Fluormex

Leaflet attached to the packaging: patient information

FLUORMEX, 133 mg/g, dental liquid

(Aminofluoride)

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary. If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same. If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

What is Fluormex dental liquid and what is it used for

Fluormex is a dental liquid for use on teeth.
Fluormex liquid 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 braces;
after correction of traumatic bite, etc.
It can be used by children over 5 years old and adults.

Important information before using Fluormex dental liquid

When not to use Fluormex dental liquid:

if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
in children under 5 years old;
at the same time as other preparations with high fluoride concentrations;
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 must not swallow the liquid while brushing.
Prolonged ingestion of certain amounts of substances containing fluoride compounds, even at low concentrations, may cause symptoms of chronic poisoning in the form of dental fluorosis (fluoride spots on teeth).

Fluormex dental liquid 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 liquid, as recommended or under the supervision of a doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should not use Fluormex liquid.
The medicine should not be used during breastfeeding, as its safety has not been established.

Driving and using machines

Fluormex dental liquid has no effect on the ability to drive vehicles and operate machines.

How to use Fluormex dental liquid

Fluormex dental liquid is recommended for use under control, strictly according to the dentist's instructions, as one series of treatments per year. A series of treatments means using the liquid every two weeks, for a total of 5 to 10 times, i.e., one brushing every 2 weeks for 10 to 20 weeks.
Brushing - cleaning the teeth before the procedure is very beneficial, but not necessary, as Fluormex liquid is highly adhesive.
Children under 9 years old must be supervised by adults during the use of the medicine and must not swallow the liquid while brushing.
6 to 9 drops of the liquid are applied to the toothbrush and the teeth are brushed for 3 minutes.
Applying - 0.5 to 1 ml of the liquid is applied to a cotton swab (in a dental office), and then carefully and slowly rubbed into the dried tooth surfaces, so that the liquid can penetrate the grooves and fissures. Before starting the fluoridation of tooth enamel, it is necessary to thoroughly remove dental tartar.
After completing the brushing or applying procedure, spit out the saliva.
Do not rinse the mouth and do not eat for at least half an hour after the procedure.

Use in children

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

Using more than the recommended dose of Fluormex dental liquid

No symptoms of overdose are known when the medicine is used according to the instructions 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 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 failure, 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, contact a doctor immediately.

Missing a dose of Fluormex dental liquid

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

Stopping the use of Fluormex dental liquid

If you have any further doubts about using this medicine, consult your 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 dental liquid".

Reporting side effects

If you experience any side effects, including those not listed in this 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 dental liquid

Store in a temperature below 25°C.
Store the bottle tightly closed.
Medicines should be kept out of 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 bottle. The expiration date means 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 that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Fluormex dental liquid contains

• The active substance of the medicine is fluoride in the form of aminofluorides. 1g of the liquid contains 133 mg of aminofluorides, which is 10 mg of active fluoride (10,000 ppm).
• The other ingredients are: glycerol, purified water, flavor and aroma enhancer (peppermint flavor).

What Fluormex dental liquid looks like and what the package contains

Fluormex dental liquid is a yellow, oily liquid with a peppermint aroma.
A plastic bottle with a dropper and screw cap, placed in a cardboard box, contains 50 g of the liquid.

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 revision of the leaflet: 2016-11-21