Vitensonsok

Package leaflet: Information for the patient

Vitensonsok 50,000 IU hard capsules

colecalciferol
Please read this entire 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 others, even if they have the same symptoms as you, 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 Vitensonsok is and what it is used for
2. What you need to know before taking Vitensonsok
3. How to take Vitensonsok
4. Possible side effects
5. How to store Vitensonsok
6. Contents of the pack and other information

1. What Vitensonsok is and what it is used for

Vitensonsok contains vitamin D (also known as colecalciferol) for regulating the absorption and
metabolism of calcium and for calcium integration into bone tissue.
Vitensonsok is used for the initial treatment of vitamin D deficiency in adults.

2. What you need to know before taking Vitensonsok

Do not take Vitensonsok

• if you are allergic to colecalciferol or to any of the other ingredients of this medicine (listed in section 6)
• if you have 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 have 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 do not function properly and if you have problems excreting calcium and phosphate through the kidneys. The effect of treatment on calcium-phosphate balance must be monitored by your doctor.
• if you are being treated with medicines that increase urine excretion (benzothiadiazine derivatives) or if your mobility is greatly reduced, as in these cases 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 affecting connective tissue of the lungs, skin, and joints), as there is a risk of increased conversion of vitamin D into its active forms. In such cases, calcium levels in blood and urine must be monitored by your doctor.
• if you have pseudohypoparathyroidism (a disorder of parathyroid hormone balance).
• if you are already taking other medicines containing vitamin D (e.g. multivitamin preparations) or certain types of foods containing vitamin D.

During high-dose and/or long-term treatment with Vitensonsok, your doctor must monitor calcium levels in blood and urine and also check kidney function. This monitoring is particularly important in elderly patients and when treatment is carried out simultaneously with cardiac glycosides (medicines that stimulate heart muscle function) or diuretics (medicines that stimulate urine excretion). If blood calcium levels (hypercalcemia) or urine calcium levels (hypercalciuria) increase, or if other signs of impaired kidney function occur, the dose must be reduced or treatment must be discontinued.

Children and adolescents
Vitensonsok must 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 may be reduced by simultaneous use of:

• phenytoin (a medicine used to treat epilepsy) or barbiturates (medicines used to treat epilepsy, sleep disorders, and for anesthesia)
• glucocorticoids (medicines used to treat certain allergic conditions and 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(s) of Vitensonsok may be intensified by simultaneous use of:

• vitamin D metabolites or analogues (e.g. calcitriol). Concomitant intake with Vitensonsok should be avoided.
• medicines that increase urine excretion (e.g. thiazide diuretics). Reduced elimination of calcium through the kidneys may cause increased calcium concentration in the blood (hypercalcemia). Therefore, calcium levels in blood and urine must be monitored during long-term treatment.

When taken simultaneously, Vitensonsok may increase the risk of adverse effects of:

• cardiac glycosides (medicines used to enhance heart muscle function): The risk of heart rhythm disturbances may increase as a result of elevated blood calcium levels during vitamin D treatment. In such cases, your treating physician should perform ECG monitoring as well as monitoring of calcium levels in blood and urine and of medicine levels in blood.
• antacids (medicines used to neutralize stomach acidity) or other products containing magnesium: magnesium-containing products should not be taken during long-term treatment with Vitensonsok, as there is a risk of high magnesium levels in the blood.
• phosphate-containing products: concomitant use of high-dose phosphate-containing products may lead to high phosphate levels in the blood.

Vitensonsok with food and drink
See section 3.

Fertility, pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Vitensonsok is not recommended during pregnancy. During pregnancy, women should follow their doctor's advice, as individual needs may vary depending on the severity of the disease and response to treatment.
Vitamin D overdose must be avoided during pregnancy, as prolonged hypercalcemia may lead to delayed physical and mental development and congenital heart or eye diseases in the newborn.

Breastfeeding
Vitensonsok is not recommended during breastfeeding. Vitamin D and its metabolites are excreted in breast milk.

Fertility
No adverse effects have been observed in reproductive fertility studies with colecalciferol. Normal endogenous levels of vitamin D are not expected to have negative effects on fertility.

Driving and using machines
Vitensonsok does not affect or has a negligible effect on 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 exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
This medicine is for oral use. The capsules must be swallowed whole with a sufficient
amount of water, preferably at the time of the main meal of the day.
The dose must be individually determined by your treating physician based on the required level of
vitamin D supplementation. The dose should be adjusted according to the desired serum levels
of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease, and the patient's response
to treatment.
As a dosage recommendation, the following may be applied:
Use in adults
1 capsule (50,000 IU) once weekly for up to a maximum of 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 dosing 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 physician's discretion.
Use in children and adolescents
Vitensonsok must not be used in children and adolescents under 18 years of age.
Administration of the medicine
The capsule must be swallowed whole with a sufficient amount of water, preferably at the time of 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 the central part of the capsule, as this may cause it to break.

If you take more Vitensonsok than you should
If you take more Vitensonsok than you should, contact your doctor immediately.
Signs of overdose are not very specific and may present as thirst, nausea, vomiting, initial diarrhoea
progressing to constipation, loss of appetite, fatigue, headache, muscle and joint pain, persistent
drowsiness, altered consciousness, arrhythmia (irregular heartbeat), azotemia (elevated blood nitrogen levels),
increased sensation of thirst, increased urge to urinate, and eventually dehydration.
Consult your doctor if you notice any signs of vitamin D overdose.
Your 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 the forgotten dose.
If you stop taking Vitensonsok
Symptoms may reappear or worsen if you stop treatment prematurely.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
You must stop taking Vitensonsok 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
• hives and difficulty breathing.

The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)
Hypercalcaemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine).

Rare (may affect up to 1 in 1000 people)
Itching sensation, skin rash or hives.

Not known (frequency cannot be estimated from the available data)
Gastrointestinal problems (constipation, flatulence, nausea, abdominal pain or diarrhoea).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Vitensonsok contains

• The active substance is: colecalciferol. One hard capsule contains 1.25 mg of colecalciferol (equivalent to 50,000 IU of vitamin D).
• The other components are: medium-chain triglycerides, gelatin, anhydrous colloidal silica, titanium dioxide (E 171), quinoline yellow (E 104), butylated hydroxytoluene (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 an oily liquid ranging from colourless to pale yellow. The capsules have a colourless band.
Vitensonsok is available in packs containing 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 European Economic Area member states under the following names:
Austria: Dekristolmin 50,000 I.E. Hartkapseln
Croatia: Dekristol 50 000 IU
Italy: Vitensonsok 50,000 UI hard capsules
Poland: Cholecalciferol mibe 50 000 IU