0.25 mg lozenges

What does Fludent Raspberry contain?

the active substance is fluorine.

The other ingredients are xylitol (E967), sorbitol (E420), macrogol, talc, raspberry aroma, povidone, and magnesium stearate.

1. WHAT IS FLUENT RASPBERRY AND WHAT IS IT USED FOR?

What is Fludent Raspberry used for?

Fluid Raspberries contain fluoride. Fluoride in the lozenge makes tooth enamel more resistant to caries (holes in the teeth).

Fluid Raspberry lozenges are used to prevent 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.

2. BEFORE USING FLUDENT RASPBERRY

Do not use Fludent Raspberries

– if you are allergic (hypersensitive) to fluoride or any of the other ingredients of this medicine.

Take special care with Fludent Raspberries:

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

Pregnancy

No known risks when used during pregnancy.

Breast-feeding

No known risks when using during breast-feeding.

Driving and using machines:

No known risks.

Important information about some of the excipient (s) in Fludent Raspberry:

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

3. HOW TO USE FLUDENT RASPBERRY

Dosage instructions

Suck on the tablet so that it stays in your mouth for as long as possible. Distribute the dose one over the day. Feel free to take the lozenge after you have eaten.

The usual dose for adults and children over 12 years:

1 lozenge 6 times 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.

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.

Please note that the dentist/doctor or dental hygienist may have prescribed the lozenges for another use and/or with a different dosage than that stated in the package leaflet. Always follow the prescription of the dentist/doctor or dental hygienist or the instructions on the label on the medicine package.

If you use too much Fludent Raspberry

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Fludent Raspberry Pi can cause side effects, although not everybody gets them.

Common (more than 1 patient in 100, less than 1 patient in 10): In children under 12 years of age, too high fluoride doses – the simultaneous use of several fluoride preparations such as toothpaste, tablets, and/or chewing gum – can give rise to 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 mouthwash with sodium fluoride for caries prevention.

Stop taking Fludent Raspberry and contact a doctor immediately if you get any of the following symptoms ( angioedema )

• swelling of the face, tongue, or throat

• difficulty swallowing

• hives and difficulty breathing.

5. STORAGE OF FLUENT RASPBERRY

Do not store above 30 ° C.

Do not use this medicine after the expiry date which is stated on the label after the abbreviation “EXP:”. The expiration date is the last day of the specified month.

Keep out of sight and reach of children.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

Content declaration

 the active substance is fluorine.

The other ingredients are xylitol (E967), sorbitol (E420), macrogol, talc, raspberry aroma, povidone, and magnesium stearate.

What the medicine looks like and the contents of the pack

White to light red, round tablet, marked “NaF” on one side and the other side without marking.

Plastic jar / HDPE with 100, 200, 300, 400 and 540 lozenges.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

Muhammad Nadeem

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