Zymafluor

Package leaflet: Information for the patient

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 because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms.

Contents of this leaflet:

1. What ZYMAFLUOR is and what it is used for
2. What you need to know before taking 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 ZYMAFLUOR is and what it is used for

ZYMAFLUOR contains the active substance sodium fluoride, which belongs to a group of medicines used to strengthen tooth enamel, promote its remineralization, and reduce acid production by bacteria present on the teeth (dental plaque).
This medicine is indicated for the prevention of dental caries in cases where the use of toothpaste is difficult, or as an addition to toothpaste in individuals at high risk of developing caries.

2. What you need to know before taking ZYMAFLUOR

Do not take ZYMAFLUOR

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

Warnings and precautions
Before starting treatment with ZYMAFLUOR, check whether you are receiving fluoride from other sources
to avoid 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 your drinking water exceeds 0.7 mg per litre, ZYMAFLUOR is not recommended (see
section “How to take ZYMAFLUOR”).
In particular, if you have kidney problems (e.g. renal impairment), consult your doctor before taking ZYMAFLUOR.

Other medicines and ZYMAFLUOR
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking medicines used to reduce stomach acidity (antacids) containing calcium, aluminium or magnesium salts, take ZYMAFLUOR at least 2 hours before or 2 hours after taking these medicines, as they reduce fluoride absorption.

ZYMAFLUOR with food and drink
Do not take ZYMAFLUOR with milk or dairy products, as they impair fluoride absorption.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
ZYMAFLUOR may be used to supplement fluoride intake in both the mother and the nursing infant (see section “How to take ZYMAFLUOR”).

Driving and using machines
ZYMAFLUOR does not affect the ability to drive or operate machinery.

ZYMAFLUOR contains sodium, benzoic acid and sorbitol

3. How to take ZYMAFLUOR

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The dose to be taken depends on the child's age, the fluoride content of drinking water, and the amount of fluoride ingested through food or fluoride-containing toothpastes.
For the duration of treatment, consult your doctor or dentist.
Do not exceed the recommended doses without consulting your doctor.
Begin ZYMAFLUOR treatment in children before teeth erupt, but not before 6 months of age.

If the fluoride content in drinking water is less than 0.3 mg per litre, or if the water is not fluoridated, the recommended dose is:

• 0.25 mg daily (4 drops or 1 tablet of 0.25 mg) for children aged between 6 months and 2 years and for breastfed infants (See section “Use during pregnancy and breastfeeding”);
• 0.50 mg daily (8 drops or 2 tablets of 0.25 mg or 1 tablet of 0.50 mg) for children aged between 2 and 6 years;
• 1 mg daily (1 tablet of 1 mg) for children aged between 6 and 16 years, or as prescribed by the doctor;
• 1 mg daily (1 tablet of 1 mg) for adolescents over 16 years of age.

If the fluoride content in drinking water is between 0.3 and 0.7 mg per litre, the recommended dose is:

• 0.25 mg daily (4 drops or 1 tablet of 0.25 mg) for children aged between 2 and 6 years;
• 0.50 mg daily (2 tablets of 0.25 mg or 1 tablet of 0.50 mg) for children aged between 6 and 16 years;
• 0.50 mg daily (2 tablets of 0.25 mg) for adolescents over 16 years of age and adults.

If the fluoride content in drinking water exceeds 0.7 mg per litre, fluoride treatment is not recommended (See section “Warnings and precautions”).

Use during pregnancy and breastfeeding
If you are pregnant or breastfeeding, the recommended supplemental intake is 1 tablet of 1 mg daily. Since fluoride ion content in breast milk is negligible, it is recommended that a breastfed infant receive 1 tablet of 0.25 mg or, preferably considering the infant’s age, 4 drops of Zymafluor daily (equivalent to 0.25 mg of fluoride ions).

Administration method:

ZYMAFLUOR oral drops
The drops are particularly suitable for administration in infants from six months of age.
You may give the drops to the child as a single daily dose either directly or by adding them to a bottle with a small amount of water.
Do not dissolve them in milk (See section “ZYMAFLUOR with food and drink”).
Please read the following instructions carefully before using ZYMAFLUOR oral drops:

• open and remove the bottle cap;
• tilt the bottle into an almost vertical position to facilitate the release of drops without squeezing 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.
Allow the tablets to dissolve slowly in the mouth, placing them between the cheek and the gum, alternating between the left and right side. Do not swallow the tablets whole.
Take the tablets in the evening, before going to bed, after brushing teeth, so as to maintain a high concentration of fluoride in the 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 a doctor.

If you take more ZYMAFLUOR than you should
Following long-term ingestion of an excessive dose of ZYMAFLUOR (chronic overdose), discoloured spots may appear on tooth enamel (dental fluorosis); see section 4 for possible side effects. Long-term chronic intoxication may also lead to skeletal fluorosis. Following acute ingestion of an excessive dose of ZYMAFLUOR (acute overdose), the following symptoms may occur:

• salivation, nausea, abdominal pain, thirst, vomiting, haemorrhagic diarrhoea;
• fatigue, muscle weakness, tremor, altered sensation in the extremities and face, reduced nerve conduction, involuntary and forceful muscle contractions;
• seizures;
• shortness of breath, severe breathing difficulties (respiratory failure);
• reduced heart function (heart failure);
• kidney problems (kidney failure);
• decreased levels of calcium (hypocalcaemia) and sugar (hypoglycaemia) in the blood;
• progressive respiratory paralysis, shock;
• death, which may occur within 2–4 hours.

In case of accidental ingestion of an excessive dose of ZYMAFLUOR, contact your doctor immediately or go to the nearest hospital.
Your doctor will determine the appropriate treatment based on the severity of your symptoms.

If you forget to take ZYMAFLUOR
Do not take a double dose to make up for the missed dose.

If you stop taking ZYMAFLUOR
If you have any 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 everyone will experience them.
The following side effects may occur rarely (affecting up to 1 in 1,000 people):

• mild skin irritations (erythema, rash, urticaria) which disappear quickly if you stop treatment,
• hypersensitivity reactions (including gastrointestinal symptoms),
• dental fluorosis.

Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
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 use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and to the product in its original, undamaged packaging stored correctly.
Store ZYMAFLUOR 14 mg/ml oral drops at a temperature below 30°C.
Store ZYMAFLUOR 0.25 mg tablets at a temperature below 25°C, in the original packaging, and keep the bottle tightly closed to protect the medicine from moisture.
ZYMAFLUOR 0.50 mg and ZYMAFLUOR 1 mg tablets do not require any special storage temperature conditions. Store in the original packaging and keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines 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 substance is sodium fluoride (see section 2 "Zymafluor contains sodium, benzoic acid and sorbitol"). Each ml of solution contains 2.52 mg of sodium fluoride (equivalent to 1.14 mg of fluoride ions).
• The other components are: benzoic acid (see section 2 "Zymafluor contains sodium, benzoic acid and sorbitol"), glycerol, non-crystallizable liquid sorbitol (see section 2 "Zymafluor contains sodium, benzoic acid and sorbitol"), purified water.

What ZYMAFLUOR 0.25 mg tablets contain

• The active substance is sodium fluoride (see section 2 "Zymafluor contains sodium, benzoic acid and sorbitol"). Each tablet contains 0.56 mg of sodium fluoride (equivalent to 0.25 mg of fluoride ions).
• The other components are: sorbitol (see section 2 "Zymafluor contains sodium, benzoic acid and sorbitol"), anhydrous colloidal silica, peppermint flavor, magnesium stearate.

What ZYMAFLUOR 0.50 mg tablets contain

• The active substance is sodium fluoride (see section 2 "Zymafluor contains sodium, benzoic acid and sorbitol"). Each tablet contains 1.105 mg of sodium fluoride (equivalent to 0.50 mg of fluoride ions).
• The other components are: sorbitol (see section 2 "Zymafluor contains sodium, benzoic acid and sorbitol"), anhydrous colloidal silica, magnesium stearate, powdered peppermint essential oil, E 172, mixture of colorants E172 and E171.

What ZYMAFLUOR 1 mg tablets contain

• The active substance is sodium fluoride (see section 2 "Zymafluor contains sodium, benzoic acid and sorbitol"). Each tablet contains approximately 2.3 mg of sodium fluoride (equivalent to 1 mg of fluoride ions).
• The other components are: sorbitol (see section 2 "Zymafluor contains sodium, benzoic acid and sorbitol"), anhydrous colloidal silica, colorant E172, magnesium stearate.

Description of the appearance of ZYMAFLUOR and contents of the pack
ZYMAFLUOR 1.14 mg/ml oral drops, solution
Oral drops, solution, contained in a dropper bottle.
Pack size: 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.
Pack size: 200 tablets.
ZYMAFLUOR 0.50 mg tablets
0.50 mg tablets, round, biconvex, pale orange speckled, with a peppermint odor.
Pack size: 100 tablets.
ZYMAFLUOR 1 mg tablets
1 mg tablets, round, yellowish-beige in color, slightly mottled, practically odorless.
Pack size: 100 tablets.

Marketing Authorization Holder
Meda Pharma S.p.A., Via Felice Casati 20, 20124 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