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FLUORETTEN 0.5 mg tablets 300 pcs Prophylaxis, dental caries in children
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FLUORETTEN 0.5 mg tablets 300 pcs Prophylaxis, dental caries in children
Fluoretten® 0.5mg tablets, Prophylaxis, dental caries in children
Active ingredient: Sodium fluoride
Use:
Prophylaxis of dental caries in children from 3 years and under 6 years
Important information (mandatory information):
Fluoretten 0.5 mg lozenges for use in children aged 3 years and over, adolescents and adults Active ingredient: sodium fluoride Indications: Medicine for the prevention of tooth decay with the active ingredient sodium fluoride.
For risks and side effects, read the package leaflet and ask your doctor or pharmacist.
Package leaflet: Information for the user
Fluoretten 0.5 mg lozenges for use in children aged 3 years and over, adolescents and adults
Active ingredient: sodium fluoride
Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Fluoretten 0.5 mg must be used as directed.
- 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 side effects listed affect you seriously, or you notice side effects not listed in this leaflet, please inform your doctor or pharmacist.
This package leaflet contains:
1. WHAT ARE FLUORETTEN 0.5 MG AND WHAT ARE THEY USED FOR?
2. WHAT YOU NEED TO CONSIDER BEFORE YOU USE FLUORETTEN 0.5 MG?
3. HOW SHOULD YOU USE FLUORETTEN 0.5 MG?
4. POSSIBLE SIDE EFFECTS?
5. HOW SHOULD YOU STORE FLUORETTEN 0.5 MG?
6. FURTHER INFORMATION
1. WHAT ARE FLUORETTEN 0.5 MG AND WHAT ARE THEY USED FOR?
Fluoretten 0.5 mg is a medicine for preventing tooth decay containing the active ingredient sodium fluoride.
2. WHAT YOU NEED TO CONSIDER BEFORE YOU USE FLUORETTEN 0.5 MG?
Fluoretten 0.5 mg must not be used
- if your child is hypersensitive (allergic) to sodium fluoride or any of the other ingredients,
- if you already provide your child with sufficient fluoride, for example through fluoridated table salt, drinking, mineral or table water.
Particular caution is required when taking Fluoretten 0.5 mg
- if your child has a serious, chronic illness that impairs growth. In this case, you should consult your doctor to determine whether caries prevention with fluoride is suitable for your child.
Children who are on a balanced diet due to a congenital metabolic disorder do not require fluoride tablets.
If you use fluoridated table salt when preparing your child's food, please refrain from administering further fluoride.
Do not increase the dosage of Fluoretten 0.5 mg above the recommended dose, as constant overdose can lead to enamel stains on the permanent teeth and, in the case of very significant, long-term overdose, disorders of bone formation (see "Chronic Overdose"). Consult your dentist or doctor regarding the additional use of fluoride gels or varnishes for local fluoridation.
Using Fluoretten 0.5 mg with other medicines
Please inform your doctor or pharmacist if you are using or have recently used any other medicines on your child or yourself, even if these are medicines obtained without a prescription.
Using Fluoretten 0.5 mg with food and drink
The simultaneous consumption of milk and dairy products does not significantly reduce the absorption of fluoride.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine. Fluoretten can be taken during pregnancy, but is probably of no benefit to the development of the child's teeth. Only a very small amount of the active ingredient in Fluoretten passes into breast milk. Therefore, fluoride should be given directly to the infant to prevent tooth decay.
Ability to drive and operate machinery
Not applicable.
Important information about certain other ingredients of Fluoretten 0.5 mg
Fluoretten 0.5 mg contains lactose. Therefore, if you know that you have an intolerance to certain sugars, please only give or take
Fluoretten 0.5 mg after consulting your doctor. 3. HOW TO USE FLUORETTEN 0.5 MG
Always use Fluoretten 0.5 mg exactly as directed in this package leaflet. Please ask your doctor or pharmacist if you are not sure. The dosage depends on your child's age and should be determined taking into account other fluoride intake. To ensure that only an oral form of fluoride is administered, the pediatrician or dentist should consider the use of fluoridated table salt, fluoride tablets (including the daily dose), fluoride gels/varnishes, fluoride-rich mineral water, and the fluoride content of drinking water when recommending dosage. The following dosage schedule provides guidelines for supplemental fluoride intake. If the fluoride concentration in drinking water/mineral water is greater than 0.7 mg/l, additional administration of fluoride tablets is not necessary.
In the Federal Republic of Germany, the fluoride content of drinking water is – with a few exceptions – below 0.3 mg/l. You can find out the fluoride content from your local waterworks.
Unless otherwise prescribed, the following dosage should be observed regularly, 1 lozenge daily of the appropriate strength:
- Age 0 to under 3 years: Fluoride concentration in drinking water/mineral water below 0.3 mg/l = 0.5 mg fluoride per day
- Age 0 to under 3 years: Fluoride concentration in drinking water/mineral water below 0.3 - 0.7 mg/l = 0.00 mg fluoride per day
- Age 3 to under 6 years: Fluoride concentration in drinking water/mineral water below 0.3 mg/l = 0.5 mg fluoride per day
- Age 3 to under 6 years: Fluoride concentration in drinking water/mineral water below 0.3 - 0.7 mg/l = 0.5 mg fluoride per day
- Age 6 years and over: Fluoride concentration in drinking water/mineral water below 0.3 mg/l = 1.0 mg fluoride per day
- Age 6 years and over: Fluoride concentration in Drinking water/mineral water below 0.3 - 0.7 mg/l = 0.5 mg fluoride per day
Method of administration
The lozenges should be sucked slowly, as part of the effect is due to the locally higher fluoride concentrations in the mouth. Small children can be given the crushed lozenge on a spoon with food, water or tea. The best time to use is in the evening after brushing their teeth, as this ensures that the high fluoride concentrations on the teeth are retained for a particularly long time.
Duration of use
Use should begin as early as possible and be continued consistently for at least the first 12 years of life. Continuing prophylaxis into adulthood is recommended.
If you have used more Fluoretten 0.5 mg than you should
In the event of a slight overdose, the product can be discontinued for a few days, depending on the dose taken and the duration of use.
Acute overdose
If large amounts of fluoride are ingested acutely, symptoms such as nausea, vomiting, abdominal pain and diarrhea may occur. For fluoride doses up to 100 mg or 5 mg/kg body weight, calcium supplementation (plenty of milk, calcium tablets) is recommended. Further treatment options are determined by the dentist or doctor. Acute overdose must be avoided at all costs (risk of poisoning).
Chronic overdose:
In the case of long-term overdose, the product must be discontinued. There is a risk of enamel staining on the permanent teeth, and with very significant, long-term overdose, bone formation disorders may develop. The doctor will decide on further treatment options depending on the clinical picture.
If you forget to use Fluoretten 0.5 mg
If you forget to take Fluoretten once, it is recommended that you continue taking Fluoretten 0.5 mg as usual. There is no need to increase the dose.
If you stop using Fluoretten 0.5 mg
When you stop taking Fluoretten, the protection against caries is gradually lost; if you stop taking it for a longer period of time, it is reduced.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, Fluoretten 0.5 mg can cause side effects, although not everybody gets them. Very rarely (less than 1 in 10,000 people treated), hypersensitivity reactions (allergic
reactions) have been reported. Please inform your doctor or pharmacist if you suspect a side effect in your child, if any of the side effects listed affect you or your child seriously, or if you notice side effects not listed in this leaflet.
5. HOW SHOULD FLUORETTEN 0.5 MG BE STORED?
Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister packs after "Use by". The expiry date refers to the last day of that month.
No special storage conditions are required.
6. FURTHER INFORMATION
What Fluoretten 0.5 mg contains:
1 lozenge contains 1.106 mg sodium fluoride (equivalent to 0.5 mg fluoride). The other ingredients are: lactose monohydrate, spray-dried gum arabic, macrogol 4000, magnesium stearate (Ph. Eur.) [vegetable], sodium saccharin, raspberry flavor.
What Fluoretten 0.5 mg looks like and contents of the pack:
White, round, biconvex faceted lozenges with "0.5" debossed on one side.
Fluoretten 0.5 mg are available in packs of 300 lozenges.
Pharmaceutical Entrepreneur:
Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
Postal Address:
PO Box 80 08 60
65908 Frankfurt am Main
Manufacturer:
Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
Alternatively:
A. Nattermann & Cie GmbH
Nattermannallee 1
50829 Cologne
Sanofi-Aventis Sp. z oo
Drug Production and Distribution Plant
ul. Lubelska 52, 35-233 Rzeszów
Poland
This leaflet was last revised in January 2013.
Source: Information from the package leaflet
as of: 01/2015Active ingredient: Sodium fluoride Applications: Medicine for caries prevention with the active ingredient sodium fluoride.
Fluoretten 0.5 mg lozenges for use in children aged 3 years and over, adolescents and adults Active ingredient: sodium fluoride Indications: Medicine for the prevention of tooth decay with the active ingredient sodium fluoride.
For risks and side effects, read the package leaflet and ask your doctor or pharmacist.
Package leaflet: Information for the user
Fluoretten 0.5 mg lozenges for use in children aged 3 years and over, adolescents and adults
Active ingredient: sodium fluoride
Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Fluoretten 0.5 mg must be used as directed.
- 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 side effects listed affect you seriously, or you notice side effects not listed in this leaflet, please inform your doctor or pharmacist.
This package leaflet contains:
1. WHAT ARE FLUORETTEN 0.5 MG AND WHAT ARE THEY USED FOR?
2. WHAT YOU NEED TO CONSIDER BEFORE YOU USE FLUORETTEN 0.5 MG?
3. HOW SHOULD YOU USE FLUORETTEN 0.5 MG?
4. POSSIBLE SIDE EFFECTS?
5. HOW SHOULD YOU STORE FLUORETTEN 0.5 MG?
6. FURTHER INFORMATION
1. WHAT ARE FLUORETTEN 0.5 MG AND WHAT ARE THEY USED FOR?
Fluoretten 0.5 mg is a medicine for preventing tooth decay containing the active ingredient sodium fluoride.
2. WHAT YOU NEED TO CONSIDER BEFORE YOU USE FLUORETTEN 0.5 MG?
Fluoretten 0.5 mg must not be used
- if your child is hypersensitive (allergic) to sodium fluoride or any of the other ingredients,
- if you already provide your child with sufficient fluoride, for example through fluoridated table salt, drinking, mineral or table water.
Particular caution is required when taking Fluoretten 0.5 mg
- if your child has a serious, chronic illness that impairs growth. In this case, you should consult your doctor to determine whether caries prevention with fluoride is suitable for your child.
Children who are on a balanced diet due to a congenital metabolic disorder do not require fluoride tablets.
If you use fluoridated table salt when preparing your child's food, please refrain from administering further fluoride.
Do not increase the dosage of Fluoretten 0.5 mg above the recommended dose, as constant overdose can lead to enamel stains on the permanent teeth and, in the case of very significant, long-term overdose, disorders of bone formation (see "Chronic Overdose"). Consult your dentist or doctor regarding the additional use of fluoride gels or varnishes for local fluoridation.
Using Fluoretten 0.5 mg with other medicines
Please inform your doctor or pharmacist if you are using or have recently used any other medicines on your child or yourself, even if these are medicines obtained without a prescription.
Using Fluoretten 0.5 mg with food and drink
The simultaneous consumption of milk and dairy products does not significantly reduce the absorption of fluoride.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine. Fluoretten can be taken during pregnancy, but is probably of no benefit to the development of the child's teeth. Only a very small amount of the active ingredient in Fluoretten passes into breast milk. Therefore, fluoride should be given directly to the infant to prevent tooth decay.
Ability to drive and operate machinery
Not applicable.
Important information about certain other ingredients of Fluoretten 0.5 mg
Fluoretten 0.5 mg contains lactose. Therefore, if you know that you have an intolerance to certain sugars, please only give or take
Fluoretten 0.5 mg after consulting your doctor. 3. HOW TO USE FLUORETTEN 0.5 MG
Always use Fluoretten 0.5 mg exactly as directed in this package leaflet. Please ask your doctor or pharmacist if you are not sure. The dosage depends on your child's age and should be determined taking into account other fluoride intake. To ensure that only an oral form of fluoride is administered, the pediatrician or dentist should consider the use of fluoridated table salt, fluoride tablets (including the daily dose), fluoride gels/varnishes, fluoride-rich mineral water, and the fluoride content of drinking water when recommending dosage. The following dosage schedule provides guidelines for supplemental fluoride intake. If the fluoride concentration in drinking water/mineral water is greater than 0.7 mg/l, additional administration of fluoride tablets is not necessary.
In the Federal Republic of Germany, the fluoride content of drinking water is – with a few exceptions – below 0.3 mg/l. You can find out the fluoride content from your local waterworks.
Unless otherwise prescribed, the following dosage should be observed regularly, 1 lozenge daily of the appropriate strength:
- Age 0 to under 3 years: Fluoride concentration in drinking water/mineral water below 0.3 mg/l = 0.5 mg fluoride per day
- Age 0 to under 3 years: Fluoride concentration in drinking water/mineral water below 0.3 - 0.7 mg/l = 0.00 mg fluoride per day
- Age 3 to under 6 years: Fluoride concentration in drinking water/mineral water below 0.3 mg/l = 0.5 mg fluoride per day
- Age 3 to under 6 years: Fluoride concentration in drinking water/mineral water below 0.3 - 0.7 mg/l = 0.5 mg fluoride per day
- Age 6 years and over: Fluoride concentration in drinking water/mineral water below 0.3 mg/l = 1.0 mg fluoride per day
- Age 6 years and over: Fluoride concentration in Drinking water/mineral water below 0.3 - 0.7 mg/l = 0.5 mg fluoride per day
Method of administration
The lozenges should be sucked slowly, as part of the effect is due to the locally higher fluoride concentrations in the mouth. Small children can be given the crushed lozenge on a spoon with food, water or tea. The best time to use is in the evening after brushing their teeth, as this ensures that the high fluoride concentrations on the teeth are retained for a particularly long time.
Duration of use
Use should begin as early as possible and be continued consistently for at least the first 12 years of life. Continuing prophylaxis into adulthood is recommended.
If you have used more Fluoretten 0.5 mg than you should
In the event of a slight overdose, the product can be discontinued for a few days, depending on the dose taken and the duration of use.
Acute overdose
If large amounts of fluoride are ingested acutely, symptoms such as nausea, vomiting, abdominal pain and diarrhea may occur. For fluoride doses up to 100 mg or 5 mg/kg body weight, calcium supplementation (plenty of milk, calcium tablets) is recommended. Further treatment options are determined by the dentist or doctor. Acute overdose must be avoided at all costs (risk of poisoning).
Chronic overdose:
In the case of long-term overdose, the product must be discontinued. There is a risk of enamel staining on the permanent teeth, and with very significant, long-term overdose, bone formation disorders may develop. The doctor will decide on further treatment options depending on the clinical picture.
If you forget to use Fluoretten 0.5 mg
If you forget to take Fluoretten once, it is recommended that you continue taking Fluoretten 0.5 mg as usual. There is no need to increase the dose.
If you stop using Fluoretten 0.5 mg
When you stop taking Fluoretten, the protection against caries is gradually lost; if you stop taking it for a longer period of time, it is reduced.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, Fluoretten 0.5 mg can cause side effects, although not everybody gets them. Very rarely (less than 1 in 10,000 people treated), hypersensitivity reactions (allergic
reactions) have been reported. Please inform your doctor or pharmacist if you suspect a side effect in your child, if any of the side effects listed affect you or your child seriously, or if you notice side effects not listed in this leaflet.
5. HOW SHOULD FLUORETTEN 0.5 MG BE STORED?
Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister packs after "Use by". The expiry date refers to the last day of that month.
No special storage conditions are required.
6. FURTHER INFORMATION
What Fluoretten 0.5 mg contains:
1 lozenge contains 1.106 mg sodium fluoride (equivalent to 0.5 mg fluoride). The other ingredients are: lactose monohydrate, spray-dried gum arabic, macrogol 4000, magnesium stearate (Ph. Eur.) [vegetable], sodium saccharin, raspberry flavor.
What Fluoretten 0.5 mg looks like and contents of the pack:
White, round, biconvex faceted lozenges with "0.5" debossed on one side.
Fluoretten 0.5 mg are available in packs of 300 lozenges.
Pharmaceutical Entrepreneur:
Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
Postal Address:
PO Box 80 08 60
65908 Frankfurt am Main
Manufacturer:
Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
Alternatively:
A. Nattermann & Cie GmbH
Nattermannallee 1
50829 Cologne
Sanofi-Aventis Sp. z oo
Drug Production and Distribution Plant
ul. Lubelska 52, 35-233 Rzeszów
Poland
This leaflet was last revised in January 2013.
Source: Information from the package leaflet
as of: 01/2015Active ingredient: Sodium fluoride Applications: Medicine for caries prevention with the active ingredient sodium fluoride.
Description
Product code: FLUORETTEN 0.5 mg tablets 300 pcs Prophylaxis, dental caries in children
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FLUORETTEN 0.5 mg tablets 300 pcs Prophylaxis, dental caries in children
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