ZYMAFLUOR D 500 tablets, 3x300 pcs

Instructions for use for ZYMAFLUOR D 500 tablets, 3x300 pcs

Detailed instructions for ZYMAFLUOR D 500 tablets, 3x300 pcs

Field of use

• The medicine is a preventive remedy for tooth decay and rachitis.
• Application areas
  • For prevention against rickets and caries in infants and toddlers up to the 2nd year of life.

Active ingredients / ingredients / ingredients

12.5 µg Colecalciferol
500 Ie Colecalciferol
0.553 mg sodium fluoride
0.25 mg fluoride ion
alpha-tocopherol auxiliary material (+)
Cellulose, microcrystalline auxiliary material (+)
Crospovidon auxiliary material (+)
Gelatine auxiliary substance (+)
Lactose 1-water auxiliary substance (+)
Magnesium stair auxiliary material (+)
Corn starch auxiliary substance (+)
Saccharin sodium 2-water Hedge substance (+)
Saccharosis auxiliary substance (+)
Silicium dioxide, high disperser auxiliary substance (+)
SoybeansOil Hedge substance (+)
Vanillin auxiliary substance (+)

Contradictions

• The preparation must not be given,
  • in case of hypersensitivity (allergy) compared to sodium fluoride, Colecalciferol or one of the other components of the preparation,
  • if the calcium in the blood (hypercalcemia) or urine (hypercalcuria) is increased,
  • with limited mobility (e.g. because of a plaster association) or
  • if fluorides are fed in another way, e.g. B. with drinking, mineral or table water.

dosage

• Always take the medicine exactly according to this instruction. Please ask your doctor or pharmacist if you are not quite sure.
• Infants and toddlers up to 2 years receive 1 tablet for preventive treatment.
• In order to ensure that only a systemic form of fluoride intake is used, the pediatrician or the dentist should take into account the use of fluoridated dining salt, fluoride tablets (including the daily dose), fluoride -rich mineral water and the fluoride content of the drinking water in the dosage recommendation.
• The following dosing scheme indicates guidelines for the supplementary fluoride intake. If the fluoride concentration in drinking water/mineral water is more than 0.7 mg/l, an additional administration of fluoride tablets is not required.
• Unless otherwise prescribed, the following dosage must be observed regularly, 1 tablet each daily of the corresponding strength:
  • Age (years): 0 to
    • Fluoride concentration in drinking water / mineral water (mg / l):
      • Fluoride (mg/day): 0.25
  • Age (years): 3 to
    • Fluoride concentration in drinking water / mineral water (mg / l):
      • Fluoride (mg/day): 0.5
    • Fluoride concentration in drinking water / mineral water (mg / l): 0.3 - 0.7
      • Fluoride (mg/day): 0.25
  • Age (years): from 6
    • Fluoride concentration in drinking water / mineral water (mg / l):
      • Fluoride (mg/day): 1
    • Fluoride concentration in drinking water / mineral water (mg / l): 0.3 - 0.7
      • Fluoride (mg/day): 0.5

 

• Duration of the application
  • The doctor decides on the duration of the treatment.
  • If only insufficient amounts of fluoride and vitamin D are absorbed in the long run, the medicine should be taken by the end of the age of second.

 

• If you have given a larger amount than you should
  • The following symptoms can occur in acute poisoning with sodium fluoride: gastrointestinal disorders (nausea, vomiting, diarrhea, bleeding, abdominal pain or cramps), fatigue, tremor, seizures, breath, cardiovascular symptoms (collapse, asystolia).
  • With a chronic overdose of sodium fluoride in the first years of life Develop bit and with very significant, long -term overdose disorders of bone structure.
  • Long -term overdose of vitamin D (from 1800 I.E. per day) can lead to hypercalcemia and hypercalcuria. With considerable and long -term exceeding the need, calculations can occur parenchymatous organs.

 

• If you have forgotten to give the medicine
  • Once a tablet has been forgotten, the gift is continued unchanged, i.e. an intake forgotten the day before is not made up for.
  • If the preparation has not been given over several weeks, the gift can be extended by the corresponding period after consultation with your doctor.

Taking

• Let 1 tablet disassemble in a teaspoon with liquid. After that, it is best to give it directly into the mouth.
• Notice:
  • In order to prevent undesirable complications such as accidental "swallowing" of the tablet into the airways, the tablet should never be administered indoors!
    

Patient information

• Particular caution is required when taking it
  • In the case of early and deficiency-born infants, caries prophylaxis should only be used by systemic fluoride intake after a body weight of 3000 g and with normal physical development.
  • If infants are fed with accounted diets or if their bottle food is produced with drinking or mineral water, which contains over 0.3 mg/l* fluoride, or the artificial baby milk is sufficiently enriched with vitamin D, the administration of the drug is not recommended. (This restriction does not apply to children who are only breastfed.)
    • * In the Federal Republic of Germany, the fluoride content in drinking water - apart from exceptions - is below 0.3 mg/l. Please inquire about the fluoride content of your community's tap water via the responsible waterworks.
  • The administration of fluoride tablets is not necessary for children who receive a balance sheet due to an innate metabolic disorder.
  • In the case of severe, long -term diseases affecting growth, your doctor must weigh whether the medicine can be given.
  • If systemic fluoride intake takes place, no fluoride -containing toothpastes should be used in children under 3 years.

 

• Wateriness and operating machines
  • Not applicable.

Pregnancy

• This medicine is only intended for children.

 

Hints

Miscellaneous

- If the water (drinking, mineral or table water) used to prepare the infant or toddler contains more than 0.3 mg fluoride per liter, an additional fluoride intake is not required. - Do not use any additional fluoride (tablets or salt) while taking the drug- do not use fluoride-containing toothpaste when taking the drug

Manufacturer:  MEDA Pharma GmbH & Co.KG, Benzstraße 1, 61352 Bad Homburg