Vigantoletten 1000
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet! Information on the outer packaging in a foreign language.
Vigantoletten 1000 (Vigantol 1000 I.E. Vitamin D3 Tabletten)
25 micrograms (1000 IU), tablets
Cholecalciferolum
Vigantoletten 1000 and Vigantol 1000 I.E. Vitamin D3 Tabletten are different trade names for the
same medicine.
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.
This medicine should always be used 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 adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If your condition does not improve or worsens, contact your doctor.
Table of contents:
- What Vigantoletten 1000 is and what it is used for
- Important information before taking Vigantoletten 1000
- How to take Vigantoletten 1000
- Possible side effects
- How to store Vigantoletten 1000
- Contents of the pack and other information
1. What Vigantoletten 1000 is and what it is 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 upon exposure to UV radiation and can also be obtained through diet.
Deficiency of vitamin D leads to impaired bone mineralization (rickets) or loss of calcium from bones (osteomalacia).
Vigantoletten 1000 is used:
- for the prevention of rickets and osteomalacia in children and adults,
- for the prevention of diseases associated with 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 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 hypercalcaemia (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 Vigantoletten 1000, consult a 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 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 diuretics,
- 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.
Other medicines and Vigantoletten 1000
Inform your doctor or pharmacist about all medicines the patient is currently taking,
has recently taken, or plans to take.
Antacids containing aluminium, used in the treatment of acidosis, taken together with
Vigantoletten 1000 may increase aluminium levels in the blood, increasing the risk of toxic
aluminium effects on bones.
Antacids containing magnesium, when used concomitantly with Vigantoletten 1000,
may increase magnesium levels in the blood.
Certain antiepileptic, sedative or hypnotic drugs (containing phenytoin
or barbiturates), when used simultaneously with Vigantoletten 1000, may reduce its
effectiveness.
Some diuretics may lead to hypercalcaemia (increased calcium levels) due to reduced
renal excretion of calcium. During prolonged treatment, serum and urinary calcium levels should be monitored.
Concomitant use of glucocorticosteroids (synthetic corticosteroid hormones) may counteract the effect of Vigantoletten 1000.
Vigantoletten 1000 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.
Concomitant use of vitamin D metabolites or analogues (e.g. calcitriol) and Vigantoletten 1000 is possible only on a doctor's prescription and only in exceptional cases, provided serum calcium levels are monitored.
Rifampicin and isoniazid may reduce the effectiveness of Vigantoletten 1000.
Pregnancy and breastfeeding
During pregnancy, while breastfeeding, or if pregnancy is suspected or planned, consult a doctor before using this medicine.
Pregnancy
Vigantoletten 1000 may be taken during pregnancy only on a doctor's advice. Vitamin D overdose during pregnancy should be avoided, 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
Vigantoletten 1000 has no influence on the ability to drive motor vehicles or operate machinery.
Vigantoletten 1000 contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a 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
your doctor or pharmacist. If in doubt, consult your doctor.
Dosage
The tablet may 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).
This medicine should not be used long-term or in doses higher than recommended without medical
supervision.
Supportive treatment of osteoporosis in adults
Two tablets per day (corresponding to 0.050 mg or 2000 IU of vitamin D).
This medicine should not be used long-term, or at a dose of 2000 IU per day or higher, without
medical supervision.
Without medical supervision, do not take other medicines, dietary supplements, or fortified foods
containing vitamin D (cholecalciferol), calcitriol, or other metabolites and analogues of vitamin D.
Newborns, infants and young children
Vigantoletten 1000 should be used in newborns, infants and young children only under medical
supervision.
Do not exceed the recommended dose.
Inform your doctor if the child is receiving vitamin D-fortified food.
Method of administration
Newborns, infants and young children
Dissolve half a tablet of Vigantoletten 1000 in water on a teaspoon (tea spoon) and administer the
aqueous suspension directly into the child's mouth, preferably during a meal. Ensure that the tablet
has completely dissolved before administration.
It is not recommended to add the prepared aqueous suspension to the contents of a baby bottle
(newborn) or other food, as this may prevent the full dose from being administered. However, if
Vigantoletten 1000 tablets must be given with food (liquid), the food (milk) must be boiled beforehand.
Adults
Take the tablet with a sufficient amount of liquid.
Taking more than the recommended dose of Vigantoletten 1000
If more than the recommended dose of Vigantoletten 1000 has been taken, contact your doctor. The
doctor will decide on appropriate treatment.
Symptoms of overdose: nausea, vomiting, diarrhoea followed by constipation, loss of appetite,
fatigue, headache, muscle pain, joint pain, muscle weakness, drowsiness, azotemia (increased blood
nitrogen compounds), excessive thirst, polyuria and dehydration. With high calcium levels in the
blood, disturbances in heart function, kidney failure, psychoses and even coma may occur.
Laboratory findings include hypercalcemia (elevated blood calcium levels), hypercalciuria (excessive
calcium excretion in urine), and increased serum 25-hydroxycholecalciferol levels. Overdose requires
measures to control hypercalcemia, which is often prolonged and may sometimes be life-threatening.
Missed dose of Vigantoletten 1000
Do not take a double dose to make up for a missed dose.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody will get them.
Gastrointestinal disorders such as constipation, bloating, nausea, abdominal pain or diarrhoea.
Hypersensitivity reactions such as itching, rash or urticaria.
In case of long-term use of high doses, hypercalcaemia (excess calcium in the blood) and hypercalciuria (excessive excretion of calcium in urine) may occur. In isolated cases, fatal outcomes have been reported.
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Vigantoletten 1000
Keep this 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 this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Translation of some information on the immediate packaging:
Verwendbar bis/Ch.-B. – expiry date/lot number
siehe Randprägung – see embossing.
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 pack and other information
What Vigantoletten 1000 contains
- The active substance is cholecalciferol (cholecalciferol, powder containing: cholecalciferol, α-tocopherol, medium-chain triglycerides, modified starch, sodium ascorbate, sucrose, anhydrous colloidal silicon dioxide).
- Other ingredients are: mannitol, microcrystalline cellulose, anhydrous colloidal silicon dioxide, maize starch, sodium carboxymethyl starch (type C), talc, magnesium stearate.
What Vigantoletten 1000 looks like and contents of the pack
25, 50 or 100 tablets.
PVC/Al blisters in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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 Český Těšín
Czech Republic
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Euceryn Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
Wł. Żeleńskiego 45
31-353 Kraków
German, country of export, Marketing Authorisation Number: 6154298.01.00
Parallel Import Authorisation Number: 441/22
[Trademark information]