VITENSON 25.000 U.I. Kapsułka twarda
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Treść ulotki
Vitenson 25.000 UI hard capsules
colecalciferol
Read this leaflet carefully before taking this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Vitenson 25.000 UI is and what it is used for
- 2. What you need to know before you use Vitenson 25.000 UI
- 3. How to use Vitenson 25.000 UI
- 4. Possible side effects
- 5. How to store Vitenson 25.000 UI
- 6. Contents of the pack and other information
1. What is Vitenson 25,000 IU and what is it used for
Vitenson 25,000 IU contains vitamin D (also known as cholecalciferol) for the regulation
of calcium absorption and metabolism and for the integration of calcium into bone tissue.
Vitenson 25,000 IU is used in adults
- for the treatment of vitamin D deficiency
- for the prevention of vitamin D deficiency in adults with an identified risk when therapeutic adherence (or compliance) is not achieved with the daily administration of low doses of cholecalciferol.
2. What you need to know before using Vitenson 25,000 IU
Do not take Vitenson 25,000 IU
- if you are allergic to cholecalciferol, sunset yellow FCF (E110) or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from hypercalcemia (high levels of calcium in the blood).
- if you have hypercalciuria (high levels of calcium in the urine).
- if you have been diagnosed with hypervitaminosis D (high levels of vitamin D in the blood).
- if you suffer from pseudohypoparathyroidism (disease of parathyroid hormone balance).
- if you have kidney stones or if your kidney function is impaired. Warnings and precautionsTalk to your doctor or pharmacist before taking Vitenson 25,000 IU:
- if you are prone to developing calcium-containing kidney stones.
- if your kidneys are not functioning properly and if you have problems excreting calcium and phosphate through the kidneys. The effect of treatment on calcium and phosphate balance must be monitored by your doctor.
- if you are being treated with medicines that increase urine excretion (thiazide diuretics) or if your mobility is severely reduced, as in this case there is a risk of hypercalcemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine).
- if you have sarcoidosis (a disease that affects the connective tissue of the lungs, skin and joints), as there is a risk of increased conversion of vitamin D into its active forms.
- In these cases, calcium levels in the blood and urine must be monitored by your doctor.
- if you suffer from pseudohypoparathyroidism (disease of parathyroid hormone balance).
- if you are already taking other medicines that contain vitamin D (e.g. multivitamin preparations) or certain foods that contain vitamin D.
During treatment with Vitenson 25,000 IU, at daily doses higher than 1,000 IU of vitamin D, the
doctor must monitor calcium levels in the blood and urine and also check kidney function.
This monitoring is particularly important in elderly patients and when treatment is carried out
concurrently with the administration of cardiac glycosides (medicines that stimulate the function of the
heart muscle) or diuretics (medicines that stimulate urine excretion). If calcium levels in the blood (hypercalcemia) or urine (hypercalciuria) increase or other signs of impaired
kidney function occur, the dose should be reduced or treatment should be discontinued.
Children and adolescents
Vitenson 25,000 IU should not be used in children and adolescents under 18 years of age.
Other medicines and Vitenson 25,000 IU
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The effect of Vitenson 25,000 IU can be weakened by the simultaneous use of:
- phenytoin (a medicine used to treat epilepsy) or barbiturates (medicines used to treat epilepsy and sleep disorders and for anesthesia)
- glucocorticoids (medicines used to treat certain allergic conditions and to treat inflammation)
- rifampicin and isoniazid (medicines used to treat tuberculosis)
- cholestyramine (a medicine used to lower high cholesterol levels), laxatives containing liquid paraffin
- orlistat (a medicine used to treat obesity)
- actinomycin (a medicine used to treat cancer)
- imidazole (an antifungal agent).
The effect/effects of Vitenson 25,000 IU may be intensified by the simultaneous use of:
- vitamin D metabolites or analogues (e.g. calcitriol) Administration with Vitenson 25,000 IU should be avoided
- medicines that increase urine excretion (e.g. thiazide diuretics) A reduction in calcium excretion through the kidneys can cause an increase in calcium concentration in the blood (hypercalcemia). Calcium levels in the blood and urine should therefore be monitored during long-term treatment. When taken concurrently, Vitenson 25,000 IU may increase the risk of side effects of:
- cardiac glycosides (medicines used to increase heart muscle function): The risk of cardiac arrhythmias may increase as a result of increased calcium levels in the blood during treatment with vitamin D. In these cases, the attending physician must perform an ECG monitoring as well as monitoring of calcium levels in the urine and drug levels in the blood.
Vitenson 25,000 IU with food and drink
Vitenson 25,000 IU should preferably be taken with food and drink.
Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
During pregnancy, women should follow their doctor's advice as their needs may
vary depending on the severity of their illness and their response to treatment.
Overdosage of vitamin D should be avoided during pregnancy as prolonged hypercalcemia can
lead to physical and mental retardation and congenital heart or eye diseases in the baby.
When vitamin D supplementation is required during pregnancy, it should be administered at
lower doses.
Breastfeeding
Vitamin D and its metabolites are excreted in breast milk. In the case of vitamin D deficiency,
Vitenson 25,000 IU can be used at the recommended doses during breastfeeding. This should be
taken into consideration when administering additional vitamin D to the baby.
Fertility
The effects of vitamin D on fertility have not been studied. However, no adverse effects
on fertility are expected with normal endogenous (present in the body) levels of vitamin D.
Driving and operating machinery
Vitenson 25,000 IU does not impair or negligibly impairs the ability to drive and operate
machinery.
3. How to take Vitenson 25,000 IU
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
This medicine must be taken orally. The capsules must be swallowed whole with a
sufficient amount of water, preferably with the main meal of the day.
The dose must be determined individually by the treating physician based on the degree of
vitamin D supplementation needed. The dose must be adjusted based on desirable serum levels of
25-hydroxycholecalciferol (25(OH)D), the severity of the disease and the patient's response to treatment.
Use in adults
For the treatment of vitamin D deficiency:
1 capsule of Vitenson 25,000 IU once a week (25,000 IU/week) for 8-12 weeks.
After the first month, lower doses may be considered.
For the prevention of vitamin D deficiency:
1 capsule of Vitenson 25,000 IU once a month (25,000 IU)
Use in children and adolescents
Vitenson 25,000 IU should not be used in children and adolescents under 18 years of age.
Taking the medicine
The capsules must be swallowed whole with a sufficient amount of water, preferably with the
main meal of the day.
To remove the capsule from the blister:
- Press only one end of the capsule to push it out of the blister
- Do not press on the central part of the capsule as this could break it.
If you take more Vitenson 25,000 IU than you should
If you take more Vitenson 25,000 IU than you should, contact your doctor immediately.
The signs of an overdose are not very characteristic, they manifest as thirst, nausea, vomiting, initial diarrhea that progresses to constipation, loss of appetite, fatigue, headache, muscle and
joint pain, persistent drowsiness, loss of consciousness, arrhythmia (irregular heartbeat), azotemia (high
levels of nitrogen in the blood), increased sensation of thirst, increased urge to urinate and eventually
dehydration.
Contact your doctor in case of signs of vitamin D overdose
The doctor will then take the necessary countermeasures.
There is no specific antidote.
If you forget to take Vitenson 25,000 IU
Do not take a double dose to make up for a missed dose.
If you stop taking Vitenson 25,000 IU
Symptoms may reappear or worsen if you stop treatment prematurely.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking Vitenson 25,000 IU and contact your doctor immediately if you experience any of the
following signs of a severe allergic reaction:
- swelling of the face, lips, tongue or throat
- difficulty swallowing
- urticaria and labored breathing.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)
Hypercalcemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine).
Rare (may affect up to 1 in 1,000)
Itching, rash or urticaria
Not known (frequency cannot be estimated based on available data)
Gastrointestinal problems (constipation, flatulence, nausea, abdominal pain or diarrhea)
Sunset Yellow FCF (E 110) may cause allergic reactions.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vitenson 25,000 IU
Keep this medicine out of the sight and reach of children.
Store in the original package to protect the medicine from light.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Vitenson 25,000 IU contains
- The active ingredient is: cholecalciferol. One hard capsule contains 0.625 mg of cholecalciferol (equivalent to 25,000 IU of vitamin D).
- The other ingredients are: medium-chain triglycerides, gelatin, anhydrous colloidal silica, titanium dioxide (E 171), quinoline yellow (E 104), butylhydroxytoluene, FD&C yellow no. 6 (E 110).
Description of the appearance of Vitenson 25,000 IU and contents of the pack
Vitenson 25,000 IU are hard gelatin capsules with an opaque yellow body and a head, filled with colorless-pale yellow oily liquid.
The capsules have a colorless band.
Vitenson 25,000 UI is available in blisters in packs of 2, 4, 5, 6, 8, 10 or 12 capsules.
Not all pack sizes may be marketed.
Marketing authorisation holder
mibe pharma Italia S.r.l.
via Leonardo Da Vinci, 20/B
39100 Bolzano
Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Netherlands: Dekristol 25,000 IU hard capsules
Italy: Vitenson 25,000 UI hard capsules
Poland: Dekristol Pro
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- Kraj rejestracji
- Postać farmaceutycznaHard capsule, 25.000 U.I.
- Kod ATCA11CC05
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki VITENSONPostać farmaceutyczna: Film-coated tablet, 1000 IUSubstancja czynna: colecalciferolProducent: I.B.N. SAVIO S.R.LWymaga receptyPostać farmaceutyczna: Film-coated tablet, 800 IUSubstancja czynna: colecalciferolProducent: I.B.N. SAVIO S.R.LWymaga receptyPostać farmaceutyczna: Soft capsule, 10,000 IUSubstancja czynna: colecalciferolProducent: PHARMACARE S.R.L.Wymaga recepty
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VITENSON wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w VITENSON jest colecalciferol. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
VITENSON jest produkowany przez MIBE PHARMA ITALIA S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie VITENSON jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić VITENSON w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (colecalciferol) to m.in. ANNEXXO, ANNOVA, ANORSIA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
