This medicine is a vitamin D.

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

Not applicable.

Do not take ZYMAD 10 000 IU/ml, Oral Solution in drops in case of:

-known allergy 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).

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.

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.

Not applicable.

Not applicable.

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.

Not applicable.

Not applicable.

Not applicable.

Oral use.

The drops may be taken undiluted in a teaspoon or mixed in a liquid or semi-liquid food.

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

From 0 to 24 months:

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

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

owith pigmented skin: 8 drops per day.

Children and teenagers:

without digestive pathology: 2 to 3 drops per day

owith digestive 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.

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.

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;

Abundant urine , intense thirst, dehydration;

renal calculus , calcifications of tissues, especially kidney and vessels;

renal failure (failure of kidney function).

Biological signs of overdose are:

-increased calcium 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.

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.

Not applicable.

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.

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 bottle.

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.

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.

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).

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.

ROTTAPHARM

83/85 BOULEVARD VINCENT AURIOL

75013 PARIS