Holecalciferol mibe

Package Leaflet: Information for the Patient

Cholecalciferol mibe, 50,000 IU, hard capsules

Cholecalciferolum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

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

2. Important information before taking Cholecalciferol mibe

When not to take Cholecalciferol mibe:

• if you are allergic to cholecalciferol, orange yellow FCF (E 110) or any of the other ingredients of this medicine (listed in section 6);
• if you have hypercalcemia (high calcium levels in the blood);
• if you have hypercalciuria (high calcium levels in the urine);
• if you have been diagnosed with hypervitaminosis D (high levels of vitamin D in the blood);
• if you have pseudo-hypoparathyroidism (a disorder of parathyroid hormone balance);
• if you have kidney stones or severe kidney function disorders.

Warnings and precautions

Before starting treatment with Cholecalciferol mibe, discuss it with your doctor or pharmacist:

• if you have a tendency to form kidney stones containing calcium;
• if you have kidney function disorders and do not excrete calcium and phosphates properly. Your doctor should monitor the effect of treatment on calcium and phosphate metabolism;
• if you are taking diuretics (thiazide derivatives) or are immobilized, as there is a risk of hypercalcemia (high calcium levels in the blood) and hypercalciuria (high calcium levels in the urine);
• if you have sarcoidosis (a disease that affects connective tissue in the lungs, skin, and joints), as there is a risk of increased conversion of vitamin D to its active form. In such cases, your doctor should monitor calcium levels in the blood and urine; 1/6
• if you have pseudo-hypoparathyroidism (a disorder of parathyroid hormone balance);
• if you are taking other medicines containing vitamin D (e.g., multivitamin products) or certain foods containing vitamin D.

During treatment with high doses and/or long-term treatment with Cholecalciferol mibe, your doctor should monitor calcium levels in the blood and urine and kidney function.
Monitoring is especially important in elderly patients and those taking digitalis glycosides (medicines that stimulate heart muscle) or diuretics (medicines that increase urine production) at the same time. If calcium levels in the blood (hypercalcemia) or urine (hypercalciuria) increase, or other signs of kidney function disorders 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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about medicines you plan to take.
The effect of Cholecalciferol mibe may be reduced by concomitant use of:

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

The effect of Cholecalciferol mibe or side effects may be increased by concomitant use of:

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

Cholecalciferol mibe used at the same time increases the risk of side effects:

• digitalis glycosides (medicines used to stimulate heart muscle): the risk of cardiac arrhythmias may increase due to increased calcium levels in the blood during vitamin D treatment. In such cases, the doctor should perform ECG tests, monitor calcium levels in the blood and urine, and the level of the medicine in the blood;
• antacids (medicines that neutralize stomach 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 high magnesium levels in the blood.
• products containing phosphorus: concomitant use of products containing phosphorus in high doses may lead to increased phosphorus levels in the blood.

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Cholecalciferol mibe with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
Pregnancy
Cholecalciferol mibe should not be used during pregnancy. During pregnancy, women should follow their doctor's recommendations, as their requirements may vary depending on the severity of the disease and response to treatment.
Excessive intake of vitamin D should be avoided during pregnancy, as prolonged hypercalcemia may lead to delayed physical and mental development and heart and eye diseases in the child.
Breastfeeding
Cholecalciferol mibe should not be used during breastfeeding. Vitamin D and its metabolites pass into human milk.
Fertility
No effect of cholecalciferol on fertility has been observed. No adverse effect on fertility is expected with normal, physiological levels of vitamin D.
Cholecalciferol mibe has no or negligible influence on the ability to drive and use machines.

Cholecalciferol mibe contains orange yellow FCF (E 110)

Orange yellow FCF (E 110) may cause allergic reactions.

3. How to take Cholecalciferol mibe

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
This medicine should be taken orally. The capsules should be swallowed whole, with a sufficient amount of water, preferably with the main meal of the day.
The dosage must be determined individually by the doctor, depending on the extent of necessary vitamin D supplementation. The dose should be adjusted according to the desired level of 25-hydroxycholecalciferol (25(OH)D) in serum, disease severity, and patient response to treatment.
Recommendations for dosing:

Use in adults

1 capsule (50,000 IU) per week for up to 6 weeks.
Then, a smaller maintenance dose may be considered, depending on the level of 25-hydroxycholecalciferol (25(OH)D) in serum, disease severity, and response to treatment.
Country-specific guidelines for dosing in the treatment of vitamin D deficiency may also be followed.
The treatment duration is usually limited to the first month of treatment, depending on the doctor'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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Taking the medicine
The capsules should be swallowed whole, with a sufficient amount of water, preferably with the main meal of the day.
To remove a capsule from the blister:

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

Overdose of Cholecalciferol mibe

If you have taken more than the recommended dose of Cholecalciferol mibe, contact your doctor immediately.
Symptoms of overdose are non-specific and may include thirst, nausea, vomiting, initial diarrhea leading to constipation, loss of appetite, fatigue, headache, muscle and joint pain, muscle weakness, persistent drowsiness, impaired consciousness, arrhythmia (irregular heartbeat), azotemia (high nitrogen levels in the blood), increased thirst, increased urine production, and - in the final stage - dehydration.
Ask your doctor about further symptoms of vitamin D overdose.
If necessary, your doctor will take the necessary measures.
No specific antidote is known.

Missed dose of Cholecalciferol mibe

Do not take a double dose to make up for a missed dose.

Stopping treatment with Cholecalciferol mibe

If treatment is stopped prematurely, symptoms may return or worsen.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cholecalciferol mibe can cause side effects, although not everybody gets them.
Stop taking Cholecalciferol mibe and contact your doctor immediately if you experience symptoms of severe allergic reactionsuch as:

• 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):
hypercalcemia (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 people):
itching, rash, or hives
Frequency not known (frequency cannot be estimated from the available data):
gastrointestinal disorders (constipation, bloating, nausea, abdominal pain, or diarrhea)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cholecalciferol mibe

Keep the medicine out of the sight and reach of children.
Store in the original package to protect from light.
No special precautions for storage temperature are necessary.
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 month.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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).
• The other ingredients are: medium-chain triglycerides, gelatin, colloidal silicon dioxide, 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 a hard gelatin capsule with an opaque orange body and a yellow cap, filled with a colorless to slightly yellowish oily liquid. The capsules have a colorless band.
Cholecalciferol mibe is available in PVC/PVDC/Aluminum blisters in a cardboard box containing 2, 4, or 6 capsules.
Not all pack sizes may be marketed.
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Marketing authorization holder

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
phone: +49 (34954) 247-0

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

This medicine is authorized 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

Date of last revision of the package leaflet:

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