Detrical

Package Leaflet: Information for the Patient

DETRICAL, 7000 IU, Coated Tablets

Cholecalciferol

Read the Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically 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 D and what is it used for
• 2. Important information before taking D
• 3. How to take D
• 4. Possible side effects
• 5. How to store D
• 6. Contents of the pack and other information

1. What is D and what is it used for

D is a medication containing cholecalciferol (vitamin D3) as the active substance, in the amount of 7000 IU (international units) per coated tablet. Vitamin D3 is involved in many metabolic processes, and its deficiency has an adverse effect on health and performance. Vitamin D3 supports calcium and phosphorus metabolism in the body and ensures proper bone mineralization.

Vitamin D is produced in the skin under the influence of sunlight and is also supplied to the body with food. A deficiency of vitamin D may occur when the diet and lifestyle (inadequate exposure to sunlight) do not provide sufficient amounts of it, or when the demand for vitamin D is increased.

D is indicated for use in:

• treatment of vitamin D deficiency,
• prevention of vitamin D deficiency in adults at high risk (obese individuals, elderly),
• as a supplement to specific treatment of osteoporosis in patients with vitamin D deficiency or at risk of vitamin D deficiency.

2. Important Information Before Taking D

When Not to Take D:

• if you are allergic to the active substance or any of the other ingredients of this medication (listed in section 6),
• in case of increased calcium levels in the blood (hypercalcemia),
• in case of increased calcium excretion in the urine (hypercalciuria),
• in case of increased vitamin D levels in the blood (hypervitaminosis D),
• if you have diseases and/or conditions leading to hypercalcemia and/or hypercalciuria,
• if you have kidney stones,
• if you have severe kidney failure (glomerular filtration rate <30 ml min 1.73 m²).< li>
• if you have pseudo-hypoparathyroidism (the demand for vitamin D may be reduced due to periods of normal sensitivity to this vitamin, leading to overdose). In this case, vitamin D derivatives that are easier to control are available.
• in children and adolescents under 18 years of age. For this group of patients, vitamin D derivatives with lower potency are available.
• in pregnant and breastfeeding women. For this group of patients, vitamin D derivatives with lower potency are available.

Warnings and Precautions

Before starting to take D, discuss it with your doctor or pharmacist.

During long-term use of this medication, it is necessary to monitor calcium levels in the serum, calcium excretion in the urine, and kidney function by measuring serum creatinine levels. This is especially important in elderly patients and patients taking digitalis glycosides or diuretics, as well as in cases of hyperphosphatemia (elevated phosphate levels in the blood) and in patients with an increased risk of kidney stones.

Symptoms that may indicate an excess of vitamin D in the body are:

• malaise, confusion, and weakness, hyperactivity,
• nausea and vomiting, abdominal pain, loss of appetite, constipation,
• excessive thirst,
• increased urination,
• headache, eye pain, and skin pain,
• skin itching.

If such symptoms occur, consult a doctor.

In patients with severe kidney failure, vitamin D in the form of cholecalciferol is not properly metabolized, and other vitamin D derivatives should be used.

Before starting to take D, inform your doctor if:

• you have pseudo-hypoparathyroidism;
• you have sarcoidosis (a disease of the immune system characterized by the formation of small inflammatory nodules);
• you are immobilized and have osteoporosis (a metabolic bone disease characterized by a decrease in bone mineral density and their weakening);
• you are taking other products containing vitamin D (see section: Medication and other medications);
• you have kidney disorders;
• you are being treated with digitalis glycosides or diuretics.

Children and Adolescents

D is contraindicated in children and adolescents under 18 years of age.

In this case, vitamin D derivatives with lower potency are available.

D and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

Do not take other medications, dietary supplements, or food products containing vitamin D (cholecalciferol) without medical supervision.

Antacids containing aluminum (used to treat stomach acid) taken with D may increase aluminum levels in the blood, increasing the risk of toxic aluminum effects on bones.

Antacids containing magnesium, when taken with D, may increase magnesium levels in the blood.

Certain antiepileptic, sedative, or hypnotic medications (containing phenytoin or barbiturates) taken with D may reduce its effectiveness.

Certain diuretics may lead to hypercalcemia (elevated calcium levels) caused by reduced calcium excretion by the kidneys. During long-term treatment, it is necessary to monitor calcium levels in the serum and urine.

Taking glucocorticosteroids (synthetic adrenal cortex hormones) may counteract the effect of D.

D may enhance the effect and toxicity of digitalis glycosides, creating a risk of developing heart rhythm disorders. In this case, the doctor should monitor calcium levels in the serum and urine and perform periodic ECG examinations.

Concomitant use of vitamin D metabolites or analogs (e.g., calcitriol) and D is possible only on a doctor's prescription and only in exceptional cases, provided that calcium levels in the serum are monitored.

Rifampicin and isoniazid (medications used to treat tuberculosis) may reduce the effectiveness of D.

Vitamin D may act antagonistically to medications used in hypercalcemia, such as calcitonin, etidronate, pamidronate.

Medications that cause fat absorption disorders, such as orlistat, liquid paraffin, or cholestyramine, may reduce vitamin D absorption in the gastrointestinal tract.

Cytotoxic medication – actinomycin and imidazole antifungal medications disrupt vitamin D3 activity by inhibiting the conversion in the kidneys by the enzyme 1-hydroxylase 25-hydroxyvitamin D.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medication.

Pregnancy

D is contraindicated in pregnant women.

Breastfeeding

D is contraindicated in breastfeeding women.

Driving and Operating Machinery

D does not affect the ability to drive vehicles or operate machinery.

D contains sucrose.If you have previously been diagnosed with intolerance to some sugars, consult a doctor before taking the medication.

D contains sodium.The medication contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to Take D

Always take this medication exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult a doctor or pharmacist.

Take the medication orally. Treatment should be continued until a normal level of vitamin D3 is achieved in the body.

The vitamin D content in one tablet corresponds to a weekly dose.

Dosage should be determined by a doctor.

Dosage

Adults, including the elderly

Treatment of vitamin D deficiency

1 tablet per day for several weeks until a level of 25(OH)D above 30 ng/mL is achieved, then a maintenance dose depending on the patient's age and weight, every other day.

Prevention of vitamin D deficiency

1 or 2 tablets per week.

Supplementary treatment in osteoporosis

1 tablet per week.

Special patient groups

Children and adolescents

D is contraindicated in children and adolescents under 18 years of age.

Patients with kidney function disorders or hypercalcemia (elevated calcium levels)

Consult a doctor immediately, as it may be necessary to reduce the dose or discontinue the medication. The doctor may recommend regular blood and urine tests.

Patients with liver function disorders

No dose adjustment is necessary.

Taking a Higher Dose of D Than Recommended

In case of taking a higher dose of D than recommended, consult a doctor. The doctor will decide on the appropriate treatment.

Overdose symptoms: nausea, vomiting, diarrhea, followed by constipation, loss of appetite, fatigue, headache, muscle pain, joint pain, muscle weakness, drowsiness, azotemia (elevated levels of nitrogen compounds in the blood), excessive thirst, polyuria, and dehydration. At high calcium levels in the blood, cardiac arrhythmias, kidney failure, psychosis, and even coma may occur.

Missing a Dose

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

If you have any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, D can cause side effects, although not everybody gets them.

Uncommon side effects (occurring in 1 to 10 per 1,000 patients):

• hypercalcemia (elevated calcium levels in the blood) - symptoms include: nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, excessive thirst, frequent urination, muscle weakness, drowsiness, and confusion;
• hypercalciuria (elevated calcium levels in the urine).

Rare side effects (occurring in 1 to 10 per 10,000 patients):

• itching;
• rash;
• urticaria.

Side effects with unknown frequency (cannot be estimated from available data):

• constipation;
• bloating;
• nausea;
• abdominal pain;
• diarrhea.

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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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.

Reporting side effects will help gather more information on the safety of the medication.

5. How to Store D

Store the medication out of sight and reach of children.

Do not store above 25°C. Store in the original packaging to protect from light.

Do not use this medication after the expiration date stated on the carton after: Expiration Date (EXP). The expiration date refers to the last day of the specified month.

Medications should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Pack and Other Information

What D Contains

• The active substance of D is cholecalciferol. Each coated tablet contains 70 mg of cholecalciferol concentrate (in powder form), which corresponds to 0.175 mg (7000 IU) of cholecalciferol (vitamin D3).
• Other ingredients are:
• Tablet core:
• Cholecalciferol, powder composition:
• Cholecalciferol
• Sodium ascorbate
• all-rac-α-tocopherol
• Modified corn starch
• Sucrose
• Medium-chain triglycerides
• Colloidal anhydrous silica

Excipients:

• Microcrystalline cellulose
• Sodium croscarmellose
• Magnesium stearate

Coating:

• AquaPolish P white 014.95 MS with the composition:
• Hypromellose 15 mPa.s
• Hypromellose 6 mPa.s
• Titanium dioxide (E 171)
• Talc
• Medium-chain triglycerides
• Hydroxypropylcellulose 100 mPa·s

What D Looks Like and Contents of the Pack

The coated tablets are white or almost white, round, biconvex, scored, with a diameter of about 11 mm.

PVC/PVDC/Aluminum blister pack in a cardboard box.

The pack contains: 15, 30, 45, or 60 coated tablets.

Marketing Authorization Holder and Manufacturer

Natur Produkt Pharma Sp. z o.o.,

ul. Podstoczysko 30

07-300 Ostrów Mazowiecka

Tel.: +48 29 644 29 00

Date of Last Revision of the Leaflet: