Vigantoletten 1000

Package Leaflet: 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.

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

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, contact your 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, 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 taking Vigantoletten 1000

When not to take 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 treatment with Vigantoletten 1000, discuss it with your 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 calcium levels and urine calcium levels, as well as check kidney function by measuring creatinine levels in the blood.

Other medicines and Vigantoletten 1000

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or 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 aluminum 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 this case, the doctor should monitor the patient's blood calcium levels and urine calcium levels, as well as 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 you think you may be pregnant, or if you plan to become pregnant, consult your doctor before taking this medicine.

Pregnancy

Vigantoletten 1000 should only be taken during pregnancy 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

Consult your doctor before taking the medicine.

Driving and using machines

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

Vigantoletten 1000 contains sucrose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Vigantoletten 1000

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, ask your doctor.

Dosage

The tablet can be divided into halves.
Children
Half a tablet per day (corresponding to 0.0125 mg or 500 IU of vitamin D).
Adults
One tablet per day (corresponding to 0.025 mg or 1000 IU of vitamin D).
Do not take the medicinal product for a long time or in doses higher than recommended without medical supervision.
Supportive treatment in osteoporosis in adults
Two tablets per day (corresponding to 0.050 mg or 2000 IU of vitamin D).
Do not take the medicinal product for a long time or in a dose of 2000 IU per day or higher without medical supervision.
Do not take other medicines or dietary supplements, or other types of food products containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs without medical supervision.
Newborns, infants, and small children
In newborns, infants, and small children, the medicine should only be taken under medical supervision. Do not exceed the recommended dose.
Tell your doctor if you are giving your child vitamin D-enriched food.

Method of administration

Newborns, infants, and small children
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, make sure 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) beforehand.
Adults
Take the tablet with a sufficient amount of liquid.

Taking a higher dose of Vigantoletten 1000 than recommended

If you have taken a higher dose of Vigantoletten 1000 than recommended, contact your 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, there are disorders of heart function, kidney failure, psychoses, and even coma.
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 often prolonged and sometimes life-threatening hypercalcemia.

Missing a dose of Vigantoletten 1000

Do not take 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.
Hypersensitivity reactions, such as skin itching, rash, or urticaria.
In the 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 those not listed in the leaflet, tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in the 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
Al. Jerozolimskie 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

Keep the medicine out of sight and reach of 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 month stated.

Translation of some entries on the blisters:

Verwendbar bis / Ch.-B. siehe Randprägung – Expiry date / Batch number see edge printing
Medicines should not be disposed of via wastewater or household waste. Ask your 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 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 contents of the pack

25, 50, or 100 tablets
Blisters of Al/PVC foil in a cardboard box.
For more detailed information, 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German export license number: 6154298.01.00

Parallel import license number: 478/16

Date of leaflet approval: 14.12.2023

[Information about the trademark]