Zymaduo 150 IU is an oral solution in drop form specially formulated for infants. It combines vitamin D3 and fluoride to support bone growth and prevent early tooth decay. Its appropriate dosage is suitable for babies fed with fortified milk. Easy to use, it fits seamlessly into the daily routine.
ZYMADUO 150 IU is a pediatric oral solution specifically formulated for infants aged 6 to 18 months. This unique combination of vitamin D3 and sodium fluoride provides dual protection that is essential during growth: it strengthens bone density while preventing tooth decay. For babies fed with vitamin D-fortified milk, or those with lighter skin tones, ZYMADUO 150 IU provides an ideal balance to meet their nutritional needs without excess. This product was designed to fit seamlessly into the daily lives of new parents. Thanks to its easy-to-administer droplet form, it ensures optimal absorption without disrupting your child’s feeding routine. Its effectiveness is based on two key active ingredients: cholecalciferol (vitamin D3), recognized for its role in bone mineralization and the prevention of rickets, and fluoride, which works early to combat the bacteria that cause tooth decay. It is therefore an ideal ally for healthy growth and strong teeth.
Vitamin D3, present here at a concentration of 150 IU per drop, plays a crucial role in the absorption of calcium and phosphorus, elements essential for strong bones. In young children, it contributes to skeletal development and supports the proper development of the immune system. As for fluoride, it acts directly on tooth enamel as soon as it forms, making it more resistant to acid attacks. This provides early protection against cavities, especially in children with a family history of tooth decay. ZYMADUO 150 IU is particularly recommended in cases of high caries risk: a family history of cavities, difficulty establishing good oral hygiene, frequent sugar consumption… These are all situations in which appropriate supplementation becomes a relevant preventive measure. Thanks to its carefully controlled concentration, this product eliminates any risk of overdose, particularly when enriched infant formula is already being used. Another significant advantage is its oral drop form, which you can administer directly or mix with a little water or fruit juice. This makes it easy to administer—without resistance or refusal—and ensures the treatment can be continued over the long term. And with its orange-caramel flavor, the taste is generally well-received by little ones.
Finally, ZYMADUO 150 IU is part of a comprehensive approach to prevention. It complements the hygiene and nutritional measures necessary for your child’s good health. Because the early years of life lay the foundation for future health, it’s crucial not to leave anything to chance. Targeted supplementation, a balanced diet, and daily oral hygiene: these are the pillars of healthy growth. To supplement vitamin D intake or if you’re looking for an alternative, you can also choose Pediakid Vitamin D3 200 IU 20 ml, a gentle and effective solution to support your baby’s immune and skeletal systems year-round.
Directions for use:
The recommended dosage of ZYMADUO 150 IU is 4 drops per day, to be taken orally. You can administer the drops undiluted directly into the child’s mouth or mix them with a small amount of water or fruit juice (however, avoid dairy beverages, which may interfere with absorption). The dose should be taken once a day, preferably at a quiet time, such as after a meal. The bottle is equipped with a dropper and a safety cap: close it securely after each use to ensure proper storage and prevent any accidents. This simple step is also part of essential daily safety practices.
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Precautions for use:
Before use, make sure your child is not receiving any other sources of fluoride or vitamin D (fluoridated salts, fluoridated water, other supplements, etc.). Even a moderate excess can cause side effects, including dental fluorosis or hypercalcemia. ZYMADUO 150 IU is contraindicated in cases of a historyof allergy to the product’s ingredients,excess calcium in the blood or urine, or kidney stones. It is also not recommended to combine this treatment with another fluoride-containing medication to avoid any risk of overdose. Also monitor the quality of the water used for baby bottles: some mineral waters may contain high levels of fluoride. Opt for those with a fluoride concentration below 0.3 mg/L if you are using this medication. Finally, this product contains some potentially risky excipients, such asbenzyl alcohol, methyl parahydroxybenzoate, or maltitol syrup: always consult your doctor if your child has any food intolerances or metabolic disorders.
Cholecalciferol, Sodium Fluoride, Polyoxyethylene-Hydrogenated Castor Oil, Poloxamer 407, Maltitol Syrup, Sodium Saccharin, Sodium Methyl Parahydroxybenzoate, Sodium Propyl Parahydroxybenzoate, Orange Caramel Flavor, Covi Ox T 70, Purified Water, Phosphate Buffer Solution
Presentation:
ZYMADUO 150 IU is available as an oral solution in a 12-ml bottle. Its convenient packaging with a safety dropper makes it easy to administer the correct dose to infants. This dosage form allows for simple, quick administration that can be easily adapted to the child’s daily routine.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on: 20/07/2017
Name of the medicinal product
ZYMADUO 150 IU, oral solution in drops
Cholecalciferol - Sodium Fluoride
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
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.
What is in this leaflet?
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?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
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?
Dosage
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?
Like all medicines, ZYMADUO 150 IU, oral solution in drops is likely to have undesirable effects, although not everyone is subject to it.
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
ROTTAPHARM SAS
40 - 44 WASHINGTON STREET
75008 PARIS
Marketing Authorization Operator
MYLAN MEDICAL SAS
40-44 Washington Street
75008 PARIS
Maker
ROTTAPHARM LTD
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]
Other
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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