Detriol

Package Leaflet: Information for the Patient

Detriol, 0.5 micrograms, soft capsules
Calcitriol
For use in adults

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What Detriol is and what it is used for
• 2. Before you take 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 Detriol is and what it is 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 progressive secondary hyperparathyroidism (overactivity of the parathyroid glands) leading to renal osteodystrophy (bone changes) with moderate or severe chronic kidney failure.
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hypocalcemia (low calcium levels) 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. Before you take 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 high levels of calcium in the blood or urine (hypercalcemia or hypercalciuria),
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if you have familial hypophosphatemic rickets associated with high levels of calcium 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, you should 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 increased calcium levels in the blood.
During treatment with Detriol, blood calcium levels will be regularly monitored to avoid incorrect dosing and high calcium levels in the blood (hypercalcemia) or urine (hypercalciuria) (see section 3 "How to take Detriol").
Regular laboratory tests should also include measurements of phosphate, magnesium, alkaline phosphatase, and urine phosphate levels.

• Special care should be taken when treating 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 increased calcium levels in the blood (hypercalcemia) and urine (hypercalciuria).
• Chronic hypercalcemia can lead to generalized calcification of blood vessels, kidney calcification, and other soft tissue calcifications, so treatment must be discontinued.
• Calcitriol increases inorganic phosphate levels in the blood. Although this is desirable in patients with low phosphate levels (hypophosphatemia), caution is advised in patients with chronic kidney function disorders, due to the risk of ectopic calcifications. In such cases, blood phosphate levels should be maintained within normal limits through oral phosphate binders and a low-phosphate diet.
• If the patient has both hereditary hypophosphatemic rickets and low phosphate levels, oral phosphate treatment should be continued. However, the need for oral phosphate may be reduced, as Detriol also stimulates phosphate absorption from the gut into the blood.
• When switching from ergocalciferol (vitamin D) to calcitriol treatment, it may take several months for the ergocalciferol blood levels to return to baseline values.
• If kidney function is normal, you should ensure that 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 with other medicines

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

• There is a risk of increased 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 heart rhythm disturbances due to increased calcium levels in the blood.
• Concomitant use with glucocorticoids may reduce the effectiveness of Detriol. Glucocorticoids 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 increased magnesium levels in the blood.
• If the patient is also taking phosphate binders (e.g., aluminum hydroxide or aluminum carbonate), dosing should be based on blood phosphate levels.
• If the patient is also taking enzyme inducers, such as phenobarbital (a sleep aid) or phenytoin (an antiepileptic medication), 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 disrupt the absorption of calcitriol from the gut.
• If the patient is taking orlistat (a weight loss medication), laxatives containing liquid paraffin, or cholestyramine (a cholesterol-lowering medication), the absorption of vitamin D from the gut may be reduced.

Detriol with food and drink

You should 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 are planning 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 retardation, as well as heart and eye diseases).
During treatment with Detriol in pregnant women, blood calcium levels should be closely monitored, and this period should be extended to the postpartum period (see section 3 "How to take Detriol").
Breastfeeding
It is assumed that calcitriol passes into breast milk. During treatment with Detriol in breastfeeding women, blood calcium levels 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 produce 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 allergic to peanuts or soy.

3. How to take Detriol

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Note:

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

Always follow your doctor's recommendations for supplementary calcium dosing to avoid increasing calcium levels in the blood.

Detriol 0.5 micrograms is only used in patients whose maintenance dose is 0.5 micrograms or more per day. Treatment should always start with 1 capsule of Detriol 0.25 micrograms. During treatment, blood calcium levels and urine should be regularly monitored. If high 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 progressive secondary hyperparathyroidism (overactivity of the parathyroid glands) leading to renal osteodystrophy (bone changes) with moderate or severe chronic kidney failure
At the start of treatment, 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 can be increased at 2 to 4-week intervals by 0.25 micrograms of calcitriol (1 soft capsule of Detriol 0.25 micrograms) per day.
Most patients respond to a dose of 0.5 to 1.0 micrograms of calcitriol per day.
The maximum dose should not exceed 12 micrograms per week.
Hypocalcemia (low calcium levels) 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 can 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 dosage recommendations. In children under 6 years of age, there is a risk of choking due to the pharmaceutical form (capsule).

Method of administration

Orally.
The 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.
If symptoms of overdose occur (see section 4 "Possible side effects"), you should immediately consult a doctor.

Missing a dose of Detriol

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

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 medicine, 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 increased calcium levels in the blood (hypercalcemia).
Very common (may affect more than 1 in 10 people):
Increased 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, increased 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, hives, increased thirst, dehydration, weight loss, apathy, mental disorders, muscle weakness, sensory disturbances, drowsiness, heart rhythm disturbances, constipation, intestinal obstruction due to muscle paralysis (paralytic ileus), skin redness (flush), itching, 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 high 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 return to normal within a few days after withdrawal or dose reduction, i.e., much faster than with vitamin D supplements.
As chronic side effects, muscle weakness, weight loss, sensory disturbances, fever, thirst, or increased thirst may occur, as well as increased urine output, dehydration, apathy, delayed growth, or urinary tract infections.
Concomitant increases in calcium and phosphate levels in the blood may lead to soft tissue calcification visible on X-ray.
In sensitive patients, allergic reactions (itching, rash, hives, and – very rarely – serious skin diseases with redness) may occur.
In patients with normal kidney function, persistent high calcium levels in the blood (chronic hypercalcemia) may be associated with increased creatinine levels in the blood.
No significant differences in the types of side effects are expected in specific patient groups, e.g., elderly patients.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety, 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 contents: Peanut oil, purified (peanut oil), butylated hydroxyanisole, butylated hydroxytoluene, ethanol, anhydrous.

Capsule shell:
Gelatin, glycerol 85%, sorbitol 70%, non-crystallizing, iron oxide red (E 172).
Detriol, soft capsules, 0.5 micrograms contain peanut oil (from peanuts), sorbitol, and alcohol (ethanol) (see section 2).

What Detriol looks like and contents of the pack

Detriol, soft capsules, 0.5 micrograms are opaque, red, 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