VIDENKA 0.15 MG/ML Krople doustne, roztwór
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Treść ulotki
VIDENKA
0.15 mg/ml oral drops, solution
calcifediol
Equivalent medicinal product
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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
- 1. What VIDENKA is and what it is used for
- 2. Before you take VIDENKA
- 3. How to take VIDENKA
- 4. Possible side effects
- 5. How to store VIDENKA
- 6. Contents of the pack and other information
1. WHAT IS VIDENKA AND WHAT IT IS USED FOR
VIDENKA is a medicine that contains calcifediol, metabolite and circulating form in the serum of Vitamin
D, used for the treatment of bone diseases and diseases that lead to hypocalcemia (low levels of
calcium in the blood)
VIDENKA is indicated in adults in case of:
- weak and soft bones (osteomalacia due to dietary deficiencies or malabsorption or therapies with drugs against seizures);
- fragile bones (osteoporosis with osteomalacic component or due to menopause);
- bone problems due to kidney diseases (renal osteodystrophy) and prolonged treatment with artificial kidney (prolonged hemodialysis);
- decrease in blood calcium levels due to liver problems (hypocalcemia from liver disease);
- poor functioning of the parathyroid glands without a known cause or after surgery (idiopathic or post-operative hypoparathyroidism);
- involuntary and sudden contractions (spasmophilia) due to vitamin D deficiency.
VIDENKA is indicated in children in case of:
- decrease in blood calcium levels (hypocalcemia) in the newborn, in the premature and in the immature;
- decrease in blood calcium levels (hypocalcemia), due to therapies with medicines containing cortisone or with medicines used against seizures, or poor functioning of the parathyroid glands;
- fragile and deformed bones (deficiency rickets with hypocalcemia);
- bone problems due to kidney diseases (renal osteodystrophy) and prolonged treatment with artificial kidney (prolonged hemodialysis).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIDENKA
Do not take VIDENKA if:
- you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
- you are breastfeeding;
- you have high levels of calcium in your blood (hypercalcemia).
Warnings and precautions
Talk to your doctor or pharmacist beforetakingVIDENKA if:
- you are taking preparations containing vitamin D or derivatives;
- you suffer from diseases called granulomatoses such as for example sarcoidosis or tuberculosis;
- you suffer from kidney problems;
- you are obese;
- you have suffered from kidney stones;
- you are confined to bed or in a wheelchair (immobilized).
Talk to your doctor or pharmacist if during therapywith VIDENKA:
the levels of calcium in the blood (calcemia) and/or in the urine (calciuria) become altered.
Other medicines and VIDENKA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
This is particularly important if you are taking:
- preparations containing vitamin D or derivatives;
- medicines that lower cholesterol in the blood (colestipol and colestyramine);
- medicines that lower fats in the blood (lipase inhibitors);
- medicines that increase urine production (thiazide diuretics).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice
before taking this medicine.
VIDENKA can be used during pregnancy, but not in high doses.
VIDENKA must not be used during breastfeeding.
Driving and operating machinery
VIDENKA does not impair the ability to drive or operate machinery.
VIDENKA contains propylene glycol
This medicine contains approximately 1038 mg of propylene glycol per ml equivalent to approximately 35 mg of propylene
glycol per drop.
If the child is less than 5 years old, talk to your doctor or pharmacist before administering this
medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
3. HOW TO TAKE VIDENKA
Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist
Dosage
The doctor will decide the correct dose of VIDENKA based on your blood calcium levels (calcemia) and urine (calciuria); they may also ask you to evaluate other parameters, such as the level of phosphorus in the blood (phosphoremia).
Adults
The usual dose of VIDENKA is as follows:
- osteomalaciadue to dietary deficiencies or malabsorption or therapies with drugs againstconvulsions: 10-25 drops and more per dayas needed;
- osteoporosiswith an osteomalacic component or due to menopause: 10-25 drops and more per dayas needed;
- bone problemsdue to diseases of thekidneys(renal osteodystrophy) and treatment withartificialkidney(prolonged hemodialysis): 10-25 drops and more per dayas needed;
- hypocalcemia due toproblems with theliver: 10-25 drops and more per dayas needed;
- hypocalcemia due topoor functioning of the parathyroid glandswithout a known cause or after surgery (idiopathic or post-operative hypoparathyroidism): 10-25 drops and moreper day as needed;
- involuntary and sudden contractions (spasmophilia) due to vitamin D deficiency: the doctor may prescribe one of the following therapies:
- 10 drops per day for 2-3 months. The dose may be reduced to 3 drops per day or to 10 drops per week, depending on the calcium values in the urine (calciuria). The doctor may also advise you to repeat this treatment when necessary;
- 30 drops per day for 6 weeks, together with other drugs containing phosphate (1 g in the morning) and magnesium (200 mg in the evening). This treatment should be repeated 3-4 times a year. ChildrenThe usual dose of VIDENKA is as follows:
- hypocalcemiain thenewborn, in theprematureand in theimmature: 1 or 2 drops per dayfor 5 days, in association with calcium therapy;
- hypocalcemiadue to therapies with drugs containing corticosteroids or against convulsions, or to poorfunctioning of the parathyroid glands: 5-20 drops per day;
- rachitic hypocalcemia: 4-10 drops per day, in association with calcium therapy;
- bone problems due tokidney diseases (renal osteodystrophy) and treatment with artificial kidney(prolonged hemodialysis): 4-15 drops per day. How to take VIDENKAVIDENKA is a solution for oral use, contained in a bottle equipped with a dropper. Hold the bottle upside down (vertically) over a glass with a little water (or milk or fruit juice), until you reach the prescribed number of drops. Take the contents of the glass by mouth. If you need to take more than 20 drops, you can divide them into two or three doses, as directed by your doctor. Duration of treatmentYour doctor will determine the duration of therapy; if necessary, they may decide to repeat it several times during the year. Do not interrupt the treatment without consulting your doctor. If you take more VIDENKA than you shouldyou may notice: weakness, nausea, vomiting, dry mouth, hard stools (constipation), muscle pain. In case of accidental overdose of VIDENKA, immediately inform your doctor or go to the nearest hospital, as appropriate measures may be necessary. If you forget to take VIDENKADo not take a double dose to make up for the missed dose. Just take the next dose as prescribed. If you have any doubts about the use of this medicine, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, VIDENKA can cause side effects, although not everybody gets them.
Uncommon side effects(May affect up to 1 in 100 people)
- vomiting, diarrhea
Rare side effects (May affect up to 1 in 1000)
- dizziness, fainting (syncope);
- muscle weakness or sensory problems, decreased muscle tone (hypotonia) or response to stimuli (hyporeactive to stimuli);
- calculi inside blood vessels (vascular calcification);
- increased calcium, phosphorus or magnesium in the blood (hypercalcemia, hyperphosphatemia, hypermagnesemia);
- thirst or decreased appetite (reduced appetite) or water intake (dehydration);
- increased blood pH which manifests with uncontrollable vomiting, dehydration, confusion, asthenia (metabolic alkalosis);
- increased vitamin D in the blood (hypervitaminosis D);
- itching, red spots on the skin (erythema), skin peeling (exfoliative dermatitis);
- increased calcium in the urine (hypercalciuria);
- weight loss.
Very rare side effects(may affect up to 1 in 10,000)
- allergic reaction (hypersensitivity);
- increased urine output (polyuria), kidney stones (nephrolithiasis) or of the urethra, calcium accumulation in the kidneys (nephrocalcinosis), dilation of the renal pelvis (hydronephrosis);
- increased nitrogen in the blood (azotemia);
- illness or fatigue (asthenia);
- calcium accumulation under the skin (calcinosis);
- fever or chills;
- alterations in gait.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 VIDENKA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”. The expiry
date refers to the last day of the month.
Do not store at a temperature above 30° C.
Store VIDENKA in the original packaging to protect the medicine from light.
After the first opening of the VIDENKA 0.15 mg/ml oral drops, solution bottle, the validity of the
medicine is 23 months (note the date of first opening in the designated space on the packaging). After this
period, discard any remaining medicine.
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. PACKAGE CONTENTS AND OTHER INFORMATION
What VIDENKA contains
The active ingredient is calcifediol.
1 ml of VIDENKA contains: 0.15 mg of calcifediol. One drop contains 5 mcg of calcifediol.
The other ingredients are: propylene glycol.
Description of the appearance of VIDENKAand package contents
This medicine is a clear, colorless, viscous solution contained in a dark glass bottle, equipped
with a colorless plastic dropper, with a white child-resistant polyethylene closure cap.
VIDENKA is available in 10 ml bottles.
Marketing Authorisation Holder
I.B.N. Savio S.r.l., Via del Mare, 36 – 00071 Pomezia (RM), Italy
Manufacturer responsible for batch release
Savio Industrial S.r.l., Via Emilia, 21 – 27100 Pavia, Italy
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- Kraj rejestracji
- Postać farmaceutycznaOral drops, solution, 0.15 MG/ML
- Kod ATCA11CC06
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki VIDENKAPostać farmaceutyczna: Oral drops, solution, 0.15 MG/MLSubstancja czynna: calcifediolProducent: BRUNO FARMACEUTICI S.P.A.Wymaga receptyPostać farmaceutyczna: Oral drops, solution, 0.266 MG/0.5 MLSubstancja czynna: calcifediolProducent: FARMACEUTICI CABER S.R.L.Wymaga receptyPostać farmaceutyczna: Oral drops, solution, 0,266 MG/0,5 MLSubstancja czynna: calcifediolProducent: I.B.N. SAVIO S.R.LWymaga recepty
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VIDENKA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w VIDENKA jest calcifediol. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
VIDENKA jest produkowany przez I.B.N. SAVIO 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 VIDENKA 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 VIDENKA 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 (calcifediol) to m.in. DIDROGYL, ERKAL, KALED. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
