Top Dent Fluor – Sodium fluoride uses, dose and side effects

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0.93% sodium fluoride, which corresponds to 0.42% fluorine

What Top Dent Fluor is and what it is used for

Top Dent Fluor is an agent against cavities in the teeth ( caries ). It is used as a preventive treatment against cavities in the teeth ( caries ) or when dentists have assessed that the incidence of caries is high.

What you need to know before using Top Dent Fluor

Do not use Top Dent Fluoride

  • if you are allergic to sodium fluoride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

The treatment should not be performed on an empty stomach, as any swallowed gel may cause discomfort for patients with sensitive stomachs. The excess gel should be carefully spat out. On the same day that Top Dent Fluor has been applied, other highly concentrated fluoride products such as fluoride varnishes should not be used.

Talk to your dentist/doctor or pharmacist before using Top Dent Fluor if you have:

  • severe kidney disease.

Other medicines and Top Dent Fluor

Tell your dentist or pharmacist if you are taking, have recently taken, or might take any other medicines.

Top Dent Fluoride with food and drink

You should not eat, drink or brush your teeth for the next 30 minutes after the treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your dentist or pharmacist before using this medicine.

There are no known risks with using Top Dent Fluor during pregnancy and breastfeeding.

Driving ability and use of machinery

Not relevant.

How to use Top Dent Fluor

Always use this medicine as directed by your dentist. Consult a dentist or pharmacist if you are unsure.

The treatment is carried out once a day.

Gel one is applied in spoons, which are specially adapted to the tooth bite. One spoon per jaw is used.

Gel one is applied in a thin strand (about 7-11 cm depending on the size of the jaw) so that about 1/3 of the spoon is filled. The normal dosage is 0.5 to 1.5 grams of gel for each spoonful.

You must sit in an upright position and bite around the gel spoon for 5 minutes.

After the treatment, you must spit out any remaining gel residue.

Gel one should not be swallowed.

You should not eat, drink or brush your teeth for the next 30 minutes after the treatment.

If you used too much Top Dent Fluor

Dosing one of gel one should not be exceeded, because gel one may then run over the edges of the spoon and be swallowed. If you have a sensitive stomach, you may therefore experience discomfort.

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, always contact a doctor or hospital for an assessment of the risk and advice.

If you have further questions about this medicine, contact your dentist or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Enamel fluorosis (white spots on the teeth):

In children up to 12 years of age, simultaneous administration of other fluoride products can cause mild enamel fluorosis with slightly white spots on the cheek teeth.

Very rare (may affect up to 1 in 10,000 users):

In very rare cases, swelling ( angioedema ) in the oral cavity/pharynx has been reported after the use of sodium fluoride for caries prevention.

Disorders of the immune system

Has been reported (occurs in an unknown number of users): hypersensitivity reaction (including locally in the oral cavity).

Stop taking Top Dent Fluor and contact your doctor immediately if you experience any of the following symptoms ( angioedema ):

• swelling of the face, tongue, or throat

• difficulty swallowing

• hives and breathing difficulties

How to store Top Dent Fluor

Keep this medicine out of the sight and reach of children.

Use before the expiry date stated on the packaging.

The expiration date is the last day of the specified month.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

– The active substance in TopDent is 0.93% sodium fluoride, which corresponds to 0.42% fluorine

– Other ingredients are saccharin sodium, nipastat ( preservative ), glycerol, Natrosol 25 HX-Pharm, and purified water.

Appearance and package sizes of the medicine

The tube contains 100 g or 250 g.

Marketing authorization holder and manufacturer

Bioglan AB

Box 503 10

202 13 Malmö

Phone: 040-28 75 00

Information provided by:

DAB Dental AB

Finds väg 8-10

Box 423

194 04 Upplands Väsby

Phone: 08-506 505 00

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