Detriol

Package Leaflet: Information for the Patient

Detriol, 0.25 micrograms, soft capsules
Calcitriol
For use in adults

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 Package Leaflet

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

1. What is Detriol and what is it used for

Calcitriol, the active substance of Detriol, is a metabolite of vitamin D. It is the biologically active form of vitamin D, known as hormone D (calcium metabolism regulator).
Detriol is used inthe treatment of adult patients with:
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severe or progressing secondary hyperparathyroidism (hyperparathyroidism) leading to renal osteodystrophy (bone changes) with moderate or severe chronic kidney failure.
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hypocalcemia (low calcium level) caused by hypoparathyroidism.
Hypoparathyroidism may occur:
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after surgery (postoperative hypoparathyroidism),
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without a recognizable cause (idiopathic hypoparathyroidism) or
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due to phosphate metabolism disorders (pseudohypoparathyroidism).
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hereditary (or familial) hypophosphatemic rickets (HPDR), a form of rickets that does not respond to vitamin D.

2. Important information before taking Detriol

When not to take Detriol

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if you are allergic to calcitriol, other substances in the same class (vitamin D or its metabolites), peanuts, soy, or any of the other ingredients of this medicine (listed in section 6),
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if you have any disorder related to elevated calcium levels in the blood or urine (hypercalcemia or hypercalciuria),
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if you have familial hypophosphatemic rickets associated with elevated calcium levels in the urine,
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if you have suspected hypervitaminosis D,
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if you have metastatic calcification (calcification of tissues),
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if you have nephrocalcinosis (kidney calcification) or kidney stones (nephrolithiasis).

Warnings and precautions

Before starting treatment with Detriol, discuss it with your doctor or pharmacist.
Taking Detriol may cause an increase in calcium levels in the blood (hypercalcemia).
The effect of Detriol is closely related to diet, especially calcium levels. For example, an increase in calcium levels in the blood may also be caused by changes in eating habits (increased consumption of dairy products) or uncontrolled use of calcium supplements.
Therefore, you should strictly follow the diet prescribed by your doctor and take calcium supplements only as recommended by your doctor.
Since the active substance of Detriol is the most active metabolite of vitamin D, you should not take any other vitamin D supplements during treatment with Detriol (including analogs or metabolites of vitamin D) or food products that may be enriched with vitamin D, as this may lead to an overdose of vitamin D and elevated calcium levels in the blood.
During treatment with Detriol, calcium levels in the blood serum will be regularly monitored to avoid improper dosing and elevated calcium levels in the blood (hypercalcemia) or urine (hypercalciuria) (see section 3 "How to take Detriol").
Regular laboratory tests also include measuring phosphate, magnesium, alkaline phosphatase, and urine phosphate levels.

• Particular caution should be exercised during treatment with thiazides (some diuretics), in cases of sarcoidosis, history of kidney stones, or immobilization (e.g., after surgery), as there is a higher risk of elevated calcium levels in the blood (hypercalcemia) and urine (hypercalciuria).
• Chronic hypercalcemia can lead to generalized vascular calcification, kidney calcification, and other soft tissue calcifications, so treatment must be discontinued.
• Calcitriol increases inorganic phosphate levels in serum. Although this is desirable in patients with low phosphate levels in the blood (hypophosphatemia), caution should be exercised in patients with chronic kidney function disorders due to the risk of ectopic calcifications. In such cases, serum phosphate levels should be maintained within normal limits through oral administration of phosphate-binding agents and a low-phosphate diet.
• If the patient has both familial hypophosphatemic rickets and low phosphate levels in the blood, oral phosphate treatment should be continued. However, it is possible that the need for oral phosphate may be reduced, as Detriol also stimulates phosphate absorption from the gut into the blood.
• In the event of a change from ergocalciferol (vitamin D) treatment to calcitriol treatment, it may take several months for the ergocalciferol level in the blood to return to baseline values.
• If kidney function is normal, ensure that the amount of fluid intake is adequate during treatment with Detriol.

Attention should be paid to early recognition and treatment of magnesium balance disorders due to their great importance in regulating calcium levels in the blood or urine.
Children and adolescents
Detriol is not recommended for use in children and adolescents.

Detriol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• There is a risk of elevated calcium levels in the blood (hypercalcemia) in patients also taking thiazide diuretics (some diuretics).
• In patients also taking digitalis products (heart medications), Detriol should be administered with caution, as they may experience cardiac arrhythmias due to elevated calcium levels in the blood.
• Concomitant use with glucocorticosteroids may reduce the effectiveness of Detriol. Glucocorticosteroids inhibit calcium absorption.
• If the patient is undergoing dialysis, they should not take any magnesium-containing medications (e.g., antacids) during treatment with Detriol, as this may lead to elevated magnesium levels in the blood.
• If the patient is also taking phosphate-binding agents (e.g., aluminum hydroxide or aluminum carbonate), dosing should be adjusted based on serum phosphate levels.
• If the patient is also taking enzyme inducers, such as phenobarbital (a sedative) or phenytoin (an antiepileptic), the effect of Detriol may be reduced. Enzyme inducers accelerate the breakdown of calcitriol, so higher doses of Detriol may be necessary.
• Detriol may be less effective if taken with substances that form complexes with bile acids, such as cholestyramine or sevelamer. This may limit the absorption of fat-soluble vitamins from the gut and also disrupt the absorption of calcitriol from the gut.
• If the patient is taking orlistat (a medication for obesity), laxatives containing liquid paraffin, or cholestyramine (a medication to lower high cholesterol), the absorption of vitamin D from the gut may be reduced.

Detriol with food and drink

Always follow the recommended calcium diet. Avoid sudden increases in calcium intake due to changes in eating habits (e.g., increased consumption of dairy products) or uncontrolled use of calcium supplements.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is no experience with the use of calcitriol during pregnancy and breastfeeding.
Pregnancy
Calcitriol should only be used during pregnancy if clearly necessary.
Overdose of calcitriol may harm the baby (risk of physical and mental impairment, as well as heart and eye diseases).
During treatment with Detriol in pregnant women, calcium levels in the blood serum should be closely monitored, and this period should be extended to the postpartum period (puerperium) (see section 3 "How to take Detriol").
Breastfeeding
It should be assumed that calcitriol passes into breast milk. During treatment with Detriol in breastfeeding women, calcium levels in the blood serum should be regularly monitored in both the mother and the infant.

Driving and using machines

Detriol has no or negligible influence on the ability to drive and use machines. No studies have been conducted.

Detriol contains alcohol and sorbitol

This medicine contains 0.869 mg of alcohol (ethanol) in each capsule. The amount of alcohol in 1 capsule of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
Detriol contains 6 mg of sorbitol in each dose, which corresponds to 2 mg of fructose in the body.

Detriol contains peanut oil (from peanuts)

Do not use if you are hypersensitive to peanuts or soy.

3. How to take Detriol

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Note:

The optimal daily dose of Detriol is carefully determined for each patient based on serum calcium levels. If necessary, treatment with Detriol is supplemented with calcium supplements. To avoid elevated calcium levels in the blood, always follow your doctor's recommendations for supplemental calcium dosing.

Always follow your doctor's recommendations for supplemental calcium dosing to avoid elevated calcium levels in the blood.
Always follow your doctor's recommendations for supplemental calcium dosing.
Treatment should always start with the smallest possible dose (0.25 µg) and only be increased if accompanied by close monitoring of serum and urine calcium levels. If elevated calcium levels in the blood (hypercalcemia) or urine (hypercalciuria) occur, Detriol should be discontinued until calcium levels return to normal. You should also consider reducing calcium intake in your diet.
Severe or progressing secondary hyperparathyroidism (hyperparathyroidism) leading to renal osteodystrophy (bone changes) with moderate or severe chronic kidney failure
Initially, the daily dose is 1 soft capsule of Detriol 0.25 micrograms.
In patients with normal or only slightly decreased calcium levels in the blood, 1 soft capsule of Detriol 0.25 micrograms every other day is sufficient.
If no satisfactory effect on clinical and biochemical test results is observed within 2 to 4 weeks, the dose may be increased at 2 to 4-week intervals by 0.25 micrograms of calcitriol (1 soft capsule of Detriol) per day.
Most patients respond to a dose of 0.5 micrograms to 1.0 micrograms of calcitriol per day.
Do not exceed the maximum dose of 12 micrograms per week.
Hypocalcemia (low calcium level) caused by hypoparathyroidism
The recommended initial dose is 1 soft capsule of Detriol 0.25 micrograms per day.
If there is no improvement in clinical symptoms and biochemical test results, the dose may be increased at 2 to 4-week intervals by 0.25 micrograms of calcitriol.
Hereditary (or familial) hypophosphatemic rickets (HPDR)
Treatment starts with 0.25 micrograms of calcitriol per day and must be monitored.
Elderly patients
No dose adjustment is required in elderly patients.
Renal impairment
No data are available.

Use in children and adolescents

Detriol is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of calcitriol capsules have not been sufficiently investigated to provide dosing recommendations. In children under 6 years of age, there is a risk of choking due to the pharmaceutical form (capsule).

Method of administration

Orally.
Soft capsules should be taken whole (not chewed), with a small amount of liquid, in the morning during breakfast. Patients requiring higher doses should take the total daily dose divided into 2 to 3 single doses, all with a meal.

Duration of treatment

The duration of treatment depends on the symptoms of the disease and laboratory parameters. Therefore, it must be determined individually for each patient by the attending physician.

Taking a higher dose of Detriol than recommended

No cases of acute overdose with Detriol have been reported. Based on theoretical considerations, a single overdose is unlikely to cause any symptoms.
In the event of overdose symptoms (see section 4 "Possible side effects"), consult your doctor immediately.

Missing a dose of Detriol

Do not take a double dose to make up for a missed dose. Continue taking the medicine as prescribed.

Stopping treatment with Detriol

Do not stop or discontinue treatment without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Detriol can cause side effects, although not everybody gets them.
The most commonly reported side effect was elevated calcium levels in the blood (hypercalcemia).
Very common (may affect more than 1 in 10 people):
Elevated calcium levels in the blood (hypercalcemia).
Common (may affect up to 1 in 10 people):
Headache, abdominal pain, nausea, rash, urinary tract infections.
Uncommon (may affect up to 1 in 100 people):
Decreased appetite, vomiting, elevated creatinine levels in the blood.
Rare (may affect up to 1 in 1,000 people):
Severe allergic reactions caused by peanut oil.
Frequency not known (frequency cannot be estimated from the available data):
Hypersensitivity, urticaria, increased thirst, dehydration, weight loss, apathy, psychiatric disorders, muscle weakness, sensory disturbances, somnolence, cardiac arrhythmias, constipation, intestinal obstruction due to muscle paralysis (paralytic ileus), skin redness (erythema), pruritus, delayed growth, increased urine output, nocturia, pathological calcium deposits in the skin and organs (calcification), fever, thirst.
As calcitriol has a vitamin D effect, possible side effects are comparable to symptoms of vitamin D overdose, i.e., various symptoms of elevated calcium levels in the blood (hypercalcemia syndrome) or calcium poisoning (depending on the severity and duration of elevated calcium levels in the blood).
Due to the short biological half-life of calcitriol, pharmacokinetic studies have shown that elevated calcium levels in the blood serum normalize within a few days after withdrawal or dose reduction, i.e., much faster than with vitamin D supplements.
As chronic side effects, the following may occur: muscle weakness, weight loss, sensory disturbances, fever, thirst, or increased thirst, increased urine output, dehydration, apathy, delayed growth, or urinary tract infections.
Concomitant elevated calcium and phosphate levels in the blood may lead to soft tissue calcification visible on X-ray.
In sensitive patients, allergic reactions (pruritus, rash, urticaria, and - very rarely - serious skin diseases with redness) may occur.
In patients with normal kidney function, persistent elevated calcium levels in the blood (chronic hypercalcemia) may be associated with elevated creatinine levels in the blood serum.
No significant clinical differences in the type of side effects are expected in specific patient groups, e.g., elderly patients.

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:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Detriol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep the bottle tightly closed in the outer packaging to protect from light.
Shelf life after first opening the bottle: 4 months.

6. Contents of the pack and other information

What Detriol contains

• The active substance is: calcitriol
• The other ingredients are: Capsule content: Peanut oil, purified (peanut oil), butylated hydroxyanisole, butylated hydroxytoluene, anhydrous ethanol.

Capsule shell:
Gelatin, glycerol 85%, sorbitol 70%, non-crystallizing, iron oxide red (E 172), titanium dioxide (E 171).
Detriol, soft capsules, 0.25 micrograms contain peanut oil (peanut oil), sorbitol, and alcohol (ethanol) (see section 2).

What Detriol looks like and contents of the pack

Detriol, soft capsules, 0.25 micrograms are opaque, pink, oval, soft capsules.
Detriol is available in packs of 90 or 100 soft capsules.
Not all pack sizes may be marketed .

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
phone: +48 22 350 66 69

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
Date of last revision of the leaflet:09.2022