Vigantoletten 1000

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Vigantoletten 1000 (Vigantol 1000 I.E. Vitamin D3 Tablets)

25 micrograms (1000 IU), tablets
Cholecalciferol
Vigantoletten 1000 and Vigantol 1000 I.E. Vitamin D3 Tablets are different trade names for the same medicine.

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 the 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 additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell 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 using Vigantoletten 1000
• 3. How to use Vigantoletten 1000
• 4. Possible side effects
• 5. How to store Vigantoletten 1000
• 6. Contents of the packaging 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 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, there are disorders of bone calcification (rickets) or loss of calcium from bone (osteomalacia).
Vigantoletten 1000 is used in:

• 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 using Vigantoletten 1000

When not to use Vigantoletten 1000

• 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 (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 case of alleged hypoparathyroidism.

Warnings and precautions

Before starting to use Vigantoletten 1000, you should discuss it with your doctor or pharmacist, as Vigantoletten 1000 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 (a disease of the immune system that can increase the level of vitamin D 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 control the calcium level in the blood serum and urine, as well as check kidney function by determining the creatinine level in the blood.

Other medicines and Vigantoletten 1000

You should 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 together with Vigantoletten 1000, may increase the aluminum level in the blood, increasing the risk of toxic aluminum effects on the bones.
Antacids containing magnesium, when used simultaneously with Vigantoletten 1000, may increase the magnesium level in the blood.
Certain anti-epileptic, sedative, or hypnotic medicines (containing phenytoin or barbiturates), used simultaneously with Vigantoletten 1000, may reduce its effectiveness.
Certain diuretics may lead to hypercalcemia (increased calcium levels), caused by reduced excretion of calcium by the kidneys. During long-term treatment, calcium levels in the blood serum 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, which poses a risk of developing heart rhythm disorders. In this case, the doctor should control the calcium level in the blood serum and urine of patients, as well as perform periodic ECG examinations.
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 the calcium level in the blood serum is 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 woman plans to become pregnant, before using this medicine, you should consult a doctor.

Pregnancy

Vigantoletten 1000 may be used during pregnancy only on a 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 consult a 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 some sugars, the patient should contact their doctor before taking this medicine.

3. How to use Vigantoletten 1000

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 consult your doctor.

Dosage

The tablet can be divided into halves.
Children
Half a tablet per day (which corresponds to 0.0125 mg or 500 IU of vitamin D).
Adults
One tablet per day (which corresponds to 0.025 mg or 1000 IU of vitamin D).
Without medical supervision, the medicine should not be used for a long time or in doses higher than recommended.
Supportive treatment in osteoporosis in adults
Two tablets per day (which corresponds to 0.050 mg or 2000 IU of vitamin D).
Without medical supervision, the medicine should not be used for a long time or in a dose of 2000 IU per day or higher.
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.
Newborns, infants, and small children
In newborns, infants, and small children, the medicine should only be used under medical supervision.
You should not exceed the recommended dose.
You should inform your doctor if the child is being given food with added vitamin D.

Method of taking the medicine

Newborns, infants, and small children
You should dissolve half a tablet of Vigantoletten 1000 in water on a teaspoon (for tea) and give the aqueous suspension to the child directly into the mouth, preferably during a meal. Before administration, you should make sure 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. However, if Vigantoletten 1000 in tablets must be given with food (liquid), it is necessary to boil the food (milk) beforehand.
Adults
You should take the tablet with a sufficient amount of liquid.

Using a higher dose of Vigantoletten 1000 than recommended

In case of using a higher dose of Vigantoletten 1000 than recommended, you should contact your doctor. 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 (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 blood serum are found. Overdose requires measures to control often prolonged and sometimes life-threatening hypercalcemia.

Missing a dose of Vigantoletten 1000

You 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.
Allergic reactions, such as skin itching, rash, or hives.
In case of long-term use of high doses, there is 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.
If you experience any side effects, including any possible side effects not listed in the leaflet, you should consult your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should 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
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Vigantoletten 1000

The medicine should be stored in a place invisible and inaccessible to children.
Do not store above 25°C. Store blisters in the outer packaging to protect from light.
Do not use the medicine after the expiry date stated on the packaging. The expiry date is the last day of the given month.
Translation of some information on the immediate packaging:
Verwendbar bis/Ch.-B. – expiry date/batch number
siehe Randprägung – see the edge imprint.
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 used. This will help protect the environment.

6. Contents of the packaging and other information

What Vigantoletten 1000 contains

• The active substance of the medicine is cholecalciferol (cholecalciferol, powder containing: cholecalciferol, α-tocopherol, triglycerides of fatty acids of medium chain length, modified starch, sodium ascorbate, sucrose, anhydrous colloidal silica).
• The 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 packaging contains

25, 50, or 100 tablets.
PVC/Al blisters in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

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

Manufacturer:

P&G Health Austria GmbH & Co. OG
Hösslgasse 20
9800 Spittal an der Drau
Austria

Parallel importer:

Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czeski Cieszyn
Czech Republic

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
Wł. Żeleńskiego 45 Street
31-353 Kraków
German marketing authorization number: 6154298.01.00

Parallel import authorization number: 441/22 Date of approval of the leaflet: 21.12.2022

[Information about the registered trademark]