ZYMADUO 150 UI SOLUTION BUVABLE FLACON 12 ML is a medication to prevent dental caries and vitamin-poor rickets in infants aged 0 to 18 months, when fluoride and vitamin D are administered together.
For warnings, precautions for use and contraindications, please consult the instructions for use.
Prevention of dental caries and vitamin-drive rickets in infants aged 0-18 months, when fluoride and vitamin D are administered together:
This medicine should not be taken without medical advice.
Prevention of dental caries
Prevention of vitamin-poor rickets
4 drops a day, to be taken undiluted or diluted in a little water or fruit juice (avoid milky drinks) in a single daily dose.
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EXCIPIENTS |
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Polyoxyethylenated hydrogenated castor oil (Cremophor RH 40) (side effect) |
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Poloxamer 407 (LUTROL F127) |
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Maltitol syrup (note) |
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Saccharin (E954) sodium |
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Sodium methyl parahydroxybenzoate (E219) |
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Sodium propyl parahydroxybenzoate (E217) |
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Purified water |
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Orange-caramel flavor : |
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Ethyl alcohol |
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Limonene |
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Benzaldehyde |
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Propylene glycol (E1520) |
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Benzyl alcohol |
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Coumarin |
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Vanillin |
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Ethylvanillin |
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Covi-Ox T70 : |
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Tocopherol (E306) alpha, beta, gamma and delta |
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Phosphate buffer solution: qs pH = 6.8 |
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Anhydrous sodium hydrogen phosphate |
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Potassium dihydrogen phosphate |
- Take into account any other vitamin D or fluoride intake.
- The indicated dose must not be exceeded; dental fluorosis may occur after continuous ingestion of large quantities of fluoride.
Before prescribing this drug, please :
- If vitamin D-supplemented milk is used, this formulation is not suitable (except for children with pigmented skin); in this case, use the formulation delivering 150 IU in 4 drops.
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Form |
Oral solution in drops |
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Dosage |
300 IU/0.138 mg/drop |
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Contents |
370 drops |
Caution: this medicine is not a product like any other. Read the package insert carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, ask your doctor or pharmacist for advice. Beware of incompatibilities with your current products.
Take care of your little one's health with ZYMADUO 150 UI Solution Buvable. Our solution is specially designed for the prevention of dental caries and vitaminoprivileged rickets in infants aged 0-18 months, when fluoride and vitamin D are administered together. Discover how ZYMADUO can be your baby's best ally for oral and bone health.
Protect your baby's smile: Tooth decay can occur at an early age. ZYMADUO 150 IU Oral Solution is formulated to strengthen your baby's tooth enamel, protecting him from potential cavities and preserving his radiant smile.
Support bone growth: Vitamin-poor rickets is a major concern for infants. Our solution contains vitamin D, which plays an essential role in your baby's bone development, ensuring strong, healthy growth.
Easy to administer: We understand that giving medicine to a baby can sometimes be a challenge. ZYMADUO is a pleasant-tasting drinkable solution, making it easy to administer and ensuring your baby gets the essential nutrients he needs.
Recommended by Pediatric Experts: ZYMADUO is widely recommended by pediatricians for its balanced, effective formula. You can trust it to meet your baby's specific needs.
For overall health: Oral and bone health are key elements of your baby's overall health. By using ZYMADUO, you're investing in your baby's long-term well-being.
A Healthy Ritual: Create a daily ritual of well-being by administering ZYMADUO to your baby. It's a simple gesture that will have a lasting impact on your baby's health.
Give your baby a solid foundation for a lifetime of good health with ZYMADUO 150 IU Oral Solution. Tooth decay prevention, bone growth support and ease of administration make it the ideal choice for parents concerned about their little one's health.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 20/07/2017
ZYMADUO 150 IU, oral solution in drops
Cholecalciferol - Sodium Fluoride
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
Do not use this medication for children.
1. What is ZYMADUO 150 IU, oral solution in drops and in which case is it used?
2. What should I tell you before taking ZYMADUO 150 IU, oral solution in drops ?
3. How to take ZYMADUO 150 IU, oral solution in drops ?
4. What are the possible side effects?
5. How to store ZYMADUO 150 IU, oral solution in drops ?
6. Package contents and other information.
1. WHAT IS ZYMADUO 150 IU, oral solution in drops AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: Other mineral substitutes - ATC code: A12CD51
ZYMADUO 150 IU is intended for infants aged 6 to 18 months.
Your doctor has prescribed this medicine to your child to bring him or her appropriate amounts of fluoride and vitamin D to prevent tooth decay and rickets:
· If it is fed with milk already enriched with vitamin D
· If it does not have strongly pigmented skin
· If it presents a high caries risk.
High caries risk: history of caries (people or parents or siblings), or failure to observe food or oral hygiene rules, or environmental risk factors.
This medication should not be taken without medical advice.
2. BEFORE YOU TAKE ZYMADUO 150 IU, drinkable solution in drops?
Do not take ZYMADUO 150 IU, oral solution in drops:
· if you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medication mentioned in section 6.
· if you have an increase in calcium in the blood or urine, or a kidney stone.
This product should not be combined with other fluoride-containing medicines because of the risk of overdosage.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Take special care with ZYMADUO 150 IU, oral solution in drops:
Special warnings:
In order to avoid overdose, take into account the total doses:
· of vitamin D in combination with a treatment already containing this vitamin. This specialty, which delivers only 600 IU in 4 drops, half the daily dose recommended for the prevention of rickets, is perfectly adapted when the child is fed with vitamin D supplemented milk. highly pigmented skin, it is preferable to use the formulation delivering 1200 IU in 4 drops.
· fluoride : The recommended dosage is 0.05 mg fluoride / day and per kg of body weight not to exceed 1 mg per day all fluoride intake combined Also take into account the fluorine content of certain bottled waters.
This medicine contains castor oil and can cause digestive problems (mild laxative effect, diarrhea).
This medicine contains maltitol syrup. Its use is discouraged in patients with fructose intolerance (rare hereditary disease).
This medicine contains sodium methyl parahydroxybenzoate and soda propyl parahydroxybenzoate and may cause allergic reactions.
Precautions for use:
Consider other possible intakes of vitamin D or fluoride.
The indicated dose must not be exceeded; dental fluorosis may occur after continuous ingestion of large amounts of fluoride.
Before taking this medication, you should:
· Ensure that the child is not receiving other sources of fluoride: fluoridated salts, bottled water, tap water (it is recommended to inquire at the Town Hall or the DDASS of its fluorine content). In infants, do not use mineral water that contains more than 0.3 mg fluoride per liter of water if you give your child a fluoride-containing medicine. Check the amount of fluoride mentioned on the bottle label.
· regularly check the teeth to verify the absence of development of fluorosis.
Giving a fluoridated medicine to your child does not dispense with good food hygiene!
· limit sugars, especially snacks and sugary drinks between meals
· do not let him fall asleep with a bottle containing anything but pure water.
Also pay attention to its oral hygiene:
· Brush teeth at least once a day with fluoride toothpaste containing less than 500 PPM fluoride,
· Take it regularly in consultation with the dentist
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Other medicines and ZYMADUO 150 IU oral solution in drops
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Food and drinks
Not applicable.
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
ZYMADUO 150 IU, oral solution in drops contains : sodium methyl parahydroxybenzoate, soda propyl parahydroxybenzoate, polyoxyethylenated hydrogenated castor oil (Cremophor RH 40), maltitol syrup.
3. HOW TO TAKE ZYMADUO 150 IU, oral solution in drops?
4 drops a day.
Method and route of administration
This drop counting bottle is equipped with a safety cap.
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After use, tighten the cap securely until it clicks into place.
Oral use.
The drops can be administered pure or diluted in a little water or fruit juice (avoid milk drinks), in a single daily dose.
If you take more ZYMADUO 150 IU oral solution in drops than you should:
In case of overdose, stop treatment and consult a doctor.
If you forget to take ZYMADUO 150 IU, oral solution in drops:
Do not change the usual dosage.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Exceptionally may occur:
· skin reactions such as pruritic rash, eczema, urticaria;
· digestive reactions such as regurgitation, nausea, vomiting, especially in case of overdose;
· hypercalcemia in particular in the event of overdose.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ZYMADUO 150 IU, oral solution in drops?
Keep this medicine out of the reach and sight of children.
Do not use Zymaduo 150UI, oral solution in drops after the expiry date stated on the vial.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ZYMADUO 150 IU contains, oral solution in drops
The active substances are :
Cholecalciferol (vitamin D3) ............................................. .................................................. .... 150 IU
Sodium Fluoride ............................................... .................................................. .......... 0.13880 mg
Quantity corresponding to fluorine .............................................. .............................................. 0.0625 mg
For a drop
4 drops contain 600 IU of vitamin D3 and 0.25 mg of fluoride.
The other components are :
Polyoxyethylene hydrogenated castor oil (Cremophor RH 40), poloxamer 407 (Lutrol F127), maltitol syrup, sodium soda parahydroxybenzoate, soda propyl parahydroxybenzoate, orange-caramel flavor, Covi-Ox T 70, purified water phosphate buffer.
What is ZYMADUO 150 IU, oral solution in drops and contents of the pack
This medication is in the form of a drinkable solution in drops - 12 ml bottle
Marketing Authorization Holder
40 - 44 WASHINGTON STREET
75008 PARIS
Marketing Authorization Operator
40-44 Washington Street
75008 PARIS
DAMASTOWN INDUSTRIAL PARK
Mulhuddart
DUBLIN 15
IRELAND
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
Vitamin D with fluoride
vitamin D3, fluoride
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Directions for use and dosage . Advice . Lexicon
ZYMADUO 150 IU: oral solution (orange-caramel flavoring); 12 ml bottle with dropper.
Refunded at 30%. - price: 2,50 euro (s).
ZYMADUO 300 IU: oral solution (orange-caramel flavoring); 12 ml bottle with dropper.
Refunded at 30%. - price: 2,50 euro (s).
Laboratory Meda Pharma
| p 4 beds | p 4 beds | |
| Colecalciferol (vitamin D3) | 600 IU | 1200 IU |
| Sodium fluoride | 0.552 mg | 0.552 mg |
| either Fluor | 0.25 mg | 0.25 mg |
Usual dosage:
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