (e.g. by brushing with a toothbrush or by the dentist by applying it using a gel carrier or another method).

The amine fluorides Olaflur and Dectaflur contained in elmex® Dental Gel are characterised by a particularly high affinity for tooth enamel. Studies have shown the incorporation of fluoride or the formation of new minerals under laboratory conditions and in living organisms. This increases the resistance of the tooth enamel. elmex® Dental Gel inhibits the metabolism of dental plaque bacteria. elmex® Dental Gel therefore has an anti-caries effect and - in the case of existing tooth enamel defects - a mineralising effect.

In home use:
- Treatment of incipient enamel caries in conjunction with nutritional counselling and oral hygiene
- Surface mineralisation of sensitive tooth necks
In dental practice:
- Enamel decalcification under removable splints, partial dentures and appliances for correcting malpositions of teeth
- Re-fluoridation of ground enamel surfaces
- During selective grinding and in the case of injuries to the tooth enamel.
If you do not feel better or even worse, contact your (dental) doctor.

What should you consider before taking it?

What should you consider before using elmex® Dental Gel?

elmex® Dental Gel must not be used,
- if you are allergic to one of the active ingredients Olaflur, Dectaflur, sodium fluoride or any of the other ingredients of this medicine listed in section 6.
- in the presence of abrasions of the oral mucosa.
- in persons in whom control of the swallowing reflex is not guaranteed.
- in persons with skeletal and/or dental fluorosis.
Warnings and precautions
Please talk to your (dental) doctor or pharmacist before using elmex® Dental Gel.

Due to the content of peppermint oil and spearmint oil, patients with bronchial asthma
or other respiratory diseases should consult their (dental) doctor before using elmex® Dental Gel.

elmex® Dental Gel should not be used in the case of colour or structural changes in the tooth enamel (dental fluorosis) and/or in the case of a hardened bone layer
(bone fluorosis) caused by very high fluoride intake.

elmex® Dental Gel should not be used in the case of scaling, superficial changes and ulcers of the oral mucosa.

Children
Due to the risk of swallowing, the dental gel should not be used in children under 6 years of age. Due to the risk of a possible overdose, use with a gel applicator or gel carrier is not recommended in children under 8 years of age.

Use of elmex® Dental Gel together with other medicines
Tell your (dental) doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

elmex® Dental Gel can interact with:
- Systemic fluoride administration (e.g. fluoride tablets) should be paused one day before and one day after
the use of elmex® Dental Gel in the dental practice.
- foaming products (anionic surfactants and other anionic macromolecules such as detergents).
- Calcium (e.g. contained in milk), magnesium and aluminium (contained in medicines for the treatment of stomach problems or for neutralising stomach acid, known as antacids). These ingredients can reduce the effect of fluorides if they are taken immediately after treatment with elmex® Dental Gel.
Use of elmex® Dental Gel together with food and drink
For maximum effect, neither food nor drink should be consumed for 15 to 30 minutes after use.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your (dental) doctor or pharmacist for advice before using this medicine.

Pregnancy
There is no evidence that fluorides pose any risks to the embryo. The use of elmex® Dental Gel can, if necessary, also be considered during pregnancy.
Breast-feeding
According to studies, fluorides are also excreted in breast milk. A risk to the child cannot therefore be ruled out. Therefore, a decision must be made between weaning and discontinuing treatment with elmex® Dental Gel.

Driving and using machines
The use of elmex® Dental Gel has no or negligible influence on the ability to drive and use machines.

elmex® Dental Gel contains propylene glycol
Propylene glycol can cause skin irritation.

How should the medicine be taken?

How to use elmex® Dental Gel?

For dental use.

In home use:
Always use this medicine exactly as described in this leaflet or exactly as directed by your (dental) doctor or pharmacist. Check with your (dental) doctor or pharmacist if you are not sure.

Once a week apply approx. 1 cm of elmex® Dental Gel to the toothbrush and brush the teeth. Rinse briefly after 2 to 3 minutes. The total application time (brushing and exposure time) must not exceed 5 minutes.

It is best to use it before going to bed. For maximum effect, neither food nor drink should be consumed for 15 to 30 minutes after use.

Any more frequent treatment will be determined by the dentist.

In the case of children, care should be taken to ensure that they do not swallow during brushing. elmex® Dental Gel should only be used once the child has mastered spitting out the foam.

In dental practice:
The application is carried out approx. twice or, in the case of patients with a high caries risk, several times per year. Sufficient contact time of the dental gel with the teeth (at least 2 to 4 minutes) must be ensured. However, it must not exceed 5 minutes. After use, rinse out.

elmex® Dental Gel can be applied using a cotton ball, fingertip or rotating brush. The application using a suitable gel carrier such as a Miniplast splint or spoon applicator is particularly effective.

The dental gel must not be used with a gel carrier until the age of 8 due to the risk of overdose.

If you have used more elmex® Dental Gel than you should
If you accidentally swallow larger amounts of the medicine, medical advice should be sought.

Information for medical professionals
Information on overdose can be found at the end of the package leaflet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What side effects are possible?

How to store elmex® Dental Gel?

This medicine does not require any special storage conditions.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton/container after "EXP". The expiry date refers to the last day of the month indicated.

Always place the tube on the cap.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

Special storage instructions

How to store Elmex - Dental Gel?

This medicine does not require any special storage conditions.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton/container after "EXP". The expiry date refers to the last day of the month indicated.
Always place the tube on the cap.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist,
how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

Special information on the content

Contents of the pack and further information

What elmex® Dental Gel contains:
- The active ingredients are: Olaflur, Dectaflur, sodium fluoride. 100 g contain 3.032 g Olaflur, 0.287
g Dectaflur and 2.21 g sodium fluoride
- The other ingredients are: Propylene glycol, hydroxyethylcellulose, saccharin, p-menthan-3-one, apple flavour, banana flavour, peppermint flavour, spearmint oil, purified waterTotal fluoride content: 1.25 % (fluoride),

1 gel strip of 1 cm length = 0.2 g.

What elmex® Dental Gel looks like and contents of the pack
Clear, light yellow dental gel in a laminate tube with a PE screw cap (child-proof closure),

25 g tube.