Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Vigantol (Vigantol Oel)
500 micrograms/ml (0.5 mg/ml) (20,000 IU/ml), oral drops, solution
Cholecalciferolum
Vigantol and Vigantol Oel are different brand names for the same medicine.
Please read carefully all the information in this leaflet before using the medicine, as 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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If your condition does not improve or if you feel worse, you should consult 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 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 D (cholecalciferol) is physiologically produced in the skin upon exposure to UV radiation, and can 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 in cases where there is a 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 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, 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 currently used, recently used, or planned to be used.
Antacids used in the treatment of hyperacidity containing aluminium, when used 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 blood magnesium levels.
Certain antiepileptic, sedative or hypnotic drugs (containing phenytoin and barbiturates), when used simultaneously 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 adrenal cortex 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 should be taken during pregnancy only on medical advice.
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 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 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. Dosing 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: 2 drops daily of Vigantol solution (corresponding to 1000 IU vitamin D).
Adjunctive treatment in adults with osteoporosis: 4 drops daily of Vigantol solution (corresponding to 2000 IU vitamin D).
Adults with obesity (including elderly) 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 for prolonged periods 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 infants 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.

Use of more than the recommended dose 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, psychosis, 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 hypercalcemia, which may be prolonged and sometimes life-threatening. Inform a doctor immediately in case of 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 reactions

Like all medicines, this medicine can cause adverse reactions, 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 (excessively high calcium levels 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, pharmacist or nurse. Adverse reactions can also 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
By reporting adverse reactions, additional information regarding the safety of the medicine can be collected.

5. How to store Vigantol

Keep this medicine out of sight and reach of children.
Store 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 this 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. Such measures will help protect the environment.

6. Contents of the package and other information

What Vigantol contains

The active substance is cholecalciferol. 1 ml (40 drops) contains 500 micrograms (0.5 mg) 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).
Other components: medium-chain triglycerides.

What Vigantol looks like and contents of the pack
Vigantol is an oral solution in drops.
Brown glass bottle with a polyethylene dropper and a polypropylene cap, packed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
P&G Health Germany GmbH
Sulzbacher Strasse 40
65824 Schwalbach am Taunus
Germany
Manufacturer:
Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Estrada Consiglieri Pedroso, n.̊ 66, 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
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Latvia, country of export: 98-0828
Parallel import licence number: 150/24