ELMEX GEL DENTAL 25G

ELMEX 30,32 MG/G / 2,87 MG/G / 22,1MG/G

active ingredients

100 g of dental gel contain: Dihydrofluoride of bis-(hydroxyetyl)-amino-propyl-N-hydroxyetyl-ottadecylamine 3,032 g Octocylamine hydrofluoride 0.287 g Sodium fluoride 2,210 g (Total fluoride content = 1.25%) For the full list of excipients, see paragraph 6.1.

Excellent

Propylene glycol, hydroxyethylcellulose, saccharin, green mint oil, peppermint aroma, apple aroma, DL-mentone, purified water.

Therapeutic indications

ELMEX is indicated in adults and children aged 6 for: - Prophylaxis of caries especially in subjects prepared for it. - Hypersensitivity of the dentarian collar. - Decalcification of the enamel caused by removable wounds, partial prostheses, orthodontic appliances. - Topic fluidization of dental enamel.

Contraindications

ELMEX should not be used in cases of: - Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1; - Pathological desquamations of the oral mucosa (herosion of the epithelium); - Bone fluids and/or dental enamel; - If the reflex of swallowing is compromised or not fully developed; - Children under the age of 6 (see paragraph 4.2).

Population

Population Home Use: Once a week apply approximately 1-2 cm of ELMEX (approx. 0.5 g of dental gel corresponding to 6.25 mg fluoride) on the toothbrush and thoroughly brush the teeth. Just use ELMEX using a normal toothbrush for 2-3 minutes, rinsing normally. The total time of application (cleaning time and residence) should not exceed 5 minutes. Use reserved for dentist: ELMEX can be spread over the teeth using the rotary toothbrush, or with a cotton ball. Particularly effective and lasting effect is the application by means of a door-print in plastic or wax material. It must be maintained a proper contact time of the dental gel with the teeth (at least 2-4 minutes). However, do not exceed 5 minutes. Rinse your mouth after use. - With the beveled cannula of a disposable syringe filled with gel apply the product directly to the chewing surfaces and in the spaces (from 0.5 to 1 g) ELMEX, corresponding to a quantity of fluoride between 6.25 and 12.5 mg). - With footprint holder, approximately 6-8 g of ELMEX, corresponding to about 75-100 mg of fluoride. Pediatric population: ELMEX is contraindicated in children under the age of 6 (see paragraph 4.3). Due to the risk of overdose and subsequent intoxication, the application of ELMEX with footprint is not recommended in children under the age of 8. Method of administration For dental use.

Conservation

No special precaution for conservation.

Warnings

ELMEX is not indicated for people in which control of swallowing reflex is compromised 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 mucosa of the oral cavity have rarely been reported (Pediatric 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 with footprint is not recommended in children under the age of 8.

Interactions

Systemic administration of fluoride (e.g. with fluoride tablets) must be interrupted for a few days after the application of ELMEX. There are incompatibility with anionic surfactants and other large anionic molecules and with all soluble salts of calcium, magnesium and aluminum. Calcium ingestion (e.g. milk), magnesium and aluminum (in medicines for the treatment of stomach problems; antacids) immediately following treatment with ELMEX can reduce the effects of fluorides.

Effects

The estimated frequency of adverse events is classified according to the following convention: very common (≥1/10); common (from ≥1/100 to Pathologies of skin and subcutaneous tissue Very rare: Desquamative alterations of the oral mucosa; oral irritation (stomatitis/arrossation, discomfort/mouthburn, insensitivity, swelling/edema, inflammation, oral itching, alteration of taste, dry mouth, gum); superficial erosions and ulceration of the mucosa of the oral cavity (ulcere, afte, bladders); nausea or vomiting. Immune system disorders Very rare: hypersensitivity, intolerance, allergic reactions. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Symptoms of overdose Acute overdose: In case of acute overdose, a local irritation of the oral mucosa is possible. Depending on the dose and method of application, e.g. with fingerprint holder, can be introduced into the oral cavity up to 100 mg of fluoride, corresponding to 8 g of ELMEX. In case of accidental ingestion of this amount, nausea, vomiting and diarrhea may occur. In most cases, these symptoms occur within the first hour after ingestion and resolve within 3 to 6 hours. Chronic overdose: The daily ingestion of excessive doses of fluoride (total daily doses of 2 mg fluoride) for a prolonged period of time, during the development of teeth and up to about 8 years of age, may cause fluorosis of various degrees. From 8 years of age, however, there is no risk of dental fluorosis. Treatment of overdose Acute: With slight symptoms of intoxication (less than 150 mg of fluoride, corresponding to less than 12g of ELMEX) must be given drinks containing calcium (latte, soluble calcium tablets) to bind fluoride. With severe symptoms of intoxication (more than 150 mg of fluoride, corresponding to more than 12 g ELMEX) the additional administration of activated coal is recommended. If necessary, calcium can be administered by endovena, it may also have begun forced diuresis with alcalinization of urine. Heart rate, coagulation, electrolytic balance and acid-base must be monitored carefully.

Pregnancy

Data relating to the use of fluorine in pregnant women do not exist or are in limited number (less than 300 exposed pregnancy). Animal studies show no direct or indirect harmful effects of reproductive toxicity (see paragraph 5.3). The use of ELMEX during pregnancy, it can be considered, if necessary.

Food

Pharmacodynamic/toxicological data available in animals showed fluorine excretion in milk (see paragraph 5.3). The risk for infants/ infants cannot be excluded. The decision must be taken if you stop breastfeeding or stop therapy/ refrain from therapy, with ELMEX taking into consideration 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. No harmful effects are expected.

Source: Farmadati