ZYMAD 10,000 IU / ml Oral solution in dropper vial

3400935358363

ZYMAD 10,000 IU / ml Oral solution in drops Vitamin D: This medicine contains vitamin D, which allows bone fixation of calcium and whose deficiency causes rickets . It is used to prevent and treat vitamin D deficiencies .

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

ZYMAD 10,000 IU / ml Oral solution in drops Vitamin D

In which case is the drug ZYMAD 10,000 IU / ml prescribed?

This medicine contains vitamin D, which allows the bone fixation of calcium and whose deficiency causes rickets .

It is used to prevent and treat vitamin D deficiencies .

Presentations of the drug ZYMAD 10,000 IU / ml

ZYMAD 10,000 IU / ml : oral solution (orange flavor); dropper bottle of 10 ml (333 drops)

Composition of the drug ZYMAD 10,000 IU / ml

Active substance: Colecalciferol
Excipients: Olive oil refined, Sweet orange essence, Tocopherol

Contraindications to the drug ZYMAD 10,000 IU / ml

This medicine should not be used in case of excess calcium in the blood and urine, with or without stones .

Warning

Vitamin D overdose can cause serious side effects .

Vitamin D is present in many baby milks and over-the-counter medications: consult your doctor or pharmacist to avoid the risk of overdose .

Fertility, pregnancy and lactation

This medicine can be used in pregnant women or breastfeeding women, but the dosage prescribed by the doctor should not be exceeded.

Hypercalcemia during pregnancy may be harmful to the unborn child. Be careful not to absorb several medicines containing vitamin D during pregnancy.

Instructions for use and dosage of the drug ZYMAD 10,000 IU / ml

The drops of solution can be taken pure or diluted in the milk of the bottle or fruit juice. Do not put them in a hot liquid or heat them.

Usual dosage:

The dosage is strictly individual. It depends on the age, the intake of milk enriched or not in vitamin D, the presence of a disease of the digestive system ...

Advice

Vitamin D deficiencies are particularly common in young children with dark skin or little sun exposure; indeed, vitamin D is made by the skin under the influence of ultraviolet rays.

Prevention of rickets by vitamin D should be routine in infants and young children.

Do not store the vial for more than 3 months after opening.

This medicine should be stored away from light.

VIDAL OF THE FAMILY

ZYMAD 10,000 IU / ml

Vitamin D

colecalciferol

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

ZYMAD 10 000 IU / ml: oral solution (orange flavoring); drop bottle of 10 ml (333 drops).
Refunded at 65%. - price: 1,91 euro (s).

Laboratory Meda Pharma

COMPOSITION (summary)
p gte
Colecalciferol (vitamin D3) 300 IU

INDICATIONS (summary)
This medicine contains vitamin D, which allows bone fixation of calcium and whose deficiency causes rickets .
It is used to prevent and treat vitamin D deficiencies.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • excess calcium in the blood and urine,
  • a history of kidney stones containing calcium.
WARNING (Contents)
An overdose of vitamin D exposes to serious adverse effects.
Vitamin D is present in many infant formulas and medicines available without a prescription: take the advice of your doctor or pharmacist to avoid any risk of overdose .
DRUG INTERACTIONS (summary)
Inform your doctor or pharmacist if you are taking a medication containing orlistat.
PREGNANCY AND BREAST-FEEDING (summary)
This medication may be used in pregnant or nursing women, but the dosage prescribed by the doctor should not be exceeded.
Hypercalcemia during pregnancy could be harmful to the unborn child. Be sure not to take several medications containing vitamin D during pregnancy.
DIRECTIONS FOR USE AND DOSAGE (summary)
The drops of solution can be taken pure or diluted in the milk of the bottle or fruit juice. Do not put them in a hot liquid or heat them.

Usual dosage:

In the prevention of deficiency in vitamin D:
  • Infant under 24 months: 2 to 5 drops per day, depending on the intake of a milk enriched with vitamin D (up to 8 drops for children with dark skin) throughout the year.
  • Child and adolescent: 2 or 3 drops per day, throughout the year. In the presence of a disease of the digestive system or an antiepileptic treatment, the dosage is increased.
  • Pregnant woman: 3 drops a day, from the 6th or 7th month of pregnancy.
  • Adult and elderly: 3 to 6 drops per day.
In the treatment of deficiency in vitamin D: the dosage is strictly individual.
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 should be routine in infants and young children.
The bottle should be kept away from light and should not be stored for more than 3 months after opening. Remember to note the date of first use on the packaging.
POSSIBLE ADVERSE EFFECTS (summary)
Itching, rash, swelling.
Other side effects include overdosage and medical advice: headache, tiredness, loss of appetite, weight loss, nausea, vomiting, increased urine volume, intense thirst, dehydration, kidney stones, kidney failure .


GLOSSARY (summary)


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


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


hypercalcemia
Excess of calcium in the blood, due to illness or the use of certain drugs (excess vitamin D).


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


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


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.


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).

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NOTICE

ANSM - Updated on: 20/07/2017

Name of the medicinal product

ZYMAD 10 000 IU / ml, oral solution in drops

cholecalciferol

framed

Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.

If you have any further questions, ask your doctor or pharmacist.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, ask your pharmacist.

· If symptoms worsen or persist, consult your doctor.

· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.

Review summary

In this notice :

1. WHAT IS ZYMAD 10,000 IU / ml, oral solution in drops AND WHAT IT IS USED FOR?

2. BEFORE YOU TAKE ZYMAD 10,000 IU / ml, drinkable solution in drops?

3. HOW TO TAKE ZYMAD 10,000 IU / ml oral solution in drops?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE ZYMAD 10,000 IU / ml oral solution in drops?

6. ADDITIONAL INFORMATION

1. WHAT IS ZYMAD 10,000 IU / ml, oral solution in drops AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

This medication is a vitamin D.

Therapeutic indications

It is indicated for the treatment and / or prevention of vitamin D deficiency.

2. BEFORE YOU TAKE ZYMAD 10,000 IU / ml, drinkable solution in drops?

List of information needed before taking the medication

Not applicable.

Cons-indications

Do not take ZYMAD 10 000 IU / ml, oral solution in drops if:

· allergy known to vitamin D, or to any of the other constituents;

· hypercalcaemia (excess calcium in the blood), hypercalciuria (excess calcium in the urine), calcium lithiasis (kidney stones).

Precautions for use; special warnings

Take special care with ZYMAD 10 000 IU / ml, oral solution in drops:

To avoid overdosage, take into account the total doses of vitamin D if combined with a treatment already containing this vitamin or when using milk supplemented with vitamin D.

Interaction with other medicines

Taking or using other medicines

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

Pregnancy

If needed, vitamin D may be prescribed during pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine.

feeding

If necessary, vitamin D may be prescribed during breastfeeding. However, this supplementation does not replace the administration of vitamin D in the newborn.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

Not applicable.

3. HOW TO TAKE ZYMAD 10,000 IU / ml oral solution in drops?

Instructions for proper use

Oral use.

The drops can be taken purely in a small spoon or mixed in a liquid or semi-liquid food.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dose, Frequency of Administration and Duration of Treatment

Vitamin deficiency in children

· Prevention
It is recommended for use in all infants and young children under current conditions of life in the event of insufficient sun exposure (ministerial circulars of 21 February 1963 and 6 January 1971) because of the low vitamin D.

· premature: 4 to 5 drops per day

· from 0 to 24 months:

o with milk enriched with vitamin D: 2 to 3 drops per day

o without milk enriched with vitamin D: 4 to 5 drops per day

o pigmented skin: 8 drops per day.

· child - adolescent:

o without digestive pathology: 2 to 3 drops per day

o with a digestive pathology: 2 to 6 drops per day

o receiving anti-convulsants: 5 to 6 drops per day.

· Treatment
7 to 13 drops per day for 4-6 months or 14 to 26 drops per day for 1-2 months.

Vitamin deficiency in pregnant women

· Prevention
3 drops per day from the 6 th or 7 th month.

Vitamin deficiency of the adult and the elderly

· Prevention
2 to 3 drops per day

· Treatment
7 to 66 drops per day.

If you feel that the effect of ZYMAD 10,000 IU / ml oral solution in drops is too strong or too weak, talk to your doctor or pharmacist.

Mode and / or route (s) of administration

This dropper bottle is equipped with a safety cap.

After use, tighten the cap securely until it clicks into place.

Symptoms and Instructions for Overdose

If you take more than ZYMAD 10,000 IU / mL, you should immediately consult your doctor or pharmacist.

The clinical signs of an overdose are:

· headaches, tiredness, loss of appetite, slimming, stopping growth;

· nausea, vomiting;

· abundant urine, intense thirst, dehydration;

· kidney stone, calcifications of the tissues, especially the kidney and vessels;

· renal failure (failure of kidney functions).

The biological signs of an overdose are:

· increased calcium in the blood and urine and increased phosphorus levels in the blood and urine.

In case of overdose, stop treatment, drink plenty, limit calcium intakes (milk) and consult a doctor.

Instructions for omission of one or more doses

If you forget to take ZYMAD 10,000 IU / ml, drinkable solution in drops, do not take a double dose to compensate for the dose you have forgotten to take.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, ZYMAD 10,000 IU / ml oral solution in drops is likely to have undesirable effects, although not everyone is subject to it.

· Skin and subcutaneous tissue disorders: pruritus, rash, erythema, edema.

If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.

5. HOW TO STORE ZYMAD 10,000 IU / ml oral solution in drops?

Keep out of the reach and sight of children.

Expiration date

Do not use ZYMAD 10 000 IU / ml, oral solution in drops after the expiry date stated on the vial.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep the vial in the outer carton, protected from light.

To be used within 3 months after the first opening of the bottle.

If necessary, warnings against visible signs of deterioration

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. ADDITIONAL INFORMATION

Full list of active substances and excipients

What contains ZYMAD 10 000 IU / ml, oral solution in drops?

The active substance is:

Cholecalciferol (vitamin D3) (10,000 IU / ml)

The other components are:

Essential oil of sweet orange, refined olive oil for injections, blend of alpha, beta, gamma and delta natural tocopherols (COVI-OX T70).

Pharmaceutical form and content

What is ZYMAD 10,000 IU / ml, oral solution in drops and contents of the pack?

This medication is in the form of a drinkable solution in drops.

Bottle of 10 ml.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

ROTTAPHARM

40-44 WASHINGTON STREET

75008 PARIS

exploiting

MYLAN MEDICAL SAS

40-44 Washington Street

75008 PARIS

Maker

LABORATOIRES M RICHARD

REYS DE SAULCE

26270 SAULCE SUR RHONE

or

NOVARTIS PHARMA SAS

26, RUE DE LA CHAPELLE

68330 HUNINGUE

or

ROTTAPHARM SPA

VIA VALOSA DI SOPRA, 9

20900 MONZA

ITALY

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the ANSM website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

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