1. WHAT IS ZYMAD 10,000 IU/ml, Oral Solution Drops AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine is a vitamin D.
Therapeutic indications
It is indicated in the treatment and/or prevention of vitamin D deficiency.
2. WHAT YOU SHOULD KNOW BEFORE TAKING ZYMAD 10 000 IU/ml, Oral Solution in drops
List of information needed before taking the medicine
Not applicable.
Contraindications
Do not take ZYMAD 10 000 IU/ml, Oral Solution in drops in case of:
-known allergyto 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 and special warnings
Take care with ZYMAD 10 000 IU /ml, Oral Solution in drops:
To avoid overdose, take into account the total doses of vitamin D in case of association with a treatment already containing this vitamin or in case of use of milk supplemented with vitamin D.
Interactions 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 drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and lactation
Pregnancy
If necessary, vitamin D may be prescribed during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
Breastfeeding
If necessary, vitamin D may be prescribed during breastfeeding. However, this supplementation does not replace the administration of vitamin D to the newborn.
Ask your doctor or pharmacist for advice before taking any medication.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO TAKE ZYMAD 10 000 IU/ml, Oral Solution Drops
Instructions for proper use
Oral use.
The drops may be taken undiluted in a teaspoon or mixed in a liquid or semi-liquid food.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage, frequency of administration and duration of treatment
Vitamin deficiency in children
Prevention
Its implementation is recommended for all infants and young children, in the current conditions of life in case of insufficient exposure to the sun (ministerial circulars of February 21, 1963 and January 6, 1971) because of the low content of vitamin D in food.
preemies: 4 to 5 drops per day
From0 to 24 months:
withvitamin D enriched milk: 2 to 3 drops per day
without vitamin D enriched milk: 4 to 5 drops per day
owithpigmented skin: 8 drops per day.
Childrenand teenagers:
without digestive pathology: 2 to 3 drops per day
owithdigestive pathology: 2 to 6 drops per day
orceiving 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 6th or 7th month.
Vitamin deficiency in adults and elderly people
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, consult your doctor or pharmacist.
Method and/or route(s) of administration
This dropper bottle has a safety cap.
Instructions for opening the bottle
1.Press the top of the cap firmly
2.Unscrew the cap while maintaining pressure on the cap
After use, screw the cap back on tightly to lock in the safety system.
Symptoms and instructions in case of overdose
If you have taken more ZYMAD 10 000 IU /ml, Oral Solution in drops than you should have, consult your doctor or pharmacist immediately.
Clinical signs of overdose are:
-headache, fatigue, loss of appetite, weight loss, growth arrest;
Nausea, vomiting;
Abundanturine, intense thirst, dehydration;
renalcalculus, calcifications of tissues, especially kidney and vessels;
renalfailure(failure of kidney function).
Biological signs of overdose are:
-increasedcalcium levels in blood and urine and increased phosphorus levels in blood and urine.
In the event of an overdose, treatment should be stopped, plenty of fluids should be taken, calcium intake should be limited (dairy products) and a doctor should be consulted.
Instructions in case of missed dose(s)
If you forget to take ZYMAD 10 000 IU /ml, Oral Solution in drops, do not take a double dose to make up for the one you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ZYMAD 10 000 IU /ml, Oral Solution in drops is likely to have adverse reactions, although not everyone is susceptible.
Skin and subcutaneous tissue disorders: pruritus, rash, erythema, edema.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell 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.
Expiry date
Do not use ZYMAD 10 000 IU/ml, Oral Solution in drops after the expiry date stated on the bottle.
Storage conditions
Store at a temperature not exceeding 25°C.
Keep the bottle in the outer packaging, protected from light.
Use within 3 months of first opening the bottle.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines in the sewage system or in your household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does ZYMAD 10 000 IU /ml, Oral Solution in drops contain?
The active substance is:
Cholecalciferol (vitamin D3) (10 000 IU/ml)
The other components are:
Sweet orange essential oil, refined olive oil for injection, mixture of natural tocopherols in alpha, beta, gamma and delta form (COVI-OX T70).
Pharmaceutical form and content
What is ZYMAD 10 000 IU /ml, Oral Solution in drops and what does it contain?
This medicinal product is in the form of an oral solution in drops.
10 ml bottle.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
ROTTAPHARM
83/85 BOULEVARD VINCENT AURIOL
75013 PARIS
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