Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Vigantol (Vigantol Oil)
500 micrograms/ml (20,000 IU/ml), oral drops, solution
Cholecalciferolum
Vigantol and Vigantol Oil are different brand names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet for future reference.
If advice or additional information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement or the patient feels worse, contact a doctor.

Contents of the leaflet:

What Vigantol is and what it is used for
Important information before taking Vigantol
How to take Vigantol
Possible side effects
How to store Vigantol
Contents of the pack and other information

1. What Vigantol is and what it is used for

Vigantol contains the active substance vitamin D (cholecalciferol), which is important in the process of bone formation.
Vitamin D (cholecalciferol) is physiologically produced in the skin upon exposure to UV radiation and can also be supplied to the body through food.
In vitamin D deficiency, impaired bone mineralization (rickets) or loss of calcium from bones (osteomalacia) may occur.
Vigantol is used:

for the prevention of rickets and osteomalacia in children and adults,
for the prevention of rickets in premature infants,
for the prevention of disorders in cases of risk of vitamin D deficiency in children and adults,
for the prevention of vitamin D deficiency in children and adults,
as supportive treatment in osteoporosis in adults.

2. Important information before using Vigantol

When not to use Vigantol

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
in case of hypercalcemia (excessively high calcium levels in the blood) or hypercalciuria (excessive excretion of calcium in urine),
if the patient has kidney stones or severe renal insufficiency,
in case of pseudohypoparathyroidism.

Warnings and precautions
Before starting treatment with Vigantol, consult a doctor or pharmacist, as Vigantol should be used under medical supervision:

if the patient is also taking other medicines containing vitamin D, because additional doses of vitamin D should only be taken under medical supervision,
if the patient has sarcoidosis (an immune system disorder that may increase vitamin D levels in the body),
if the patient has impaired kidney function,
if the patient is being treated with cardiac glycosides or diuretics,
in newborns, infants, and young children,
if vitamin D treatment is long-term, as in such cases the doctor should monitor serum and urinary calcium levels and assess kidney function by measuring blood creatinine levels.

Vigantol with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Antacids used to treat acidity and containing aluminium, when taken together with Vigantol, may increase aluminium levels in the blood, increasing the risk of aluminium toxicity in bones.
Antacids containing magnesium used concurrently with Vigantol may increase magnesium levels in the blood.
Some antiepileptic, sedative, or hypnotic drugs (containing phenytoin and barbiturates), when used together with Vigantol, may reduce its effectiveness.
Certain diuretics (thiazides) may lead to hypercalcemia (elevated calcium levels) due to reduced renal excretion of calcium. During long-term treatment, serum and urinary calcium levels should be monitored.
Concomitant use of glucocorticoids (synthetic corticosteroid hormones) may counteract the effect of Vigantol.
Vigantol may enhance the effect and toxicity of cardiac glycosides, increasing the risk of cardiac arrhythmias. In such cases, the doctor should monitor serum and urinary calcium levels and perform periodic ECG examinations.
Concurrent use of vitamin D metabolites or analogs (e.g. calcitriol) and Vigantol is possible only on a doctor's prescription and only in exceptional cases, provided that serum calcium levels are monitored.
Rifampicin and isoniazid may reduce the effectiveness of Vigantol.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.

Pregnancy
Vigantol should be used during pregnancy only under medical supervision.
Vitamin D overdose during pregnancy should be avoided, as it may lead to delayed physical and mental development, congenital heart defects, and retinal disorders (retinopathy) in the child.

Breastfeeding
Consult a doctor before using this medicine.

Driving and operating machinery
Vigantol has no influence on the ability to drive motor vehicles or operate machinery.

3. How to use Vigantol

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor.

Dosage

Premature infants: 2 drops daily of Vigantol solution (1000 IU vitamin D). After reaching the 40th week of corrected age, the prophylactic dose should be reduced. Dosage must be determined by the attending physician.
Newborns and infants (up to 12 months): 1 drop daily of Vigantol solution (corresponding to 500 IU vitamin D).

Vigantol should be administered under medical supervision in premature infants, newborns, and infants. Do not exceed the recommended dose.

Children and adolescents: 1 drop daily of Vigantol solution (corresponding to 500 IU vitamin D).
Adults and elderly individuals: 2 drops daily of Vigantol solution (corresponding to 1000 IU vitamin D).
Adjunctive treatment of osteoporosis in adults: 4 drops daily of Vigantol solution (corresponding to 2000 IU vitamin D).
Adults with obesity (including elderly individuals) and individuals over 75 years of age: 8 drops daily of Vigantol solution (corresponding to 4000 IU vitamin D).

Do not use this medicine long-term or in higher doses without medical supervision. Additionally, do not use other medicines, dietary supplements, or fortified foods containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs concurrently without medical supervision.

Instructions for use

Premature infants, newborns, and infants
Vigantol should be administered to children from the second week of life until the end of the first year of life.
Administer the drops with a spoonful of milk or food. If the drops are added to a bottle or mixed with food, ensure that the child consumes the entire meal; otherwise, the full dose will not be ingested.

Older children and adults
Vigantol should be taken with a spoonful of liquid.

Overdose of Vigantol

In case of an overdose of Vigantol, contact a doctor immediately. The doctor will decide on appropriate treatment.

Symptoms of overdose: nausea, vomiting, diarrhea followed by constipation, loss of appetite, fatigue, headache, muscle and joint pain, muscle weakness, drowsiness, azotemia (elevated blood nitrogen levels), excessive thirst, polyuria, and dehydration. With high calcium levels in blood, cardiac arrhythmias, kidney failure, psychosis, and even coma may occur. Laboratory findings include hypercalcemia (elevated calcium levels in blood), hypercalciuria (excessive calcium excretion in urine), and increased serum 25-hydroxycholecalciferol levels. There is no specific antidote for vitamin D. Management of overdose requires measures to control hypercalcemia, which may be prolonged and sometimes life-threatening. In case of overdose, inform the doctor, who will determine appropriate treatment.

Missed dose of Vigantol

Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Gastrointestinal disorders such as constipation, bloating, nausea, abdominal pain, or diarrhoea.
Hypersensitivity reactions such as: skin itching, rash, or urticaria.
In case of prolonged use of high doses – hypercalcemia (excess calcium concentration in blood) and hypercalciuria (excessive excretion of calcium in urine). In isolated cases, fatal outcomes have been reported.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vigantol

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original packaging, protected from light.
The shelf life of the medicine after first opening the bottle is 6 months.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vigantol contains

The active substance is cholecalciferol. 1 ml (40 drops) contains 500 micrograms of cholecalciferol (equivalent to 20,000 IU of vitamin D). One drop contains 12.5 micrograms of cholecalciferol (equivalent to 500 IU of vitamin D).
The other ingredient is: medium-chain triglycerides.

What Vigantol looks like and contents of the pack
Vigantol is an oral drop solution.
The bottle is closed with a screw cap and contains a dropper.
The bottle is placed in a cardboard carton.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Romania, country of export:
P&G Health Germany GmbH
Sulzbacher Strasse 40
65824 Schwalbach am Taunus
Germany
Manufacturer:
Lusomedicamenta Sociedade Técnica Farmacêutica, S.A
Estrada Consiglieri Pedroso, no. 69-B, Queluz de Baixo
2730-055 Barcarena
Portugal
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorization number in Romania, country of export: 8275/2015/01
Parallel import authorization number: 234/19