Vigantol drops 20,000 IU/ml (10 ml) – vitamin D3 (cholecalciferol) for prevention and treatment of vitamin D deficiency and rickets

Vigantol oral drops, solution, are a vitamin medicine containing cholecalciferol (vitamin D3). One millilitre (40 drops) contains 0.5 mg cholecalciferol, equivalent to 20,000 IU of vitamin D3, so one drop contains approximately 500 IU. Vitamin D regulates calcium and phosphate metabolism and is essential for normal bone mineralisation.

The medicine is used for the prevention and treatment of rickets, prevention of vitamin D deficiency in children and adults at identified risk, as adjunctive treatment of osteoporosis and for the treatment of hypoparathyroidism. In Serbia Vigantol is a prescription-only medicine: the dose depends on age and reason for use, and higher doses and long-term treatment require calcium monitoring. Unlike food supplements, this is an authorised medicine whose dosage is set by a doctor.

What are Vigantol drops used for and how is vitamin D3 dosed correctly?

Key facts about the medicine

What is Vigantol used for?

According to the official package leaflet, Vigantol is used for:

• prevention of rickets in children and adults;
• prevention of vitamin D deficiency in otherwise healthy people at identified risk without malabsorption (children and adults);
• adjunctive treatment of osteoporosis in adults;
• prevention of rickets in premature babies;
• prevention of vitamin D deficiency at identified risk in malabsorption (children and adults);
• treatment of rickets and osteomalacia in children and adults;
• treatment of hypoparathyroidism in adults.

How is it used and dosed?

Recommended doses according to the leaflet (1 drop ≈ 500 IU vitamin D):

• In newborns and infants the medicine is used only under medical supervision; the stated doses must not be exceeded.
• For infants and young children give the drops on a teaspoon of milk or with porridge/baby food (previously boiled and cooled) – the child should eat the whole meal to receive the full dose.
• Older children and adults take the drops on a teaspoon of liquid.
• Hold the bottle upside down; it may take a moment for the first drop to come out.
• Duration: for children from two weeks of age to the end of the first year, also recommended in the second year, especially in winter; treatment of rickets and osteomalacia lasts one year.
• Very high doses (e.g. intermittent therapy) are not started before serum 25(OH)D3 has been measured.

Special patient groups

• Infants and young children: more sensitive to high doses; use only under medical supervision and without additional vitamin D products.
• Elderly patients and people on cardiac glycosides or diuretics: monitoring of calcium and kidney function is particularly important.
• Impaired kidney function: the effect on calcium and phosphate metabolism is monitored.
• Sarcoidosis and pseudohypoparathyroidism: higher risk of overdose – monitoring or other preparations are needed.

Contraindications – when the medicine must not be used

Do not take Vigantol:

• if you are allergic to cholecalciferol or the excipient (medium-chain triglycerides);
• if you have hypercalcaemia (raised blood calcium) and/or
• hypercalciuria (raised urinary calcium).

Precautions and warnings

• Talk to your doctor if you tend to form kidney stones, have impaired calcium and phosphate excretion, are immobilised or take thiazide diuretics (benzothiadiazine derivatives) – the risk of hypercalcaemia and hypercalciuria increases.
• Sarcoidosis: increased conversion of vitamin D to its active form – calcium in blood and urine is monitored.
• Pseudohypoparathyroidism: vitamin D needs may be lower – risk of overdose.
• If other medicines with vitamin D are prescribed, the dose from Vigantol must be taken into account; additional vitamin D or calcium only under medical supervision.
• Daily dose above 500 IU: during long-term treatment calcium in blood and urine and creatinine are monitored; above 1,000 IU daily calcium is monitored especially closely, particularly in newborns and infants.

Interactions with other medicines, alcohol and food

• Phenytoin, barbiturates, glucocorticoids, rifampicin and isoniazid may reduce the effect of vitamin D.
• Thiazide diuretics may lead to hypercalcaemia – regular calcium monitoring is required.
• Vitamin D metabolites or analogues (e.g. calcitriol): concomitant use only in rare cases with calcium monitoring.
• Cardiac glycosides (e.g. digoxin): rising calcium increases the risk of arrhythmias – ECG and calcium checks.
• Other vitamin D and calcium products: only on medical advice (risk of overdose).

Pregnancy and breastfeeding

For daily doses up to 500 IU the risk in pregnancy is not known; long-term overdose must be avoided, as prolonged hypercalcaemia can lead to physical and mental retardation and congenital heart and eye disease in the child. Doses above 500 IU a day in pregnancy only if necessary, at the dose needed to correct the deficiency. Vitamin D passes into breast milk; overdose in infants via this route has not been observed.

Driving and using machines

No special precautions are needed.

Possible side effects

Side effects are a consequence of overdose; the frequency is not known.

• Hypercalcaemia and hypercalciuria – acute: heart rhythm disorders, nausea, vomiting, psychological symptoms, impaired consciousness; chronic: increased urination, thirst, loss of appetite and weight, kidney stones, calcification of kidneys and tissues.
• Gastrointestinal complaints: constipation, bloating, nausea, abdominal pain, diarrhoea.
• Hypersensitivity reactions: itching, rash, hives.
• Death has been reported in very rare cases.

Overdose, missed dose and stopping treatment

• Symptoms of overdose are non-specific: nausea, vomiting, initially diarrhoea and later constipation, loss of appetite, tiredness, headache, muscle and joint pain, muscle weakness, persistent drowsiness, increased thirst and urination, dehydration. The toxicity threshold in adults is 40,000–100,000 IU a day for 1–2 months; infants and young children may be sensitive to much lower doses.
• If overdose is suspected, stop the medicine and contact a doctor immediately; there is no specific antidote.
• Missed dose: do not take a double dose.
• Stopping too early may worsen or bring back symptoms – ask your doctor.

Composition, packaging and manufacturer

• Active substance: cholecalciferol; 1 ml (40 drops) contains 0.5 mg = 20,000 IU vitamin D3; 1 drop ≈ 500 IU.
• Excipient: medium-chain triglycerides.
• Appearance: clear, slightly yellowish, viscous oily solution.
• Pack: brown glass dropper bottle (10 ml) in a carton.
• Marketing authorisation holder: NELT CO. d.o.o. Belgrade, Maršala Tita 226B, Dobanovci (transfer of authorisation of 02.04.2026, new number 001450503 2026); previously Evropa Lek Pharma d.o.o. Belgrade (authorisation 000454855 2023 of 13.08.2024).
• Manufacturer: Lusomedicamenta – Sociedade Técnica Farmacêutica S.A., Barcarena, Portugal.

Storage

• Store in the original package to protect from light.
• Shelf life after opening the bottle: 6 months.
• Keep out of the sight and reach of children; do not use after the expiry date.

Frequently asked questions

How many IU of vitamin D are in one drop of Vigantol?

One drop contains approximately 500 IU of vitamin D3. One millilitre (40 drops) contains 20,000 IU.

How many drops of Vigantol are given to a baby?

For the prevention of rickets the usual dose is 1 drop (500 IU) a day, from two weeks of age to the end of the first year, and it is also recommended in the second year, especially in winter. In premature babies and other situations the doctor sets the dose.

Can Vigantol be combined with other vitamins containing D3?

Not without medical advice. The leaflet states that other vitamin D products should be avoided, especially in infants, and additional vitamin D or calcium should be given only under medical supervision.

How is Vigantol given to a child?

The drops are given on a teaspoon of milk or added to porridge or baby food (boiled and cooled) – the child should eat the whole meal to receive the full dose.

Is Vigantol a supplement or a medicine?

Vigantol oral drops are an authorised medicine, prescription-only in Serbia, with dosage and warnings set by the package leaflet.

Sources

• ALIMS – Package leaflet Vigantol® oral drops, solution 20,000 IU/ml (August 2024, Serbian)
• ALIMS – Summary of Product Characteristics Vigantol® (Serbian)
• ALIMS – list of authorisation transfers 01.01–30.04.2026 (Vigantol®, NELT CO. d.o.o., 02.04.2026)

Sources checked on: 23 October 2026.