ZYMAFLUOR 0.25 мг Коированная таблетка
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Инструкция по применению TSYMAFLUOR
Содержание инструкции
ZYMAFLUOR
1.14 mg/ml oral drops, solution
0.25 mg tablets
0.50 mg tablets
1 mg tablets
Sodium fluoride
Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you to do.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if you feel worse.
Contents of this leaflet:
- 1. What ZYMAFLUOR is and what it is used for
- 2. What you need to know before you take ZYMAFLUOR
- 3. How to take ZYMAFLUOR
- 4. Possible side effects
- 5. How to store ZYMAFLUOR
- 6. Contents of the pack and other information
1. What is ZYMAFLUOR and what is it used for
ZYMAFLUOR contains the active ingredient sodium fluoride which belongs to a group of medicines
used to make tooth enamel stronger, promote its remineralization and reduce the production of
acids by the bacteria present on the teeth (dental plaque).
This medicine is indicated for the prevention of tooth decay.
2. What you need to know before you take ZYMAFLUOR
Do not take ZYMAFLUOR
- if you are allergic to sodium fluoride (the active ingredient), to any of the ingredients of this medicine (listed in section 6) or to similar substances.
Warnings and precautions
Before starting treatment with ZYMAFLUOR, be careful if you are taking fluoride through other sources
to avoid an overdose (See section “How to take ZYMAFLUOR”).
If the table salt you use or your drinking water contains fluoride, reduce the dose of ZYMAFLUOR.
If the fluoride content in the water is higher than 0.7 mg per liter, ZYMAFLUOR is not recommended (See the
section “How to take ZYMAFLUOR”).
In particular,
before taking Zymafluor, consult your doctor:
Other medicines and ZYMAFLUOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
If you are taking medicines used to reduce stomach acidity (antacids) containing calcium, aluminum or magnesium salts,
take ZYMAFLUOR at least 2 hours before or 2 hours after taking these
medicines, as they reduce the absorption of fluoride.
ZYMAFLUOR with food and drink
Do not take ZYMAFLUOR with milk and dairy products as they prevent the absorption of fluoride.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
ZYMAFLUOR can be used to supplement fluoride intake in the mother and infant (See the
section “How to take ZYMAFLUOR”).
Driving and operating machinery
ZYMAFLUOR does not impair the ability to drive vehicles and operate machinery.
ZYMAFLUOR contains sodium, benzoic acid and sorbitol
3. How to take ZYMAFLUOR
Take this medicine always exactly as described in this leaflet or as your doctor or pharmacist has told you. If you have doubts, ask your doctor or pharmacist.
The dose to be taken depends on the child's age, the fluorine content of the drinking water and the amount of fluorine taken through food or the use of toothpastes containing fluorine.
For the duration of treatment, consult your doctor or dentist.
Do not exceed the recommended doses without consulting your doctor.
Start treatment with ZYMAFLUOR in children before the teeth erupt, but not before 6 months of age.
If the fluorine content in the drinking water is less than 0.3 mg per liter or if the water is not fluoridated, the recommended dose is:
- 0.25 mg per day (4 drops or 1 tablet of 0.25 mg) in children between 6 months and 2 years of age and in breastfed children (See section “Use during pregnancy and breastfeeding”); 0.50 mg per day (2 tablets of 0.25 mg or 1 tablet of 0.50 mg) in children between 2 and 4 years of age;
- 1 mg per day (1 tablet of 1 mg) in children between 4 and 16 years of age or as prescribed by your doctor;
- 1 mg per day (1 tablet of 1 mg) in adolescents over 16 years of age.
If the fluorine content in the drinking water is between 0.3 and 0.7 mg per liter, the recommended dose is:
- 0.25 mg per day in children between 2 and 4 years of age (1 tablet of 0.25 mg);
- 0.50 mg per day (2 tablets of 0.25 mg or 1 tablet of 0.50 mg) in children between 4 and 16 years of age;
- 0.75 mg per day (3 tablets of 0.25 mg) in adolescents over 16 years of age.
If the fluorine content in the drinking water is higher than 0.7 mg per liter, treatment with fluorine is not recommended (See section “Warnings and precautions”).
Use during pregnancy and breastfeeding
If you are pregnant or breastfeeding, the recommended dose as a supplement is 1 tablet of 1 mg per day. Because the fluorine ion content in breast milk is negligible, it is recommended to administer 0.25 mg tablet or, preferably given the child's age, 4 drops of Zymafluor per day to the breastfed baby (equivalent to 0.25 mg of fluorine ions).
Method of administration:
ZYMAFLUOR oral drops
The drops are particularly suitable for administration to infants from six months of age.
You can give the drops to the child in a single dose per day as they are or by adding them to the bottle with a little water.
Do not dissolve them in milk (See section “ZYMAFLUOR with food and beverages”).
Read the following instructions carefully before using ZYMAFLUOR oral drops:
- open and remove the cap of the bottle;
- tilt the bottle in an almost vertical position to facilitate the outflow of drops without pressing the bottle, as shown in the figure;
- close the bottle carefully after each use.
ZYMAFLUOR tablets
Use this formulation when your child's age allows it.
Let the tablets dissolve slowly in your mouth, placing them between your cheek and your gum, alternating the left side with the right side. Do not swallow the tablets whole.
Take the tablets in the evening, before going to bed, after brushing your teeth, so that you have a high amount of fluorine in your mouth for a longer period of time.
Open the tablet bottle as shown in the figure:
Use in patients with kidney problems
Zymafluor should be used in patients with kidney problems (e.g. kidney damage) only after consulting your doctor.
If you take more ZYMAFLUOR than you should
Following the intake of an excessive dose of ZYMAFLUOR for a long time (chronic overdose), spots can form on the enamel of the teeth (dental fluorosis) see section 4 possible side effects; chronic intoxication for a long period of time can also lead to skeletal fluorosis. Following the intake of an excessive dose of ZYMAFLUOR (acute overdose) the following symptoms may occur:
- salivation, nausea, abdominal pain, thirst, vomiting, hemorrhagic diarrhea;
- fatigue, muscle weakness, tremor, altered sensitivity of the extremities and face, reduced nerve transmission, involuntary and forced muscle contractions;
- convulsions;
- shortness of breath, serious breathing problems (respiratory failure);
- reduced heart function (heart failure);
- kidney problems (renal failure);
- decreased levels of calcium (hypocalcemia) and sugars (hypoglycemia) in the blood;
- progressive respiratory paralysis, shock;
- death, which can occur within 2-4 hours.
In case of accidental intake/ingestion of an excessive dose of ZYMAFLUOR, immediately inform your doctor or go to the nearest hospital.
The doctor will establish the appropriate therapy for you based on the severity of your symptoms.
If you forget to take ZYMAFLUOR
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can occur with rare frequency (may affect up to 1 in
- 1,000): …..):
- mild skin irritation (erythema, rash, urticaria) that disappears quickly if treatment is stopped,
- hypersensitivity reactions (including gastrointestinal symptoms),
- dental fluorosis.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at . By reporting
side effects you can help provide more information on the safety of this
medicine.
5. How to store ZYMAFLUOR
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
Store ZYMAFLUOR 14 mg/ml oral drops at a temperature not exceeding 30°C.
Store ZYMAFLUOR 0.25 mg tablets at a temperature not exceeding 25°C, in the original
packaging and keep the bottle tightly closed to protect the medicine from humidity.
ZYMAFLUOR 0.50 mg and ZYMAFLUOR 1 mg tablets do not require any particular storage
temperature. Store in the original packaging and keep the bottle tightly closed to protect the
medicine from humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.
6. Package contents and other information
What ZYMAFLUOR 1.14 mg/ml oral drops, solution contains
- The active ingredient is sodium fluoride (see section 2 "Zymafluor contains sodium, benzoic acid"). 1 ml of solution contains 2.52 mg of sodium fluoride (equivalent to fluoride ions 1.14 mg).
- The other ingredients are: benzoic acid, glycerol, non-crystallizing liquid sorbitol, purified water.
What ZYMAFLUOR 0.25 mg tablets contain
- The active ingredient is sodium fluoride (see section 2 "Zymafluor contains sodium, sorbitol"). Each tablet contains 0.56 mg of sodium fluoride (equivalent to fluoride ions 0.25 mg).
- The other ingredients are: sorbitol (see section 2 "Zymafluor contains sorbitol"), anhydrous colloidal silica, peppermint essence, magnesium stearate.
What ZYMAFLUOR 0.50 mg tablets contain
- The active ingredient is sodium fluoride (see section 2 "Zymafluor contains sodium, "). Each tablet contains 1.105 mg of sodium fluoride (equivalent to fluoride ions 0.50 mg).
- The other ingredients are: sorbitol (see section 2 "Zymafluor contains sorbitol"), anhydrous colloidal silica, magnesium stearate, peppermint oil powder, E 172, colorant mixture E172 and E171.
What ZYMAFLUOR 1 mg tablets contain
- The active ingredient is sodium fluoride (see section 2 "Zymafluor contains sodium, "). Each tablet contains approximately 2.3 mg of sodium fluoride (equivalent to fluoride ions 1 mg).
- The other ingredients are: sorbitol (see section 2 "Zymafluor contains sodium, sorbitol"), anhydrous colloidal silica, colorant E172, magnesium stearate.
Description of the appearance of ZYMAFLUOR and package contents
ZYMAFLUOR 1.14 mg/ml oral drops, solution
Oral drops, solution, contained in a dropper bottle.
The package contents are 20 ml (1 ml = 18 drops; 4 drops = 0.25 mg of fluoride ions).
ZYMAFLUOR 0.25 mg tablets
0.25 mg tablets, round, biconvex, white with a slight peppermint odor.
The package contents are 200 tablets.
ZYMAFLUOR 0.50 mg
0.50 mg tablets, round, biconvex, speckled pale orange with a peppermint odor.
The package contents are 100 tablets.
ZYMAFLUOR 1 mg tablets
1 mg tablets, round, beige-yellow in color, slightly mottled, practically odorless.
The package contents are 100 tablets.
Marketing authorization holder
ROTTAPHARM S.p.A. – Galleria Unione, 5 – 20122 – Milan – Italy
Manufacturers
ZYMAFLUOR 1.14 mg/ml oral drops, solution
Rottapharm Ltd, Damastown Industrial Park, Dublin 15 -Ireland
ZYMAFLUOR 0.25 mg, 0.50 mg and 1 mg tablets
Rottapharm Ltd, Damastown Industrial Park, Dublin 15 -Ireland
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- Страна регистрации
- Форма выпускаCoated tablet, 0.25 MG
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги TSYMAFLUORФорма выпуска: Dental gel, 25 GДействующее вещество: combinationsПроизводитель: COLGATE - PALMOLIVE COMMERCIALE S.R.L.Отпускается без рецептаФорма выпуска: Mouthwash, 0.25 %Действующее вещество: variousПроизводитель: BAYER S.P.A.Отпускается без рецептаФорма выпуска: Lozenge, 8.75 mgДействующее вещество: variousПроизводитель: BAYER S.P.A.Отпускается без рецепта
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TSYMAFLUOR производится компанией ROTTAPHARM S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения TSYMAFLUOR с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Вы можете купить TSYMAFLUOR в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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