Detritin

Package Leaflet: Information for the Patient

DETRITIN, 4000 IU, Coated Tablets

Cholecalciferol

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

Important Information for the Patient.
This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is DETRITIN and what is it used for

DETRITIN is a medication containing cholecalciferol (vitamin D3) as the active substance, in the amount of 4000 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 enough of it, or when the need for vitamin D is increased.
DETRITIN is indicated for use in the prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults with obesity [body mass index (BMI) ≥ 30].

2. Important information before taking DETRITIN

When not to take DETRITIN:

• if the patient is allergic to the active substance or any of the other ingredients of this medication (listed in section 6),
• in the case of increased calcium levels in the blood (hypercalcemia),
• in the case of increased calcium excretion in the urine (hypercalciuria),
• in the 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,
• if the patient has severe kidney function disorders (glomerular filtration rate <30 ml min 1.73 m²),< li>
• in the case of pseudo-hypoparathyroidism (a genetic metabolic disorder); in this case, vitamin D derivatives that are easier to control are available.
• in the case of children and adolescents under 18 years of age. In this case, vitamin D derivatives with lower potency are available.
• in pregnant and breastfeeding women. In this case, vitamin D derivatives with lower potency are available.

Warnings and precautions

Before starting to take DETRITIN, the patient should discuss it with their doctor or pharmacist.
During long-term use of this medication, the patient's calcium levels in the serum, calcium excretion in the urine, and kidney function should be monitored 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 include:

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

In the event of such symptoms, the patient should consult their doctor.
In patients with severe kidney impairment, vitamin D in the form of cholecalciferol is not properly metabolized, and other vitamin D derivatives should be used.
Before starting to take DETRITIN, the patient should consult their doctor if:

• the patient has pseudo-hypoparathyroidism (a genetic metabolic disorder);
• the patient has sarcoidosis (an immune system disorder characterized by the formation of small inflammatory nodules);
• the patient is immobilized and has osteoporosis (a metabolic bone disease characterized by decreased bone mineral density and bone weakening);
• the patient is taking other products containing vitamin D (see section: DETRITIN and other medications);
• the patient has kidney function disorders;
• the patient is being treated with digitalis glycosides or diuretics;
• vitamin D treatment is long-term (more than 3 months), as in such cases, the doctor should monitor the patient's calcium levels in the serum and urine, as well as check kidney function by measuring creatinine levels in the blood.

Children and adolescents

DETRITIN is contraindicated in children and adolescents under 18 years of age.
In this case, vitamin D derivatives with lower potency are available.

DETRITIN and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Other medications, dietary supplements, or food products containing vitamin D (cholecalciferol) should not be taken simultaneously with DETRITIN without medical supervision.
Antacids containing aluminum (used to treat stomach acid) taken with DETRITIN may increase aluminum levels in the blood, increasing the risk of toxic aluminum effects on bones.
Antacids containing magnesium, when taken with DETRITIN, may increase magnesium levels in the blood.
Certain antiepileptic, sedative, or hypnotic medications (containing phenytoin or barbiturates) taken with DETRITIN may reduce its effectiveness.
Certain diuretics may lead to hypercalcemia (elevated calcium levels) caused by decreased calcium excretion by the kidneys. During long-term treatment, calcium levels in the serum and urine should be monitored.
Concomitant use of glucocorticosteroids (synthetic adrenal cortex hormones) may counteract the effect of DETRITIN.
DETRITIN may enhance the effect and toxicity of digitalis glycosides, posing a risk of developing heart rhythm disorders. In such cases, the doctor should monitor the patient's calcium levels in the serum and urine, as well as perform periodic ECG tests.
Calcitonin, etidronate, and pamidronate (medications used to treat high calcium levels in the blood) should not be taken simultaneously with DETRITIN, as vitamin D may act antagonistically to them.
Rifampicin and isoniazid (medications used to treat tuberculosis) may reduce the effectiveness of DETRITIN.
Medications that cause fat absorption disorders, such as orlistat, liquid paraffin, or cholestyramine, may reduce vitamin D absorption in the gastrointestinal tract.
The cytotoxic medication actinomycin and imidazole antifungal medications disrupt vitamin D3 activity by inhibiting the conversion performed by the 1-hydroxylase enzyme of 25-hydroxyvitamin D in the kidneys.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Pregnancy
DETRITIN is contraindicated in pregnant women.
Breastfeeding
DETRITIN is contraindicated in breastfeeding women.

Driving and using machines

DETRITIN does not affect the ability to drive vehicles or operate machinery.
DETRITIN contains sucrose.If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medication.
DETRITIN 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 DETRITIN

This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Without medical supervision, this medication should not be taken for an extended period (more than 3 months) or in doses higher than recommended.

Dosage

Prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults with obesity

Typically, the recommended dose is 4000 IU per day, from October to April or throughout the year, if effective skin synthesis of vitamin D is not ensured during the summer months.
This medication should not be taken for a longer period than recommended or in higher doses, nor should other medications, dietary supplements, or food products containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs be taken simultaneously without consulting a doctor. The doctor may recommend measuring 25(OH)D levels in the blood serum.
Method of administration
The tablet should be taken with a sufficient amount of water.

Patients with kidney function disorders

This medication should not be taken in patients with kidney function disorders without medical supervision.

Patients with liver function disorders

There are no special dosage recommendations.

Children and adolescents under 18 years of age

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

Taking a higher dose of DETRITIN than recommended

In case of taking a higher dose of DETRITIN than recommended, the patient should contact their doctor. The doctor will decide on the appropriate treatment.
Symptoms of overdose: 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 of DETRITIN

A double dose should not be taken to make up for a missed tablet.
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, DETRITIN can cause side effects, although not everybody gets them.
Side effects that occur not very often (with a frequency of 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).

Side effects that occur rarely (with a frequency of 1 to 10 per 10,000 patients):

• itching;
• rash;
• hives.

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

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

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their 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 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 this medication.

5. How to store DETRITIN

The medication should be stored 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. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What DETRITIN contains

• The active substance of DETRITIN is cholecalciferol. Each coated tablet contains 40 mg of cholecalciferol (in the form of powder), which corresponds to 0.100 mg (4000 IU) of cholecalciferol (vitamin D3). Cholecalciferol powder composition:Cholecalciferol Sodium ascorbate all-rac-α-tocopherol Modified cornstarch Sucrose Medium-chain triglycerides Colloidal anhydrous silica

Other ingredients are:
Tablet core:
Microcrystalline cellulose (Type 102)
Crosarmellose sodium
Magnesium stearate
Tablet coating: Aqua Polish P white 014.95 MS
Hypromellose 15 mPa.s
Hypromellose 6 mPa.s
Titanium dioxide (E 171)
Talc
Medium-chain triglycerides
Hydroxypropylcellulose 100 mPa.s

What DETRITIN looks like and contents of the pack

White or almost white, round, biconvex coated tablets with a diameter of about 10 mm.
PVC/PVDC/Aluminum blister pack in a cardboard box.
Pack sizes: 15, 30, 60, 90, or 120 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: