Vigantol

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

VIGANTOL

500 µg/ml (20,000 IU/ml), oral drops, solution

Cholecalciferol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Vigantol and what is it used for

Vigantol contains the active substance vitamin D (cholecalciferol), which is essential for bone formation.
Vitamin D (cholecalciferol) is physiologically produced in the skin under the influence of UV radiation and can also be supplied to the body with food.
In vitamin D deficiencies, bone calcification disorders (rickets) or loss of calcium from bones (osteomalacia) occur.
Vigantol is used:

• to prevent rickets and osteomalacia in children and adults,
• to prevent rickets in premature infants,
• to prevent diseases in cases where there is a risk of vitamin D deficiency in children and adults,
• to prevent vitamin D deficiencies 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 cases of hypercalcemia (too high calcium levels in the blood) or hypercalciuria (excessive excretion of calcium in the urine),
• if the patient has kidney stones or severe kidney failure,
• in cases of alleged hypoparathyroidism.

Warnings and precautions

Before starting to use Vigantol, you should discuss it with your doctor or pharmacist, as Vigantol should be used under medical supervision:

• if the patient is also taking other medicines containing vitamin D, as additional doses of vitamin D can only be taken under medical supervision,
• if the patient has sarcoidosis (an immune system disease that can increase vitamin D levels in the body),
• if the patient has kidney function disorders,
• if the patient is being treated with cardiac glycosides or diuretics,
• in the case of newborns, infants, and young children,
• if vitamin D treatment is long-term, as the doctor should monitor the patient's blood and urine calcium levels and check kidney function by measuring creatinine levels in the blood.

Vigantol and other medicines

You should tell 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 containing aluminum, used with Vigantol, may increase aluminum levels in the blood, increasing the risk of toxic aluminum effects on bones.
Antacids containing magnesium used simultaneously with Vigantol may increase magnesium levels in the blood.
Certain antiepileptic, sedative, or hypnotic drugs (containing phenytoin and barbiturates) used simultaneously with Vigantol may reduce its effectiveness.
Certain diuretics (thiazide) may lead to hypercalcemia (elevated calcium levels) caused by reduced calcium excretion by the kidneys. During long-term treatment, calcium levels in the blood and urine should be monitored.
Concomitant use of glucocorticosteroids (synthetic adrenal cortex hormones) may counteract the effect of Vigantol.
Vigantol may enhance the effect and toxicity of digitalis glycosides, which can lead to the development of heart rhythm disorders. In this case, the doctor should monitor the patient's blood and urine calcium levels and perform periodic ECG tests.
Concomitant use of vitamin D metabolites or analogs (e.g., calcitriol) and Vigantol is only possible on a doctor's prescription in exceptional cases, provided that blood calcium levels are monitored.
Rifampicin and isoniazid may reduce the effectiveness of Vigantol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Pregnancy

Vigantol can be used during pregnancy only on a doctor's prescription.
During pregnancy, it is essential to avoid overdosing on vitamin D, as it may lead to delayed physical and mental development, heart defects, and retinopathy in the child.

Breastfeeding

Before using the medicine, the patient should consult their doctor.

Driving and using machines

Vigantol does not affect the ability to drive vehicles or operate machinery.

3. How to use Vigantol

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor.
Dosage

• Preterm infants:2 drops per day of Vigantol solution (1000 IU of vitamin D). After reaching
• 40 weeks 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 per day of Vigantol solution (corresponding to 500 IU of vitamin D).

In preterm infants, newborns, and infants, the medicine should be used under medical supervision. Do not exceed the recommended dose.

• Children and adolescents:1 drop per day of Vigantol solution (corresponding to 500 IU of vitamin D).
• Adults and the elderly:2 drops per day of Vigantol solution (corresponding to 1000 IU of vitamin D).
• Adjunctive treatment in osteoporosis in adults:4 drops per day of Vigantol solution (corresponding to 2000 IU of vitamin D).
• Adults with obesity (including the elderly) and people over 75 years old:8 drops per day of Vigantol solution (corresponding to 4000 IU of vitamin D).

Do not use the medicine for an extended period or in higher doses without medical supervision. Additionally, without medical supervision, do not use other medicines, dietary supplements, or food products containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs.

Method of administration

Preterm infants, newborns, and infants:
Vigantol is administered to children from the second week of life to the end of the first year of life.
Drops should be given with a spoonful of milk or food. If drops are added to a bottle or food, ensure the child has eaten the entire meal; otherwise, the dose will not be taken in full.
Older children and adults:
Vigantol should be administered with a spoonful of liquid.

Using a higher dose of Vigantol than recommended

If a higher dose of Vigantol than recommended is used, you should contact your doctor.
The doctor will decide on the appropriate treatment.
Symptoms of overdose: nausea, vomiting, diarrhea followed by constipation, loss of appetite, fatigue, headache, muscle pain, joint pain, muscle weakness, drowsiness, azotemia (elevated levels of nitrogen compounds in the blood), excessive thirst, polyuria, and dehydration. At high calcium levels in the blood, cardiac arrhythmias, kidney failure, psychosis, and even coma may occur.
In laboratory tests, hypercalcemia (elevated calcium levels in the blood), hypercalciuria (excessive excretion of calcium in the urine), and elevated 25-hydroxycholecalciferol levels in the blood are found. There is no specific antidote for vitamin D.
Overdose requires measures to control the often prolonged and sometimes life-threatening hypercalcemia. In case of overdose, you should inform your doctor, who will decide on the appropriate treatment.

Missing a dose of Vigantol

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Vigantol can cause side effects, although not everybody gets them.
Gastrointestinal disorders, such as constipation, bloating, nausea, abdominal pain, or diarrhea.
Hypersensitivity reactions, such as skin itching, rash, or urticaria.
In cases of prolonged use of high doses, hypercalcemia (too high calcium levels in the blood) and hypercalciuria (excessive excretion of calcium in the urine). In individual cases, fatal outcomes have been reported.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 side effects, you can help gather more information on the safety of the medicine.

5. How to store Vigantol

The medicine should be stored 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 opening the packaging is 6 months.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vigantol contains

• The active substance of Vigantol is cholecalciferol. 1 ml (40 drops) contains 500 μg of cholecalciferol (corresponding to 20,000 IU of vitamin D)
• The other ingredients are: triglycerides of fatty acids of medium chain length.

What Vigantol looks like and contents of the packaging

Vigantol is an oral drop solution.
A brown glass bottle with a polypropylene cap and a polyethylene central dropper in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

P&G Health Germany GmbH
Sulzbacher Strasse 40
65824 Schwalbach am Taunus
Germany

Manufacturer:

Lusomedicamenta Sociedade Técnica Farmacȇutica, S.A
Estrada Consiglieri Pedroso, n.̊ 69-B
Queluz de Baixo
2730-055 Barcarena
Portugal

Parallel importer:

Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czeski Cieszyn
Czech Republic

Repackaged by:

Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Number of the marketing authorization in Bulgaria, the country of export: 9900340

Number of the parallel import authorization: 114/22 Date of approval of the leaflet: 28.02.2022

[Information about the registered trademark]