0.25 mg lozenges
1. WHAT FLUDENT LEMON IS AND WHAT IT IS USED FOR
Liquid Lemon contains fluorine. Fluoride in the lozenge makes tooth enamel more resistant to caries (holes in the teeth).
Fludent Lemon 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 medicines), partial dentures, or stuck braces, or on the recommendation of a dentist/doctor or dental hygienist.
2. BEFORE USING FLUDENT LEMON
Do not use Fludent Lemon
if you are allergic (hypersensitive) to fluoride or any of the other ingredients of this medicine.
Take special care with Fludent Lemon
Children under 12 should only use fluorsugtabletter the dentist/doctor or and hygienist’s prescription.
Pregnancy and breastfeeding
No known risks when used during pregnancy.
No known risks when using during breast-feeding.
Driving and using machines
No known risks.
Important information about some of the ingredients of Fludent Lemon
Fludent Lemon 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 LEMON
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 more Fludent Lemon then you should
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 Citron 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 Lemon 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. HOW TO STORE FLUDENT LEMON
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, povidone, lemon aroma, and magnesium stearate.
What the medicine looks like and the contents of the pack
White to off-white, 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 Authorization Holder and Manufacturer
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland