Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Vigantol
500 micrograms/ml (20,000 IU/ml), oral drops, solution
Cholecalciferolum
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, 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.

Table of Contents

What Vigantol is and what it is used for
Important information before taking Vigantol
How to use 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, but may also be supplied to the body through diet.
Deficiency of vitamin D 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 associated with 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 treatment with Vigantol, consult your 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 diuretic medicines,
in newborns, infants and young children,
if vitamin D treatment is long-term, in which case 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 intends to take.
Antacids containing aluminium, used in the treatment of hyperacidity, taken together with Vigantol, may increase aluminium levels in the blood, increasing the risk of aluminium toxicity to bones.
Antacids containing magnesium 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 prolonged 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 under medical 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 should be used during pregnancy only on medical advice.
Vitamin D overdose should be avoided during pregnancy, as it may cause delayed physical and mental development, 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 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 D3). After reaching the corrected age of 40 weeks, 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).
Supportive 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 this medicine long-term or in higher doses without medical supervision. Additionally, without medical supervision, do not simultaneously use other medicines, dietary supplements, or other types of food products containing vitamin D (cholecalciferol), calcitriol, or other metabolites and analogs of vitamin D.

Instructions for 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.
Administer the drops 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:
Vigantol should be administered with a spoonful of liquid.

Accidental overdose of Vigantol
In case of an overdose of Vigantol, contact your doctor immediately. 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 arrhythmias, renal failure, psychoses, and even coma may occur. Laboratory findings include hypercalcemia (elevated calcium levels 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 to control often prolonged and potentially life-threatening hypercalcemia. Inform your doctor about the overdose; the doctor 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 effects

Like all medicinal products, this medicine can cause adverse effects, although not everyone experiences 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, 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 effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 effects allows the collection of further information on the safety of using the medicine.

5. How to store Vigantol

Keep the medicine out of sight and reach of children.
Store the bottle in the outer packaging to protect it from light.
The shelf life of the medicine after first opening the bottle is 12 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 Vigantol 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 ingredient is: medium-chain triglycerides.

What Vigantol looks like and contents of the pack
Vigantol is an oral drop solution.
Brown glass bottle with a polypropylene screw cap and a polyethylene dropper.
The pack contains a 10 ml bottle placed in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
P&G Health Germany GmbH
Sulzbacher Str. 40
65824 Schwalbach am Taunus
Germany
Manufacturer:
Lusomedicamenta Sociedade Técnica Farmacêutica, S.A
Estrada Consiglieri Pedroso, n.°66, 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:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Bulgaria, country of export: 9900340
Parallel Import Authorisation Number: 316/20