Dekristol pro

Package leaflet: Information for the patient

Dekristol Pro, 25,000 IU, hard capsules
Cholecalciferolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Dekristol Pro is and what it is used for
2. What you need to know before taking Dekristol Pro
3. How to take Dekristol Pro
4. Possible side effects
5. How to store Dekristol Pro
6. Contents of the pack and other information

1. What Dekristol Pro is and what it is used for

Dekristol Pro contains vitamin D (also known as cholecalciferol), which is used to regulate
calcium absorption and metabolism, and bone mineralization.
Dekristol Pro is used in adults:

• for the treatment of vitamin D deficiency
• for the prevention of vitamin D deficiency in adult patients at risk, when adherence to therapeutic recommendations has not been achieved with daily administration of small doses of cholecalciferol.

2. Important information before using Dekristol Pro

When not to use Dekristol Pro:

• if the patient is allergic to cholecalciferol, tartrazine (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 (excess vitamin D in the blood);
• if the patient has pseudohypoparathyroidism (a disorder affecting parathyroid hormone balance);
• if the patient has kidney stones or impaired kidney function.

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

• if the patient is prone to developing calcium-containing kidney stones;
• if the patient has kidney disorders and does 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 then an increased risk of hypercalcaemia (high calcium levels in the blood) and hypercalciuria (high calcium levels in the urine);

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• if the patient has sarcoidosis (a disease affecting 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, the doctor should monitor calcium levels in blood and urine;
• if the patient has pseudohypoparathyroidism (a disorder affecting parathyroid hormone balance);
• if the patient is taking other medicines containing vitamin D (e.g. multivitamin preparations) or certain types of food containing vitamin D.

When Dekristol Pro is used at doses exceeding 1000 IU (international units) of vitamin D per day, 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 impaired kidney function occur, the dose should be reduced or treatment discontinued.
Children and adolescents
Dekristol Pro must not be used in children and adolescents under 18 years of age.
Dekristol Pro and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
The effect of Dekristol Pro may be reduced when taken concomitantly with:

• phenytoin (a medicine used to treat epilepsy) or barbiturates (medicines used to treat epilepsy, sleep disorders, and 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 derivatives (antifungal medicines).

The effect of Dekristol Pro or the risk of adverse effects may be increased when taken concomitantly with:

• metabolites or analogues of vitamin D (e.g. calcitriol): concomitant use with Dekristol Pro 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 monitored regularly.

Concomitant use of Dekristol Pro increases the risk of adverse effects with:

• cardiac glycosides (medicines used to stimulate heart muscle function): increased risk of cardiac arrhythmias may occur due to elevated blood calcium levels during vitamin D treatment. In such cases, the treating physician should perform ECG monitoring and observe calcium levels in blood and urine as well as drug concentrations in blood.

Dekristol Pro with food and drink
Dekristol Pro should be taken with food and drink.
Fertility, pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
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a child, she should consult her doctor before using this medicine.
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.
Vitamin D overdose should be avoided during pregnancy, as prolonged hypercalcaemia may lead to delayed physical and mental development and heart and eye disorders in the child.
If vitamin D supplementation is necessary during pregnancy, it should be administered in lower doses.
Breastfeeding
Vitamin D and its metabolites pass into the breast milk of nursing mothers. In cases of vitamin D deficiency, Dekristol Pro may be used at recommended doses during breastfeeding. This should be taken into account when administering additional vitamin D to the infant.
Fertility
The effect of vitamin D on fertility has not been studied. However, no adverse effect on fertility is expected from normal physiological concentrations of vitamin D in the body.
Driving and using machines
Dekristol Pro has no effect or negligible effect on the ability to drive and operate machinery.

3. How to use Dekristol Pro

This medicine should always be used as directed by the physician or pharmacist. If in doubt,
consult your doctor or pharmacist.
This medicine should be taken orally. 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 according to the patient's
vitamin D supplementation needs. The dose should be adjusted based on the desired serum
concentration of 25-hydroxycholecalciferol (25(OH)D), the severity of deficiency, and the patient's
response to treatment.

Use in adults
For the treatment of vitamin D deficiency:
1 capsule of Dekristol Pro once weekly (25,000 IU per week) for 8–12 weeks.
After the first month of treatment, a lower dose may be considered.
For the prevention of vitamin D deficiency:
1 capsule of Dekristol Pro once monthly (25,000 IU)

Use in children and adolescents
Dekristol Pro is not recommended for use in children and adolescents under 18 years of age.

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.

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Taking more Dekristol Pro than recommended
If you have taken more than the recommended dose, seek medical advice immediately.
Symptoms of overdose are nonspecific and may include thirst, nausea, vomiting, initial diarrhoea
followed by 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.
Your treating physician can provide information on other symptoms of vitamin D overdose.
If necessary, the doctor will initiate appropriate measures.
There is no specific antidote known.

If you forget to take Dekristol Pro
Do not take a double dose to make up for a missed dose.

Stopping the use of Dekristol Pro
If treatment is stopped prematurely, symptoms may return or worsen.
If you have any further doubts regarding 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 everyone will experience them.
You should stop taking Dekristol Pro and immediately consult a doctor if symptoms of a severe allergic reaction occur, 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 urine).
Rare (may affect up to 1 in 1,000 patients):
itching, rash, or urticaria.
Frequency not known (cannot be estimated from available data):
gastrointestinal disorders (constipation, bloating, nausea, abdominal pain, or diarrhoea).
Sunset Yellow FCF (E 110) may cause allergic reactions.
Reporting of adverse reactions
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If any adverse reactions occur, including any adverse reactions 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 authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Dekristol Pro

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
No special temperature storage conditions are required 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Dekristol Pro contains

• The active substance is cholecalciferol. Each hard capsule contains 0.625 mg of cholecalciferol (corresponding to 25,000 IU of vitamin D).
• The other ingredients are: medium-chain triglycerides, gelatin, colloidal anhydrous silica, titanium dioxide (E 171), quinoline yellow (E 104), butylated hydroxytoluene (E 321), orange yellow FCF (E 110).

What Dekristol Pro looks like and contents of the pack
Dekristol Pro is a hard gelatin capsule with an opaque yellow body and cap, filled with a colourless to slightly yellow oily liquid. The capsules have a colourless band.
Dekristol Pro is available in blisters containing 2, 4, 5, 6, 8, 10 or 12 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
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