Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Vigantol
500 micrograms/ml (20,000 IU/ml), oral drops, solution
Cholecalciferol
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.
This medicine should always be taken 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 effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
If your condition does not improve or if you feel worse, you should contact your 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 package 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 D (cholecalciferol) is physiologically produced in the skin upon exposure to UV radiation, and can also be supplied to the body through diet.
In vitamin D deficiency, impaired bone mineralization occurs (rickets) or calcium loss 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. 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 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 concentration.

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 concomitantly with Vigantol, may increase aluminium levels in blood, increasing the risk of aluminium toxicity to bones.
Antacids containing magnesium used simultaneously with Vigantol may increase blood magnesium levels.
Some antiepileptic, sedative or hypnotic drugs (containing phenytoin and barbiturates), when used together with Vigantol, may reduce its effectiveness.
Some diuretics (thiazide-type) may lead to hypercalcaemia (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 effects 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.
Concomitant 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 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 plans to become pregnant, she should consult a doctor before using this medicine.

Pregnancy
Vigantol may be used during pregnancy only on a doctor's prescription.
Vitamin D overdose should be avoided during pregnancy, as it may lead to delayed physical and mental development, heart defects, and retinal disorders (retinopathy) in the child.

Breastfeeding
Consult a doctor before using this medicine.

Driving and using machines
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 this 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. 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 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 medicinal product 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 simultaneously 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.
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.

Overdose of Vigantol

If more Vigantol than recommended has been taken, contact a doctor. The doctor will decide on appropriate treatment.

Symptoms of overdose: nausea, vomiting, diarrhoea 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 dysfunction, renal failure, psychoses, and even coma may occur. Laboratory findings include hypercalcemia (increased calcium concentration in blood), hypercalciuria (excessive excretion of calcium in urine), and increased serum 25-hydroxycholecalciferol concentration. There is no specific antidote for vitamin D. Overdose requires measures to control often prolonged and potentially life-threatening hypercalcemia. Inform the 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 medicines, this medicinal product may cause adverse effects, although not everybody 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: hypercalcaemia (excess calcium concentration in the blood) and hypercalciuria (excessive excretion of calcium in urine). In isolated cases, fatal outcomes have been reported.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects enables the collection of further information on the safety of the medicine's use.

5. How to store Vigantol

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original packaging to protect 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine 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 micrograms of cholecalciferol (corresponding to 500 IU of vitamin D).
The other ingredient is: medium-chain triglycerides.

What the medicine 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 box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Slovakia, 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, n.̊ 69-B
Queluz de Baixo
2730-055 Barcarena, Portugal
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Relabelled in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Slovakia, country of export: 86/0283/95-S
Parallel import authorisation number: 295/23