Zymafluor - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Fluorine (Sodium fluoride)

ZYMAFLUOR 1.14 mg / ml oral drops, solution
ZYMAFLUOR 0.25 mg tablets
ZYMAFLUOR 0.50 mg tablets
ZYMAFLUOR 1 mg tablets

Why is Zymafluor used? What is it for?

What is it

Substance used in the prophylaxis (prevention) of dental caries: it makes the tooth enamel stronger, favors its remineralization and reduces the production of acids by bacterial plaque.

Why is it used

Zymafluor is used for the prevention of tooth decay.

Contraindications When Zymafluor should not be used

Hypersensitivity to components or other closely related substances from a chemical point of view. It is advisable to consult your doctor if this hypersensitivity reaction has occurred in the past.

Precautions for use What you need to know before taking Zymafluor

Before starting the treatment, the quantities of fluoride ingested through other sources should be taken into account, in order to avoid overdosing. In areas where table salt or water are fluoridated, the dosage of Zymafluor should be reduced. If the water contains more than 0.7 mg / l of fluoride, the supplementary intake of fluoride is not recommended.

Zymafluor is not contraindicated for people with celiac disease.

Interactions Which drugs or foods may change the effect of Zymafluor

If you are using other medicines ask your doctor or pharmacist for advice. Do not use Zymafluor together with these drinks and / or foods: milk, dairy products.

Do not take Zymafluor at the same time as antacids containing calcium, aluminum or magnesium salts as they inhibit their absorption. Leave an interval of two hours between the administration of Zymafluor and antacids.

Warnings It is important to know that:

What to do during pregnancy and breastfeeding

Zymafluor can be used during pregnancy and breastfeeding.

The recommended dose as a supplementary intake for the mother is 1 tablet of 1 mg or 16 drops of Zymafluor per day, equal to 1 mg of fluorine. Since the fluor-ion content in breast milk is negligible, the breastfed child is advised to administer one 0.25 mg tablet or, preferably given the child's age, 4 drops of Zymafluor per day (equal to 0, 25 mg of fluorine ions).

Keep this medicine out of the reach and sight of children.

Treatment with fluoride is not necessary if drinking water contains more than 0.7 mg / l. If in doubt, consult your doctor.

Strictly follow the recommended doses. The product, if accidentally ingested or if used for a long period in excessive doses, can cause toxic phenomena.

Dosage and method of use How to use Zymafluor: Dosage

  • How many

The optimal daily dose of Zymafluor depends on the fluoride content of the drinking water and the age of the child, as indicated in the table.

age in general 0.3-0.7 mg F- / l in water from 2 weeks to 2 years 4 drops or 1 tablet 0.25 mg 0 from 2 to 4 years 2 tablets 0.25 mg or 1 tablet 0.50 mg 1 tablet 0.25 mg from 4 to 16 years 1 tablet 1 mg 2 tablets 0.25 mg or 1 tablet 0.50 mg over 16 years 1 tablet 1 mg 3 tablets 0.25 mg

4 drops = 0.25 mg fluor-ions

Warning: do not exceed the indicated doses without medical advice.

When and for how long

It is advisable to start the intake of fluoride before the eruption of the teeth. It is recommended to take the tablets in the evening, before going to bed, after brushing your teeth, so that a high concentration of fluoride can be maintained in the mouth for a longer period of time.

For the duration of the treatment, ask your doctor or dentist for advice.

  • Like

To the newborn, administer the drops of Zymafluor as they are or by adding them to the bottle containing a little water, in a single daily dose. Do not dissolve the drops in milk. After each use, close the bottle carefully. As soon as age permits, it is recommended to use Zymafluor tablets letting them dissolve in the mouth between the cheek and gums, now on the left side now on the right side.

Instructions for using Zymafluor drops

After opening and removing the cap, tilt the vial almost vertically to facilitate the escape of the drops. Do not press the vial.

Overdose What to do if you have taken too much Zymafluor

If a large amount of Zymafluor is accidentally taken (more than 5 mg / kg), induce vomiting, drink milk and seek immediate medical attention.

In the event that the quantity ingested is lower than the above, make the child drink milk and contact a doctor.

In case of accidental ingestion / intake of an overdose of Zymafluor, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Zymafluor

Rare cases of mild rashes (erythema, urticaria) have been reported. They disappear rapidly with discontinuation of treatment.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

These side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist.

It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet. Request and fill in the Undesirable Effects report form available at the pharmacy (form B).

Expiry and Retention

Before use, check the expiry date indicated on the package.

Zymafluor 0.50 mg and 1 mg tablets: this medicine does not require any special storage temperatures. Store in the original packaging. Keep the bottle tightly closed to protect the medicine from moisture.

Zymafluor 0.25 mg tablets: Store at a temperature not exceeding 25 ° C. Store in the original packaging. Keep the bottle tightly closed to keep it away from moisture.

Warning: do not use the medicine after the expiry date indicated on the package.

Keep this medicine out of the reach and sight of children.

It is important to always have the information on the medicine available, so keep both the box and the package leaflet.

Composition

Zymafluor oral drops:

1 ml of solution contains: active ingredient sodium fluoride 2.52 mg (equal to 1.14 mg fluoride) - Excipients: benzoic acid; glycerol; non-crystallizable liquid sorbitol; purified water. Zymafluor tablets 0.25 mg: One tablet contains: active ingredient sodium fluoride 0.56 mg (equal to fluorion: 0.25 mg) - Excipients: sorbitol; anhydrous colloidal silica; mint essence; magnesium stearate.

Zymafluor tablets 0.50 mg:

One tablet contains: active ingredient sodium fluoride 1.105 mg (equal to fluoride: 0.50 mg) - Excipients: sorbitol; anhydrous colloidal silica; magnesium stearate; powdered mint essential oil; E172; mixture of E172 and E171 dyes.

Zymafluor tablets 1 mg:

One tablet contains: active ingredient sodium fluoride about 2.3 mg (equal to fluoride: 1 mg) - Excipients: sorbitol; anhydrous colloidal silica; mixture of dyes E172 and E171; strawberry flavor; magnesium stearate.

How it looks

Zymafluor comes in the form of:

  • oral drops, solution, contained in a dropper bottle. The contents of the pack are 20 ml (1 ml = 18 drops; 4 drops = 0.25 mg of fluorine ions).
  • 0.25 mg tablets. The contents of the pack are 200 tablets.
  • 0.50 mg tablets. The contents of the pack are 100 tablets.
  • 1 mg tablets. The contents of the pack are 100 tablets.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Zymafluor can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on the ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical data of 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 HOLDER OF THE ALL AUTHORIZATION "PLACING ON MARKETING 08.0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF PR IMA AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

ZYMAFLUOR

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Zymafluor oral drops

1 ml of solution contains: active ingredient sodium fluoride 2.52 mg (equal to 1.14 mg fluoride-ions).

Zymafluor tablets 0.25 mg

Each tablet contains: active ingredient sodium fluoride 0.56 mg (equal to 0.25 mg fluoride-ions)

Zymafluor tablets 0.50 mg

Each tablet contains: active ingredient sodium fluoride 1.105 mg (equal to 0.50 mg fluoride).

Zymafluor tablets 1 mg

Each tablet contains: active ingredient sodium fluoride 2.3 mg ca (equal to 1 mg fluoride).

03.0 PHARMACEUTICAL FORM

Oral drops, solution.

0.25 mg tablets.

0.50 mg tablets.

1 mg tablets.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Prevention of dental caries.


04.2 Posology and method of administration

The daily dose should be commensurate with the age of the child as well as the fluoride content of drinking water and fluoride ingested through other sources such as diet or fluoridated toothpaste.

It is recommended to prescribe the doses shown in the following table taking into account the fluorine content of drinking water:

CONCENTRATION OF FLUORINE IN THE WATER (MG / L) 0,3-0,7 >0,7 Supplementary intake of fluoride recommended Age (Mg / F- / day) from 2 weeks up to 2 years 0,25 0 0 from 2 to 4 years 0,50 0,25 0 from 4 to 16 years 1 0,50 0 over 16 years 1 0,75 0

If drinking water is not fluorinated, it is recommended to prescribe the following dosage:

During pregnancy and breastfeeding: 1 tablet 1 mg per day Children: - from 2 weeks up to 2 years: 4 drops a day or 1 tablet 0.25 mg per day - from 2 to 4 years: 2 tablets 0.25 mg per day or 1 tablet of 0.50 mg per day - from 4 to 16 years: 1 tablet 1 mg per day (or according to the doctor's opinion) - over 16 years: 1 tablet 1 mg per day

(4 drops = 0.25 mg fluor-ions; 1 ml = 18 drops)

Do not exceed the recommended dose.

It is advisable to start the intake of fluoride before the eruption of the teeth.

The drops are particularly suitable for facilitating administration in the newborn. The drops of Zymafluor can be given to the newborn as they are or by adding them to the bottle containing a little water, in a single daily dose. Do not dissolve the drops in milk. After each use, close the bottle carefully.

As soon as age permits, it is advisable to use the Zymafluor tablets letting them dissolve in the mouth between the cheek and the gums, now on the left side now on the right side. We recommend taking the tablets in the evening, before going to bed, after brushing your teeth, so that a high concentration of fluoride can be maintained in the mouth for a longer period of time.


04.3 Contraindications

Hypersensitivity to one of the components of the product or closely related substances from a chemical point of view.


04.4 Special warnings and appropriate precautions for use

If a supplementary intake of fluoride is considered, the quantities of fluorides ingested through other sources should be taken into account and an overdose should be avoided.

In areas where table salt or water are fluoridated, the dosage of Zymafluor should be reduced. If the water contains more than 0.7 mg / l of fluoride, supplementary fluoride intake is not recommended.

Keep this medicine out of the reach of children.


04.5 Interactions with other medicinal products and other forms of interaction

The absorption of fluorine is related to the solubility of the ingested preparation.

Absorption is inhibited by calcium, magnesium or aluminum.

Zymafluor must therefore not be administered together with milk and dairy products, or with antacids containing calcium, aluminum or magnesium salts.

An interval of two hours should elapse between administration of Zymafluor and antacids.


04.6 Pregnancy and breastfeeding

Zymafluor was used extensively for many years during pregnancy.If you decide to administer Zymafluor during pregnancy and breastfeeding, the recommended dose for the mother is 1 tablet of 1 mg of Zymafluor per day (equal to 1 mg of fluor-ions). The fluor-ion content in breast milk, however, it is negligible and the breastfed child is advised to administer 1 tablet of 0.25 mg or, preferably, given the age of the child, 4 drops of Zymafluor per day (equal to 0.25 mg of fluorine ).


04.7 Effects on ability to drive and use machines

Zymafluor has no influence on the ability to drive or operate cars.


04.8 Undesirable effects

At doses recommended for the prevention of dental caries, sodium fluoride has not been shown to have any noteworthy side effects.

However, rare cases of mild rashes (erythema, urticaria) have been reported. They disappear rapidly with discontinuation of treatment.


04.9 Overdose

Chronic overdose

The main manifestation of a chronic ingestion of excessive amounts of fluoride, for example 2 mg of fluoride per day during the years required for the calcification of the tooth enamel, is the formation of patches on the tooth enamel.

Acute overdose

Acute overdose symptoms have been reported in adults following ingestion of more than 100 mg of fluorine ions. In adults this corresponds approximately to: more than 100 tablets of Zymafluor of 1 mg or 5 bottles of Zymafluor drops.

The lethal dose in adults (70 kg) is reported to be between 2.2 g - 4.5 g of fluorine. In children weighing 10 kg, just over 200 mg of fluorine can be fatal. The reported values ​​correspond approximately: 10 bottles of Zymafluor drops or 900 tablets of Zymafluor of 0.25 mg.

Initial symptoms are mainly related to gastrointestinal intolerance: salivation, nausea, abdominal pain, vomiting and diarrhea. These symptoms can be followed by muscle weakness, chronic seizures, respiratory, heart and kidney failure.

Death can occur within 2-4 hours.

Hypocalcemia and hypoglycemia are frequent findings.

Treatment:

• if less than 5.0 mg / kg body weight of fluorions have been ingested, corresponding for a child weighing 10 kg to less than: 2 bottles of Zymafluor drops or 200 tablets of Zymafluor of 0.25 mg

- give calcium (milk) orally to relieve gastrointestinal symptoms and keep under observation for a few hours.

• if more than 5 mg / kg of body weight of fluorine ions have been ingested, corresponding for a child weighing 10 kg to more than: 2 bottles of Zymafluor drops or 200 tablets of Zymafluor of 0.25 mg

- induce vomiting;

- administer soluble calcium orally in any form (eg milk, 5% calcium gluconate or a calcium lactate solution);

- keep under observation for a few hours in the emergency room.

• if more than 15 mg / kg body weight of fluorions have been ingested, corresponding for a child weighing 10 kg to more than: 6 bottles of Zymafluor drops or 600 tablets of Zymafluor of 0.25 mg

- provide for immediate hospitalization.

The therapeutic scheme is based on the following principles:

Inpatient treatment is required in order to empty the stomach by aspiration and gastric lavage with lime water or a 1% calcium chloride solution or another calcium salt in order to precipitate the fluorine ions. Aluminum hydroxide after gastric lavage can reduce the absorption of fluorine ions. Carry out cardiac monitoring (watch out for elevated T waves and lengthened QT intervals).

To control seizures, 10 ml of a 10% calcium gluconate solution can be given intravenously, with repeated injections every 4 to 6 hours if necessary. If necessary, inject morphine or pethidine in order to control colic. Support the circulation with suitable infusions of electrolytic solutions. Breathing may need assistance. Hemodialysis may be required. Vomiting, faeces and urine should be promptly removed with water to prevent external burns from forming.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: substances used in the prophylaxis of caries.

Sodium fluoride increases tooth resistance to caries. It can make tooth enamel more resistant to acids produced by dental plaque bacteria in the presence of sugary substances, promote remineralization and influence, by reducing it, the degree of acid production by bacteria. The intake of fluoride should begin before the teeth erupt and be continued throughout life.

Before their eruption Zymafluor is conveyed by the blood towards the forming teeth thus allowing an "effective pre-eruptive fluorination.

After eruption, the teeth take in fluoride through direct contact with the fluoride contained in saliva. Zymafluor tablets should therefore not be swallowed whole: it is extremely important that they are dissolved slowly in the mouth.


05.2 "Pharmacokinetic properties

Sodium fluoride is rapidly absorbed from the gastrointestinal tract. The bioavailability of sodium fluoride is practically 100%. Fluoride is a normal component of body fluids and soft tissues.

Most of the body's fluoride is stored in bones and teeth.

Fluoride is also present in feces, sweat, saliva, milk, tears and hair. It is mainly excreted in the urine.


05.3 Preclinical safety data

LD50 orally in rats 303 mg of F- / kg. LD50 orally in mice 233 mg of F- / kg.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Oral drops: benzoic acid; glycerol; non-crystallizable liquid sorbitol; purified water.

0.25 mg tablets: sorbitulum; anhydrous colloidal silica; mint essence; magnesium stearate.

Tablets 0.50 mg: sorbitol; anhydrous colloidal silica; magnesium stearate; powdered mint essential oil; E 172; mixture of E172 and E171 dyes.

Tablets 1 mg: sorbitol; anhydrous colloidal silica; mixture of dyes E172 and E171; strawberry flavor; magnesium stearate.


06.2 Incompatibility

None known.


06.3 Period of validity

Oral drops, 0.25 mg, 0.50 mg and 1 mg tablets: 3 years.


06.4 Special precautions for storage

Oral drops: no particular.

Tablets 0.50 mg and 1 mg: This medicinal product does not require any special storage temperatures. Store in the original packaging. Keep the bottle tightly closed to protect the medicine from moisture.

0.25 mg tablets: store at a temperature not exceeding 25 ° C.

Store in the original packaging. Keep the bottle tightly closed.


06.5 Nature of the immediate packaging and contents of the package

Oral drops

High density polyethylene bottle, opacified with titanium dioxide, equipped with low density polyethylene drop counter. Bottle of 20 ml.

Tablets 0.25 mg

Polypropylene container of 200 tablets of 0.25 mg.

Tablets 0.50 mg and 1 mg

Polypropylene container of 100 tablets.


06.6 Instructions for use and handling

See the section "Posology and method of administration".

07.0 MARKETING AUTHORIZATION HOLDER

ROTTAPHARM S.p.A., Galleria Unione, 5 - 20122 Milan

08.0 MARKETING AUTHORIZATION NUMBER

Zymafluor 20 ml oral drops - AIC: 022252050

Zymafluor 200 tablets 0.25 mg - AIC: 022252035

Zymafluor 100 tablets 0.50 mg - AIC: 022252062

Zymafluor 100 tablets 1 mg - AIC: 022252047

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

AIC renewal: 1/06/2010

10.0 DATE OF REVISION OF THE TEXT

May 2013

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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