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.
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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.