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 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 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 more information, you should speak to a pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, you should contact your 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 the process of bone formation.
Vitamin D (cholecalciferol) is physiologically produced in the skin under the influence of UV radiation exposure 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 you are allergic to the active substance or to 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 you have kidney stones or severe kidney failure,
• in case 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 you are also taking other medicines containing vitamin D, as additional doses of vitamin D can only be taken under medical supervision,
• if you have sarcoidosis (a disease of the immune system that can increase the level of vitamin D in the body),
• if you have kidney function disorders,
• if you are being treated with cardiac glycosides or diuretics,
• in the case of newborns, infants, and young children,
• if vitamin D treatment is long-term, as in such a case, the doctor should monitor the calcium level in the serum and urine and check kidney function by determining the creatinine level in the blood.

Vigantol and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Antacids used to treat hyperacidity containing aluminum, used together with Vigantol, may increase the aluminum level in the blood, increasing the risk of toxic aluminum effects on the bones.
Antacids containing magnesium used simultaneously with Vigantol may increase the magnesium level 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 (increased calcium levels) caused by reduced excretion of calcium by the kidneys. During long-term treatment, calcium levels in the serum 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 poses a risk of developing heart rhythm disorders. In such a case, the doctor should monitor the calcium level in the serum and urine of patients and perform periodic ECG examinations.
Concomitant use of vitamin D metabolites or analogs (e.g., calcitriol) and Vigantol is possible only on the doctor's prescription, in exceptional cases, provided that the calcium level in the serum is monitored.
Rifampicin and isoniazid may reduce the effectiveness of Vigantol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor for advice before taking this medicine.

Pregnancy

Vigantol should be used during pregnancy only on the doctor's prescription.
During pregnancy, you should 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, you should ask your doctor for advice.

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 taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor.
Dosage

• Premature infants: 2 drops per day of Vigantol solution (1000 IU of vitamin D). After reaching the 40th week of life, 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 (which corresponds to 500 IU of vitamin D).

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

• Children and adolescents: 1 drop per day of Vigantol solution (which corresponds to 500 IU of vitamin D).
• Adults and the elderly: 2 drops per day of Vigantol solution (which corresponds to 1000 IU of vitamin D).
• Adjunctive treatment in osteoporosis in adults: 4 drops per day of Vigantol solution (which corresponds 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 (which corresponds to 4000 IU of vitamin D)

You should not use the medicine for a long time or in larger doses without medical supervision. Additionally, without medical supervision, you should not use other medicines, dietary supplements, or other types of food products containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs at the same time.

Method of administration

Premature infants, newborns, and infants:
Vigantol is given 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, you should make sure that the child has eaten the entire meal; otherwise, the dose will not be taken in full.
Older children and adults
Vigantol should be given with a spoonful of liquid.

Using a higher dose of Vigantol than recommended

If you use a higher dose of Vigantol than recommended, you should contact your 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 (increased 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 (increased calcium levels in the blood), hypercalciuria (excessive excretion of calcium in the urine), and increased levels of 25-hydroxycholecalciferol in the serum are found. There is no specific antidote for vitamin D.
Overdose requires measures to control the often prolonged and sometimes life-threatening hypercalcemia. You should inform your doctor about the overdose, who will decide on the use of appropriate treatment.

Missing a dose of Vigantol

You should not take 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 the 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 provide more information on the safety of this 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 the first opening of the bottle is 12 months.
You should not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given 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 micrograms of cholecalciferol (which corresponds to 20,000 IU of vitamin D). One drop contains 12.5 μg of cholecalciferol (which corresponds 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

Vigantol is an oral drop solution.
The bottle is made of brown glass with a polypropylene cap and a polyethylene dropper.
The packaging contains a 10 ml bottle placed in a cardboard box.
To obtain 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 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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Number of the marketing authorization in Bulgaria, the country of export:9900340
Number of the parallel import authorization:316/20

Date of approval of the leaflet: 08.11.2024

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