Elmex dental gel 30, 32 mg/g + 2, 87 mg/g + 22, 1 mg/g 25 g

Elmex Dental Gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g is a dental gel with a high concentration of fluoride , designed to offer effective protection against tooth decay and for the remineralization of tooth enamel . Thanks to its advanced formulation, which combines bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-octadecylamine dihydrofluoride , amine hydrofluoride and sodium fluoride , Elmex Dental Gel guarantees a targeted action in the prevention of tooth decay , especially in predisposed subjects, and helps to strengthen tooth enamel making it more resistant to acid attacks.

Ideal for adults and children aged 6 and over , this anti-caries dental gel is also particularly indicated in cases of hypersensitivity of the dental neck and for decalcification of the enamel caused by orthodontic appliances, partial dentures or removable splints. Weekly use of Elmex dental gel allows for intense topical fluoridation , promoting long-term protection of the teeth and helping to maintain a healthy mouth.

The presence of peppermint and apple aromas makes the application pleasant, while the gel texture ensures uniform distribution over the entire tooth surface. Elmex dental gel 25 g is a reference product in online pharmacies for those looking for a professional home treatment against tooth decay and for the care of sensitive gums . Choose Elmex for advanced enamel protection and effective prevention of tooth decay thanks to the synergistic action of its active ingredients.

ACTIVE INGREDIENTS

Active ingredients contained in Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g - What is the active ingredient in Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g?

100 g of dental gel contain: Bis-(hydroxyethyl)-amino-propyl-N-hydroxyethyl-octadecylamine dihydrofluoride 3.032 g Octadecylamine hydrofluoride 0.287 g Sodium fluoride 2.210 g (Total fluoride content = 1.25%) Excipients with known effect: peppermint flavour, apple flavour, DL-menthone which in turn contains benzyl alcohol, limonene, linalool, eugenol, benzyl benzoate, citronellol and geraniol. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g - What does Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g contain?

Propylene glycol, hydroxyethylcellulose, saccharin, spearmint oil, peppermint flavor, apple flavor, DL-menthone, purified water.

DIRECTIONS

Therapeutic indications Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g - Why is Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g used? What is it used for?

ELMEX is indicated in adults and children aged 6 years and over for: - Caries prophylaxis, especially in subjects predisposed to it. - Hypersensitivity of the dental neck. - Enamel decalcification caused by removable splints, partial dentures, orthodontic appliances. - Topical fluoridation of dental enamel.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g - When should Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g not be used?

ELMEX must not be used in cases of: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - Pathological desquamative changes in the oral mucosa (erosion of the epithelium); - Fluorosis of bone and/or dental enamel; - If the swallowing reflex is impaired or not yet fully developed; - Children under 6 years of age (see section 4.2).

DOSAGE

Quantity and method of taking Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g - How is Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g taken?

Dosage 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 the toothbrush and brush the teeth thoroughly. It is sufficient to use ELMEX using a normal toothbrush for 2-3 minutes, rinsing normally. The total application time (brushing time and residence time) must not exceed 5 minutes. For dentist use only : ELMEX can be spread on the teeth using a rotating toothbrush or with a cotton ball. Particularly effective and long-lasting is the application using a plastic or wax impression tray. 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 the mouth after use. - Using the blunt cannula of a disposable syringe filled with gel, apply the product directly to the chewing surfaces and interdental spaces (0.5 to 1 g of ELMEX, corresponding to a quantity of fluoride between 6.25 and 12.5 mg). - Using an impression tray, apply approximately 6-8 g of ELMEX, corresponding to approximately 75-100 mg of fluoride. Paediatric population : ELMEX is contraindicated in children under 6 years of age (see section 4.3). Due to the risk of overdose and consequent intoxication, the application of ELMEX with an impression tray is not recommended in children under 8 years of age. Method of administration For dental use.

CONSERVATION

Storage Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g - How is Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g stored?

No special storage precautions.

WARNINGS

Warnings Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g - On Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g it is important to know that:

ELMEX is not indicated for persons whose 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. Scaling, superficial erosions and ulceration of the oral mucosa have been reported rarely (<1/10,000, including individual cases) following applications through impression trays, repeated after short intervals (see section 4.8). Due to the peppermint flavour 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 pharmaceutical forms with a precise dosage, such as fluoride tablets. Due to the risk of overdose and subsequent intoxication, the application of ELMEX through impression trays is not recommended in children under 8 years of age. Important information about some of the excipients Elmex gel contains propylene glycol. Propylene glycol may cause skin irritation. This medicinal product contains a flavouring which 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. In addition to allergic reactions in sensitised patients, non-sensitised patients may become sensitised. This medicinal product contains 0.002232 mg of benzyl alcohol per g of product. Benzyl alcohol may cause mild local irritation.

INTERACTIONS

Interactions Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g - Which medicines or foods can modify the effect of Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g?

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

SIDE EFFECTS

Like all medicines, Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g can cause side effects - What are the side effects of Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g?

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 (≥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/oedema, inflammation, oral pruritus, taste alteration, dry mouth, gingivitis); superficial erosions and ulceration of the oral cavity 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 that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g - What are the risks of Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g in case of overdose?

Symptoms of overdose Acute overdose: In the 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 fluoride, corresponding to 8 g ELMEX, can be introduced into the oral cavity. If this amount is accidentally ingested, nausea, vomiting and diarrhoea may occur. In most cases, these symptoms occur within the first hour after ingestion and resolve within 3 to 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 dental fluorosis. Treatment of Acute Overdose : With mild symptoms of intoxication (less than 150 mg fluoride, corresponding to less than 12 g 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 ELMEX) additional administration of activated charcoal is recommended. If necessary, calcium can be administered intravenously, forced diuresis with alkalinization of the urine can also be started. Heart rate, coagulation, electrolyte and acid-base balance should be carefully monitored.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g

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 (see section 5.3). The use of ELMEX during pregnancy may be considered, if necessary. Breast -feeding Available pharmacodynamic/toxicological data in animals have shown excretion of fluoride in milk (see section 5.3). A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy with ELMEX, taking into account the benefit of breast-feeding 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.

DRIVING AND USE OF MACHINERY

Taking Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g before driving or using machines - Does Elmex dental gel 30.32 mg/g + 2.87 mg/g + 22.1 mg/g 25 g affect driving or using machines?

ELMEX has no or negligible influence on the ability to drive or use machines.