ZYMAFLUOR * 100CPR 0.50MG

ZYMAFLUOR * 100CPR 0.50MG

Therapeutic indications

Prevention of dental caries.

Dosage and method of use

The daily dose should be commensurate with the age of the child as well as the fluoride content of the drinking water and the 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 fluorine content of the drinking water:

If the drinking water is not fluorinated, it is advisable to prescribe the following dosage:

Do not exceed the recommended dose. It is recommended to start the fluoride intake before the teeth erupt. The drops are particularly suitable for facilitating administration in the newborn. To the newborn the drops of Zymafluor can be given 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, close the bottle carefully. As soon as age permits, it is recommended to use Zymafluor tablets 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 kept in the mouth for a longer period of time. Administration should begin in infancy, but not earlier than 6 months of age.

Contraindications

Hypersensitivity to one of the components of the product or closely related substances 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 been shown to have any noteworthy side effects. However, rare cases of mild rashes (erythema, rash, urticaria) have been reported. They disappear rapidly with discontinuation of treatment. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio 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 intake of fluoride is considered, the quantities of fluorides ingested through other sources should be considered and an overdose should be avoided. In patients with renal impairment, the product should only be administered after consulting your 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 (23 mg) sodium per dose, i.e. essentially 'sodium-free'.

Pregnancy and breastfeeding

Zymafluor was used extensively for many years during pregnancy. If the decision is made to administer Zymafluor during pregnancy and breastfeeding, the recommended dose for the mother is 1 tablet of 1 mg of Zymafluor per day (equivalent to 1 mg of fluorine). The content of fluor-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 child's age, 4 drops of Zymafluor per day ( equal to 0.25 mg of fluorine ions). 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. 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 retention

Oral drops: ckeep 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 in order to protect from moisture. 0.25 mg tablets: store at a temperature 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, or with antacids containing calcium, aluminum or magnesium salts. An interval of two hours should elapse between administration of Zymafluor and antacids.

Overdose

Chronic overdose The main manifestation of a chronic ingestion of excessive amounts of fluoride, for example 2 mg of fluoride per day during the years necessary for the calcification of the tooth enamel, is the formation of patches on the tooth enamel (dental fluorosis) see section 4.8 effects unwanted. Chronic intoxication over a long period of time can also lead to skeletal fluorosis. Acute overdose Acute overdose symptoms have been reported in adults following ingestion of more than 100 mg of fluoride ions. In adults this corresponds approximately to: more than 100 tablets of Zymafluor of 1 mg or 5 bottles of Zymafluor drops. The lethal dose in adults (70 kg) is about 5 g of sodium fluoride, which corresponds to 2.2 g of fluoride, in children the toxic dose of sodium fluoride which can be lethal in single cases is 11 mg / kg (equivalent to 5 mg / kg of fluorine ions). 2 g in adults causes severe intoxication. In these cases, immediate hospitalization is mandatory. Initial symptoms are mainly related to gastrointestinal intolerance: salivation, nausea, abdominal pain, thirst, vomiting and hemorrhagic diarrhea. These symptoms may be followed by fatigue, 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 frequent findings. Treatment: - if they have been ingestedless than 5.0 mg / kg body weightof fluor-ions, corresponding for a child weighing 10 kg to less than: 2 bottles of Zymafluor drops or 200 tablets of Zymafluor of 0.25 mg • give calcium (milk) orally to relieve gastro-intestinal symptoms and keep under observation for a few hours. - if they had been ingestedmore than 5 mg / kg of body weightof fluor-ions, corresponding for a child weighing 10 kg to more than: 2 bottles of Zymafluor drops or 200 tablets of Zymafluor of 0.25 mg • induce vomiting; • administer soluble calcium orally in any form (eg milk, 5% calcium gluconate or a calcium lactate solution); • provide for immediate hospitalization. The therapeutic 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 precipitate the fluorine ions. Administration of aluminum hydroxide after gastric lavage may reduce the absorption of fluor-ions. Carry out cardiac monitoring (pay attention to elevated T waves and lengthened QT intervals). To control seizures, 10 ml of a 10% calcium gluconate solution can be given intravenously, with repeated injections every 4 to 6 hours if necessary. If necessary, inject morphine or pethidine in order to control colic. Support the circulation with suitable infusions of electrolytic solutions. Breathing may need assistance. Hemodialysis may be required. Vomiting, faeces and urine should be promptly removed with water to prevent external burns from forming. 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 1.14 mg fluoride-ions).Zymafluor tablets 0.25 mgEach tablet contains: active ingredient sodium fluoride 0.56 mg (equal to 0.25 mg fluoride-ions).Zymafluor tablets 0.50 mgEach tablet contains: active ingredient sodium fluoride 1.105 mg (equal to 0.50 mg fluoride ions).Zymafluor tablets 1 mgEach tablet contains: active ingredient sodium fluoride 2.3 mg ca (equal to 1 mg fluoride ions). Excipients with known effects: benzoic acid and sorbitol For a full list of excipients, see section 6.1.

Excipients

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