Vigantoletten 1000

Package Leaflet: Information for the User

Vigantoletten 1000

25 micrograms (1000 IU), tablets
(Cholecalciferol)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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 Vigantoletten 1000 and what is it used for
• 2. Important information before taking Vigantoletten 1000
• 3. How to take Vigantoletten 1000
• 4. Possible side effects
• 5. How to store Vigantoletten 1000
• 6. Contents of the pack and other information

1. What is Vigantoletten 1000 and what is it used for

Vigantoletten 1000 contains the active substance vitamin D (cholecalciferol), which is essential 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 loss of calcium from bones (osteomalacia) occur.
Vigantoletten 1000 is used for:

• preventing rickets and osteomalacia in children and adults,
• preventing diseases in cases where there is a risk of vitamin D deficiency in children and adults,
• preventing vitamin D deficiencies in children and adults,
• supportive treatment in osteoporosis in adults.

2. Important information before taking Vigantoletten 1000

When not to take Vigantoletten 1000

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• in cases 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 cases of alleged hypoparathyroidism.

Warnings and precautions

Before starting treatment with Vigantoletten 1000, the patient should discuss it with their doctor or pharmacist, as Vigantoletten 1000 should be taken 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 small children,
• if treatment with vitamin D 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.

Other medicines and Vigantoletten 1000

The patient should inform 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, taken with Vigantoletten 1000, may increase aluminum levels in the blood, increasing the risk of toxic effects on bones.
Antacids containing magnesium, when taken with Vigantoletten 1000, may increase magnesium levels in the blood.
Certain antiepileptic, sedative, or hypnotic drugs (containing phenytoin or barbiturates), taken with Vigantoletten 1000, may reduce its effectiveness.
Certain diuretics 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 Vigantoletten 1000.
Vigantoletten 1000 may enhance the effect and toxicity of digitalis glycosides, posing a risk of developing heart rhythm disorders. In such cases, the doctor should monitor the patient's blood and urine calcium levels and perform periodic ECG tests.
Concomitant use of vitamin D metabolites or analogs (e.g., calcitriol) and Vigantoletten 1000 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 Vigantoletten 1000.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if pregnancy is suspected, or if the patient is planning to become pregnant, they should consult their doctor before taking this medicine.

Pregnancy

Vigantoletten 1000 should only be taken during pregnancy on a doctor's prescription.
During pregnancy, the patient 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 taking the medicine, the patient should consult their doctor.

Driving and using machines:

Vigantoletten 1000 does not affect the ability to drive vehicles or operate machines.

Vigantoletten 1000 contains sucrose.

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Vigantoletten 1000

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor.

Dosage

The tablet can be divided into halves.
Children
Half a tablet per day (equivalent to 0.0125 mg or 500 IU of vitamin D).
Adults
One tablet per day (equivalent to 0.025 mg or 1000 IU of vitamin D).
Without medical supervision, the patient should not take the medicinal product for a long time or in doses higher than recommended.
Supportive treatment in osteoporosis in adults
Two tablets per day (equivalent to 0.050 mg or 2000 IU of vitamin D).
Without medical supervision, the patient should not take the medicinal product for a long time or in a dose of 2000 IU per day or higher.
Without medical supervision, the patient should not take other medicines, dietary supplements, or other types of food products containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs.
Newborns, infants, and small children
In newborns, infants, and small children, the medicine should only be taken under medical supervision. The recommended dose should not be exceeded.
The doctor should be informed if the child is being given food with added vitamin D.

Method of administration

Newborns, infants, and small children
Half a tablet of Vigantoletten 1000 should be dissolved in water on a teaspoon (for tea) and given to the child directly into the mouth, preferably during a meal. Before administration, it should be ensured that the tablet has completely dissolved.
It is not recommended to add the prepared aqueous suspension to the contents of a baby bottle (newborn) or other food, as it cannot be guaranteed that the full dose of the medicine will be taken.
If, however, Vigantoletten tablets need to be given with food (liquid), it is necessary to boil the food (milk) first.
Adults
The tablet should be taken with a sufficient amount of liquid.

Taking a higher dose of Vigantoletten 1000 than recommended

In case of taking a higher dose of Vigantoletten 1000 than recommended, the patient should contact their doctor. The doctor will decide on the 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, psychosis, and even coma may occur.
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. Overdose requires measures to control the often prolonged and sometimes life-threatening hypercalcemia.

Missing a dose of Vigantoletten 1000

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Vigantoletten 1000 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 cases of long-term use of high doses, hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (excessive excretion of calcium in the urine) occur. In individual cases, fatal outcomes have been reported.
If any side effects occur, including any possible side effects not listed in the leaflet, the patient should consult their doctor.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Vigantoletten 1000

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Protect from light.
Do 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 containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vigantoletten 1000 contains

• The active substance of the medicine is cholecalciferol (cholecalciferol, powder containing: cholecalciferol, D,L-α-tocopherol, triglycerides of saturated fatty acids of medium chain length, modified starch, sodium ascorbate, sucrose, anhydrous colloidal silica).
• Other ingredients are: mannitol, microcrystalline cellulose, anhydrous colloidal silica, corn starch, sodium carboxymethylcellulose (type C), talc, magnesium stearate.

What Vigantoletten 1000 looks like and what the pack contains

30 or 90 tablets
Al/PVC film-coated blisters in a cardboard box.

Marketing authorization holder:

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

Manufacturer:

P&G Health Austria GmbH & CO. OG
Hösslgasse 20
9800 Spittal/Drau
Austria

Date of last revision of the leaflet: