Vigantol

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Vigantol

500 micrograms/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 this leaflet for the patient or as directed by a doctor or pharmacist.

• The leaflet should be kept so that it can be read again if necessary.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 important 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, there are disorders of bone calcification (rickets) or loss of calcium from bone (osteomalacia).
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 any of the other ingredients of this medicine (listed in section 6),
• in case 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 case of alleged hypoparathyroidism.

Warnings and precautions

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Before starting to use Vigantol, the patient should discuss it with their 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Antacids used to treat hyperacidity containing aluminum, used together 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 examinations.
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 should only be used during pregnancy on a doctor's prescription.
During pregnancy, it is necessary to avoid overdosing on vitamin D, as this can 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.
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Driving and operating machinery

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 this leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their 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. The recommended dose should not be exceeded.

• 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)

The product should not be used for a long time or in higher doses without medical supervision. Additionally, without medical supervision, other medicines, dietary supplements, or other types of food products containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs should not be used.
The patient should not use a double dose to make up for a missed dose.

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, the patient should ensure that 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.

Use of a higher dose of Vigantol than recommended

In case of use of a higher dose of Vigantol than recommended, the patient should contact their doctor.
The doctor will decide on the use of 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, there are disorders of heart function, kidney failure, psychoses, and even coma. 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. The doctor should be informed about the overdose, and they will decide on the use of appropriate treatment.

Missing a dose of Vigantol

The patient should 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 case 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 the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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, more information can be collected on the safety of the use of the medicine.

5. How to store Vigantol

The medicine should be stored out of sight and reach of children.
The bottle should be stored in the outer packaging to protect it from light.
The shelf life of the medicine after opening the bottle is 12 months.
The medicine should not be used after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer used. 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 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 ingredients are: triglycerides of fatty acids of medium chain length.

What Vigantol looks like and what the packaging contains

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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, the patient 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 FARMACÊUTICA, S.A., Estrada Consiglieri Pedroso, no 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 9900340

Parallel import authorization number: 115/21

Date of leaflet approval: 27.11.2023

[Information about the trademark]
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