Package leaflet: information for the patient

FLUORMEX, 133 mg/g, dental solution
(Aminofluoridum)
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary. In case of any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same. If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:
What Fluormex dental solution is and what it is used for
Important information before using Fluormex dental solution
How to use Fluormex dental solution
4. Possible side effects
5. How to store Fluormex dental solution
6. Contents of the pack and other information

What Fluormex dental solution is and what it is used for
Fluormex is a dental solution intended for application to the teeth.
Fluormex dental solution is used for topical fluoridation of teeth:

for caries prophylaxis;
in cases of underdevelopment of dental hard tissues;
in cases of cervical tooth hypersensitivity;
in enamel decalcifications;
on sensitive tooth surfaces abraded by clasps, splints, partial dentures, and orthodontic appliances;
after traumatic occlusion correction, etc.
It may be used by children over 5 years of age and by adults.

Important information before using Fluormex dental solution
When not to use Fluormex dental solution:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
in children under 5 years of age;
simultaneously with other preparations containing high concentrations of fluorides;
in areas where the fluoride content in drinking water exceeds 0.7 mg/L;
in individuals without caries or at low risk of caries;
more frequently than once every two weeks and no more than 10 times per year;
during pregnancy and breastfeeding.

Warnings and precautions
Exercise particular caution in children under 9 years of age.
Children under 9 years of age must be supervised by an adult during product use and must not swallow the solution during brushing.
Long-term ingestion of certain amounts of substances containing fluorides, even at low concentrations, may lead to symptoms of chronic poisoning in the form of dental fluorosis (mottled enamel).

Fluormex dental solution and other medicines
Do not use another concentrated fluoride preparation simultaneously.
Toothpastes (fluoride content up to 1500 ppm) and mouthwashes (fluoride content up to 250 ppm) intended for daily use may be used together with Fluormex solution, as recommended or under the supervision of a dentist.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should not use Fluormex solution.
The medicine should not be used during breastfeeding, as safety has not been established.

Driving and operating machinery
Fluormex dental solution has no effect on the ability to drive vehicles or operate machinery.

How to use Fluormex dental solution
Fluormex dental solution is recommended for use under supervision, strictly according to the dentist's instructions, as one course of treatment per year. A treatment course means using the solution every two weeks, a total of 5 to 10 times, i.e., one brushing session every two weeks for 10 to 20 weeks.

Brushing – cleaning the teeth before treatment is beneficial but not essential, as Fluormex solution is highly adhesive.
Children under 9 years of age must be supervised by an adult during use and must not swallow the solution while brushing.
Apply 6 to 9 drops of the solution onto a toothbrush and brush the teeth for 3 minutes.

Rubbing in – apply 0.5 to 1 mL of the solution onto a cotton swab (in the dental office), then carefully and slowly rub it into the dried tooth surfaces, ensuring the solution penetrates into pits and fissures. Prior to fluoride application, dental calculus must be thoroughly removed.

After completing the brushing or rubbing procedure, spit out saliva.
Do not rinse the mouth or eat for at least half an hour after the procedure.

Use in children
Children under 9 years of age must be supervised by an adult during use and must not swallow the solution while brushing.

Use of a higher than recommended dose of Fluormex dental solution
Symptoms of overdose are not known when the medicine is used according to the indications and recommended method of administration.
The acceptable daily intake of fluoride is 3 to 4 mg per day (from drinking water, beverages, food products). Accidental ingestion of significant amounts of fluoride-containing products, especially those with high fluoride content, may lead to acute poisoning.
Symptoms of acute poisoning may include: nausea, vomiting, abdominal pain, diarrhea, hypersalivation, lacrimation, weakness, headache, cyanosis, dyspnea, tetany, muscle cramps in the limbs – hypocalcemia, decreased blood pressure and arrhythmia, ventricular fibrillation – hyperkalemia, rapid or imperceptible pulse, respiratory and metabolic acidosis, respiratory paralysis, and cardiac arrest.
The lethal (life-threatening) dose for an adult is 32 to 64 mg of fluoride per kg of body weight; for children, it is 15 mg per kg of body weight.
In case of accidental ingestion of the medicine, contact a doctor immediately.

Missed use of Fluormex dental solution
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

Discontinuation of Fluormex dental solution
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this product may cause side effects, although not everybody gets them.
Side effects may occur in case of overdose; see section "Use of a higher than recommended dose of Fluormex dental solution."

Reporting of side effects
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49-21-301
Fax: +48 22 49-21-309
e-mail: [email protected]
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

How to store Fluormex dental solution
Store below 25°C.
Keep the bottle tightly closed.
Store the medicine out of sight and reach of children.
Pay attention to the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Fluormex dental liquid contains

The active substance is fluorine in the form of amine fluorides. 1 g of the liquid contains 133 mg of amine fluorides, corresponding to 10 mg of available fluorine (10,000 ppm).
Other ingredients: glycerol, purified water, flavouring agent (mint flavour).

What Fluormex dental liquid looks like and contents of the pack
Fluormex dental liquid is a yellow, oily liquid with a mint odour.
The pack contains a 50 g bottle made of plastic with a dropper and a screw cap, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
CHEMA-ELEKTROMET
Labour Cooperative
Przemysłowa 9 Street
35-105 Rzeszów
Phone: +48 17 862 05 90
Email: [email protected]