VITENSONSOK 50.000 IU Hard capsule
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Инструкция по применению VITENSONSOK
Содержание инструкции
Vitensonsok 50,000 IU 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 Vitensonsok is and what it is used for
- 2. What you need to know before you use Vitensonsok
- 3. How to use Vitensonsok
- 4. Possible side effects
- 5. How to store Vitensonsok
- 6. Contents of the pack and other information
1. What is Vitensonsok and what is it used for
Vitensonsok contains vitamin D (also known as cholecalciferol) for the regulation of calcium absorption and
calcium metabolism and for the integration of calcium into bone tissue.
Vitensonsok is used for the initial treatment of vitamin D deficiency in adults.
2. What you need to know before you use Vitensonsok
Do not take Vitensonsok
- if you are allergic to cholecalciferol or to 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 (a disorder of parathyroid hormone balance)
- if you have kidney stones or if your kidney function is severely impaired.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vitensonsok
- 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 the treatment on calcium-phosphorus balance must be monitored by the doctor.
- if you are being treated with medicines that increase urine excretion (benzothiadiazine derivatives) 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 the doctor.
- if you suffer from pseudohypoparathyroidism (a disorder 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 high doses and/or long-term treatment with Vitensonsok, the doctor must monitor calcium levels in
the blood and urine and also check kidney function. This monitoring is important
especially in elderly patients and when treatment is carried out simultaneously 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 in the
urine (hypercalciuria) increase or other signs of impaired kidney function occur, the dose should be reduced
or treatment should be discontinued.
Children and adolescents
Vitensonsok should not be used in children and adolescents under 18 years of age.
Other medicines and Vitensonsok
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The effect of Vitensonsok can be reduced 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 or ketoconazole (an antifungal agent).
The effect/side effects of Vitensonsok may be intensified by the simultaneous use of
- vitamin D metabolites or analogues (e.g. calcitriol) Taking with Vitensonsok 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 together, Vitensonsok may increase the risk of side effects of
- cardiac glycosides (medicines used to increase heart muscle function): The risk of heart rhythm disturbances 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 blood and urine and levels of the medicine in the blood.
- Antacids (medicines used to neutralize stomach acidity) or other products containing magnesium: products containing magnesium should not be taken during long-term treatment with Vitensonsok because there is a risk of high magnesium levels in the blood.
- products containing phosphorus: The concomitant use of products containing phosphorus in high doses can lead to high levels of phosphorus in the blood.
Vitensonsok with food and drink
See section 3.
Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Vitensonsok is not recommended during pregnancy. During pregnancy, women should follow
the instructions of their doctor as their needs may vary depending on the severity of the
disease and the response to treatment.
Overdosage of vitamin D should be avoided during pregnancy as prolonged hypercalcemia can
lead to physical and mental delay and congenital heart or eye diseases in newborns.
Breastfeeding
Vitensonsok is not recommended during breastfeeding. Vitamin D and its metabolites are excreted into
breast milk.
Fertility
No effects have been observed in reproductive fertility studies with cholecalciferol. Normal levels of endogenous vitamin D are not expected to have adverse effects on fertility.
Driving and using machines
Vitensonsok does not impair or negligibly impairs the ability to drive and use machines.
Vitensonsok contains Sunset Yellow FCF (E 110)
Sunset Yellow FCF (E 110) may cause allergic reactions.
3. How to take Vitensonsok
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 doctor based on the degree of
vitamin D supplementation needed. The dose must be adjusted based on the desired serum
levels of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease and the patient’s
response to treatment.
As a dose recommendation, the following can be applied:
Use in adults
1 capsule (50,000 IU) per week for up to 6 weeks.
Subsequently, lower doses may be considered, based on serum levels of
25-hydroxycholecalciferol (25(OH)D), the severity of the disease and the response to treatment.
Alternatively, national dosage recommendations for the treatment of
vitamin D deficiency may be followed.
The duration of use is usually limited to the first month of treatment, at the doctor's discretion.
Use in children and adolescents
Vitensonsok should not be used in children and adolescents under 18 years of age.
Taking the medicine
The capsule 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 middle of the capsule as this could cause it to break.
If you take more Vitensonsok than you should
If you take more Vitensonsok than you should, contact your doctor immediately.
The signs of an overdose are not very specific, they manifest as thirst, nausea, vomiting, initial diarrhea that progresses to constipation, loss of appetite, fatigue, headache, muscle and
joint pain, persistent drowsiness, altered 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 Vitensonsok
Do not take a double dose to make up for a missed dose.
If you stop taking Vitensonsok
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 Vitensonsok and contact your doctor immediately if you experience any of the
following signs of a serious allergic reaction:
- swelling of the face, lips, tongue or throat
- difficulty swallowing
- hives and wheezing.
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 1000)
Feeling of itching, rash or hives.
Not known (frequency cannot be estimated from available data)
Gastrointestinal problems (constipation, flatulence, nausea, abdominal pain or diarrhoea).
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 Vitensonsok
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is reported 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 dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Vitensonsok contains
- The active ingredient is: cholecalciferol. One hard capsule contains 1.25 mg of cholecalciferol (equivalent to 50,000 IU of vitamin D).
- The other ingredients are: medium-chain saturated triglycerides, gelatin, anhydrous colloidal silica, titanium dioxide (E 171), quinoline yellow (E 104), butylhydroxytoluene (E 321), sunset yellow FCF (E 110).
Description of the appearance of Vitensonsok and contents of the pack
Vitensonsok are hard gelatin capsules with an opaque yellow and orange body, filled with colourless to pale yellow oily liquid
and have a colourless band.
Vitensonsok is available in packs of 2, 4, or 6 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, Italy
Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Austria: Dekristolmin 50,000 I.U. Hard Capsules
Croatia: Dekristol 50 000 IU
Italy: Vitensonsok 50,000 IU hard capsules
Poland: Cholecalciferol mibe 50,000 IU
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- Страна регистрации
- Форма выпускаHard capsule, 50.000 IU
- Код АТХA11CC05
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги VITENSONSOKФорма выпуска: Film-coated tablet, 1000 IUДействующее вещество: colecalciferolПроизводитель: I.B.N. SAVIO S.R.LОтпускается по рецептуФорма выпуска: Film-coated tablet, 800 IUДействующее вещество: colecalciferolПроизводитель: I.B.N. SAVIO S.R.LОтпускается по рецептуФорма выпуска: Soft capsule, 10,000 IUДействующее вещество: colecalciferolПроизводитель: PHARMACARE S.R.L.Отпускается по рецепту
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Аналог VITENSONSOK в Испания
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Аналог VITENSONSOK в Украина
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Часто задаваемые вопросы
VITENSONSOK требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество VITENSONSOK — colecalciferol. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
VITENSONSOK производится компанией MIBE PHARMA ITALIA S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения VITENSONSOK с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить VITENSONSOK в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (colecalciferol) включают ANNEXXO, ANNOVA, ANORSIA. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
