Vigantol

Package Leaflet: 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

Read the 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 leaflet for the patient or as directed by the doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.

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 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 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 calcium loss from bone (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 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 calcium excretion in the urine),
• if the patient has kidney stones or severe kidney failure,
• in case of alleged hypoparathyroidism.

Warnings and precautions

Before starting to use Vigantol, the doctor or pharmacist should be consulted, 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 doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as any medicines the patient plans to use.
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 the bones.
Antacids containing magnesium used simultaneously with Vigantol may increase magnesium levels in the blood.
Certain anti-epileptic, 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, creating a risk of developing 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 the doctor's instructions, 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, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.

Pregnancy

Vigantol can be used during pregnancy only on the doctor's instructions.
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 doctor should be consulted.

Driving and using machines

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

3. How to use Vigantol

This medicine should always be used exactly as described in this leaflet for the patient or as directed by the doctor or pharmacist. In case of doubt, the doctor should be consulted.
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 persons over 75 years of age: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. Furthermore, 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 simultaneously.

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 are given with a spoonful of milk or food. If drops are added to a bottle or food, it should be ensured 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 doctor should be contacted.
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, cardiac arrhythmias, kidney failure, psychoses, and even coma may occur. Laboratory tests show hypercalcemia (elevated calcium levels in the blood), hypercalciuria (excessive calcium excretion in the urine), and elevated 25-hydroxycholecalciferol levels in the blood. 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, who will decide on the use of appropriate treatment.

Missing a dose of Vigantol

A double dose should not be used to make up for a missed dose.

4. Possible side effects

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

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. 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
Reporting side effects 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 in a temperature below 25°C, in the original packaging to protect from light.
The shelf life of the medicine after opening the bottle is 12 months.
The medicine should not be used 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. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack 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).
• Other ingredients are: triglycerides of medium-chain fatty acids.

What Vigantol looks like and contents of the pack

Vigantol is an oral drop solution.
The bottle with a dropper is closed with a cap.
The bottle is placed in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Slovakia, 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:

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
Authorization number in Slovakia, the country of export: 86/0283/95-S

Parallel import authorization number: 295/23

Date of leaflet approval: 19.12.2023

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