Videnka

Italy
Brand name Videnka
Form drops, oral solution
Active substance / Dosage
CALCIFEDIOLO
Prescription type Prescription only
ATC code
A11CC06
Registration number 048177
Manufacturer I.B.N. SAVIO S.R.L

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

VIDENKA

0.15 mg/ml oral drops, solution
calcifediol
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, consult 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, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact 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 VIDENKA IS AND WHAT IT IS USED FOR

VIDENKA is a medicine containing calcifediol, a metabolite and the circulating form of Vitamin D in serum, used for the treatment of bone diseases and conditions leading to hypocalcemia (low calcium levels in the blood).

VIDENKA is indicated in adults in the following cases:

  • soft and weak bones (osteomalacia due to dietary deficiencies, malabsorption, or treatment with anticonvulsant drugs);
  • fragile bones (osteoporosis with an osteomalacic component or due to menopause);
  • bone disorders due to kidney diseases (renal osteodystrophy) and prolonged treatment with artificial kidney (prolonged hemodialysis);
  • decreased calcium levels in the blood due to liver disorders (hypocalcemia associated with hepatic diseases);
  • reduced parathyroid function without a known cause or following surgery (idiopathic or postoperative hypoparathyroidism);
  • sudden, involuntary muscle contractions (spasmophilia) due to vitamin D deficiency.

VIDENKA is indicated in children in the following cases:

  • decreased calcium levels in the blood (hypocalcemia) in newborns, premature infants, and immature infants;
  • decreased calcium levels in the blood (hypocalcemia) due to treatment with corticosteroid-containing medicines or anticonvulsant drugs, or due to impaired parathyroid function;
  • fragile and deformed bones (nutritional rickets with hypocalcemia);
  • bone disorders due to kidney diseases (renal osteodystrophy) and prolonged treatment with artificial kidney (prolonged hemodialysis).

2. WHAT YOU SHOULD KNOW BEFORE TAKING VIDENKA

Do not take VIDENKA if:

  • you are allergic to the active substance 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 before taking VIDENKA if:

  • you are taking preparations containing vitamin D or its derivatives;
  • you suffer from granulomatous diseases such as sarcoidosis or tuberculosis;
  • you have kidney problems;
  • you are obese;
  • you have previously suffered from kidney stones;
  • you are confined to bed or wheelchair (immobilized).

Talk to your doctor or pharmacist if, during treatment with VIDENKA,
your calcium levels in the blood (calcemia) and/or in the urine (calciuria) become abnormal.
Other medicines and VIDENKA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
This is particularly important if you are taking:

  • preparations containing vitamin D or its derivatives;
  • medicines that lower cholesterol in the blood (colestipol and cholestyramine);
  • medicines that lower fats in the blood (lipase inhibitors);
  • medicines that increase urine production (thiazide diuretics).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor
before taking this medicine.
VIDENKA may be used during pregnancy, but not at high doses.
VIDENKA must not be used during breastfeeding.
Driving and using machines
VIDENKA does not affect 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 under 5 years of age, speak with 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 exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
Your doctor will determine the correct dose of VIDENKA based on your blood calcium levels (calcemia) and
urinary calcium levels (calciuria). They may also ask you to monitor other parameters, such as blood phosphate levels (phosphoremia).
Adults
The usual dose of VIDENKA is as follows:

  • Osteomalacia due to dietary deficiencies, malabsorption, or treatment with anticonvulsant drugs: 10–25 drops or more daily, according to need;
  • Osteoporosis with an osteomalacic component or due to menopause: 10–25 drops or more daily, according to need;
  • Bone disorders due to kidney disease (renal osteodystrophy) and treatment with artificial kidney (prolonged hemodialysis): 10–25 drops or more daily, according to need;
  • Hypocalcemia due to liver disease: 10–25 drops or more daily, according to need;
  • Hypocalcemia due to underactive parathyroid glands without a known cause or following surgery (idiopathic or postoperative hypoparathyroidism): 10–25 drops or more daily, according to need;
  • Involuntary and sudden muscle contractions ( tetany ) due to vitamin D deficiency: your doctor may prescribe one of the following treatment regimens:
    • 10 drops daily for 2–3 months. The dose may then be reduced to 3 drops daily or 10 drops weekly, depending on urinary calcium levels (calciuria). Your doctor may also recommend repeating this treatment when necessary;
    • 30 drops daily for 6 weeks, together with other medications containing phosphate (1 g in the morning) and magnesium (200 mg in the evening). This treatment should be repeated 3–4 times per year.
      Children The usual dose of VIDENKA is as follows:
  • Hypocalcemia in the newborn, premature, and immature infant: 1 or 2 drops daily for 5 days, in combination with calcium therapy;
  • Hypocalcemia due to treatment with corticosteroid or anticonvulsant drugs, or to underactive parathyroid glands: 5–20 drops daily;
  • Nutritional rickets with hypocalcemia: 4–10 drops daily, in combination with calcium therapy;
  • Bone disorders due to kidney disease (renal osteodystrophy) and treatment with artificial kidney (prolonged hemodialysis): 4–15 drops daily.
    How to take VIDENKA
    VIDENKA is an oral solution contained in a bottle equipped with a dropper. Hold the bottle upside down (vertically) over a glass containing a small amount of water (or milk or fruit juice), and dispense the prescribed number of drops. Take the contents of the glass by mouth. If you need to take more than 20 drops, the dose may be divided into two or three administrations, as directed by your doctor.
    Duration of treatment
    Your doctor will determine how long you should take this medicine. If necessary, they may decide to repeat the treatment several times within a year. Do not stop treatment without consulting your doctor.
    If you take more VIDENKA than you should
    You may experience: weakness, nausea, vomiting, dry mouth, hard stools (constipation), muscle pain. In case of accidental overdose, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required.
    If you forget to take VIDENKA
    Do not take a double dose to make up for the missed dose. Take the next dose as prescribed. If you have any questions about the use of this medicine, consult your doctor.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, VIDENKA can cause adverse reactions, although not everyone experiences them.

Uncommon adverse reactions (may affect up to 1 in 100 people)

  • vomiting, diarrhoea

Rare adverse reactions (may affect up to 1 in 1,000 people)

  • dizziness, fainting (syncope);
  • muscle weakness or sensory disturbances, decreased muscle tone (hypotonia) or reduced responsiveness to stimuli (hyporesponsiveness to stimuli);
  • calcification within blood vessels (vascular calcification);
  • increased levels of calcium, phosphorus or magnesium in the blood (hypercalcemia, hyperphosphatemia, hypermagnesemia);
  • thirst or decreased appetite (reduced appetite) or reduced water intake (dehydration);
  • increased blood pH, presenting as intractable vomiting, dehydration, confusion, weakness (metabolic alkalosis);
  • increased vitamin D levels in the blood (hypervitaminosis D);
  • itching, red skin rash (erythema), skin peeling (exfoliative dermatitis);
  • increased calcium in the urine (hypercalciuria);
  • weight loss.

Very rare adverse reactions (may affect up to 1 in 10,000 people)

  • allergic reaction (hypersensitivity);
  • increased urine production (polyuria), kidney stones (nephrolithiasis) or urethral stones, calcium accumulation in the kidneys (nephrocalcinosis), dilation of the renal pelvis (hydronephrosis);
  • increased nitrogen levels in the blood (azotemia);
  • malaise or fatigue (asthenia);
  • calcium deposition under the skin (calcinosis);
  • fever or chills;
  • disturbances in gait.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide further 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 stated on the pack after “Exp.”. The expiry date refers to the last day of the month.
Do not store above 30°C.
Keep VIDENKA in the original packaging to protect the medicine from light.
After first opening the bottle of VIDENKA 0.15 mg/ml oral drops, solution, the medicine remains valid for 23 months (record the date of first opening in the designated space on the carton). After this period, dispose of any remaining medicine.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What VIDENKA contains
The active substance is calcifediol.
1 ml of VIDENKA contains: 0.15 mg of calcifediol. One drop contains 5 mcg of calcifediol.
The other component is: propylene glycol.

Description of the appearance of VIDENKA and pack sizes
This medicine is a clear, colourless, viscous solution contained in a dark glass bottle with a colourless plastic dropper and a white child-resistant polyethylene closure cap.
VIDENKA is available in a 10 ml bottle.

Marketing Authorisation Holder
I.B.N. Savio S.r.l., Via del Mare, 36 – 00071 Pomezia (RM), Italy

Responsible manufacturer for batch release
Savio Industrial S.r.l., Via Emilia, 21 – 27100 Pavia, Italy

This patient information leaflet was last approved on