Fludent Mint 0.25 mg, 0.50 mg and 0.75 mg * Fludent Banana 0.25 mg lozenges 

What do the lozenges contain?

Active substance : Sodium fluoride corresponding to 0.25 mg, 0.5 mg and 0.75 mg of fluorine respectively.

Other ingredients: Macrogol, magnesium stearate, polyvidone, sorbitol (E 420), xylitol (E 967), talc, peppermint, and banana aromas.

Appearance: White, round tablet, marked “NaF” on one side and the other side without marking for 0.25 mg and marked with “2” for 0.5 mg and marked with “3” for 0.75 mg.

Taste: Peppermint and banana respectively.

How do lozenges work?

When you suck on Fludent lozenges, fluoride is released into the saliva. From there, fluoride is taken up by the tooth enamel and makes it more resistant to caries attacks (holes in the teeth).

Holder of a marketing authorization

Actavis Group PTC ehf

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

What are lozenges used for?

Liquid lozenges are used for the prevention of caries (holes in the teeth) in people with an increased risk of caries, including dry mouth (eg when treated with certain drugs), partial dentures, or stuck braces or on the recommendation of a dentist/doctor or dental hygienist.

Things to consider before and when using lozenges

Children under 12 should only use fluoride lozenges at the dentist/doctor or and hygienist’s prescription.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Pregnancy

No known risks when used during pregnancy.

Breast-feeding

No known risks when using during breast-feeding.

Traffic warning

No known risks.

Dosage instructions

Usual dose for adults and children over 12 years:

Lozenges 0.25 mg : 1 lozenge 6 times daily. Lozenges 0.50 mg : 1 lozenge 3 times daily. Lozenges 0.75 mg : 1 lozenge twice daily.

When using fluoride toothpaste, fluoride chewing gum, or fluoride rinsing at the same time, the dose should be reduced.

Dosage for children under 12 years:

Only according to the recommendation of a dentist/doctor or dental hygienist.

Distribute the dose one over the day. Feel free to take the lozenge after you have eaten.

Instructions for use

Suck on the tablet so that it stays in your mouth for as long as possible. If it is difficult for the youngest children to suck on the tablet, it can be crushed before ingestion. The child may be able to chew the lozenge.

What happens if you take too large a dose?

If you have taken too much medicine, always contact a doctor, hospital, or the Poison Information Center.

What side effects can lozenges cause?

In children under 12 years of age, excessive fluoride doses – the simultaneous use of several fluoride preparations such as toothpaste, tablets, and/or chewing gum – can give rise to a slight enamel change (enamel fluorosis) with insignificant, white spots on the cheek teeth as a result.

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

Storage and durability

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton.

All medicines should be kept out of the reach of children.

For environmental and safety reasons, leftover or too old medicine from the public must be left at the pharmacy for disposal.

Muhammad Nadeem

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