FLUORETTEN 0.25 mg tablets, 300 pcs

Area of application

Fluoretten 0.25 mg tablets are a medicine used to prevent tooth decay.The active ingredient in this preparation is sodium fluoride.No prescription is required for this product.

Active ingredients / ingredients / ingredients

Each lozenge contains 0.553 mg of sodium fluoride, which corresponds to 0.25 mg of fluoride.The following excipients are also included: lactose monohydrate, spray-dried arabic gum, macrogol 4,000, magnesium stearate (vegetable), saccharin sodium and raspberry flavor.

Contraindications

The medicine must not be used if there is hypersensitivity to sodium fluoride or any of the other ingredients.It should also not be used if sufficient fluoride is already supplied through fluoridated table salt, drinking, mineral or table water.Children under 3 years of age should not use toothpaste containing fluoride.

Dosage

The dosage of Fluoretten 0.25 mg tablets depends on the child's age and other fluoride intake.It is important that only an oral form of fluoride administration is used.The pediatrician or dentist should consider the use of fluoridated table salt, fluoride tablets, gels/varnishes, fluoride-rich mineral water and the fluoride content of drinking water.

If the fluoride concentration in drinking water or mineral water is more than 0.7 mg/l, additional administration of fluoride tablets is not necessary.In Germany, the fluoride content of drinking water is usually below 0.3 mg/l.

The recommended dosage is as follows:

Age 0 to under 3 years: Fluoride concentration in drinking water/mineral water below 0.3 mg/l = 0.25 mg fluoride per day.Fluoride concentration in drinking water/mineral water below 0.3 - 0.7 mg/l = 0.00 mg fluoride per day.

Age 3 to under 6 years: Fluoride concentration in drinking water/mineral water below 0.3 mg/l = 0.5 mg fluoride per day.Fluoride concentration in drinking water/mineral water below 0.3 - 0.7 mg/l = 0.25 mg fluoride per day.

Age from 6 years: Fluoride concentration in drinking water/mineral water below 0.3 mg/l = 1.0 mg fluoride per day.Fluoride concentration in drinking water/mineral water below 0.3 - 0.7 mg/l = 0.5 mg fluoride per day.

Application should begin as early as possible and be carried out consistently at least during the first 12 years of life.Continuing prophylaxis into adulthood is recommended.

In the event of a slight overdose, the preparation can be discontinued for a few days.If large amounts of fluoride are acutely ingested, symptoms such as nausea, vomiting, abdominal pain and diarrhea may occur.For fluoride amounts up to 100 mg or 5 mg/kg body weight, administration of calcium is recommended.An acute overdose must be avoided at all costs.

In the event of a long-term overdose, the preparation must be discontinued.There is the possibility of enamel stains forming on the permanent teeth and, in the event of a very significant, long-term overdose, bone structure disorders can develop.

Intake

The lozenges should be sucked slowly as part of the effect comes from the locally higher fluoride concentrations in the mouth.Infants and young children can be given the crushed lozenge on a spoon with food, water or tea.It can be added to bottle feeding if it is expected that the bottle will be completely drunk.

The best time to use it is in the evening after brushing your teeth, as the high fluoride concentrations on the teeth are retained for a particularly long time.

Patient information

Particular caution is required when taking it in premature and malborn infants as well as in children with severe chronic illnesses that impair growth.Infants who receive a balanced nutrient intake and children on a balanced diet do not require additional fluoride administration.

If the water used to prepare the food contains more than 0.3 mg of fluoride per liter, additional fluoride administration is not necessary.When using fluoridated table salt, additional fluoride administration should be avoided.

Do not increase the dosage of the preparation beyond the recommended dose, as enamel stains can develop on the permanent teeth with constant overdose and bone structure disorders can develop with very significant, long-term overdose.

Pregnancy

According to current knowledge, the drug has no harmful effects on child development or birth.There is no evidence that the medicine should not be used during breastfeeding.

Other

The simultaneous intake of calcium and magnesium does not significantly reduce the absorption of fluoride.In the first two years of life, combined rickets and caries prophylaxis can be carried out with a combination preparation containing vitamin D/sodium fluoride.In this case, the use of Fluoretten 0.25 mg tablets should be avoided.

Manufacturer

Zentiva Pharma GmbH, Linkstrasse 2, 10785 Berlin