FLUORETTEN

D FLUORETTEN 500 tablets

Important notes (mandatory information)

D-Fluoretten 500 I. U., tablets for preparing a solution for oral administration, for use in infants and toddlers up to 2 years of age Areas of application: for the combined prevention of rickets and caries in infants and children in the first two years of life.

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


Patient information: Information for the user
For use in infants and toddlers up to 2 years of age
D-Fluoretten 500 I. U., tablets for preparing a solution for oral administration
Active ingredients: Colecalciferol dry concentrate, sodium fluoride

Read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, D-Fluoretten 500 I. U. must be used as directed in order to achieve the best possible treatment results.
- Keep the package leaflet. You may want to read it again later.
- Ask your pharmacist if you need more information or advice.
- If any of the listed side effects occur severely or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT ARE D-FLUORETTEN 500 I. U. AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING D-FLUORETTEN 500 I. U.?
3. HOW SHOULD D-FLUORETTEN 500 I. U. BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD D-FLUORETTEN 500 I. U. BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE D-FLUORETTEN 500 I. U. AND WHAT ARE THEY USED FOR?
D-Fluoretten 500 I. U. is a vitamin and mineral supplement with the active ingredients colecalciferol (vitamin D3) and sodium fluoride.
D-Fluoretten 500 I. U. is used for the combined prevention of rickets and caries in infants and children in the first two years of life.

2. WHAT SHOULD YOU CONSIDER BEFORE USING D-FLUORETTEN 500 I. U.?
D-Fluoretten 500 I. U. must not be used,
- if your child is hypersensitive (allergic) to colecalciferol, sodium fluoride or any of the other ingredients of D-Fluoretten 500 I. U.,
- if your child has excessive calcium in their blood,
- if your child excretes increased amounts of calcium in their urine,
- if your child's mobility is restricted (e.g. due to a plaster cast),
- if you are already giving your child sufficient fluoride through e.g. fluoridated table salt, drinking, mineral or table water.

Special care should be taken when taking D-Fluoretten 500 I. U.
- if your child was born prematurely or with a low birth weight. In this case, caries prevention with D-Fluoretten 500 I. U. should only begin after a body weight of 3000 g has been reached and with normal physical development.
- if your child is prone to kidney stones or suffers from sarcoidosis (Morbus Boeck),
- if your child is being treated with thiazides (diuretics). In these cases, special care should be taken when administering vitamin D (risk of excessive calcium in the blood and urine).
- if your child has a serious chronic illness that affects growth. In this case, you should consult the treating physician as to whether caries prevention with fluoride is suitable for your child.

Infants who are fed a balanced diet and children who receive a balanced diet due to a congenital metabolic disorder do not require D-Fluoretten 500 I. U. If you use vitamin D3-enriched milk to prepare your child's food, it may not be necessary to administer vitamin D3 as a medication. If the water used to prepare your child's food (drinking, mineral or table water) contains more than 0.3 mg fluoride per litre, additional administration of fluoride-containing tablets is not necessary*. In these cases, only rickets prevention with vitamin D3 should be carried out. This restriction does not apply if you are exclusively breastfeeding your child, as fluoride passes into breast milk only to a very small extent.

*In the Federal Republic of Germany, the fluoride content in drinking water - with a few exceptions - is below 0.3 mg per litre. The fluoride content can be obtained from the responsible waterworks.

If you are already carrying out combined prevention of rickets and caries with DFluoretten 500 I. U. for your child, please refrain from further fluoride administration, e.g. as tablets or fluoridated salt.
Fluoride-containing toothpastes should not be used in children under 3 years of age who are taking D-Fluoretten 500 I. U. (due to the risk of swallowing the toothpaste).

When using D-Fluoretten 500 I. U. with other medicines
Please inform your doctor or pharmacist if your child is taking or has recently taken any other medicines, even if they are non-prescription medicines. If thiazides (diuretics) are taken at the same time, the risk of excessive calcium in the blood (hypercalcaemia) is increased. D-Fluoretten 500 I. U. should only be given in exceptional cases and under monitoring of the calcium levels in the blood together with other medicines that contain vitamin D.

When using D-Fluoretten 500 I. U. with food and drink
The simultaneous intake of calcium and magnesium, as occurs in a diet with milk and dairy products, does not significantly reduce the absorption of fluoride.

Pregnancy and breastfeeding
D-Fluoretten 500 I. U. is only intended for use in children.

Driving and operating machinery
Not applicable.

Important information about certain other ingredients of D-Fluoretten 500 I. U.
This medicine contains lactose and sucrose. Please only administer D-Fluoretten 500 I. U. after consulting your doctor if you know that your child has an intolerance to certain sugars.

3. HOW SHOULD D-FLUORETTEN 500 I. U. BE USED?
Always use D-Fluoretten 500 I. U. exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is 1 tablet per day for preparing a solution for oral administration (corresponding to 500 I. U. vitamin D3 and 0.25 mg fluoride) from the end of the first week of life. When determining the dosage, the doctor will take into account other forms of fluoride intake. The once-daily use of D-Fluoretten 500 I. U. corresponds to the fluoride dosage specified by the German Nutrition Society (reference values for nutrient intake of the German Nutrition Society, 1st edition, p. 185, 2000) for children under 4 years of age with a fluoride concentration in drinking water/mineral water below 0.3 mg/l.

Method of administration
Place the tablet for preparing a solution for oral administration in the bottle with about 2-3 tablespoons of liquid, e.g. tea or water, allow to dissolve and administer to the child or dissolve the tablet for preparing a solution for oral administration on a teaspoon with liquid and give the solution directly into the child's mouth (the solution for oral administration is tasteless). It is important that the solution is taken before a meal so that the active ingredients of D-Fluoretten 500 I. U. are fully administered to the child.

Duration of use
The doctor decides on the duration of administration of D-Fluoretten 500 I. U. If insufficient amounts of fluoride and vitamin D are taken in with the food in the long term, D-Fluoretten 500 I. U. should be taken until the end of the second year of life.

If you have used more D-Fluoretten 500 I. U. than you should
No side effects are to be expected in the event of a single overdose. In the event of a slight overdose, the preparation can be discontinued for a few days, depending on the dose taken and the duration of the overdose, while simultaneously administering a low-calcium diet.

Acute overdose
In the event of acute ingestion of very high doses, treatment should be decided by a doctor. Treatment should be carried out in a hospital, if necessary, according to intensive medical criteria.

Chronic overdose
In the event of long-term overdose of fluoride in the first years of life, there is a possibility of enamel mottling on the permanent teeth and, in the event of very significant, long-term overdose, bone development disorders may develop. Long-term overdose of vitamin D (from 1800 I. U./day) can lead to increased calcium levels in the blood and urine and consequently to soft tissue calcification. Treatment of an overdose should be carried out under medical supervision or in a hospital, if necessary, according to intensive medical criteria.

If you forget to use D-Fluoretten 500 I. U.
If the administration of D-Fluoretten 500 I. U. has been forgotten once, it is recommended to continue administering D-Fluoretten 500 I. U. as usual, i.e. an intake forgotten on the previous day is not made up for. If the preparation has not been administered for several weeks, the administration of D-Fluoretten 500 I. U. can be extended by the corresponding period of time if the doctor considers this necessary.

If you stop using D-Fluoretten 500 I. U.
If the administration of D-Fluoretten 500 I. U. is stopped earlier than recommended by the doctor, rickets may develop, especially in the winter months. Caries protection is reduced.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?
No side effects are to be expected when D-Fluoretten 500 I. U. is used properly. Gastrointestinal complaints (such as abdominal pain, diarrhoea) have been reported (how often this side effect occurs is not known, i.e. the frequency cannot be estimated from the available data). Since gastrointestinal complaints can also occur in this age group for other reasons, a doctor should be consulted.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the
Federal Institute for Drugs and Medical Devices
Dept. of Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD D-FLUORETTEN 500 I. U. 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 the blister packs after "Use by". The expiry date refers to the last day of the month.
Storage conditions: Do not store above 25 °C. Store in the original packaging to protect the contents from light.

6. FURTHER INFORMATION

What D-Fluoretten 500 I. U. contains

The active ingredients are colecalciferol dry concentrate and sodium fluoride. 1 tablet for preparing a solution for oral administration contains 5 mg colecalciferol dry concentrate (corresponding to 500 I. U. vitamin D3), 0.553 mg sodium fluoride (corresponding to 0.25 mg fluoride). The other ingredients are: lactose monohydrate (milk sugar), crospovidone type B, microcrystalline cellulose, talc, magnesium stearate (Ph. Eur.) [vegetable], sucrose, RRR-?-tocopherol, medium-chain triglycerides, gum arabic, corn starch.

What D-Fluoretten 500 I. U. looks like and contents of the pack

White, round, biplane (flat on both sides) tablets for preparing a solution for oral administration with a facet (bevelled edge on the rim) and one-sided embossing: "D".
D-Fluoretten 500 I. U. is available in packs of 30 and 90 tablets for preparing a solution for oral administration.

Pharmaceutical entrepreneur

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main

Postal address

Postfach 80 08 60
65908 Frankfurt am Main
Telephone: (01 80) 2 22 20 10*
Telefax: (01 80) 2 22 20 11*
*0.06 EUR/call (German landline); max. 0.42 EUR/min (mobile).

Manufacturer

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main

Alternative

A. Nattermann & Cie GmbH
Nattermannallee 1
50829 Köln

Sanofi-Aventis Sp. z o. o.
Drug Production and Distribution Plant
ul. Lubelska 52, 35-233 Rzeszów
Poland

This leaflet was last revised in October 2014.

Source: Information from the package leaflet
Status: 01/2015
Areas of application: for the combined prevention of rickets and caries in infants and children in the first two years of life.