Decristol

Package leaflet: Information for the patient

Dekristol, 20,000 IU, soft capsules
Cholecalciferolum
Please read carefully all the information in this leaflet before using this 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 pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

• in the initial treatment of vitamin D deficiency in adults.

2. Important information before using Dekristol

When not to use Dekristol:

• if the patient is allergic to cholecalciferol, peanuts, soy 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 vitamin D hypervitaminosis (excess vitamin D in the blood);
• if the patient has pseudohypoparathyroidism (a disorder affecting parathyroid hormone balance);
• if the patient has kidney stones, nephrocalcinosis (calcification of the kidneys) or severe kidney function disorders;
• if the patient is taking other medicines containing vitamin D (e.g. multivitamin products).

Warnings and precautions
Before starting treatment with Dekristol, 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;

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• 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);
• 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 into its active form. In such cases, the doctor should monitor calcium levels in the blood and urine.

When using Dekristol at a dose exceeding 1000 IU (international units) of vitamin D per day, the doctor should monitor calcium levels in blood and urine and check kidney function. Monitoring is particularly important in elderly patients and in patients also taking cardiac glycosides (medicines stimulating heart muscle function) or diuretics (medicines increasing urine production). If calcium levels in blood (hypercalcaemia) or urine (hypercalciuria) increase, treatment should be discontinued. In case of symptoms indicating impaired kidney function, 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 in swallowing the capsule and risk of choking. Instead, drops or soluble tablets are recommended. Due to lack of dosing data, use in adolescents aged 12 to 18 years is not recommended.

Dekristol and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or might take in the future.

The effect of Dekristol 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 anaesthesia);
• glucocorticosteroids (medicines used to treat certain allergic 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 or the risk of adverse effects may be increased by concomitant use of:

• metabolites or analogues of vitamin D (e.g. calcitriol): Concomitant use with Dekristol should be avoided;
• diuretics (e.g. thiazide diuretics): Reduced excretion of calcium by the kidneys may lead to increased calcium levels in blood (hypercalcaemia). Therefore, during long-term treatment, calcium levels in blood and urine should be systematically monitored.

Concomitant use of Dekristol 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 serum drug concentrations.
• 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 blood.

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Dekristol with food and drink
Dekristol is best taken with food and drink.

Pregnancy and breastfeeding

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

During pregnancy and breastfeeding, high-dose vitamin D products are not recommended; lower-dose products should be used.

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

Pregnancy
Vitamin D overdose should be avoided during pregnancy, as prolonged hypercalcaemia may lead to physical and mental impairment, supravalvular aortic stenosis (a congenital heart defect) and retinopathy (a disease of the retina) in the child.

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

Breastfeeding
High doses of vitamin D should not be used 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 administering additional vitamin D to the infant.

Driving and operating machinery
Dekristol has no effect or negligible effect on the ability to drive and operate machinery.

Dekristol contains peanut oil.
Do not use if hypersensitivity to peanuts or soy has been diagnosed.

3. How to use Dekristol

This medicine should always be used as directed by a physician. In case of 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.
Recommended dose:
For initial treatment of vitamin D deficiency:
Recommended dose: 1 capsule per week (corresponding to 20,000 IU).
After the first month of treatment, lower doses may be considered depending on the desired
serum concentration of 25-hydroxycholecalciferol (25(OH)D), disease severity, and the patient's
response to treatment.
National guidelines for the treatment of vitamin D deficiency may also be followed.
The duration of use is usually limited to the first month of treatment, depending on the physician's
decision.
Use in children and adolescents
Dekristol should not be used in infants and children under 12 years of age due to possible
difficulty swallowing the capsule and the risk of choking (see also section 2). Instead, drops or
effervescent tablets are recommended. Due to lack of dosing data, use in adolescents aged 12 to
18 years is not recommended.
Taking more Dekristol than recommended
If a dose higher than recommended has been taken, seek medical advice immediately.
Symptoms of overdose are nonspecific and may include nausea, vomiting, initial diarrhea
progressing to constipation, loss of appetite, fatigue, headache, muscle and joint pain, arrhythmia
(irregular heartbeat), pancreatitis, azotemia (high blood nitrogen levels), increased thirst, increased
urination, and in the final stage, dehydration.
Your doctor can provide further information on other symptoms of vitamin D overdose.
If necessary, the doctor will apply appropriate measures.
There is no known specific antidote.
Missing a dose of Dekristol
Do not take a double dose to make up for a missed dose.
Stopping Dekristol treatment
If treatment is stopped prematurely, symptoms may return or worsen.
In case of any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment with Dekristol should be discontinued and immediate medical advice sought 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 effects may occur:
Not commonly (may affect up to 1 in 100 patients):
hypercalcaemia (high calcium levels in the blood) and hypercalciuria (high calcium levels in urine).
Rarely (may affect up to 1 in 1,000 patients):
itching, rash or urticaria.
Frequency not known (cannot be estimated from available data):
gastrointestinal disturbances (constipation, bloating, nausea, abdominal pain or diarrhoea).
Arachis oil may very rarely cause severe allergic reactions.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
4/6
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Dekristol
Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Keep the bottle tightly closed.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the container after "EXP".
The expiry date refers to the last day of the stated month.
The shelf-life after first opening the bottle is 2 years.
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 Dekristol contains

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

What Dekristol looks like and contents of the pack
Dekristol is a clear 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 Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69
Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
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Austria: Dekristolmin 20,000 I.E. Weichkapseln
Croatia: Dekristol 20,000 IU meke kapsule
Germany: Vitamin D3 acis 20,000 I.E. Weichkapseln
Poland: Dekristol
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