NOTICE
ANSM - Updated on : 10/07/2025
Product name
STEROGYL 2 000 000 Ul/100 ml, oral solution in drops
Ergocalciferol
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is STEROGYL 2,000,000 Ul/100 ml, Oral Solution in drops and what is it used for?
2. What do I need to know before taking STEROGYL 2,000,000 Ul/100 ml, Oral Solution in drops?
3. How do I take STEROGYL 2,000,000 Ul/100 ml, Oral Solution in drops?
4. What are the possible side effects?
5. How to store STEROGYL 2 000 000 Ul/100 ml, solution buvable en gouttes?
6. Package contents and other information.
1. WHAT IS STEROGYL 2,000,000 Ul/100 ml, Oral Solution in drops AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: VITAMIN D - A11CC01 (A: Digestive system and metabolism).
This medicine contains vitamin D, which enables calcium to be bound to the bones.
It is indicated for the prevention and/or treatment of vitamin D deficiency.
You should consult your doctor if you do not feel any improvement or if you feel less well.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING STEROGYL 2,000,000 Ul/100 ml, Oral Solution in drops?
Never take STEROGYL 2 000 000 Ul/100 ml, Oral Solution in drops:
- if you are allergic (hypersensitive) to the active substance or to any of the other components of this medicine listed in section 6;
- Hypercalcemia (abnormally high level of calcium in the blood);
- Hypercalciuria (abnormally high levels of calcium in the urine);
- Calcium lithiasis (kidney stone);
- Hypervitaminosis D (abnormally high levels of vitamin D in the blood);
- Nephrocalcinosis (presence of calcium deposits in the kidneys);
- Pathologies and/or conditions leading to hypercalcemia (abnormally high levels of calcium in the blood) and/or hypercalciuria (abnormally high levels of calcium in the urine).
Warnings and precautions
This medicine contains propylene glycol, i.e. 20.75 mg per drop equivalent to 1.0375 g per ml. If your baby is less than 4 weeks old, ask your doctor or pharmacist before taking this medicine, especially if the baby is taking other medicines containing propylene glycol or alcohol.
To avoid vitamin D overdosage, follow the dosage instructions and tell your doctor if you are taking vitamin D in combination with a treatment already containing this vitamin, or if you are using vitamin D-supplemented milk.
In the event of repeated administration of high doses of vitamin D, or in association with high doses of calcium, it is necessary to monitor calcium levels in the blood and urine.
Ask your doctor or pharmacist before taking STEROGYL 2,000,000 Ul/100 ml, Oral Solution in drops.
Children and adolescents
Not applicable.
Other medicinal products and STEROGYL 2,000,000 Ul/100 ml, Oral Solution in drops
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
STEROGYL 2 000 000 Ul/100 ml, solution buvable en gouttes with food and drink
Not applicable.
Pregnancy and breast-feeding
Pregnancy
Data on the use of ergocalciferol in pregnant women are limited. Overdosage of vitamin D during pregnancy should be avoided, as prolonged hypercalcemia (increased concentration of calcium in the blood) may cause physical and mental retardation, as well as adverse effects on the heart and eyes of the unborn child.
Vitamin D is not recommended for the prevention of deficiency in pregnant women. In case of deficiency, STEROGYL 2,000,000 Ul/100 ml, oral solution in drops may be prescribed during pregnancy.
Follow the dosage prescribed by your doctor.
Breast-feeding
Vitamin D passes into breast milk.
In case of deficiency, STEROGYL 2,000,000 Ul/100 ml, solution buvable en gouttes may be prescribed during breast-feeding. However, this supplementation does not replace the administration of vitamin D to the newborn.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking any medication.
Driving and using machines
Not applicable.
3. HOW DO I TAKE STEROGYL 2,000,000 Ul/100 ml, Oral Solution in drops?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Prevention of deficiency :
The recommended dose is :
o Children aged 0 to 18: 1 to 2 drops per day in healthy children.
o 2 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 or adults with digestive pathologies (intestinal malabsorptions and cystic fibrosis): 1,000 to 2,000 IU per day, i.e. 2 to 5 drops per day.
o Children or adults receiving anticonvulsant treatment: 1,500 to 4,000 IU per day, i.e. 3 to 10 drops per day.
o Children or adults with renal insufficiency: 400 to 2,000 IU per day, i.e. 1 to 5 drops per day.
o Children or adults under the following conditions:
§ no sun exposure or high skin pigmentation with :
§ unbalanced diet (low-calcium, vegetarian, etc.)
§ or extensive dermatological pathology,
§ or granulomatous disease (tuberculosis, leprosy, etc.)
§ subjects receiving long-term corticosteroid treatment,
§ hepatic insufficiency:
400 to 1,000 IU per day, i.e. 1 to 2 drops per day.
o Elderly subjects: 400 to 2,000 IU per day, i.e. 1 to 5 drops per day.
Treatment of deficiency (rickets, osteomalacia, neonatal hypocalcemia) : 2,000 to 4,000 IU/day, i.e. 5 to 10 drops per day for 3 to 6 months.
o Pregnant and breast-feeding women
In case of deficiency, doses of up to 2,000 IU/day (i.e. 5 drops) or a maximum of 4,000 IU/day (i.e. 10 drops per day) are recommended.
Method and route of administration
Oral administration.
To open the bottle, turn the cap by exerting pressure (child-resistant). Close bottle tightly after each use.
Do not take undiluted, but dilute in water, milk or fruit juice.
Always take this medicine exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
If you have taken more STEROGYL 2,000,000 Ul/100 ml, Oral Solution in drops than you should have
The appearance of headaches, fatigue, loss of appetite, weight loss, stunted growth, nausea, vomiting, excessive urination, intense thirst and high blood pressure are signs of excessive vitamin D intake, particularly in the event of accidental ingestion of the bottle by infants or children. TELL YOUR DOCTOR IMMEDIATELY.
If you forget to take STEROGYL 2 000 000 Ul/100 ml, Oral Solution in drops
Not applicable.
If you stop taking STEROGYL 2 000 000 Ul/100 ml, Oral Solution in drops
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
As with all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Veryrareadverse reactions(may affect up to 1 in 10,000 patients) :
o hypercalcemia
o hypercalciuria
Undetermined frequency (cannot be estimated on the basis of available data) :
o pruritus
o rash
o erythema
o edema
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effect 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 CONSERVE STEROGYL 2 000 000 Ul/100 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 outer packaging. The expiration date refers to the last day of that month.
Protect from light.
After first opening, this medicine should be stored for a maximum of 6 months.
Do not use this medicine if you notice any visible signs of deterioration.
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 STEROGYL 2,000,000 Ul/100 ml, Oral Solution in drops contains
- The active substance is :
Ergocalciferol......................................................................................................... 2,000,000 IU
per 100 ml of oral solution.
- The other components are :
Propylene glycol.
1 drop contains 400 IU vitamin D2 and 20.75 mg propylene glycol.
1 ml oral solution corresponds to 50 drops.
What STEROGYL 2,000,000 Ul/100 ml is and what it contains
Oral solution in drops, 20 ml bottle (=1000 drops), box of 1 bottle.
Marketing authorization holder
DESMA PHARMA
111 AVENUE VICTOR HUGO
75784 PARIS CEDEX 16
Marketing authorization holder
DESMA PHARMA
87 RUE LA BOETIE
75008 PARIS
Manufacturer
LABORATORIO FARMACEUTICO SIT S.r.l.
VIA PROVINCIALE PER LECCO, 78
22038 TAVERNERIO (CO)
ITALY
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.