Fluormex

Leaflet attached to the packaging: patient information

FLUORMEX, (33.19 mg + 22.1 mg)/g, gel
(Aminofluoridum + Natrii fluoridum)
12.5 mg of fluoride/g (12,500 ppm)

Read the 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 doctor or pharmacist.

• Keep this leaflet, you may need to read it again. If you need advice or additional information, consult a pharmacist. If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet:

What is Fluormex gel and what is it used for
Important information before using Fluormex gel
How to use Fluormex gel

• 4. Possible side effects How to store Fluormex gel
• 6. Package contents and other information

What is Fluormex gel and what is it used for

Fluormex gel is used for contact fluoridation of teeth:
for the prevention of caries;
in cases of underdevelopment of hard tooth tissues;
for hypersensitivity of tooth necks;
for enamel demineralization;
on sensitive surfaces of teeth worn by orthodontic appliances, partial dentures, and other appliances;
after correction of traumatic bite, etc.
It can be used by children over 5 years old and adults.

Important information before using Fluormex gel

When not to use Fluormex gel:

if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);

• in children under 5 years old; simultaneously with other high-fluoride preparations;
• in areas where the fluoride content in drinking water exceeds 0.7 mg/l; in people without caries or with low risk of caries;
• more often than once every two weeks and no more than 10 times a year;
• during pregnancy and breastfeeding.

Warnings and precautions

Particular caution should be exercised in children under 9 years old.
Children under 9 years old must be supervised by adults during the use of the product and should not swallow the gel while brushing; they should rinse their mouth lightly after the procedure.
Prolonged swallowing of certain amounts of fluoride-containing substances, even at low concentrations, may cause symptoms of chronic poisoning in the form of dental fluorosis (fluoride spots on teeth).

Fluormex gel and other medicines

Do not use another concentrated fluoride preparation at the same time.
Toothpastes (fluoride content up to 1500 ppm) and mouthwashes (fluoride content up to 250 ppm) for daily use can be used together with Fluormex gel as directed by a doctor or under their supervision.

Pregnancy and breastfeeding

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

Driving and operating machinery

Fluormex gel has no effect on the ability to drive vehicles and operate machinery.
Fluormex gel contains propyl parahydroxybenzoate and methyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions)

How to use Fluormex gel

Fluormex gel should be used strictly according to the following description:
During the year, one series of treatments should be used. A series of treatments means using the gel every two weeks, for a total of 5 to 10 times, i.e., 1 brushing every 2 weeks for 10 to 20 weeks.
Brushing - cleaning teeth before the procedure is very beneficial but not necessary, as Fluormex gel is highly adhesive.
About 1 cm of squeezed gel is applied to the toothbrush and the teeth are brushed for 3 minutes.
Children under 9 years old must be supervised by adults during the use of the gel to prevent swallowing; they should rinse their mouth lightly after the procedure.
Application - about 1 cm of squeezed gel is applied to all tooth surfaces using a cotton swab (in a dental office). In children under 9 years old with advanced caries, it is recommended to leave small amounts of gel in the grooves on the chewing surfaces of the teeth. Before starting fluoridation of tooth enamel, it is necessary to thoroughly remove dental plaque.
After completing the brushing or application procedure, spit out the saliva.
Do not rinse your mouth (except for children under 9 years old, who should rinse their mouth lightly). Do not eat for at least half an hour after the procedure.
Fluormex gel can also be used for preventive and therapeutic use in children at high risk of caries, including professionally in children with special care needs.
A very good method is to use individual applicators (squeezing spoons) lined with sponge, on which about 1 cm of squeezed gel is applied. The procedure lasts 4 to 5 minutes, with the use of a saliva ejector.
In case of doubts related to the use of the medicine, consult a doctor or pharmacist.

Use in children

Children under 9 years old must be supervised by adults during the use of the product and should not swallow the gel while brushing.

Using more than the recommended dose of Fluormex gel

There are no known symptoms of overdose of the medicine when used according to the indications and recommended method of use.
The permissible daily dose 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 products, especially those with high fluoride content, acute poisoning may occur.
Symptoms of acute poisoning may include: nausea, vomiting, abdominal pain, diarrhea, salivation, tearing, weakness, headache, cyanosis, shortness of breath, tetany, muscle cramps in the limbs - hypocalcemia, decreased blood pressure and arrhythmia, atrial fibrillation - hyperkalemia, rapid or imperceptible pulse, respiratory and metabolic acidosis, respiratory paralysis, and cardiac arrest.
The lethal dose (life-threatening) for an adult is from 32 to 64 mg of fluoride/kg of body weight, for children 15 mg/kg of body weight.
In case of ingestion of the medicine, contact a doctor immediately.

Missing a dose of Fluormex gel

In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

Stopping the use of Fluormex gel

In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may occur in case of overdose of the product, see section Using more than the recommended dose of Fluormex gel.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Fluormex gel

Store in a temperature below 25°C.
Keep the tube tightly closed.
Medicines should be kept out of the sight and reach of children.
Pay attention to the expiration date of the medicine.
Do not use this medicine after the expiration date stated on the tube. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fluormex gel contains

• The active substance of the medicine is fluoride in the form of aminofluorides and sodium fluoride. 1 g of gel contains 33.19 mg of aminofluorides (Aminofluoridum)+ 22.1 mg of sodium fluoride (Natrii fluoridum). 1 g of gel contains 12.5 mg of active fluoride (12,500 ppm).
• Other ingredients are: glycerol, propyl parahydroxybenzoate, methyl parahydroxybenzoate, hydroxyethyl cellulose, polyoxyethylene-polyoxypropylene glycol, purified water, flavor and aroma enhancer (peppermint flavor).

What Fluormex gel looks like and what the package contains

Fluormex gel is a gel-like mass, colorless or light yellow to yellow, with a minty taste and smell.
A laminated tube with a polyethylene or polypropylene cap, placed in a cardboard box, contains 50 g of gel.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
phone: 17 862 05 90
e-mail: chema@chema.rzeszow.pl
Date of last update of the leaflet:06.04.2016