Dekristol Forte

Package Leaflet: Information for the Patient

Dekristol Forte, 50,000 IU, Hard 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 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 leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Dekristol Forte contains vitamin D (also known as cholecalciferol) used to regulate calcium absorption and metabolism, as well as bone mineralization. Dekristol Forte is used to treat vitamin D deficiency and prevent vitamin D deficiency in adult patients at high risk.

2. Important information before taking Dekristol Forte

When not to take Dekristol Forte:

• 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 failure.

Warnings and precautions

Before starting treatment with Dekristol Forte, 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 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;

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• if you have pseudo-hypoparathyroidism (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 Forte in a dose exceeding 1,000 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 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, or other signs of kidney dysfunction occur, the dose should be reduced or the medicine should be discontinued.

Children and adolescents

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

Dekristol Forte 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 Forte may be reduced by concurrent 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 Forte or side effects may be increased by concurrent use of:

• vitamin D metabolites or analogs (e.g., calcitriol): concurrent use with Dekristol Forte should be avoided;
• diuretics (e.g., thiazide diuretics): reduced calcium excretion 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.

Dekristol Forte used 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 tests, monitor calcium levels in the blood and urine, and the level of the medicine in the blood.

Dekristol Forte with food and drink

Dekristol Forte 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.

Pregnancy

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The recommended daily dose of vitamin D during pregnancy is 400 IU, but in the case of women with vitamin D deficiency, a higher dose (up to 2,000 IU/day) may be necessary. 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.

It is not recommended to treat pregnant women with high doses of vitamin D.

During pregnancy, it is necessary to avoid vitamin D overdose, as prolonged hypercalcemia can lead to delayed physical and mental development, as well as heart and eye diseases in the child.

Breastfeeding

Vitamin D and its metabolites pass into breast milk. It is not recommended to treat breastfeeding women with high doses of vitamin D.

Fertility

There are no data on the effect of cholecalciferol on fertility. No adverse effect on fertility is expected at normal, physiological levels of vitamin D.

Driving and using machines

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

Dekristol Forte contains orange yellow FCF (E 110)

The medicine may cause allergic reactions.

3. How to take Dekristol Forte

This medicine should always be taken exactly as advised 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.

Use in adults

Vitamin D deficiency prevention: 1 capsule (50,000 IU) every 2 months. In the population of patients at high risk (see below), the dose may be increased to 1 capsule every month.

Vitamin D deficiency treatment: 1 capsule (50,000 IU) every week for 6-8 weeks, followed by maintenance treatment (1,400-2,000 IU/day may be required, i.e., 1 capsule every month).

After 3-4 months from the start of maintenance treatment, a test to confirm the desired vitamin D level should be performed.

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

Certain populations are at high risk of vitamin D deficiency and may require higher doses and monitoring of vitamin D levels in the blood. These include:

• people living in closed institutions or hospitalized,
• people with dark skin,
• people with limited effective sun exposure due to protective clothing or use of sunscreens,
• obese people,
• patients monitored for osteoporosis,
• people taking certain medicines (e.g., antiepileptics, glucocorticosteroids),
• patients with malabsorption, including non-specific intestinal inflammation and celiac disease,

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• people recently treated for vitamin D deficiency and requiring maintenance treatment.

Use in children and adolescents

Dekristol Forte is not recommended for use 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.

Overdose of Dekristol Forte

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

Overdose symptoms 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 overdose symptoms of vitamin D.

If necessary, your doctor will take the necessary measures.

No specific antidote is known.

Missing a dose of Dekristol Forte

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

Stopping treatment with Dekristol Forte

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

Stop taking Dekristol Forte 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:

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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

If you experience any side effects, including those not listed in this 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:

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +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 Forte

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 stated.

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. Contents of the pack and other information

What Dekristol Forte 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, silicon dioxide, titanium dioxide (E 171), quinoline yellow (E 104), butylhydroxytoluene (E 321), orange yellow FCF (E 110).

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What Dekristol Forte looks like and contents of the pack

Dekristol Forte is a hard gelatin capsule with an opaque orange body and a yellow cap, filled with a colorless to light yellow oily liquid. The capsules have a colorless band.

Dekristol Forte is available in PVC/PVDC/Aluminum blisters in a carton containing 6, 8, 10, 12, 15, 20, 30, 35, or 40 capsules.

Not all pack sizes may be marketed.

Marketing authorization 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

SUN-FARM Sp. z o.o.

ul. Dolna 21

05-092 Łomianki

Date of last revision of the leaflet:01.2024

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