Dekristol Pro

Package Leaflet: Information for the Patient

Dekristol Pro, 25,000 IU, Hard Capsules

Cholecalciferol

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 those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Dekristol Pro and what is it used for
• 2. Important information before taking Dekristol Pro
• 3. How to take Dekristol Pro
• 4. Possible side effects
• 5. How to store Dekristol Pro
• 6. Package contents and other information

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

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

• to treat vitamin D deficiency
• to prevent vitamin D deficiency in adult patients at risk, when therapeutic recommendations are not achieved with daily administration of small doses of cholecalciferol.

2. Important information before taking Dekristol Pro

When not to take Dekristol Pro:

• 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 pseudohypoparathyroidism (a disorder of parathyroid hormone balance);
• if you have kidney stones or kidney function disorders.

Warnings and precautions

Before starting treatment with Dekristol Pro, 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 (benzothiadiazine 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);

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• 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;
• if you have pseudohypoparathyroidism (a disorder of parathyroid hormone balance);
• if you are taking other medicines containing vitamin D (e.g., multivitamin preparations) or certain foods containing vitamin D.

If you are taking Dekristol Pro in a dose exceeding 1000 IU (international units) of vitamin D per day, your doctor should monitor calcium levels in the blood and urine, as well as kidney function. Monitoring is particularly important in elderly patients and those taking digitalis glycosides (heart stimulants) or diuretics (urine-stimulating medicines) at the same time. If calcium levels in the blood (hypercalcemia) or urine (hypercalciuria) increase, or if there are signs of kidney function disorders, the dose should be reduced or the medicine should be discontinued.

Children and adolescents

Dekristol Pro should not be used in children and adolescents under 18 years of age.

Dekristol Pro and other medicines

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

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

The effect of Dekristol Pro or side effects may be increased by concomitant use of:

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

Dekristol Pro used at the same time increases the risk of side effects:

• digitalis glycosides (medicines used to stimulate heart function): The risk of cardiac arrhythmias (irregular heartbeat) 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.

Dekristol Pro with food and drink

Dekristol Pro is best taken with food and drink.

Fertility, pregnancy, and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Pregnancy
During pregnancy, women should follow their doctor's recommendations, as their needs may vary depending on the severity of the disease and response to treatment.
Avoid overdosing on vitamin D during pregnancy, as prolonged hypercalcemia can lead to delayed physical and mental development, as well as heart and eye diseases in the child.
If vitamin D supplementation is necessary during pregnancy, it should be given in smaller doses.
Breastfeeding
Vitamin D and its metabolites pass into breast milk. If there is a deficiency of vitamin D, Dekristol Pro can be used in the recommended doses during breastfeeding. This should be taken into account when giving additional vitamin D to the child.
Fertility
The effect of vitamin D on fertility has not been studied. However, no adverse effect on fertility is expected with normal, physiological levels of vitamin D.

Driving and using machines

Dekristol Pro has no or negligible influence on the ability to drive and use machines.

3. How to take Dekristol Pro

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, 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 needs for vitamin D supplementation. The dose should be adjusted based on the desired level of 25-hydroxycholecalciferol (25(OH)D) in serum, the degree of deficiency, and the patient's response to treatment.

Administration in adults

For the treatment of vitamin D deficiency:
1 capsule of Dekristol Pro once a week (25,000 IU per week) for 8-12 weeks.
After the first month of treatment, a smaller dose may be considered.
For the prevention of vitamin D deficiency:
1 capsule of Dekristol Pro once a month (25,000 IU)

Administration in children and adolescents

Dekristol Pro should not be used in children and adolescents under 18 years of age.

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 the center of the capsule, as it may cause it to break.

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Overdose of Dekristol Pro

If you have taken more than the recommended dose, 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.
Your doctor can provide information about other symptoms of vitamin D overdose. If necessary, the doctor will take the necessary measures. There is no specific antidote known.

Missed dose of Dekristol Pro

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

Stopping treatment with Dekristol Pro

If treatment is stopped prematurely, symptoms may recur 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, Dekristol Pro can cause side effects, although not everybody gets them.
Stop taking Dekristol Pro 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).
Rare (may affect up to 1 in 1,000 people):
itching, rash, or hives.
Frequency not known (cannot be estimated from the available data):
gastrointestinal disorders (constipation, bloating, nausea, abdominal pain, or diarrhea).
Orange yellow FCF (E 110) may cause allergic reactions.

Reporting side effects

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If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dekristol Pro

Keep this medicine out of the sight and reach of children.
Store in the original package to protect from light.
No special temperature storage conditions are required.
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 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 Dekristol Pro contains

• The active substance is cholecalciferol. Each hard capsule contains 0.625 mg of cholecalciferol (equivalent to 25,000 IU of vitamin D).
• The other ingredients are: medium-chain triglycerides, gelatin, anhydrous colloidal silica, titanium dioxide (E 171), quinoline yellow (E 104), butylhydroxytoluene (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 colorless to light yellow oily liquid. The capsules have a colorless ring.
Dekristol Pro is available in blisters containing 2, 4, 5, 6, 8, 10, or 12 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

SUN-FARM Sp. z o.o.
Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
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Date of last revision of the package leaflet:02.2021
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