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Zymafluor D 500 Tabletten, 90 St

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Cholecalciferol (vitamin D _{3): The drug interferes with protein production.}It triggers the production of a protein from which binds calcium per se, and delivers it to the bloodstream. In this way, the blood calcium level is increased. Fluoride: About the mechanism of action are no hard evidence before.The following mechanisms are discussed: inhibition of acid producing microorganisms in dental plaque, installed in the enamel and thus a higher resistance to acids, as well as an improvement of the mineral balance of the tooth enamel.

What is included in medicines?

The amounts indicated are based on 1 tablet

Active substance	Colecalciferol	12.5 microgram
Excipient	Cellulose, microcrystalline	+
Excipient	Gelatin	+
Excipient	Sucrose	+
Excipient	Cornstarch	+
Excipient	Silica, fumed	+
Excipient	Vanillin	+
Excipient	Soy	+
equivalent	Colecalciferol	500 International Units
Active substance	Sodium fluoride	0.553 mg
equivalent	Fluoride ion	0.25 mg
Excipient	Crospovidone	+
Excipient	Magnesium stearate	+
Excipient	Saccharin sodium 2-Water	+
Excipient	DL alpha tocopherol	+
Excipient	Lactose-1-water	+

What adverse effects may occur?

For the drug are no known side effects when used as intended. Overdose If overdose is suspected, or change during treatment, consult your doctor or pharmacist. For information on this point in particular side effects are taken into account, the occur in at least one of 1,000 patients treated.

How is the drug dosage?

Who?	Single dose	Total dose	When?
Infants and young children during the first two years of life	1 tablet	1 tablet per day	to the meal

Please take into consideration the additional fluoride intake from food, beverages and drugs in dosage. Inform yourself. Consult your doctor or pharmacist

Product Details

Applications of Zymafluor® D 500 tablets

In order to prevent rickets and caries in infants and young children under the age of 2 years of age.

Dosage of Zymafluor® D 500 tablets

Infants and young children up to 2 years received preventive treatment daily 1 tablet.

To ensure that only a systemic form of fluoride intake is used, the pediatrician or dentist should stop taking fluoridated salt, fluoride tablets (including the daily dose), consider fluoride-rich mineral water and the fluoride content of drinking water at the dose recommendation.

The following dosage schedule is indicative of a supplementary Flouridzufuhr. When 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 dose must be maintained regularly, 1 tablet daily of the respective strength:

	Fluoride concentration in drinking water / mineral water (mg / l)
	<0.3	0,3 - 0,7	> 0.7
Age	Fluoride (mg / day)
0 to <3	0.25	-	-
3 to <6	0.5	0.25	-
from 6	1	0.5	-

Duration of treatment:

The duration of treatment, the doctor decides. If insufficient amounts of fluoride and vitamin D be obtained from the diet in the long run, solltedas drugs are taken by the end of the second year

Overdose:

In acute poisoning with sodium fluoride following symptoms may occur: gastrointestinal disturbances (nausea, vomiting, diarrhea, bleeding, abdominal pain or cramps), fatigue, tremor, seizures, difficulty breathing, cardiovascular symptoms (collapse, asystole).

In chronic overdose of sodium fluoride in the first years of life a dental fluorosis with enamel defects at the permanent dentition and at very considerable, long-term overdose can develop disorders of bone formation.

Long-term overdose of vitamin D (from 1800 IU per day) can lead to hypercalcemia and hypercalciuria. With significant and prolonged exceeding the requirements may lead to calcification of parenchymal organs.

Lost revenue:

Once a tablet was forgotten the gift will continue unchanged, ie a previously forgotten day intake will not be rescheduled. Where the medicinal product is not given over several weeks, as may be extended after consultation with your doctor the gift to the corresponding period.

Interactions of Zymafluor® D 500 tablets

Please inform your doctor or pharmacist if you are taking other medicines / are taking or have recently taken / used, even if it is obtained without a prescription.

The drug should be prescribed by a doctor along with other medicines that contain vitamin D, given only in exceptional cases.

Side effects of Zymafluor® D 500 tablets

Like all medicines, the drug can cause side effects, although not everybody gets them.

: In evaluating side effects Frequencies are defined as
Very common: more than 1 user in 10
Common: 1 to 10 users in 100
Uncommon: 1 to 10 users in 1,000
Rare: 1 to 10 users in 10,000
Very rare: less than 1 in 10,000
Not known: frequency can not be estimated from the available data

Possible side effects
If used properly, are not expected side effects.

Tablet excipients may rarely cause allergic reactions.

Please tell your doctor or pharmacist if any of the side effects
gets serious, or if you notice any side effects not listed here.

Contraindications

Must not be given,

- In case of hypersensitivity (allergy) to sodium fluoride, colecalciferol or any of the excipients

- When the calcium in the blood (hypercalcaemia) or urine (hypercalciuria) is increased,

- With limited range of motion (eg due to a plaster cast) or

- If fluorides are supplied in a different way, for example, with drinking, mineral or tap water.

pregnancy and breast feeding period

This medicine is only for children.

Application

Disintegrate each 1 tablet in a teaspoon of liquid. Then best be administered directly into the mouth.

Note: To prevent unwanted complications such as accidental "swallowed" the tablet into the airways, the tablet should never be administered unresolved!

Patient Instructions

In premature infants and infants lack the caries prevention should begin by systemic fluoride intake only after reaching a body weight of 3000 g and normal physical development.

When infants are fed with balanced diets or if their infant formula is prepared with drinking or mineral water, which contains about 0.3 * mg / l of fluoride, or the artificial baby milk is enriched with plenty of vitamin D, the gift of the drug is not recommended. (For children who are exclusively breastfed, this restriction does not apply.)

* In the Federal Republic of Germany, the fluoride content in drinking water - with some exceptions - below 0.3 mg / l. Please inquire about the local water authority the fluoride content of the tap water in your community.

The administration of fluoride tablets in children who received a balanced diet because of a congenital metabolic disorder, not required. In severe, long-lasting, affecting the growth of disease has to be weighed by your doctor if the drug can be given. Unless systemic fluoride is supplied, no fluoride-containing toothpastes should be used in children under 3 years.

Driving and using machines: Not applicable.

Store drug out of reach of children.

Composition of Zymafluor® D 500 tablets

Containing 1 tablet.

Active ingredients

500 IU cholecalciferol
0.01mg colecalciferol
00:55 mg sodium fluoride
00:25 mg fluoride ion

Excipients

Magnesium stearate
Crospovidone
Silica, fumed
Saccharin sodium 2-Water
Cellulose, microcrystalline
Gelatin (bovine)
Vanillin
Soybean oil
Sucrose
Cornstarch
Lactose-1-water
DL -? - Tocopherol

For risks and side effects read the package insert and ask your doctor or pharmacist.