D FLUORETTEN 500 tablets 90 pcs sodium fluoride, colecalciferol for infants, babes

Zentiva Pharma GmbH

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D-Fluoretten 500 tablets

Active ingredient: Sodium fluoride 0.553mg (corresponding to 0.25mg fluoride), Colecalciferol 0.0125mg (corresponding to 500 IU Vit. D3)

Areas of application:
Combined rickets and caries prophylaxis in infants and children in the first two years of life .

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

D FLUORETTEN 500 tablets 90 pcs sodium fluoride, colecalciferol for infants, babes

What is sodium fluoride?

Sodium fluoride (NaF) is an inorganic compound with the formula NaF. It is used in trace amounts in the fluoridation of drinking water, toothpaste, in metallurgy.

What does sodium fluoride do?

Sodium Fluoride is a naturally occurring mineral that serves to protect teeth from dental caries. It is scientifically proven that the correct amount of fluoride in water and use of fluoride-containing toothpastes and mouth rinses have a significant benefit on oral health and help to reduce tooth decay.

What is colecalciferol used for?

Colecalciferol is a form of vitamin D used in the prevention and treatment of vitamin D deficiency conditions. It may also be prescribed for certain bone conditions, such as thinning of the bone (osteoporosis) when it will be given to you with other medicines.


Infants and young children under 2 years of age 1 tablet 1 tablet per day before a meal

D FLUORETTEN 500 for infants, babes Application Effects:

How do the ingredients of the drug work?

The drug consists of a combination of active ingredients. There is still no reliable knowledge about the mechanism of action of fluoride. The following mechanisms are discussed: inhibition of acid-producing microorganisms in plaque, incorporation into the tooth enamel and thus a higher resistance to acids, as well as an improvement in the mineral balance of the tooth enamel. The active ingredient vitamin D3 (colecalciferol) intervenes in protein production. It triggers the formation of a protein that binds calcium to itself and releases it into the bloodstream. In this way, the blood calcium level is increased, this calcium is then in turn available for building bones.

D FLUORETTEN 500 for infants, babes Application area:

- Prevention of rickets
- Prevention of tooth decay

D FLUORETTEN 500 for infants, babes Application Info:

Make sure that children do not use toothpaste containing fluoride as well.
Please take into account the additional fluoride intake from food, beverages and pharmaceuticals when determining the dosage. Find out more about this from your doctor or pharmacist.
For infants and children in the first two years of life:

D FLUORETTEN 500 for infants, babes Application Notes:

The total dose should not be exceeded without consulting a doctor or pharmacist.

Type of application?
Prepare and take the medicine. To prepare the medicine, dissolve or disintegrate it in 1 teaspoon of water. In babies, you can put the medicine directly into the bottle. If you add the medicine to the formula, make sure that the bottle is completely drunk. The tablets are tasteless.

Duration of application?
Your doctor will determine the duration of use.

A variety of overdose symptoms can occur, including tooth discoloration and bone structure disorders. If you suspect an overdose, contact a doctor immediately.

Forgot to take?
Continue taking it at the next prescribed time as normal (i.e. not with double the amount).

The general rule is: Pay attention to a conscientious dosage, especially with infants, small children and the elderly. If in doubt, ask your doctor or pharmacist about any effects or precautionary measures.

A dosage prescribed by a doctor may differ from the information on the package insert. Since the doctor will tailor them individually, you should therefore use the medicine according to his instructions.

Side Effects

What adverse effects may occur?

No side effects are currently known for the drug when used as intended.

If you notice any disturbances or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects that occur in at least one in 1,000 patients treated are primarily taken into account.


What speaks against an application?

- Hypersensitivity to the ingredients
- Limited mobility (e.g. due to a plaster cast)
- Increased calcium levels
- Increased calcium excretion in the urine

Under certain circumstances - talk to your doctor or pharmacist about this:
- tendency to develop kidney stones
- sarcoidosis (Boeck's disease) ( rare, often inherited disease, with the formation of small tissue nodules, especially in the lungs)
- growth disorders, caused by chronic diseases

The drug is unsuitable if there is an adequate supply of fluoride, e.g. table salt, mineral water or food in babies. Your doctor or pharmacist will advise you on this.

Which age group do I have to consider?
- Children from 2 years of age: The drug should not be used in this age group as a rule.

What about pregnancy and lactation?
- Pregnancy: There is no evidence on this. If in doubt, seek advice from your doctor or pharmacist.
- Breastfeeding: Get advice from your doctor or pharmacist on this, as there is no information on this.

If the medicine has been prescribed for you despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit may be greater than the risk of contraindication.

D FLUORETTEN 500 for infants, babes Important Notes:

What should you watch out for?
- Beware of allergy to talc!
- Beware of allergies to Arabic gum (EU number E 414)!
- Caution is advised if you are known to be hypersensitive to sorbitol or fructose (fruit sugar). Gastrointestinal complaints can be triggered.
- There may be drugs with which there may be interactions. You should therefore generally tell the doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or that were used some time ago.

D FLUORETTEN 500 for infants, babes Storage

The medicinal product must be stored in the dark (eg in the outer carton)
protected from heat .