Vigantoletten 500

Package Leaflet: Information for the User

Vigantoletten 500

12.5 micrograms (500 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 further information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Vigantoletten 500 and what is it used for
• 2. Important information before taking Vigantoletten 500
• 3. How to take Vigantoletten 500
• 4. Possible side effects
• 5. How to store Vigantoletten 500
• 6. Contents of the pack and other information

1. What is Vigantoletten 500 and what is it used for

Vigantoletten 500 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, bone calcification disorders (rickets) or loss of calcium from bones (osteomalacia) occur.
Vigantoletten 500 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 500

When not to take Vigantoletten 500

• 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 500, discuss it with your doctor or pharmacist, as Vigantoletten 500 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 500

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Antacids used to treat hyperacidity containing aluminum, taken with Vigantoletten 500, may increase aluminum levels in the blood, increasing the risk of toxic aluminum effects on bones.
Antacids containing magnesium, when taken with Vigantoletten 500, may increase magnesium levels in the blood.
Certain anti-epileptic, sedative, or hypnotic medicines (containing phenytoin or barbiturates) taken with Vigantoletten 500 may reduce its effectiveness.
Certain diuretics may lead to hypercalcemia (elevated calcium levels) due to 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 500.
Vigantoletten 500 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 examinations.
Concomitant use of vitamin D metabolites or analogs (e.g., calcitriol) and Vigantoletten 500 is only possible on a doctor's prescription, in exceptional cases, and under the condition of monitoring blood calcium levels.
Rifampicin and isoniazid may reduce the effectiveness of Vigantoletten 500.

Pregnancy and breastfeeding

In pregnancy, during breastfeeding, or if you suspect you are pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

Pregnancy

Vigantoletten 500 should only be taken during pregnancy on a doctor's prescription.
During pregnancy, 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 500 does not affect the ability to drive vehicles or operate machines.

Vigantoletten 500 contains sucrose.

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

3. How to take Vigantoletten 500

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

Dosage

Children
One tablet per day (corresponding to 0.0125 mg or 500 IU of vitamin D).
Adults (including the elderly)
Two tablets of 500 IU 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
Four 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 and 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.
Inform your doctor if you are giving your child food with added vitamin D.

Method of administration

Newborns, infants, and small children
Dissolve the tablet 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 guarantee the intake of the full dose of the medicine.
If, however, Vigantoletten in tablets must be given with food (liquid), it is necessary to boil the food (milk) beforehand.
Adults
Take the tablet with a sufficient amount of liquid.

Overdose of Vigantoletten 500

In case of overdose, 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, 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 levels of 25-hydroxycholecalciferol in the blood are found. Overdose requires measures to control often prolonged and sometimes life-threatening hypercalcemia.

Missed dose of Vigantoletten 500

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

4. Possible side effects

Like all medicines, Vigantoletten 500 can cause side effects, although not everybody gets them.
Gastrointestinal disorders, such as constipation, bloating, nausea, abdominal pain, or diarrhea.
Allergic reactions, such as itching, rash, or hives.
In case of long-term use of high doses, hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (excessive excretion of calcium in the urine) may occur. In individual cases, fatal outcomes have been reported.
If you experience any side effects, including those not listed in the leaflet, consult 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, 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: [email protected]
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Vigantoletten 500

Keep the medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vigantoletten 500 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 500 looks like and contents of the pack

30 or 90 tablets
Al/PVC foil 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: