Vigantol

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Vigantol
500 micrograms/ml (20,000 IU/ml), oral drops, solution
Cholecalciferolum
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 this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, consult your doctor.

Table of contents of the leaflet:

1. What is Vigantol and what is it used for
2. What you need to know before using Vigantol
3. How to use Vigantol
4. Possible side effects
5. How to store Vigantol
6. Contents of the pack and other information

1. What is Vigantol and what is it 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 diet.
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 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 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, 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 or recently taken, as well as any medicines you plan to take.
Antacids used in the treatment of hyperacidity and containing aluminium, when taken together with Vigantol, may increase aluminium levels in the blood, increasing the risk of aluminium toxicity to bones.
Antacids containing magnesium taken simultaneously with Vigantol may increase magnesium levels in the blood.
Certain antiepileptic, sedative or hypnotic drugs (containing phenytoin and barbiturates), when used concomitantly with Vigantol, may reduce its effectiveness.
Some diuretics (thiazides) may lead to vitamin D-induced 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 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.
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 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 become pregnant, she should consult a doctor before using this medicine.

Pregnancy
Vigantol may be taken during pregnancy only under medical supervision.
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 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 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: 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) 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 foodstuffs containing vitamin D (cholecalciferol), calcitriol, or other metabolites and analogues of vitamin D concurrently without medical supervision.
Instructions for use
Premature infants, newborns, and infants:
Vigantol should be given to children from the second week of life until the end of the first year of life.
Administer drops with a spoonful of milk or food. If drops are added to a bottle or food, ensure 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
If an overdose of Vigantol is taken, contact your doctor immediately.
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. At high calcium levels in blood, cardiac arrhythmias, renal failure, psychoses, and even coma may occur. Laboratory tests reveal hypercalcemia (increased 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. 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 may 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 (excess calcium in the blood) and hypercalciuria (excessive excretion of calcium in urine). In isolated cases, fatal outcomes have been reported.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 continued monitoring of the medicine's safety and allows for the collection of additional information on its safe use.

5. How to store Vigantol

Keep the medicine out of the sight and reach of children.
Store the bottle in the outer packaging to protect it from light.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
The shelf life of the medicine after first opening the container is 12 months.
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 (equivalent to 20,000 IU of vitamin D).
• The other ingredient is: medium-chain triglycerides.

What Vigantol looks like and contents of the pack
Vigantol is an oral solution in the form of drops.
Pack containing 10 ml of solution. The pack consists of a brown glass bottle with a polypropylene screw cap and a polyethylene dropper insert, placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in Bulgaria, the 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa

Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń

CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa

Bulgaria (country of export) marketing authorization number: 9900340
Parallel import authorization number: 427/21