Detrical

Poland
Brand name Detrical
Form tablets, film-coated
Active substance / Dosage
cholecalciferol · 7000 IU
Prescription type Prescription only
ATC code
A11CC05
Registration number 100432363
Manufacturer Natur Produkt Pharma Sp. z o.o.
Detrical tablets, film-coated

Table of Contents

Package leaflet: Information for the patient

DETRICAL, 7000 IU, coated tablets
Cholecalciferolum
Please read this leaflet carefully before taking the 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 doubts, please consult your doctor or pharmacist.
  • This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
  • If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

D is a medicine containing as the active substance cholecalciferol (vitamin D3) in an amount of 7000 IU (international units, IU) in each coated tablet. Vitamin D3 is involved in many metabolic processes, and its deficiency adversely affects health and well-being. Vitamin D3 supports calcium and phosphorus metabolism in the body and ensures adequate bone mineralization.
Vitamin D is produced in the skin under the influence of sunlight and is also supplied to the body through food. Vitamin D deficiency may occur when diet and lifestyle (insufficient exposure to sunlight) do not provide sufficient amounts, or when the requirement 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 individuals),
  • as an adjunct to specific osteoporosis treatment in patients with vitamin D deficiency or in patients at risk of vitamin D deficiency.

2. Important information before taking medicine D

When not to take medicine D:

  • if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
  • in case of increased calcium levels in the blood (hypercalcemia),
  • in case of increased calcium excretion in urine (hypercalciuria),
  • in case of increased vitamin D levels in the blood (hypervitaminosis D),
  • if the patient has diseases and (or) conditions leading to hypercalcemia and (or) hypercalciuria,
  • if the patient has kidney stones (nephrolithiasis),
  • if the patient has severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m²),
  • if the patient has pseudohypoparathyroidism (vitamin D requirement 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 patient group, less potent vitamin D derivatives are available.
  • in pregnant and breastfeeding women. For this patient group, less potent vitamin D derivatives are available.

Warnings and precautions
Before starting to take D, discuss this with your doctor or pharmacist.
During long-term use of this medicine, serum calcium levels, urinary calcium excretion, and kidney function (by measuring serum creatinine concentration) should be monitored. This is particularly important in elderly patients, patients concurrently taking cardiac glycosides or diuretics, in patients with hyperphosphatemia (increased blood phosphate levels), and in patients at increased risk of kidney stones.
Symptoms that may indicate vitamin D excess in the body include:

  • malaise, lethargy and weakness, irritability,
  • nausea and vomiting, abdominal pain, loss of appetite, constipation,
  • excessive thirst,
  • increased frequency of urination,
  • headaches, eye and skin pain,
  • skin itching.

If such symptoms occur, consult a doctor.
In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol is not adequately metabolized and other vitamin D derivatives should be used.
Before starting medicine D, inform your doctor if:

  • the patient has pseudohypoparathyroidism;
  • the patient has sarcoidosis (an immune system disorder characterized by formation of small inflammatory nodules);
  • the patient is immobilized and has osteoporosis (a metabolic bone disease characterized by decreased bone mineral density and weakening of bones);
  • if the patient is taking other products containing vitamin D (see section: Medicine D and other medicines);
  • the patient has kidney disorders;
  • the patient is being treated with cardiac glycosides or diuretics.

Children and adolescents
Medicine D is contraindicated in children and adolescents under 18 years of age.
In this case, less potent vitamin D derivatives are available.
Medicine D and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take other medicines, dietary supplements, or food products containing vitamin D (cholecalciferol) simultaneously with medicine D without medical supervision.
Antacids containing aluminum (used in the treatment of gastric hyperacidity), when taken together with medicine D, may increase aluminum levels in the blood, increasing the risk of aluminum's toxic effects on bones.
Antacids containing magnesium, when used concurrently with medicine D, may increase magnesium levels in the blood.
Some antiepileptic, sedative or hypnotic drugs (containing phenytoin or barbiturates), when used concurrently with medicine D, may reduce its effectiveness.
Some diuretics may lead to hypercalcemia (increased calcium levels) caused by reduced renal calcium excretion. During long-term treatment, serum and urinary calcium levels should be monitored.
Concomitant use of glucocorticosteroids (synthetic corticosteroid hormones) may counteract the effect of medicine D.
D may enhance the effects and toxicity of cardiac glycosides, increasing the risk of cardiac arrhythmias. In such cases, the doctor should monitor serum and urinary calcium levels and perform periodic ECG examinations.
Concomitant use of vitamin D metabolites or analogs (e.g. calcitriol) and medicine D is possible only on a doctor's prescription and only in exceptional cases, provided serum calcium levels are monitored.
Rifampicin and isoniazid (medicines used in the treatment of tuberculosis) may reduce the effectiveness of medicine D.
Vitamin D may act antagonistically to drugs used in hypercalcemia such as calcitonin, etidronate, pamidronate.
Medicines that cause fat malabsorption, e.g. orlistat, liquid paraffin or cholestyramine, may reduce vitamin D absorption in the gastrointestinal tract.
The cytotoxic drug actinomycin and imidazole antifungal agents may impair vitamin D3 activity by inhibiting the renal enzyme 1-hydroxylase-mediated conversion of 25-hydroxyvitamin D.

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 or pharmacist before using this medicine.
Pregnancy
Medicine D is contraindicated in pregnant women.
Breastfeeding
Medicine D is contraindicated in breastfeeding women.
Driving and operating machinery
Medicine D has no influence on the ability to drive motor vehicles or operate machinery.
Medicine D contains sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Medicine D contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take medicine D

This medicine should always be taken exactly as described in this patient leaflet, or as advised by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally. Treatment should be continued until normal vitamin D3 levels
in the body are achieved.
The vitamin D content in one tablet corresponds to a weekly dose.
The dosage should be determined by a doctor.

Dosage
Adults, including elderly patients
Treatment of vitamin D deficiency
1 tablet daily for several weeks until 25(OH)D levels exceed 30 ng/mL, followed by a maintenance
dose depending on the patient's age and body weight, every two days.
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
Medicine D is contraindicated in children and adolescents under 18 years of age.

Patients with impaired kidney function or hypercalcemia (elevated calcium levels)
You should contact your doctor immediately, as the dose may need to be reduced or treatment
discontinued. Your doctor may recommend regular blood and urine tests.

Patients with impaired liver function
Dosage adjustment is not required.

If you take more medicine D than recommended
If you take more than the recommended dose, contact your doctor. The doctor will decide on
appropriate treatment.
Symptoms of overdose: nausea, vomiting, diarrhea followed by constipation, loss of appetite,
fatigue, headache, muscle pain, joint pain, muscle weakness, drowsiness, azotemia (increased
blood levels of nitrogen compounds), excessive thirst, polyuria (excessive urination), and dehydration.
In cases of markedly elevated blood calcium levels, disturbances in heart function, kidney failure,
psychoses, and even coma may occur.

If you forget to take medicine D
Do not take a double dose to make up for a missed tablet.
If you have any further questions about 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 everybody will experience them.
Adverse effects occurring not very frequently (frequency of 1 to 10 per 1,000 patients):

  • Hypercalcaemia (excessively high calcium levels in the blood) – symptoms include: nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, excessive thirst, increased frequency of urination, muscle weakness, drowsiness and confusion;
  • Hypercalciuria (excessively high calcium levels in urine).

Rare adverse effects (frequency of 1 to 10 per 10,000 patients):

  • Itching;
  • Rash;
  • Urticaria.

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

  • Constipation;
  • Bloating;
  • Nausea;
  • Abdominal pain;
  • Diarrhoea.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store medicine D

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton after: Expiry (EXP). The expiry date refers to the last day of the stated month.
Medicines must 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 package and other information

What the medicine contains D

  • The active substance is cholecalciferol. Each coated tablet contains 70 mg of Cholecalciferol concentrate (in powder form), corresponding to 0.175 mg (7000 IU) of Cholecalciferol (vitamin D3).
  • Other components:

    • Tablet core:

      • Cholecalciferol, powder composition:
        • Cholecalciferol
        • Sodium ascorbate
        • all-rac-α-tocopherol
        • Modified maize starch
        • Sucrose
        • Medium-chain triglycerides
        • Colloidal anhydrous silica

    • Excipients:

      • Microcrystalline cellulose
      • Sodium croscarmellose
      • Magnesium stearate

    • Tablet coating:

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

What Detrical D looks like and contents of the pack
The coated tablets are white or almost white, round, biconvex, film-coated, with a diameter of approximately 11 mm.
PVC/PVDC/Aluminium blister in a cardboard box.
Pack contents: 15, 30, 45 or 60 coated tablets.

Marketing Authorisation Holder and Manufacturer
Natur Produkt Pharma Sp. z o.o.,
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
Tel.: + 48 29 644 29 00