VIGANTOL

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
VIGANTOL
500 µg/ml (20,000 IU/ml), oral drops, solution
Cholecalciferolum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If your condition does not improve or if you feel worse, consult your doctor.

Contents of the leaflet:

1. What VIGANTOL is and what it is used for
2. What you need to know before taking VIGANTOL
3. How to take VIGANTOL
4. Possible side effects
5. How to store VIGANTOL
6. Contents of the pack and other information

1. What VIGANTOL is and what it is used for

VIGANTOL contains the active substance vitamin D (cholecalciferol), which is important in the process of bone formation.
Vitamin D (cholecalciferol) is physiologically produced in the skin upon exposure to UV radiation and can also be supplied to the body through diet.
Deficiency of vitamin D leads to disturbances in bone mineralization (rickets) or loss of calcium from bones (osteomalacia).
VIGANTOL is used:

• for the prevention of rickets and osteomalacia in children and adults,
• for the prevention of rickets in premature infants,
• for the prevention of disorders in cases where there is a risk of vitamin D deficiency in children and adults,
• for the prevention of vitamin D deficiency 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 case of hypercalcemia (excessively high calcium levels in the blood) or hypercalciuria (excessive excretion of calcium in urine),
• if the patient has kidney stones or severe renal insufficiency,
• in case of pseudohypoparathyroidism.

Warnings and precautions
Before starting treatment with Vigantol, consult a doctor or pharmacist, as Vigantol should be used under medical supervision:

• if the patient is also taking other medicines containing vitamin D, because additional doses of vitamin D should only be taken under medical supervision,
• if the patient has sarcoidosis (an immune system disorder that may increase vitamin D levels in the body),
• if the patient has impaired kidney function,
• if the patient is being treated with cardiac glycosides or diuretic medicines,
• in newborns, infants, and young children,
• if vitamin D treatment is long-term, as in such cases the doctor should monitor serum and urinary calcium levels and assess kidney function by measuring blood creatinine levels.

Vigantol and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.
Antacids containing aluminium, used in the treatment of acidity and taken together with Vigantol, may increase aluminium levels in the blood, increasing the risk of aluminium toxicity on bones.
Antacids containing magnesium, when used concurrently with Vigantol, may increase magnesium levels in the blood.
Some antiepileptic, sedative, or hypnotic drugs (containing phenytoin and barbiturates), when used together with Vigantol, may reduce its effectiveness.
Some diuretics (thiazides) may lead to hypercalcemia (increased calcium levels) due to reduced renal excretion of calcium. During long-term treatment, serum and urinary calcium levels should be monitored.
Concomitant use of glucocorticosteroids (synthetic adrenal cortex hormones) may counteract the effect of Vigantol.
Vigantol may enhance the action and toxicity of cardiac glycosides, increasing the risk of cardiac arrhythmias. In such cases, the doctor should monitor serum and urinary calcium levels and perform periodic ECG examinations.
Concurrent use of vitamin D metabolites or analogs (e.g. calcitriol) and Vigantol is possible only on a doctor's prescription and only in exceptional cases, under the condition of monitoring serum calcium levels.
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 become pregnant, she should consult a doctor before using this medicine.

Pregnancy
Vigantol may be used during pregnancy only on a doctor's prescription.
Vitamin D overdose should be avoided during pregnancy, as it may lead to delayed physical and mental development, heart defects, and retinal disorders (retinopathy) in the child.

Breastfeeding
Consult a doctor before using this medicine.

Driving and operating machinery
Vigantol has no influence on the ability to drive mechanical 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 a doctor or pharmacist. If in doubt, consult a doctor.

Dosage

• Premature infants: 2 drops daily of Vigantol solution (1000 IU vitamin D). After reaching the 40th week 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 daily of Vigantol solution (corresponding to 500 IU vitamin D).

Vigantol should be used under medical supervision in premature infants, newborns, and infants. Do not exceed the recommended dose.

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

Do not use this medicine long-term or in higher doses without medical supervision. Additionally, do not use other medicines, dietary supplements, or foodstuffs containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs concurrently without medical supervision.

Instructions for use

Premature infants, newborns, and infants:
Vigantol should be administered to children from the second week of life until the end of the first year of life. Administer the drops with a spoonful of milk or food. If the drops are added to a bottle or food, ensure the child consumes the entire meal; otherwise, the full dose will not be ingested.

Older children and adults:
Vigantol should be administered with a spoonful of liquid.

Overdose of Vigantol

If more Vigantol than recommended has been taken, contact a doctor immediately. The doctor will decide on appropriate treatment.

Symptoms of overdose: nausea, vomiting, diarrhea followed by constipation, loss of appetite, fatigue, headache, muscle pain, joint pain, muscle weakness, drowsiness, azotemia (increased concentration of nitrogen compounds in blood), excessive thirst, polyuria, and dehydration. With high calcium levels in blood, cardiac arrhythmias, renal failure, psychosis, and even coma may occur. Laboratory tests may reveal hypercalcemia (elevated calcium levels in blood), hypercalciuria (excessive excretion of calcium in urine), and increased serum 25-hydroxycholecalciferol levels. There is no specific antidote for vitamin D. Management of overdose requires measures to control hypercalcemia, which may be prolonged and sometimes life-threatening. In case of overdose, inform a doctor immediately, who will decide on appropriate treatment.

Missed dose of Vigantol

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Gastrointestinal disorders such as constipation, bloating, nausea, abdominal pain or diarrhoea.
Hypersensitivity reactions such as itching, rash or urticaria.
In case of prolonged use of high doses: hypercalcaemia (excess calcium in the blood) and
hypercalciuria (excessive excretion of calcium in urine). In isolated cases, fatal outcomes have been reported.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions enables more information on the safety of the medicine to be collected.

5. How to store Vigantol

Keep the medicine out of the sight and reach of children.
Store the bottle in the outer packaging to protect it from light.
The shelf life of the medicine after first opening the container 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What the medicine Vigantol contains

• The active substance is cholecalciferol. 1 ml (40 drops) contains 500 μg of cholecalciferol (corresponding to 20,000 IU of vitamin D).
• Other ingredients: medium-chain triglycerides.

What Vigantol looks like and contents of the pack
Vigantol is an oral solution in drops.
The medicine comes in a brown glass bottle with a polypropylene screw cap and a polyethylene dropper insert, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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, n.̊ 69-B
Queluz de Baixo
2730-055 Barcarena
Portugal
Parallel importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Český Těšín
Czech Republic
Repackaged in:
Euceryna Pharmaceutical Factory 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
Marketing authorisation number in Bulgaria, the country of export: 9900340
Parallel import authorisation number: 114/22
[Trademark information]