Fluormex

Package leaflet: information for the patient

FLUORMEX, (33.19 mg + 22.1 mg)/g, gel
(Aminofluoridum + Natrii fluoridum)
12.5 mg fluorine/g (12,500 ppm)
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again. If advice or additional information is needed, consult a pharmacist. If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse, consult a doctor.

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

What Fluormex gel is and what it is used for
Fluormex gel is used for topical dental fluoridation:
for caries prevention;
in cases of underdevelopment of dental hard tissues;
in cases of cervical dentin hypersensitivity;
in enamel demineralization;
on tooth surfaces worn 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 adults.

Important information before using Fluormex gel
When not to use Fluormex gel:
if the patient is allergic to the active substance or any of the other components 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 fluoride content in drinking water exceeds 0.7 mg/L;
• in individuals without caries or at low caries risk;
• 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 when using the product and must not swallow the gel during brushing; they should gently rinse the mouth after the procedure.
Long-term ingestion of certain amounts of substances containing fluorides, even at low concentrations, may cause symptoms of chronic poisoning in the form of mottled enamel (dental fluorosis).

Fluormex gel 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) for daily use may be used together with Fluormex gel as recommended or under the supervision of a physician.

Pregnancy and breastfeeding
Fluormex gel should not be used during pregnancy.
The medicine should not be used during breastfeeding, as safety has not been established.

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

Fluormex gel contains propyl parahydroxybenzoate and methyl parahydroxybenzoate, which
may cause allergic reactions (delayed-type reactions possible).

How to use Fluormex gel
Fluormex gel should be used strictly according to the following instructions:
One series of treatments should be performed per year. A treatment series consists of using the gel every two weeks, a total of 5 to 10 times, i.e., one brushing every two weeks for 10 to 20 weeks.

Brushing – cleaning teeth before treatment is beneficial but not necessary, as Fluormex gel is highly adhesive.
Approximately 1 cm of gel should be squeezed onto a toothbrush and teeth brushed for 3 minutes.
Children under 9 years of age must be supervised by an adult during gel application to prevent swallowing; they should gently rinse the mouth after the procedure.

Rubbing in – approximately 1 cm of squeezed gel is rubbed into all tooth surfaces using a cotton swab (in a dental office). In children under 9 years of age with advanced caries, it is recommended to leave small amounts of gel in the fissures of occlusal tooth surfaces. Prior to initiating fluoride application, dental calculus must be thoroughly removed.
After completion of brushing or rubbing in, saliva should be spat out.
Do not rinse the mouth (except for children under 9 years of age, for whom gentle rinsing of the oral cavity is recommended). Do not eat for at least half an hour after the procedure.

Fluormex gel can also be used for preventive and therapeutic purposes in children at increased or high caries risk, including professionally in children requiring special care.
A very effective method is the use of individual applicators (impression trays) lined with sponges, onto which approximately 1 cm of squeezed gel is applied. The procedure lasts 4 to 5 minutes, using a saliva ejector.

If there are any doubts regarding the use of the medicine, consult a doctor or pharmacist.

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

Use of a higher than recommended dose of Fluormex gel
Symptoms of overdose are not known when the medicine is used according to indications and the recommended method of use.
The acceptable daily intake of fluoride is 3 to 4 mg/day (drinking water, beverages, food products). In the event of accidental ingestion of significant amounts of fluoride-containing product, especially one with high fluoride content, acute poisoning may occur.
Symptoms of acute poisoning may include: nausea, vomiting, abdominal pain, diarrhea, salivation, 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 dose (life-threatening) for an adult is 32 to 64 mg fluorine/kg body weight; for children, 15 mg/kg body weight.
If the medicine is swallowed, seek immediate medical advice.

Missed application of Fluormex gel
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

Discontinuation of Fluormex gel use
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this product may cause side effects, although not everyone will experience them.
Adverse effects may occur in case of overdose; see section "Use of a higher than recommended dose of Fluormex gel".

Reporting of adverse 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 to provide more information on the safety of the medicine.

How to store Fluormex gel
Store below 25°C.
Keep the cap tightly closed on the tube.
Keep 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 tube. 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. This will help protect the environment.

6. Contents of the package and other information

What Fluormex gel contains

• The active substance is fluorine in the form of amine fluorides and sodium fluoride. 1 g of gel contains 33.19 mg of amine fluorides (Aminofluoridum) + 22.1 mg of sodium fluoride (Natrii fluoridum). 1 g of gel contains 12.5 mg of active fluorine (12,500 ppm).
• Other components: glycerol, propyl parahydroxybenzoate, methyl parahydroxybenzoate, hydroxyethylcellulose, polyoxyethylene-polyoxypropylene glycol, purified water, flavouring agent (mint flavour).

What Fluormex gel looks like and contents of the pack
Fluormex gel is a jelly-like mass, colourless or ranging from light yellow to yellow, with a mint taste and odour.
The laminate tube with a polyethylene or polypropylene cap, placed in a cardboard box, contains 50 g of gel.

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