DEKRISTOL Fluor 500 IU/0.25 mg tablets, 90 pcs

Instructions for use for DEKRISTOL Fluor 500 IU/0.25 mg tablets, 90 pcs

Detailed instructions for DEKRISTOL Fluor 500 IU/0.25 mg tablets, 90 pcs

Field of use

Dekristol Fluor 500 I.E./0.25 mg tablets (pack size: 90 pc) for combined, preventive treatment of caries and rachitis in infants and children up to the age of 18 months when the fluoride concentration in drinking/mineral water below 0 , 3 mg/l lies and no other fluoride is taken (e.g. fluoride tablets, use of fluoride -containing toothpaste, fluoride salt).

Active ingredients / ingredients / ingredients

Ingredients of Dekristol Fluor 500 I.E./0.25 mg tablets (pack size: 90 pc) :

Colecalciferol dry concentrate
500 Ie Colecalciferol
12.5 µg Colecalciferol
0.55 mg sodium fluoride
0.25 mg fluoride ion
alpha-tocopherol auxiliary material (+)
Carboxymethylar, sodium salt auxiliary material (+)
Cellulose, microcrystalline auxiliary substance (+)
Magnesium stair (Ph. EUR.) [pflanzlich] Hedge material (+)
Corn starch auxiliary substance (+)
Natrium Ascorbate Hedge substance (+)
Poly {O-[hydrogen-(oct-1-en-1-yl) succinyl] strength}, sodium salt auxiliary substance (+)
Povidon K25 Hedge material (+)
0.96 mg sucrose auxiliary material (+)
Silicium dioxide, high disperser auxiliary substance (+)
Triglyceride, medium -chain auxiliary material (+)
23 mg total sodium ion hedge material (+)
Total sodium ion hedge material (+)

Contradictions

In the case of known hypersensitivity to individual ingredients , Dekristol Fluor 500 I.E./0.25 mg tablets (pack size: 90 pc) should not be taken.

dosage

Dosage of Dekristol Fluor 500 I.E./0.25 mg tablets (pack size: 90 pc):

Infants and toddlers up to the age of 18 months receive 1 tablet daily (corresponding to 0.0125mg or 500 i.e. vitamin D3 and 0.25 mg fluoride) as preventive treatment. DEKRISTOL Fluor 500 I.E./0.25 mg tablets (pack size: 90 pc) is not intended for early or deficiency-born infants (body weight of less than 3000 g) and children over 18 months.

Let the tablet decay on a teaspoon or in a small transparent vessel (e.g. a small glass) into approx. 5-10ml of water. The decay takes 1-2 minutes. The decay can be accelerated by slightly moving the teaspoon.

Taking

• Let the tablet decay on a teaspoon or in a small transparent vessel (e.g. a small glass) into approx. 5 - 10 ml of water. The decay takes 1 - 2 minutes. The decay can be accelerated by slightly moving the teaspoon. Unwanted complications, such as B. to avoid accidental penetration of the tablet into the airways ("swallowing"), the tablet must never administered infants and small children without any problems. The dissolved tablet afterwards to better exploit the local fluoride effects in the mouth (if possible). The best time of application is in the evening after brushing your teeth, as the high fluoride concentrations on the teeth are retained longer. If a fluoride -containing toothpaste is used, treatment with the medicine must be ended. If further treatment with vitamin D3 is required, the doctor should be asked for advice.
• When adding the crumbled tablets for a bottle or pet mole, make sure that the entire portion is used up, otherwise the entire amount of active ingredient is not added. Cook/heat the food first and let it cool before you add the tablet.

Patient information

• Warnings and Precautions
  • Please speak to your doctor or pharmacist before giving the medicine.
  • Special caution is required,
    • if your child is fed with balance sheet diets (e.g. due to a congenital metabolic disease) or if your bottle food is produced with drinking or mineral water, which contains more than 0.3 mg fluoride per liter. In this case, an additional fluoride intake (e.g. with fluoride tablets) is not recommended.
    • if milk is used with vitamin D3. In this case, the addition of vitamin D3 may not be necessary.
    • if your child tends to calcium kidney stones.
    • if your child suffers from sarcoidosis because the risk of increasing conversion of vitamin D3 insists in its active shape. In this case, the calcium levels in the blood and urine should be monitored in your child.
    • if the parathormone household is disturbed (pseudohypoparathyroidism), since the vitamin D requirement can be reduced by the phases of normal vitamin D sensitivity. Then there is a risk of long overdose. For this purpose, more controllable active ingredients with vitamin D activity are available.
  • The drug should also not be used if your child suffers from restricted kidney or liver function.
  • In the case of chronic diseases that affect growth, your doctor must decide in individual cases on the use of this combination prophylaxis (prevention), since due to the solid combination, an appropriate dosage of fluoride and vitamin D3 cannot be possible. In order to avoid overdosing fluoride, your child's body weight must be at least 3000 g.
  • If a malabsorption (poor absorption of nutrients from the digestive system) has been found in your child, the application is not recommended. The recommended dosage may not be enough to cover the daily need for vitamin D3. Higher doses can lead to an overdose of fluoride and are therefore not recommended.
  • If other vitamin D3-containing medicines are prescribed, the dose of vitamin D3 must be taken into account in this preparation. Additional administration of vitamin D3 or calcium should only be carried out under medical monitoring. In such cases, the calcium levels in the blood and urine must be monitored.
  • This medicine should be used particularly carefully in infants and toddlers, since they may not be able to swallow the tablets. It is recommended to dissolve the tablets as in the "Type of application" category.
  • During long -term treatment with the medicine, the calcium levels in the blood and urine should be monitored regularly and the kidney function should be checked by measuring the serum creatinine. This review is particularly important when treating heart glycosides (medicinal products for promoting the function of the cardiac muscles) or diuretics (medicinal products for promoting urine excretion).
  • In the case of hypercalcemia (increased calcium concentration in the blood) or hypercalcuria (increased calcium levels in urine), treatment must be interrupted. If there is signs of reduced kidney function, the dose must be reduced or the treatment is interrupted.
• Wateriness and ability to use machines
  • No clinical examinations were carried out.

Pregnancy

In pregnant and breastfeeding women, the application of DEKRISTOL fluor 500 I.E./0.25 mg tablets (pack size: 90 pc) is not intended.

Hints

Dekristol Fluor 500 I.E./0.25 mg tablets (pack size: 90 pc) contains saccharosis.

Manufacturer:  MIBE GmbH Arzneimittel, Munich Straße 15, 06796 Brehna