Dekristol

Package Leaflet: Information for the Patient

Dekristol, 20,000 IU, Soft Capsules

Cholecalciferol

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

• Keep this 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. 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 leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Dekristol and what is it used for

Dekristol contains vitamin D (also called cholecalciferol) used to regulate the absorption and metabolism of calcium and bone mineralization. Dekristol is used:

• for initial treatment of vitamin D deficiency in adults.

2. Important information before taking Dekristol

When not to take Dekristol:

• if you are allergic to cholecalciferol, peanuts, soy, 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, kidney calcification, or severe kidney dysfunction;
• if you are taking other medicines containing vitamin D (e.g., multivitamin products).

Warnings and precautions

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

• if you have a tendency to form kidney stones containing calcium;
• if you have kidney problems and they do not properly remove calcium and phosphates. Your doctor should monitor the effect of treatment on calcium and phosphate metabolism;

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• 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.

If you are taking Dekristol in a dose exceeding 1000 IU (International Units) of vitamin D per day, your doctor should monitor calcium levels in the blood and urine and check kidney function. Monitoring is especially important in elderly patients and those taking digitalis glycosides (heart stimulants) or diuretics (urine-stimulating drugs) at the same time. If calcium levels in the blood (hypercalcemia) or urine (hypercalciuria) increase, treatment should be discontinued. If signs of kidney dysfunction appear, the dose should be reduced or treatment discontinued.

Infants, young children, and adolescents

Dekristol should not be used in infants and children under 12 years of age due to possible difficulties with swallowing the capsule and the risk of choking. Instead, it is recommended to use drops or soluble tablets. Due to the lack of data on dosing, use in adolescents from 12 to 18 years of age is not recommended.

Dekristol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• 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 diseases),
• 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 to treat cancer);
• imidazole derivatives (antifungal medicines).

The effect of Dekristol or side effects may be increased by taking:

• vitamin D metabolites or analogs (e.g., calcitriol): Avoid concomitant use with Dekristol
• diuretics (e.g., thiazide diuretics): Reduced excretion of calcium by the kidneys may cause an increase in calcium levels in the blood (hypercalcemia). Therefore, during long-term treatment, calcium levels in the blood and urine should be systematically checked.

Dekristol taken at the same time increases the risk of side effects:

• digitalis glycosides (medicines used to stimulate heart function): The risk of cardiac arrhythmias may increase due to increased calcium levels in the blood during vitamin D treatment. In such cases, the attending physician should perform ECG examinations, monitor calcium levels in the blood and urine, and the level of the medicine in the blood.
• antacids or other products containing magnesium: During treatment with Dekristol, products containing magnesium should not be taken, as there is a risk of high magnesium levels in the blood.

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Dekristol with food and drink

Dekristol is best taken with food and drink.

Pregnancy and breastfeeding

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.

During pregnancy and breastfeeding, it is not recommended to use high-dose products; products with lower doses should be used.

During pregnancy and breastfeeding, adequate intake of vitamin D is necessary. The recommended daily intake of vitamin D during pregnancy and lactation, according to national guidelines, is about 600 IU.

Pregnancy

Avoid overdosing on vitamin D during pregnancy, as prolonged hypercalcemia can lead to physical and mental impairment, supravalvular aortic stenosis (a heart defect developing before birth), and retinopathy (a disease of the retina) in the child.

Daily doses during pregnancy should not exceed 4000 IU of vitamin D. Animal studies have shown the toxic effects of high doses of vitamin D on reproduction.

Breastfeeding

Do not take high doses of vitamin D during breastfeeding. Vitamin D and its metabolites pass into breast milk. If treatment with Dekristol is clinically indicated during breastfeeding, this should be taken into account when giving the child an additional dose of vitamin D.

Driving and using machines

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

Dekristol contains arachis oil.

Do not use if you are allergic to peanuts or soy.

3. How to take Dekristol

This medicine should always be taken exactly as advised by your doctor. 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.

Recommended dose:

For initial treatment of vitamin D deficiency:

Recommended dose: 1 capsule per week (corresponding to 20,000 IU).

After the first month, it may be considered to use smaller doses, depending on the desired level of 25-hydroxycholecalciferol (25(OH)D) in serum, disease severity, and patient response to treatment.

You can also follow national guidelines for the treatment of vitamin D deficiency.

The duration of treatment is usually limited to the first month of treatment, depending on the doctor's decision.

Use in children and adolescents

Dekristol should not be used in infants and children under 12 years of age due to possible difficulties with swallowing the capsule and the risk of choking (see also section 2). Instead, it is recommended to use drops or soluble tablets. Due to the lack of data on dosing, use in adolescents from 12 to 18 years of age is not recommended.

Overdose of Dekristol

If you have taken more than the recommended dose, contact your doctor immediately.

Symptoms of overdose are non-specific and may include nausea, vomiting, initial diarrhea leading to constipation, loss of appetite, fatigue, headache, muscle and joint pain, arrhythmia (irregular heartbeat), pancreatitis, azotemia (high nitrogen levels in the blood), increased thirst, increased urination, and - in the final stage - dehydration.

Your doctor can provide information on other symptoms of vitamin D overdose.

If necessary, your doctor will take the necessary measures.

No specific antidote is known.

Missed dose of Dekristol

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

Stopping treatment with Dekristol

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, Dekristol can cause side effects, although not everybody gets them.

Stop taking Dekristol and contact your doctor immediately if you experience symptoms of a 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).

Arachis oil may rarely cause severe allergic reactions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product 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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dekristol

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Keep the bottle tightly closed.

Store in the original package to protect from light and moisture.

Do not use this medicine after the expiry date stated on the packaging after "EXP".

The expiry date refers to the last day of the month.

The shelf life after first opening the bottle is 2 years.

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 pack and other information

What Dekristol contains

• The active substance is cholecalciferol. Each soft capsule contains 500 micrograms of cholecalciferol (corresponding to 20,000 IU of vitamin D) in the form of cholecalciferol oil concentrate.
• The other ingredients are: purified arachis oil, gelatin, glycerol 85%, saturated fatty acid triglycerides of medium chain length, purified water, all-rac-α-tocopherol.

What Dekristol looks like and contents of the pack

Dekristol is a light yellow, round, transparent, soft gelatin capsule.

Dekristol is available in blisters containing 14 or 50 capsules or in glass bottles containing 14 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

SUN-FARM Sp. z o.o.

Dolna 21

05-092 Łomianki

Phone: +48 22 350 66 69

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:

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Austria:

Dekristolmin 20,000 I.E. Weichkapseln

Croatia:

Dekristol 20,000 IU soft capsules

Germany:

Vitamin D3 acis 20,000 I.E. Weichkapseln

Poland:

Dekristol

Date of last revision of the leaflet:12.2024

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