Over-the-counter medication

ZYMADUO 300 IU ORAL SOLUTION BOTTLE 12 ML

Name: ZYMADUO 300 UI SOLUTION BUVABLE FLACON 12 ML
Brand: Mylan Viatris
SKU: 7166
Price: 3.99 EUR
Availability: InStock

Brand : Mylan Viatris

€3.63 EXCL. VAT €3.99 INCL. VAT

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Reference : 3400934810695

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ZYMADUO 300 IU ORAL SOLUTION BOTTLE 12 ML is a drug for the prevention of dental caries and rickets vitaminoprive in infants 0-18 months in the case where fluorine and vitamin D are administered jointly.

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ZYMADUO 300 IU ORAL SOLUTION 12 ML BOTTLE

For warnings, precautions for use and contraindications, please consult the instructions for use.

Description of ZYMADUO 300 IU ORAL SOLUTION BOTTLE 12 ML

Prevention of dental caries and vitaminoprive rickets in infants from 0 to 18 months in the case where fluorine and vitamin D are administered jointly:

if no milk supplemented with vitamin D is used,
in children with pigmented skin when using milk supplemented with vitamin D.

This medication should not be taken without medical advice.

Prevention of tooth decay

Prevention of vitaminoprive rickets

There are many causes of rickets :

vitamin D deficiency: deficiency of intake, lack of sun exposure, digestive malabsorption, abnormality of vitamin D metabolism, hypophosphatemia ...;
resistance of target organs to the action of vitamin D;
chronic renal failure;
phosphate or calcium regulation disorders;
metabolic acidosis; taking certain drugs or intoxication (lead, cadmium, aluminum ...) ...

Using advice and opinion on ZYMADUO 300 UI ORAL SOLUTION BOTTLE 12 ML

4 drops per day, to be taken pure or diluted in a little water or fruit juice (avoid milk drinks) in a single daily intake.

Composition of ZYMADUO 300 IU ORAL SOLUTION VIAL 12 ML

EXCIPIENTS

Polyoxyethylene hydrogenated castor oil (Cremophor RH 40) (known effect)

Poloxamer 407 (LUTROL F127)

Maltitol syrup (notorious effect)

Saccharin (E954) sodium

Sodium methyl parahydroxybenzoate (E219)

Sodium propyl parahydroxybenzoate (E217)

Purified water

Orange-caramel flavor:

Ethyl alcohol

Limonene

Benzaldehyde

Propylene glycol (E1520)

Benzyl alcohol

Coumarin

Vanillin

Ethylvanillin

Covi-Ox T70:

Tocopherol (E306) alpha, beta, gamma and delta

Phosphate buffer solution: qs pH = 6.8

Sodium hydrogen phosphate anhydrous

Potassium dihydrogen phosphate

Precaution for use with ZYMADUO 300 IU ORAL SOLUTION BOTTLE 12 ML

- Take into account any other vitamin D or fluoride intake.
- The indicated dose should not be exceeded; dental fluorosis may appear after continuous ingestion of large amounts of fluoride.
Before prescribing this medication, you should:

make sure that the patient does not receive other sources of fluorine: fluorinated salts, bottled water, tap water (it is recommended to inquire at the town hall or with the DDASS of its fluorine content) ...
regularly check the teeth to check for the development of fluorosis.

- In the case of using a milk supplemented with vitamin D this formulation is not suitable (with the exception of children with pigmented skin); then use the formulation delivering 150 IU in 4 drops.

Presentation of ZYMADUO 300 IU ORAL SOLUTION BOTTLE 12 ML

Form	Oral solution in drops
Dosage	300 IU / 0.138 mg / drop
Capacity	370 drops

Drug warnings

Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please inform your online pharmacist of the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
Click here to find the leaflet for this medication on the website of the National Agency for the Safety of Medicines and Health Products.

Notice

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Updated on: 20/07/2017

Name of the medicinal product

ZYMADUO 300 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 300 IU, oral solution in drops and in which cases it is used?

2. What should I tell you before taking ZYMADUO 300 IU, oral solution in drops?

3. How to take ZYMADUO 300 IU, oral solution in drops?

4. What are the possible side effects?

5. How to store ZYMADUO 300 IU, oral solution in drops?

6. Package contents and other information.

1. WHAT IS ZYMADUO 300 IU, oral solution in drops AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group: Other mineral supplements - ATC code: A12CD51

ZYMADUO 300 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:

- In the absence of the use of milk supplemented with vitamin D,

- In children with pigmented skin when using vitamin D-supplemented milk.

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 300 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 300 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 300 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 delivering 1200 IU of vitamin D in 4 drops is perfectly adapted when the child is fed in breast or by milk not supplemented with vitamin D, or in the child with pigmented skin when using milk supplemented in vitamin D.

· of fluorine : The recommended dosage is 0.05 mg fluoride / day and per kg body weight without exceeding 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). Do not use a mineral water in the infant that contains more than 0.3 mg of fluoride per liter of water if you are giving your child a fluoride-containing medication. Check the fluorine level mentioned on the bottle.

· 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 nibbles and sugary drinks between meals

· Do not let him fall asleep with a bottle containing anything other than 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 300 IU oral solution

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 300 IU, oral solution in drops contains : Sodium methyl parahydroxybenzoate, Sodium propyl parahydroxybenzoate, Polyoxyethylenated hydrogenated castor oil (Cremophor RH 40), Maltitol syrup

3. HOW TO TAKE ZYMADUO 300 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.

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 300 IU oral solution in drops than you should:

In case of overdose, stop treatment and consult a doctor.

If you forget to take ZYMADUO 300 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 300 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 300 IU, oral solution in drops?

Keep out of sight and reach of children.

Do not use Zymaduo 300UI, 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 300 IU contains, oral solution in drops

· The active substances are:

Cholecalciferol (vitamin D3) ............................................. ................................................ 300 IU

Sodium Fluoride ............................................... .................................................. .... 0.138 mg

Quantity corresponding to fluorine .............................................. ......................................... 0.062 mg

For a drop

4 drops contain 1200 IU of vitamin D3 and 0.25 mg of fluoride.

· Other components are: Polyoxyethylenated hydrogenated castor oil (Cremophor RH 40), poloxamer 407 (Lutrol F127), maltitol syrup, sodium saccharine, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, orange-caramel flavor, Covi-Ox T 70 , purified water, phosphate buffer solution.

What is ZYMADUO 300 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).

Vidal file

VIDAL OF THE FAMILY

ZYMADUO

Vitamin D with fluoride

vitamin D3, fluoride

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Directions for use and dosage . Advice . Lexicon

PRESENTATIONS ^(summary)

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

COMPOSITION ^(summary)

	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

INDICATIONS ^(summary)

This medication combines two substances:

fluoride , which is incorporated into the enamel of the teeth and increases their resistance to caries;
of vitamin D, which allows the bone fixation of calcium and whose deficiency causes rickets .

It is used in infants from 6 to 18 months in the preventive treatment of tooth decay and vitamin D deficiencies.

CONTRAINDICATIONS ^(summary)

This medication should not be used in the following cases:

excess calcium in the blood and urine,
calculations channels urinary containing calcium.

WARNING ^(Contents)

This medication should not be used without prior medical advice because of the risk of overdose with vitamin D or fluoride, which can lead to serious adverse reactions. The physician considers the possible use of a baby milk enriched with vitamin D and the fluorine content of the water consumed.

DRUG INTERACTIONS ^(summary)

This medicine should not be combined with other fluoride-containing medicines: risk of dental enamel staining.

DIRECTIONS FOR USE AND DOSAGE ^(summary)

The solution can be taken pure or diluted in a little water or fruit juice.

Usual dosage:

Infant from 6 to 18 months: 4 drops a day, in one catch.

Dosage to 300 IU is reserved for infants who do not benefit from other vitamin D (non-enriched milk) or dark-skinned intake.

TIPS ^(summary)

The deficiencies in vitamin D are especially common in young children or little dark skin exposed to the sun; in fact, vitamin D is made by the skin under the influence of ultraviolet rays. Prevention of rickets by vitamin D is routine in infants and young children.

GLOSSARY ^(summary)

deficiency
Deficit usually involving nutrients, vitamins, minerals, etc. A diversified diet is the best prevention of deficiencies.

fluorine
A mineral substance which has the property of being fixed on the bones and on the teeth, and which increases their hardness.

infant
Child from one to 30 months. A child under one month is a newborn.

rickets
Disease of growth due to deficiency of vitamin D. It results in a deformation of the bones and cartilages, and disorders of the general state. Vitamin D is manufactured in the skin provided that it is sufficiently exposed to the sun; it promotes the absorption and fixation of calcium and phosphorus, the main constituents of bone.

overdose
Taking an excessive amount of a drug exposes you to an increase in the intensity of adverse effects, or even to the appearance of particular adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.

preventive treatment
Treatment intended to prevent a disease (synonym: prophylaxis), or to limit the frequency of seizures or outbreaks in a chronic disease.

ultraviolet
Ultraviolet rays are radiation emitted naturally by the sun or artificially by certain lamps. UV A and UVB are distinguishable. Short-wave UV B are stopped in the outermost layers of the skin. They are responsible for burns (sunburn). The UVA, of wider wavelength, penetrate deeply and reach the dermis. They induce pigmentation (tanning). Repeated intense UV exposure causes premature aging of the skin and increases the risk of skin cancer.
Abbreviation: UV.

vitamin
An essential ingredient for the growth and proper functioning of the body. Vitamin requirements are normally covered by a varied diet. In developed countries, only vitamin D deficiency, in the young child or the old man who is exposed to the sun, justifies systematic supplementation. Superior intake, especially with medicines, can lead to overdose and various disorders (mainly vitamins A and D).

way

Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
Set of hollow organs allowing the passage of air (respiratory tract), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.