Elmex Gel dentale - dental caries prophylaxis 25 g

Warnings

Elmex is not indicated for people 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.
Desquamation, superficial erosions, and ulceration of the oral mucosa have been reported rarely (<1/10,000, including individual cases) following applications through an impression tray, repeated after short intervals.
Due to the peppermint flavor and spearmint oil contained in the gel, allergic reactions may occur in patients with bronchial asthma or other airway disorders.
Paediatric patients: For children under 6 years of age, it is recommended to use alternative dosage forms with a precise dosage, such as fluoride tablets.
Due to the risk of overdose and subsequent intoxication, the application of Elmex with an impression tray is not recommended in children under 8 years of age.

Contraindications

Elmex must not be used in cases of:

• Hypersensitivity to the active substances or to any of the excipients;
• Pathological desquamative changes in the oral mucosa (erosion of the epithelium);
• Fluorosis of the bones and/or tooth enamel;
• If the swallowing reflex is impaired or not yet fully developed;
• Children under 6 years of age.

Interactions

Systemic administration of fluoride (e.g. with fluoride tablets) should be discontinued for a few days after applying Elmex.
There are incompatibilities with anionic surfactants and other large anionic molecules and with all soluble calcium, magnesium and aluminium salts.
Ingestion of calcium (e.g. milk), magnesium and aluminium (in medicines to treat stomach problems; antacids) immediately following treatment with Elmex may reduce the effects of fluorides.

Undesirable effects

The estimated frequency of adverse events is classified according to the following convention:

very common (>1/10);
common (>1/100 to <1/10);
uncommon (>1/1,000 to <1/100);
rare (from ≥1/10,000 to <1/1,000);
very rare (<1/10,000). 

Skin and subcutaneous tissue disorders:

Very rare: desquamative changes in the oral mucosa; oral irritation (stomatitis/redness, oral discomfort/burning, numbness, swelling/edema, inflammation, oral itching, taste disturbance, dry mouth, gingivitis); superficial erosions and ulcerations of the oral mucosa (ulcers, aphthae, blisters); nausea or vomiting.

Immune system disorders:

Very rare: hypersensitivity, intolerance, allergic reactions.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

Symptoms of overdose: Acute overdose: In case of acute overdose, local irritation of the oral mucosa is possible.
Depending on the dose and method of application, e.g. With an impression tray, up to 100 mg of fluoride, corresponding to 8 g of Elmex, can be introduced into the oral cavity.
Accidental ingestion of this amount 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: Daily ingestion of excessive doses of fluoride (total daily fluoride dose of 2 mg) over a prolonged period of time, during tooth development and up to approximately 8 years of age, can cause fluorosis of varying degrees.
From the age of 8 years, however, there is no longer any risk of fluorosis. no risk of dental fluorosis.
Treatment of Acute Overdose: With mild symptoms of intoxication (less than 150 mg fluoride, corresponding to less than 12 g of Elmex), calcium-containing drinks (milk, soluble calcium tablets) should be given to bind the fluoride.
With severe symptoms of intoxication (more than 150 mg fluoride, corresponding to more than 12 g of Elmex), supplemental administration of activated charcoal is recommended.
If necessary, calcium can be administered intravenously, forced diuresis with alkalinization of the urine can also be initiated.
Heart rate, coagulation, electrolyte and acid-base balance should be carefully monitored.

Pregnancy and breastfeeding

Pregnancy:
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of fluoride in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
The use of Elmex during pregnancy may be considered, if necessary.
Breastfeeding:
Available pharmacodynamic/toxicological data in animals have shown excretion of fluoride in milk.
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy with Elmex, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility:
There is no information on the possible effects of the product on fertility.
However, no harmful effects are expected.

Storage

No special storage precautions.

Format

25 g tube