Composition
Active ingredients: 5 mg dry concentrate, cholecalciferol, 0.55 mg sodium fluoride.
Excipients: Crospovidone, Microcrystalline cellulose, Magnesium stearate (vegetable), Triglycerides, medium chain, Sucrose, corn starch, Lactose-1-water, (R, R, R)-α-tocopherol, Gum arabic, talc.
Scope
The drug is used for the comprehensive prevention of rickets and caries in infants and children of the first two years of age.
Dosage
Always take this medicine exactly as your doctor or pharmacist has advised you.
Unless otherwise prescribed by your doctor, the usual dose is 1 tablet for oral solution (equivalent to 500 IU vitamin D3 and 0.25 mg fluoride) per day from the end of the first week of life.
When determining the dosage, the doctor will consider other forms of fluoride administration.
A once-daily application corresponds to the fluoride dosage established by the German Nutrition Society (Reference Values for Nutrient Intakes of the German Nutrition Society, 1st edition, p. 185, 2000) for children under 4 years of age with a fluoride concentration in drinking/mineral water below 0.3 mg/l.
Duration of administration
The duration of administration of the product is determined by the doctor.
If insufficient fluoride and vitamin D are consumed with food over a long period of time, the product should be taken until the end of the second year of life.
If you have used more than you should
In case of a single overdose, no side effects are expected.
In case of a minor overdose, the product can be discontinued for several days depending on the dose taken and the duration of the overdose, while a low-calcium diet is prescribed.
Acute overdose
In case of acute ingestion of very high doses, treatment must be prescribed by a doctor. If necessary, treatment should be carried out in a hospital according to the criteria of intensive care.
Chronic overdose
Long-term overdose of fluoride in the first years of life may lead to staining of the enamel of permanent teeth, and long-term severe overdose may lead to disturbances in bone formation. Long-term overdose of vitamin D (more than 1800 IU/day) may lead to increased calcium levels in the blood and urine, resulting in calcification of soft tissue. Overdose should be treated under medical supervision or in a hospital, if necessary, according to the criteria of intensive care.
Side effects
No side effects are expected when the product is used correctly.
Gastrointestinal disturbances (such as abdominal pain, diarrhea) have been reported (the frequency of this side effect is unknown, i.e. the frequency cannot be estimated from the available data). Since gastrointestinal complaints may also occur for other reasons in this age group, a doctor should be consulted.
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