Descrizione Clinica
Oral hygiene Zymafluor os gtt fl 20ml Zymafluor
ZYMAFLUOR
active ingredients
Zymafluor Oral Drops 1 ml of solution contains: active ingredient sodium fluoride mg 2.52 (equal to fluoro-ion 1,14 mg). Zymafluor tablets 0.25 mg Each tablet contains: active ingredient sodium fluoride mg 0.56 (equal to fluoro-ion 0.25 mg). Zymafluor Tablets 0.50 mg Each tablet contains: active ingredient sodium fluoride mg 1,105 (equal to fluoro-ion 0.50 mg). Zymafluor Tablets 1 mg Each tablet contains: active ingredient sodium fluoride mg 2,3 ca (equal to fluoro-ion 1 mg). Excipients with known effects: benzoic acid and sorbitol For the full list of excipients, see paragraph 6.1.Excellent
Oral drops: benzoic acid; glycerol; liquid sorbitol not crystallized; purified water. Tablets 0.25 mg: sorbital; anidra colloidal silica; mint essence; magnesium stearate. Tablets 0.50 mg: sorbitol; anidra colloidal silica; magnesium stearate; essential mint oil powder; E 172; coloring mixture E172 and E171. Tablets 1 mg: sorbitol; anidra colloidal silica; coloring E172; magnesium stearate.Therapeutic indications
Prevention of dental caries.Contraindications
Hypersensitivity to one of the components of the product or substances closely related to the chemical point of view.Population
The daily dose should be measured according to the age of the child as well as the fluorine content of drinking water and fluorine ingested through other sources such as diet or fluorine toothpaste. It is recommended to prescribe the doses shown in the following table taking into account the fluorine content of drinking water:| Fluore concentration in water (mg/l) | 0,3-0,7 | > 0,7 | |
| Recommended Fluore Supplementary Approach | |||
| Age | (Mg/F-/day) | ||
| from 6 months up to 2 years | 0,25 | 0 | 0 |
| from 2 to 4 years | 0,50 | 0,25 | 0 |
| from 4 to 16 years | 1 | 0,50 | 0 |
| over 16 years | 1 | 0,75 | 0 |
| During pregnancy and nursing: | 1 tablet 1 mg per day |
| Children: | |
| • from 6 months to 2 years: | 4 drops per day or 1 tablet 0.25 mg per day |
| • from 2 to 4 years: | 2 tablets 0.25 mg per day or 1 tablet 0.50 mg per day |
| • from 4 to 16 years: | 1 tablet 1 mg per day (or according to the doctor's opinion) |
| • over 16 years: | 1 tablet 1 mg per day |
| (4 drops = 0.25 mg fluorine-ion; 1 ml = 18 drops) | |
Conservation
Oral drops: ctemperature not exceeding 30°C Tablets 0.50 mg and 1 mg: this medicine does not require any special storage temperature. Store in the original packaging. Keep the bottle closed to protect the medicine from moisture. Tablets 0.25 mg: Store at a temperature not exceeding 25°C. Store in the original packaging. Keep the bottle closed.Warnings
If an integrated fluorine intake is considered, the amount of fluorides ingested through other sources should be taken into consideration and avoid overdose. In patients with renal impairment, the product should only be administered after consulting the doctor. In areas where kitchen salt or water are fluorated, Zymafluor's posology should be reduced. If the water contains more than 0.7 mg/l of fluorine, we do not recommend the supplementary supply of fluorine. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’.Interactions
Fluore absorption is related to the solubility of the ingested preparation. Absorption is inhibited by calcium, magnesium or aluminum. Zymafluor must therefore not be administered together with milk and dairy products, nor with antacids containing calcium, aluminum or magnesium salts. A two-hour interval must be between the administration of Zymafluor and antacids.Effects
Undesirable effects are listed below by organic systemic class and frequency (number of patients expected to have reaction), using the following categories: • Very common (≥1/10) • Common (≥1/100, Immune system disorders Unknown frequency Hypersensitivity reactions (including gastrointestinal symptoms) Gastrointestinal diseases Frequency not known Dental Fluorosis At the recommended doses for the prevention of dental caries, fluoride sodium did not show that it had no significant side effects. However, rare cases of small rashes were reported (erythema, rash, urticaria). They disappear quickly with the interruption of treatment. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.Overdosing
Chronic overdose The main manifestation of a chronic ingestion of excessive amounts of fluorine, for example 2 mg of fluorine per day during the years necessary for the calcification of the enamel of the teeth, consists in the formation of nails on the enamel of the teeth (dentary fluids) see paragraph 4.8 side effects. Chronic intoxication for a long time can also lead to skeletal fluorosis. Acute overdose Symptoms of acute overdose have been reported in adult after ingestion of more than 100 mg of fluoro-ion. In the adult this corresponds approximately to: more than 100 tablets of Zymafluor from 1 mg or 5 bottles of Zymafluor drops. The lethal dose in the adult (70 kg) is about 5 g of fluoride sodium, which corresponds to 2.2 g of fluoro-ion, in children the toxic dose of fluoride sodium that can be lethal in single cases is 11 mg/kg (equivalent to 5 mg/kg fluoro-ion). 2 g in adults cause severe poisoning. In these cases immediate obsessiveization is mandatory. The initial symptoms are mainly related to gastro-intestinal intolerance: salivation, nausea, abdominal pain, thirst, vomiting and hemorrhagic diarrhea. These symptoms can be followed by fatigue, muscle weakness, tremor, paresthesia in the ends and face, depression of the central nervous system, tetania, possible seizures, short breath, respiratory insufficiency, heart and kidney, progressive respiratory paralysis, shock. Death can occur within 2-4 hours. Hypocalcemia and hypoglycemia are frequently found. Treatment: - if they were ingested less than 5.0 mg/kg body weight of fluoro-ion, corresponding for a child weighing 10 kg less than: 2 bottles of Zymafluor drops or 200 tablets of Zymafluor from 0.25 mg • administer calcium (latte) orally to relieve gastro-intestinal symptoms and keep under observation for a few hours. - if they were ingested more than 5 mg/kg body weight of fluoro-ion, corresponding for a child weighing 10 kg to more than: 2 bottles of Zymafluor drops or 200 tablets of Zymafluor from 0.25 mg • induce vomiting; • administer oral soluble calcium in any form (e.g. milk, calcium gluconate 5% or a calcium lactate solution); • provide immediate hospitalization. The therapeutic scheme is based on the following principles: hospital treatment is required in order to empty the stomach by suction and gastric lavender with lime water or a calcium chloride solution at 1% or another calcium salt in order to precipitate fluoro-ion. The administration of aluminum hydroxide after gastric lavender can reduce fluoro-ion absorption. Implement heart monitoring (be careful of rising T waves and extended QT intervals). To control convulsions you can administer intravenously 10 ml of a 10% gluconate calcium solution, repeating injections, if necessary, every 4-6 hours. If necessary to administer morphine or petidine injective in order to control the colic. Support the circle with suitable infusions of electrolytic solutions. Breathing may require assistance. It may be necessary to practice hemodialysis. Vomito, feces and urine must be removed promptly with water to prevent the formation of external burns. Rehydration and good diuresis must be maintained. In severe cases, the patient's urine must be alkalined.Zymafluor has been widely used for many years during pregnancy. If you decide to administer Zymafluor during pregnancy and breastfeeding, the recommended dose for your mother is 1 tablet of 1 mg of Zymafluor per day (equal to 1 mg of fluoro-ion). The content in fluoro-ion in breast milk, however, is negligible and breast breast-feeded baby is recommended to administer 1 0.25 mg tablet or, preferably, given the age of the child, 4 drops of Zymafluor per day (equal to 0.25 mg of fluoro-ion). 0.25 mg tablets contain 38,239 mg of sorbitol per tablet. 0.5 mg tablets contain 47,205 mg of sorbitol per tablet. 1 mg tablets contain 36,509 mg of sorbitol per tablet. 1,14 ml/ml drops contain 66.6 mg of sorbitol in 4 drops that are equivalent to 300mg/ml. Patients with hereditary fructose intolerance should not be given this medicine.
Source: Farmadati
