NOTICE
ANSM - Updated on : 12/08/2025
Product name
ADRIGYL 10 000 IU/ml, oral solution in drops
Cholecalciferol
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
What does this leaflet contain?
1. What is ADRIGYL 10,000 IU/ml, Oral Solution in drops and what is it used for?
2. What do I need to know before taking ADRIGYL 10,000 IU/ml, Oral Solution in drops?
3. How should I take ADRIGYL 10,000 IU/ml, Oral Solution in drops?
4. What are the possible side effects?
5. How to store ADRIGYL 10,000 IU/ml, solution buvable en gouttes?
6. Package contents and other information.
1. WHAT IS ADRIGYL 10,000 IU/ml, Oral Solution in drops AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: VITAMIN D AND ANALOGUES - A11CC05
(A: Digestive system and metabolism)
This drug is indicated for the treatment and/or prevention of vitamin D deficiency.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING ADRIGYL 10,000 IU/ml, Oral Solution in drops?
Never take ADRIGYL 10,000 IU/ml, Oral Solution in drops:
- if you are allergic (hypersensitive) to the active substance or to any of the other ingredients listed in section 6;
- if you have hypercalcemia (increased calcium levels in the blood), hypercalciuria (increased calcium levels in the urine), calcium lithiasis (kidney stones) or calcium deposits in the kidneys (nephrocalcinosis) ;
- in case of diseases and/or disorders that may lead to hypercalcemia and/or hypercalciuria;
- in cases of hypervitaminosis D (vitamin D intoxication).
Warnings and precautions
Ask your doctor, pharmacist or nurse before taking ADRIGYL 10,000 IU/ml, Oral Solution in drops.
To avoid vitamin D overdosage, follow the dosage instructions and tell your doctor, taking into account total vitamin D doses in case of combination with a treatment already containing this vitamin, or if vitamin D-supplemented milk is used.
In the event of repeated administration of high doses of vitamin D, or in combination with high doses of calcium, it is necessary to monitor calcium levels in the blood and urine.
Children and adolescents
Not applicable.
Other medicinal products and ADRIGYL 10,000 IU/ml, oral solution in drops
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ADRIGYL 10,000 IU/ml, Oral Solution in drops with food and drink
Not applicable.
Pregnancy and breast-feeding
Pregnancy
Data on the use of cholecalciferol in pregnant women are limited.
Cholecalciferol overdosage should be avoided during pregnancy, due to the risk of prolonged hypercalcemia (increased concentration of calcium in the blood), which may lead to delayed physical and mental development, as well as adverse effects on the heart and eyes of the unborn child.
ADRIGYL 10,000 IU/ml is not recommended for the prevention of calcium deficiency in pregnant women. In cases of suspected or confirmed deficiency, ADRIGYL 10,000 IU/ml, solution buvable en gouttes may be prescribed during pregnancy.
Ask your doctor or pharmacist for advice before taking any medication.
Breast-feeding
Cholecalciferol passes into breast milk. In cases of suspected or confirmed deficiency, ADRIGYL 10,000 IU/ml, Oral Solution in drops may be prescribed during breastfeeding. However, this supplementation does not replace the administration of vitamin D to newborns.
Ask your doctor or pharmacist for advice before taking any medication.
Driving and use of machinery
Not applicable.
ADRIGYL 10 000 IU/ml, oral solution in drops contains
Not applicable.
3. HOW DO I TAKE ADRIGYL 10,000 IU/ml, Oral Solution in drops?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
Vitamin deficiency in children
- Prevention
o Premature :
2 to 3 drops per day during stay in neonatal intensive care units.
For premature babies born before 32 weeks' gestation or weighing less than 1,500 g at one month of age, a vitamin D dosage is recommended.
o Children aged 0-18 years:
1 to 2 drops per day in healthy children.
3 to 4 drops per day for children aged 2 to 18 in cases of reduced vitamin D availability (obesity, pigmented skin, lack of sun exposure) or reduced intake (vegan diet).
o Children and adolescents with digestive pathologies: 2 to 6 drops per day.
o Children and adolescents receiving anti-convulsants: 4 to 6 drops per day.
- Treatment
6 to 12 drops per day for 4-6 months or 12 to 24 drops per day for 1-2 months, without exceeding 600,000 IU/year.
Vitamin deficiency in pregnant women
In cases of suspected or confirmed deficiency, doses of up to 6 drops or a maximum of 12 drops per day are recommended.
Vitamin deficiency in adults and the elderly
- Prevention
2 to 3 drops per day.
- Treatment
6 to 60 drops per day, not exceeding 600,000 IU/year.
Method and route of administration
Take orally.
Pour drops into a teaspoon. Drops may be taken undiluted or mixed with liquid or semi-liquid food. Do not heat, boil or add to hot food. It is preferable not to put the drops into a bottle of water or milk, as the product may settle on the bottle wall.
If you have taken more ADRIGYL 10,000 IU/ml, oral solution in drops than you should have
Clinical signs of overdose are:
- headache, fatigue, loss of appetite, weight loss, growth failure;
- nausea, vomiting;
- profuse urination, intense thirst, dehydration;
- kidney stones, calcifications of tissues, particularly kidneys and vessels;
- kidney failure.
The biological signs of overdosage are :
- increased calcium levels in blood and urine and increased phosphorus levels in blood and urine.
In the event of overdose, stop taking ADRIGYL, drink plenty of fluids, limit calcium intake (dairy products) and consult a doctor.
If you forget to take ADRIGYL 10,000 IU/ml, Oral Solution in drops
Do not take a double dose to make up for the one you forgot to take.
If you stop taking ADRIGYL 10 000 IU/ml, Oral Solution in drops
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
The following adverse reactions have been reported very rarely, particularly in the event of overdose:
- hypersensitivity reaction, hypercalcemia, hypercalciuria, calcium lithiasis.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO STORE ADRIGYL 10,000 IU/ml, Oral Solution in drops?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the bottle after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Use within 3 months of first opening.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ADRIGYL 10,000 IU/ml Oral Solution Drops contains
- The active substance is :
Cholecalciferol (vitamin D3) at 40,000 IU/mg..................................................................... 25 mg
Quantity corresponding to cholecalciferol.................................................................. 1,000,000 IU
per 100 ml.
- The other excipient components are :
Calpha tocopherol acetate, saccharin, sorbic acid, lemon essential oil, oleic macroglycerides.
What ADRIGYL 10,000 IU/ml is and what it contains
This medicine is available as an oral solution in drops in a 10 ml dropper bottle.
Marketing authorization holder
Laboratoires CRINEX
1 BIS rue RENE ANJOLVY
94250 GENTILLY
Marketing authorization holder
Laboratoires CRINEX
1 BIS rue RENE ANJOLVY
94250 GENTILLY
Manufacturer
Laboratoires CRINEX
1 BIS rue RENE ANJOLVY
94250 GENTILLY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.