ZYMAFLUOR*200CPR 0.25MG

ZYMAFLUOR*200CPR 0.25MG

Therapeutic indications

Prevention of tooth decay.

Dosage and method of use

The daily dose should be based on the age of the child as well as the fluoride content of drinking water and fluoride ingested through other sources such as diet or fluoridated toothpaste. It is recommended to prescribe the doses shown in the following table taking into account the fluoride content of drinking water:

If drinking water is not fluoridated, it is recommended to prescribe the following dosage:

Do not exceed the recommended dose. It is advisable to start fluoride intake before the teeth erupt. The drops are particularly suitable for facilitating administration in newborns. Zymafluor drops can be given to the newborn as they are or by adding them to the bottle containing a little water, in a single daily dose. Do not dissolve the drops in milk. After each use, carefully close the bottle. As soon as age allows it, it is recommended to use Zymafluor tablets by letting them dissolve in the mouth between the cheek and gums, now on the left side, now on the right side. It is recommended to take the tablets in the evening, before going to bed, after brushing your teeth, so that a high concentration of fluoride can be maintained in the mouth for a longer period of time. Administration should begin in early childhood, but not before 6 months of age.

Contraindications

Hypersensitivity towards one of the components of the product or substances closely related from a chemical point of view.

Side effects

Undesirable effects are listed below by system organ class and frequency (number of patients expected to have the reaction), using the following categories: • Very common (≥1/10) • Common (≥1/100, immune system Frequency not known Hypersensitivity reactions (including gastrointestinal symptoms)Gastrointestinal disordersFrequency not known Dental fluorosis At doses recommended for the prevention of dental caries, sodium fluoride has not shown to have noteworthy side effects. However, rare cases of modest skin rashes (erythema, rash, urticaria) have been reported. They disappear quickly when treatment is stopped. Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

If a supplementary fluoride intake is considered, the quantities of fluorides ingested through other sources should be taken into consideration and overdose should be avoided. In patients with renal impairment, the product should be administered only after consulting the doctor. In areas where table salt or water is fluoridated, the dosage of Zymafluor should be reduced. If the water contains more than 0.7 mg/l of fluoride, supplementary fluoride intake is not recommended. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.

Pregnancy and breastfeeding

Zymafluor has been widely used during pregnancy for many years. If you decide to administer Zymafluor during pregnancy and breastfeeding, the recommended dose for the mother is 1 tablet of 1 mg of Zymafluor per day (equal to 1 mg of fluoride ions). The content of fluoride ions in breast milk, however, is negligible and the breast-fed baby is advised to administer 1 tablet of 0.25 mg or, preferably, given the age of the baby, 4 drops of Zymafluor per day ( equal to 0.25 mg of fluorine ions). The 0.25 mg tablets contain 38.239 mg of sorbitol per tablet. The 0.5 mg tablets contain 47.205 mg of sorbitol per tablet. The 1 mg tablets contain 36.509 mg of sorbitol per tablet. The 1.14ml/ml drops contain 66.6mg of sorbitol in 4 drops which is equivalent to 300mg/ml. Patients with hereditary fructose intolerance should not be given this medicine.

Expiration and conservation

Oral drops: cStore at a temperature not exceeding 30°C0.50 mg and 1 mg tablets: this medicine does not require any particular storage temperature. Store in the original packaging. Keep the bottle tightly closed to protect from moisture. 0.25 mg tablets: store at temperatures not exceeding 25°C. Store in the original packaging. Keep the bottle tightly closed.

Interactions with other drugs

The absorption of fluoride 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. An interval of two hours should elapse between the administration of Zymafluor and antacids.

Overdose

Chronic overdose The main manifestation of chronic ingestion of excessive quantities of fluoride, for example 2 mg of fluoride per day during the years necessary for the calcification of tooth enamel, consists in the formation of patches on the tooth enamel (dental fluorosis) see paragraph 4.8 effects unwanted. Chronic intoxication over a long period of time can also lead to skeletal fluorosis. Acute overdose Symptoms of acute overdose have been reported in adults following ingestion of more than 100 mg of fluorides. In adults this corresponds approximately to: more than 100 Zymafluor 1 mg tablets or 5 bottles of Zymafluor drops. The lethal dose in adults (70 kg) is approximately 5 g of sodium fluoride, which corresponds to 2.2 g of fluoride ions, in children the toxic dose of sodium fluoride which can be lethal in individual cases is 11 mg/kg (equivalent to 5 mg/kg of fluorine ions). 2 g in adults causes serious intoxication. In these cases immediate hospitalization is mandatory. The initial symptoms are mainly related to gastro-intestinal intolerance: salivation, nausea, abdominal pain, thirst, vomiting and haemorrhagic diarrhoea. These symptoms may be followed by tiredness, muscle weakness, tremor, paraesthesia in the extremities and face, central nervous system depression, tetany, possible convulsions, shortness of breath, respiratory, cardiac and renal failure, progressive respiratory paralysis, shock. Death can occur within 2-4 hours. Hypocalcemia and hypoglycemia are frequently encountered findings. Treatment: - if they have been ingestedless than 5.0 mg/kg body weightof fluorine ions, corresponding for a child weighing 10 kg less than: 2 bottles of Zymafluor drops or 200 Zymafluor 0.25 mg tablets • administer calcium (milk) orally to relieve gastro-intestinal symptoms and keep under observation for a few hours. - if they have been ingestedmore than 5 mg/kg body weightof fluorides, corresponding for a child weighing 10 kg to more than: 2 bottles of Zymafluor drops or 200 Zymafluor 0.25 mg tablets • induce vomiting; • administer soluble calcium orally in any form (e.g. milk, calcium gluconate 5% or a calcium lactate solution); • arrange for immediate hospitalization. The treatment scheme is based on the following principles: hospital treatment is required in order to empty the stomach by aspiration and gastric lavage with lime water or a 1% calcium chloride solution or another calcium salt in order to make precipitate fluorine ions. Administration of aluminum hydroxide after gastric lavage may reduce the absorption of fluoride ions. Implement cardiac monitoring (watch for elevated T waves and prolonged QT intervals). To control convulsions, 10 ml of a 10% calcium gluconate solution can be administered intravenously, repeating the injections, if necessary, every 4-6 hours. If necessary, administer morphine or pethidine by injection to control colic. Support the circulation with suitable infusions of electrolyte solutions. Breathing may need assistance. Hemodialysis may be necessary. Vomit, 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 alkalized.

Active principles

Zymafluor oral drops1 ml of solution contains: active ingredient sodium fluoride 2.52 mg (equal to fluorine ions 1.14 mg).Zymafluor tablets 0.25 mgEach tablet contains: active ingredient sodium fluoride 0.56 mg (equal to fluoride ions 0.25 mg).Zymafluor tablets 0.50 mgEach tablet contains: active ingredient sodium fluoride 1.105 mg (equal to fluoride ions 0.50 mg).Zymafluor tablets 1 mgEach tablet contains: active ingredient sodium fluoride approximately 2.3 mg (equal to fluorine ions 1 mg). Excipients with known effects: benzoic acid and sorbitol For the full list of excipients, see section 6.1.

Excipients

Oral drops: benzoic acid; glycerol; non-crystallizable liquid sorbitol; purified water.Tablets 0.25 mg: sorbitole; anhydrous colloidal silica; mint essence; magnesium stearate.Tablets 0.50 mg:sorbitol; anhydrous colloidal silica; magnesium stearate; mint essential oil powder; E 172; mixture of dyes E172 and E171.1 mg tablets:sorbitol; anhydrous colloidal silica; dye E172; magnesium stearate.