PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the 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 trade names for the same medicine.
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your condition does not improve or worsens, contact your doctor.

Leaflet contents:

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 for bone formation.
Vitamin D3 (cholecalciferol) is physiologically produced in the skin upon exposure to UV radiation, and can also be supplied to the body through diet.
Vitamin D deficiency leads to impaired bone mineralization (rickets) or loss of calcium from bones (osteomalacia).
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 adjunctive 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 hypercalcaemia (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 to use 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 which 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 your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Antacids used to treat hyperacidity and containing aluminium, when taken together with Vigantol, may increase aluminium levels in the blood, increasing the risk of aluminium's toxic effects on bones.
Antacids containing magnesium, when used concurrently with Vigantol, may increase magnesium levels in the blood.
Certain antiepileptic, sedative or hypnotic drugs (containing phenytoin and barbiturates), when used together with Vigantol, may reduce its effectiveness.
Some diuretics (thiazides) may lead to hypercalcaemia (increased calcium levels) due to reduced renal excretion of calcium. During long-term treatment, serum and urinary calcium levels should be monitored.
Concomitant use of glucocorticosteroids (synthetic corticosteroid hormones) may counteract the effect of Vigantol.
Vigantol may enhance the action 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 analogues (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 or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Pregnancy
Vigantol may be taken during pregnancy only under medical supervision.
Excessive intake of vitamin D during pregnancy should be avoided, as it may lead to delayed physical and mental development, congenital heart defects, and retinal abnormalities (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 leaflet or as directed by your doctor or pharmacist. If in doubt, consult your 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. The 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 used 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 D3).
Adults and elderly individuals: 2 drops daily of Vigantol solution (corresponding to 1000 IU vitamin D3).
Adjunctive treatment of osteoporosis in adults: 4 drops daily of Vigantol solution (corresponding to 2000 IU vitamin D3).
Adults with obesity (including elderly individuals) and individuals over 75 years of age: 8 drops daily of Vigantol solution (corresponding to 4000 IU vitamin D3).

Do not use the medicinal product long-term or in higher doses without medical supervision. Additionally, do not use other medicines, dietary supplements, or foodstuffs containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites or analogs concurrently without medical supervision.
Method of administration
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. Drops should be given with a spoonful of milk or food. If the drops are added to a bottle or food, ensure that the child consumes the entire meal; otherwise, the full dose will not be ingested.
Older children and adults
The medicinal product Vigantol should be administered with a spoonful of liquid.
Use of a higher than recommended dose of Vigantol
If a higher than recommended dose of Vigantol is taken, contact your doctor. The doctor will decide on appropriate treatment.
Symptoms of overdose: nausea, vomiting, diarrhea followed by constipation, loss of appetite, fatigue, headache, muscle pain, joint pain, muscle weakness, drowsiness, azotemia (increased concentration of nitrogen compounds in blood), excessive thirst, polyuria, and dehydration. With high calcium levels in blood, cardiac function disturbances, renal failure, psychoses, and even coma may occur. Laboratory tests reveal hypercalcemia (increased calcium concentration in blood), hypercalciuria (excessive excretion of calcium in urine), and increased serum 25-hydroxycholecalciferol levels. There is no specific antidote for vitamin D. Overdose requires measures aimed at controlling often prolonged and sometimes life-threatening hypercalcemia. In case of overdose, inform your doctor, who will decide on 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.
With prolonged use of high doses, hypercalcaemia (excess calcium in the blood) and hypercalciuria (excessive excretion of calcium in urine) may occur. In isolated cases, fatal outcomes have been reported.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicine.

5. How to store Vigantol

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light.
The shelf life 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 packaging and other information

What the Vigantol medicine contains

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

What the Vigantol medicine looks like and contents of the pack
Vigantol is an oral drops preparation.
Brown glass bottle with a white polyethylene dropper and a white polypropylene cap, in a cardboard box.
For more detailed information, please contact the responsible party or the 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, 66
69-B, Queluz de Baixo
2730-055 Barcarena
Portugal
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorization number in Romania, country of export: 8275/2015/01
Parallel import authorization number: 55/19