ZYMAFLUOR

ZYMAFLUOR D 500 tablets

Important notes (mandatory information)

Zymafluor D 500. Areas of application: For the prevention of rickets and caries in infants and toddlers up to the completion of the 2nd year of life.

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


Instructions for use: Information for the user
Zymafluor D 500
Vitamin D3 500 I.U. and fluoride 0.25 mg per tablet
For use in infants and toddlers up to the completed 2nd year of life
Active ingredients: Colecalciferol and sodium fluoride

Read the entire instructions for use carefully, as they contain important information for you. This medicine is available without a prescription. However, Zymafluor D 500 must be used as prescribed to achieve the best possible treatment results.
. Keep the instructions for use. You may want to read them again later.
. Ask your pharmacist if you need more information or advice.
. If any of the listed side effects affect you significantly or if you notice side effects that are not listed in these instructions for use, please inform your doctor or pharmacist.

These instructions for use include
1. WHAT IS ZYMAFLUOR D 500 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ZYMAFLUOR D 500?
3. HOW SHOULD ZYMAFLUOR D 500 BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ZYMAFLUOR D 500 BE STORED?
6. FURTHER INFORMATION

1. WHAT IS ZYMAFLUOR D 500 AND WHAT IS IT USED FOR?

Zymafluor D 500 is a preventive measure against caries and rickets.

Areas of application
For the prevention of rickets and caries in infants and toddlers up to the completion of the 2nd year of life.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ZYMAFLUOR D 500?

Zymafluor D 500 must not be given
- in case of known hypersensitivity (allergy) to sodium fluoride, colecalciferol, soya, peanuts or other components of Zymafluor D 500.
- if the calcium in the blood (hypercalcemia) or in the urine (hypercalcuria) is increased,
- in case of restricted mobility (e.g. due to a plaster cast) or
- if fluorides are supplied in another way, e.g. with drinking, mineral or table water.

Special care should be taken when taking Zymafluor D 500 In premature and underweight infants, caries prophylaxis by means of systemic fluoride intake should only start after reaching a body weight of 3000 g and with normal physical development.

If infants are fed with balanced diets or if their bottle feed is prepared with drinking or mineral water that contains more than 0.3 mg/l fluoride, or if the artificial baby milk is sufficiently enriched with vitamin D, the administration of Zymafluor D 500 is not recommended. (This restriction does not apply to children who are exclusively breastfed.) The administration of fluoride tablets is not necessary for children who receive a balanced diet due to a congenital metabolic disorder.

In the case of severe, long-term illnesses that impair growth, your doctor should weigh up whether Zymafluor D 500 can be given. If systemic fluoride intake is taking place, fluoride-containing toothpastes should not be used in children under 3 years of age.

When taking Zymafluor D 500 with other medicines
Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines. Zymafluor D 500 should only be given together with other medicines that contain vitamin D in exceptional cases and as prescribed by a doctor.

Pregnancy and breastfeeding
This medicine is only intended for children.

Driving and operating machinery
Not applicable.

Important information about certain other components of Zymafluor D 500
This medicine contains lactose and sucrose. Please only take Zymafluor D 500 after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD ZYMAFLUOR D 500 BE TAKEN?

Always give your child Zymafluor D 500 exactly as instructed in these instructions for use. Please ask your doctor or pharmacist if you are not sure.

Infants and toddlers up to 2 years of age receive 1 tablet of Zymafluor D 500 daily for preventive treatment.

To ensure that only a systemic form of fluoride intake is used, the pediatrician or dentist should take into account the intake of fluoridated table salt, fluoride tablets (including the daily dose), fluoride-rich mineral water and the fluoride content of the drinking water when making the dosage recommendation.

The following dosage regimen provides guidelines for supplementary fluoride intake. If the fluoride concentration in the drinking water/mineral water is more than 0.7 mg/l, an additional dose of fluoride tablets is not necessary.

Unless otherwise prescribed, the following dosage should be adhered to regularly, 1 tablet daily of the corresponding strength

Fluoride concentration in drinking water / mineral water (mg/l)
	< 0.3	0.3 – 0.7	> 0.7
Age (years)	Fluoride (mg/day)
0 to <3	0.25	–	–
3 to <6	0.50	0.25	–
from 6	1.00	0.50	–

Method of application
Dissolve 1 tablet in a teaspoon with liquid. Then it is best to administer it directly into the mouth.

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

Duration of application
The doctor decides on the duration of the treatment. If insufficient amounts of fluoride and vitamin D are ingested with food in the long term, Zymafluor D 500 should be taken until the end of the second year of life.

If you have given more Zymafluor D 500 than you should
In the event of acute poisoning with sodium fluoride, the following symptoms may occur: gastrointestinal disorders (nausea, vomiting, diarrhea, bleeding, abdominal pain or cramps), fatigue, tremor, seizures, shortness of breath, cardiovascular symptoms (collapse, asystole). In the event of chronic overdose of sodium fluoride in the first years of life, dental fluorosis with enamel defects on the permanent teeth and, in the case of very significant, long-term overdose, bone growth disorders can develop. Long-term overdose of vitamin D (from 1800 I.U. per day) can lead to hypercalcemia and hypercalcuria. If the requirement is significantly and permanently exceeded, calcification of parenchymatous organs can occur.

If you have forgotten to give Zymafluor D 500
If a tablet of Zymafluor D 500 has been forgotten once, the administration is continued unchanged, i.e. an intake forgotten the day before is not made up for. If Zymafluor D 500 has not been given for several weeks, the administration can be extended by the corresponding period of time after consultation with your doctor.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Zymafluor D 500 can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated patients
Common:	1 to 10 in 100 treated patients
Uncommon:	1 to 10 in 1,000 treated patients
Rare:	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
Not known:	frequency cannot be estimated from the available data.

Possible side effects No side effects are to be expected if used properly. Soya oil can very rarely cause allergic reactions.

Please inform your doctor or pharmacist if any of the listed side effects affect you significantly or if you notice side effects that are not listed in these instructions for use.

5. HOW SHOULD ZYMAFLUOR D 500 BE STORED?

Keep medicines out of the reach of children.

Do not use the medicine after the expiry date which is stated on the folding box and blister after "Use by".

Storage instructions
Do not store above 25°C.

6. FURTHER INFORMATION

What Zymafluor D 500 contains 1 tablet contains as active ingredients 12.5 μg colecalciferol (equivalent to 5001 I.U. vitamin D3) and 0.553 mg sodium fluoride (equivalent to 0.25 mg fluoride).

The other ingredients are

Lactose 1H2O; microcrystalline cellulose; crospovidone; gelatin (beef); sucrose; magnesium stearate; corn starch; highly dispersed silicon dioxide; saccharin sodium 2 H2O; vanillin flavoring; soya oil; DL-a-tocopherol.

Appearance of Zymafluor D 500 and contents of the pack
Zymafluor D 500 are round, biconvex, white tablets and are available in packs of 30 tablets/N2, 90 tablets/N3 and as a hospital pack.

Pharmaceutical entrepreneur
Rottapharm I Madaus GmbH
51101 Cologne
Tel.: 0221/8998-0
Fax: 0221/8998-711
Email: info@rottapharm-madaus.de

Marketing authorization holder and manufacturer
Madaus GmbH
51101 Cologne

These instructions for use were last revised in April 2013.

Source: Information from the package leaflet
Status: 08/2015
Areas of application: For the prevention of rickets and caries in infants and toddlers up to the completion of the 2nd year of life.