Cholecalciferol mibe

Package leaflet: Information for the patient

Cholecalciferol mibe, 50,000 IU, hard capsules
Cholecalciferolum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Cholecalciferol mibe is and what it is used for
2. Important information before taking Cholecalciferol mibe
3. How to use Cholecalciferol mibe
4. Possible side effects
5. How to store Cholecalciferol mibe
6. Contents of the pack and other information

1. What Cholecalciferol mibe is and what it is used for

Cholecalciferol mibe contains vitamin D (also known as cholecalciferol), which is used to regulate calcium absorption and metabolism, as well as bone mineralization.
Cholecalciferol mibe is used in the initial treatment of clinically significant vitamin D deficiency in adults.

2. Important information before using Cholecalciferol mibe

When not to use Cholecalciferol mibe:

• if the patient is allergic to cholecalciferol, sunset yellow FCF (E 110), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypercalcaemia (high calcium levels in the blood);
• if the patient has hypercalciuria (high calcium levels in the urine);
• if the patient has been diagnosed with hypervitaminosis D (high levels of vitamin D in the blood);
• if the patient has pseudohypoparathyroidism (a disorder affecting parathyroid hormone balance);
• if the patient has kidney stones (nephrolithiasis) or severe kidney function disorders.

Warnings and precautions
Before starting treatment with Cholecalciferol mibe, discuss the following with your doctor or pharmacist:

• if the patient has a tendency to form calcium-containing kidney stones;
• if the patient has kidney disorders and the kidneys do not properly excrete calcium and phosphates. The doctor should monitor the effect of treatment on calcium-phosphate metabolism;
• if the patient is taking diuretics (benzothiadiazine derivatives) or is immobilized, as there is an increased risk of hypercalcaemia (high blood calcium levels) and hypercalciuria (high urine calcium levels);
• if the patient has sarcoidosis (a disease affecting connective tissue in the lungs, skin, and joints), as there may be increased conversion of vitamin D into its active form. In such cases, the doctor should monitor calcium levels in blood and urine; 1/6
• if the patient has pseudohypoparathyroidism (a disorder affecting parathyroid hormone balance);
• if the patient is taking other medicines containing vitamin D (e.g. multivitamin products) or certain types of food containing vitamin D.

During high-dose and/or long-term treatment with Cholecalciferol mibe, the doctor should monitor calcium levels in blood and urine and assess kidney function. Monitoring is particularly important in elderly patients and in patients concurrently taking cardiac glycosides (medicines that stimulate heart muscle function) or diuretics (medicines that increase urine production). If elevated calcium levels in blood (hypercalcaemia) or urine (hypercalciuria), or other signs of kidney dysfunction occur, the dose should be reduced or treatment discontinued.

Children and adolescents
Cholecalciferol mibe is not recommended for use in children and adolescents under 18 years of age.

Cholecalciferol mibe and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

The effect of Cholecalciferol mibe may be reduced when used concomitantly with:

• phenytoin (a medicine used to treat epilepsy) or barbiturates (medicines used to treat epilepsy, sleep disorders, or for anaesthesia);
• glucocorticosteroids (medicines used to treat certain allergic and inflammatory conditions);
• rifampicin and isoniazid (medicines used to treat tuberculosis);
• cholestyramine (a medicine used to lower elevated cholesterol levels), laxatives containing liquid paraffin;
• orlistat (a medicine used to treat obesity);
• actinomycin (a medicine used in cancer treatment);
• imidazole or ketoconazole (antifungal medicines).

The effect of Cholecalciferol mibe or the risk of adverse effects may be increased when used concomitantly with:

• metabolites or analogues of vitamin D (e.g. calcitriol): concomitant use with Cholecalciferol mibe should be avoided;
• diuretics (e.g. thiazide diuretics): reduced renal excretion of calcium may lead to increased calcium levels in blood (hypercalcaemia). Therefore, during long-term treatment, calcium levels in blood and urine should be regularly monitored.

Cholecalciferol mibe, when used simultaneously, increases the risk of adverse effects of:

• cardiac glycosides (medicines used to stimulate heart muscle function): the risk of cardiac arrhythmias may increase due to elevated blood calcium levels during vitamin D treatment. In such cases, the treating physician should perform ECG examinations and monitor calcium levels in blood and urine, as well as drug concentration in blood;
• antacids (medicines that neutralize gastric acid) or other products containing magnesium: during long-term treatment with Cholecalciferol mibe, products containing magnesium should not be used, as there is a risk of developing high magnesium levels in blood;
• phosphate-containing products: concomitant use of phosphate-containing products in high doses may lead to increased phosphate levels in blood.

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Cholecalciferol mibe with food and drink
See section 3.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.

Pregnancy
Use of Cholecalciferol mibe is not recommended during pregnancy. During pregnancy, women should follow their doctor's advice, as their requirements may vary depending on the severity of the disease and response to treatment.
Excessive intake of vitamin D during pregnancy should be avoided, as prolonged hypercalcaemia may lead to delayed physical and mental development and heart and eye disorders in the child.

Breastfeeding
Use of Cholecalciferol mibe is not recommended during breastfeeding. Vitamin D and its metabolites pass into human milk.

Fertility
No effect of cholecalciferol on fertility has been observed. No adverse effect of normal, physiologically occurring vitamin D concentrations on fertility is expected.

Cholecalciferol mibe has no effect or a negligible effect on the ability to drive or operate machinery.

Cholecalciferol mibe contains sunset yellow FCF (E 110)
Sunset yellow FCF (E 110) may cause allergic reactions.

3. How to use Cholecalciferol mibe

This medicine should always be taken as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
This medicine is for oral use. The capsules should be swallowed whole with an adequate amount of
water, preferably with the main meal of the day.
The dosage must be individually determined by the treating physician, depending on the required
range of vitamin D supplementation. The dose should be adjusted according to the desired
serum concentration of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease, and the
patient's response to treatment.
Dosage recommendations:
Use in adults
1 capsule (50,000 IU) weekly for up to 6 weeks.
Afterwards, a lower maintenance dose may be considered, depending on serum levels of
25-hydroxycholecalciferol (25(OH)D), disease severity, and response to treatment.
National guidelines for vitamin D deficiency treatment may also be followed.
The duration of treatment is usually limited to the first month of therapy, depending on the
physician's decision.
Use in children and adolescents
Cholecalciferol mibe is not recommended for use in children and adolescents under 18 years of age.
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How to take the medicine
The capsules should be swallowed whole with an adequate amount of water, preferably with the
main meal of the day.
To remove the capsule from the blister pack:

• press only on the edge of the capsule to push it through the foil;
• do not press in the center of the capsule, as this may cause it to break.

Taking more Cholecalciferol mibe than prescribed
If more than the prescribed dose of Cholecalciferol mibe has been taken, consult a doctor
immediately.
Symptoms of overdose are nonspecific and may include thirst, nausea, vomiting, initial diarrhea
leading to constipation, loss of appetite, fatigue, headache, muscle and joint pain, muscle weakness,
persistent drowsiness, disturbances in consciousness, arrhythmia (irregular heartbeat), azotemia
(elevated blood nitrogen levels), increased thirst, increased urination, and in the final stage,
dehydration.
Ask your doctor about further symptoms of vitamin D overdose.
If necessary, the doctor will take appropriate measures.
There is no specific antidote.
Missing a dose of Cholecalciferol mibe
Do not take a double dose to make up for a missed dose.
Stopping Cholecalciferol mibe treatment prematurely
If treatment is stopped early, symptoms may return or worsen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should stop taking Cholecalciferol mibe and immediately contact your doctor if you experience symptoms of severe allergic reaction such as:

• swelling of the face, lips, tongue or throat;
• difficulty swallowing;
• hives and breathing difficulties.

The following adverse reactions may occur:
Not common (may affect up to 1 in 100 patients):
hypercalcaemia (high calcium levels in the blood) and hypercalciuria (high calcium levels in the urine)
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Rare (may affect up to 1 in 1,000 patients):
itching, rash or urticaria
Frequency not known (frequency cannot be estimated from the available data):
gastrointestinal disorders (constipation, bloating, nausea, abdominal pain or diarrhoea)
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Cholecalciferol mibe

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
No special temperature storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after:
"EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the package and other information

What Cholecalciferol mibe contains

• The active substance is cholecalciferol. Each hard capsule contains 1.25 mg of cholecalciferol (equivalent to 50,000 IU of vitamin D).
• Other ingredients are: medium-chain triglycerides, gelatin, colloidal anhydrous silica, titanium dioxide (E 171), quinoline yellow (E 104), butylhydroxytoluene (E 321), orange yellow FCF (E 110).

What Cholecalciferol mibe looks like and contents of the pack
Cholecalciferol mibe is hard gelatin capsules with an opaque orange body and a yellow cap, filled with a colourless to slightly yellow oily liquid. The capsules have a colourless band.
Cholecalciferol mibe is available in PVC/PVDC/Aluminium foil blisters, packed in a cardboard box containing 2, 4 or 6 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
tel. +49 (34954) 247-0

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:
Poland: Cholecalciferol mibe
Croatia: Dekristol 50 000 IU
Austria: Dekristolmin 50 000 I.E. Hartkapseln
Italy: Vitenson D50
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