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 .
For warnings, precautions for use and contraindications, please consult the instructions for use.
This medicine contains vitamin D , which allows calcium to be fixed in the bone and whose deficiency causes rickets . It is used to prevent and treat vitamin D deficiencies .
Vitamin D plays a major role in bone growth and mineralization. If the major source of vitamin D remains exposure to light (the body synthesizes it from a cholesterol derivative under the action of light), food should not be neglected, even if little are good sources of vitamin D.
Food is no longer enough to compensate for the lack of vitamin D synthesis linked to insufficient sunshine. Indeed, the usual diet of populations living in France provides amounts of Vitamin D lower than those required. Indeed, in France, the SUVIMAX study (2003) had shown that more than 70% of adults (men and women) have an insufficient intake of vitamin D.
The main populations are postmenopausal women, the elderly, people with dark or black skin, lactating women, people little exposed to the sun ...
There are symptoms of lack of vitamin D. These symptoms are fatigue, muscle weakness, sometimes dry skin and cramps. All these symptoms reflect the action of vitamin D and in these cases, one can ask the question of knowing if one is lacking in vitamin D.
Excipients : Refined olive oil, Sweet orange essence, Tocopherol
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.
The dosage is strictly individual. It depends on age, the intake of milk enriched or not with vitamin D, the presence of a disease of the digestive system ...
This medication should not be used in case of excess calcium in the blood and urine, with or without lithiasis .
An overdose of vitamin D exposes to serious undesirable effects .
Vitamin D is present in many baby milks and medicines available without a prescription: take the advice of your doctor or pharmacist to avoid any risk of overdose .
This medication can be used in pregnant or breastfeeding women, but the dosage prescribed by the doctor should not be exceeded.
Hypercalcemia during pregnancy could be harmful to the unborn child. Be careful not to take more than one vitamin D medication during pregnancy.
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.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 20/07/2017
ZYMAD 10 000 IU / ml, oral solution in drops
cholecalciferol
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.
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?
This medication is a vitamin D.
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.
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.
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?
Oral use.
The drops can be taken purely in a small spoon or mixed in a liquid or semi-liquid food.
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.
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.
Do not use ZYMAD 10 000 IU / ml, oral solution in drops after the expiry date stated on the vial.
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.
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.
40-44 WASHINGTON STREET
75008 PARIS
40-44 Washington Street
75008 PARIS
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.
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Not applicable.
Vitamin D
colecalciferol
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
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
p gte | |
Colecalciferol (vitamin D3) | 300 IU |
Usual dosage:
In the prevention of deficiency in vitamin D: