ZYMAFLUOR * 100CPR 0.50MG
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:
| CONCENTRATION OF FLUORIDE IN WATER (MG / L) || || 0.3-0.7 || > 0.7 |
|Supplementary intake of fluoride recommended || || || |
| Age ||(Mg / F-/day) |
|from 2 weeks 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 |
If the drinking water is not fluorinated it is recommended to prescribe the following dosage:
| During pregnancy and breastfeeding: ||1 tablet 1 mg per day |
| Children: || |
|- from 2 weeks up to 2 years: ||4 drops a day |
|or 1 tablet 0.25 mg per day |
|- from 2 to 4 years: ||2 tablets 0.25 mg per day |
|1 tablet of 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-ions; 1 ml = 18 drops) Do not exceed the recommended dose. It is recommended to start the fluoride intake before the teeth erupt. The drops are particularly suitable to facilitate 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.
Hypersensitivity to one of the components of the product or closely related substances from a chemical point of view.
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, urticaria) have been reported. They disappear quickly with discontinuation of treatment.
If a supplementary intake of fluoride is considered, the quantities of fluorides ingested through other sources should be taken into consideration and an overdose should be avoided. 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. Keep this medicine out of the reach of children.
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-ions). The content of fluorine-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).
Expiration and retention
Oral drops: no particular. Tablets 0.50 mg and 1 mg: This medicinal product does not require any special storage temperatures. 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.
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 required for tooth enamel to calcify, is the formation of patches on the tooth enamel. Acute overdose Acute overdose symptoms have been reported in adults following ingestion of more than 100 mg of fluorine 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 the adult (70 kg) is reported to lie between 2.2 g - 4.5 g of fluorine – ions. In children weighing 10 kg, just over 200 mg of fluoride ions can be fatal. The reported values correspond approximately to: 10 bottles of Zymafluor drops or 900 tablets of Zymafluor of 0.25 mg. Initial symptoms are mainly related to gastrointestinal intolerance: salivation, nausea, abdominal pain, vomiting and diarrhea. These symptoms can be followed by muscle weakness, chronic convulsions, respiratory, heart and kidney failure. Death can occur within 2–4 hours. Hypocalcemia and hypoglycemia are frequent findings. Treatment: • if less than 5.0 mg / kg body weight of fluorions have been ingested, corresponding for a child weighing 10 kg less than: 2 bottles of Zymafluor drops or 200 tablets of Zymafluor of 0.25 mg - administer calcium (milk) orally to relieve gastrointestinal symptoms and keep under observation for a few hours. • if more than 5 mg / kg body weight of fluorine-ions have been ingested, 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 the He retched; - administer soluble calcium by mouth in any form (e.g. milk, calcium gluconate 5% or a calcium lactate solution); - keep under observation for a few hours in the emergency room. • if more than 15 mg / kg body weight of fluorions have been ingested, corresponding for a child weighing 10 kg to more than: 6 bottles of Zymafluor drops or 600 tablets of Zymafluor of 0.25 mg - proceed immediately hospitalization. The therapeutic scheme is based on the following principles: inpatient treatment is required in order to empty the stomach by aspiration and gastric lavage with lime water or a solution of calcium chloride at 1% or another calcium salt in order to precipitate the fluorine-ions. Administration of aluminum hydroxide after gastric lavage may reduce the absorption of fluorine 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 administered intravenously%, repeating the injections, if necessary, every 4–6 hours. 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.
Zymafluor oral drops 1 ml of solution contains: active ingredient sodium fluoride 2.52 mg (equal to 1.14 mg fluorine-ions). Zymafluor tablets 0.25 mg Each tablet contains: active ingredient sodium fluoride 0.56 mg (equal to 0.25 mg fluorine-ions) Zymafluor tablets 0.50 mg Each tablet contains: active ingredient sodium fluoride 1.105 mg (equal to 0.50 mg fluoride). Zymafluor tablets 1 mg Each tablet contains: active ingredient 2.3 mg sodium fluoride (equivalent to 1 mg fluoride).
Oral drops: benzoic acid; glycerol; non crystallizable liquid sorbitol; purified water. 0.25 mg tablets: sorbitulum; anhydrous colloidal silica; mint essence; magnesium stearate. Tablets 0.50 mg: sorbitol; anhydrous colloidal silica; magnesium stearate; powdered mint essential oil; E 172; mixture of E172 and E171 dyes. Tablets 1 mg: sorbitol; anhydrous colloidal silica; mixture of E172 and E171 dyes; strawberry flavor; magnesium stearate.