Vigantol

Package Leaflet: Information for the User

Vigantol

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

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

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, contact a doctor.

Package Leaflet Contents

• 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. Package contents 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 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 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, 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

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 anti-epileptic, sedative, or hypnotic medicines (containing phenytoin and barbiturates) used simultaneously with Vigantol may reduce its effectiveness.
Certain diuretics (thiazide) may lead to hypercalcemia (increased 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, posing 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 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 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 a doctor's prescription.
During pregnancy, vitamin D overdose should be avoided, as it may lead to delayed physical and mental development, heart defects, and retinopathy in the child.

Breastfeeding

Before using the medicine, consult a doctor.

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 package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, consult a 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 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 of age:8 drops per day of Vigantol solution (corresponding to 4000 IU of vitamin D).

Do not use the medicinal product for a long time or in higher doses without medical supervision.
Furthermore, without medical supervision, do not use other medicines, dietary supplements, or other types of 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 are given with a spoonful of milk or food. If drops are added to a bottle or food, make sure the child has eaten the entire meal, otherwise, the dose will not be taken in full.
Older children and adults
The Vigantol medicinal product should be administered with a spoonful of liquid.

Using a higher dose of Vigantol than recommended

In case of using a higher dose of Vigantol than recommended, contact a doctor.
The doctor will decide on the use of appropriate treatment.
Overdose symptoms: 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 blood calcium levels, cardiac arrhythmias, kidney failure, psychosis, 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-hydroxy calciferol levels in the blood. There is no specific antidote for vitamin D. Overdose requires measures to control often prolonged and sometimes life-threatening hypercalcemia. In case of overdose, inform a doctor who will decide on the use of 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, this medicine can cause side effects, although not everybody gets them.
Gastrointestinal disorders, such as constipation, bloating, nausea, abdominal pain, or diarrhea.
Allergic reactions, such as skin itching, rash, or hives.
In 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 you experience any side effects, including any possible side effects not listed in this package leaflet, 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vigantol

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Protect from light.
The shelf life of the medicine after opening the package is 12 months.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Vigantol contains

• The active substance of the medicine is cholecalciferol. 1 ml (40 drops) contains 500 μg of cholecalciferol (corresponding to 20,000 IU of vitamin D). One drop contains 12.5 μg of cholecalciferol (corresponding to 500 IU of vitamin D).
• The other ingredients are: triglycerides of saturated fatty acids of medium chain length.

What Vigantol looks like and what the package contains

Vigantol is an oral drop solution.
The bottle is closed with a cap and contains a dropper.
The package contains a 10 ml or 30 ml bottle placed in a cardboard box.

Marketing authorization holder:

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

Manufacturer:

Lusomedicamenta Sociedade Técnica Farmacȇutica, S.A.
Estrada Consiglieri Pedroso, n.̊ 66, 69-B
Queluz de Baixo
2730-055 Barcarena
Portugal
Date of last revision of the package leaflet: 08/2024