Инструкция по применению DERIL
Содержание инструкции
DERIL 1 mcg capsule
Alfacalcidol
Generic medicine
Read this leaflet carefully before you take/give this medicine to the child because
it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed only for you/the child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What DERIL is and what it is used for
- 2. What you need to know before you take/give DERIL to the child
- 3. How to take/give DERIL to the child
- 4. Possible side effects
- 5. How to store DERIL
- 6. Contents of the pack and other information
1. What is DERIL and what is it used for
DERIL contains alfacalcidol, a precursor of vitamin D. DERIL is indicated in adults and adolescents weighing over
20 kg for the treatment of:
- fragility and decrease in bone mass and predisposition to fractures in patients with a kidney disease (Renal osteodystrophy) who are undergoing dialysis (a blood filtration system) or not.
- reduced functionality of the parathyroid glands, located in the neck (hypoparathyroidism).
- bone diseases caused by poor vitamin D metabolism, even in patients with a kidney disease (Vitamin D-resistant or D-dependent rachitis and osteomalacia (pseudo-deficient), rachitis and osteomalacia from other renal actions due to vitamin D metabolism).
- loss of bone consistency after menopause (Postmenopausal osteoporosis) (only in adult women in post menopause).
2. What you need to know before taking/giving DERIL to the child
Do not take DERIL
- if you are allergic to alfacalcidol or any of the other ingredients of this medicine (listed in section 6),
- if you are pregnant,
- if you suffer from high levels of calcium in the blood (hypercalcemia).
Warnings and precautions
Consult your doctor or pharmacist before taking/giving DERIL to the child.
Throughout the treatment period, your doctor will ask you/the child to undergo blood tests (calcium and phosphate levels, PTH, alkaline phosphatase and the calcium x phosphate product) and regular checks.
An increase in blood calcium levels (hypercalcemia) may occur during treatment with
DERIL, the symptoms of which may include loss of appetite (anorexia), fatigue, nausea and vomiting,
constipation or diarrhea, frequent need to urinate (polyuria), sweating, headache, intense thirst
(polydipsia), high blood pressure (hypertension), drowsiness and dizziness (see section 4 Possible
side effects).
In particular, inform your doctor if you/the child suffers from:
- hardening of the arteries, the large blood vessels of the body (arteriosclerosis), hardening (sclerosis) of the heart valves, stones (pebbles) in the kidney (nephrolithiasis), as in these cases it may
develop transient or permanent kidney damage;
- accumulation of calcium in the lung (calcification of lung tissue). This can cause heart disease;
- a bone disease caused by a kidney problem (renal bone disease) or severely reduced kidney function. The doctor may prescribe a medicine called a phosphate binder to avoid high levels of phosphate in the blood (hyperphosphatemia) and potential calcium deposits in healthy tissues (metastatic calcification);
- an inflammatory disease that can affect the whole body and leads to the formation of nodules (sarcoidosis) or a similar disease;
- a kidney disease (chronic renal failure).
Also inform your doctor if you/the child are taking digitalis glycosides, medicines to treat
heart disorders. You may experience increased calcium levels in the blood while taking these
medicines and consequently increases the possibility of heart rhythm disturbances.
Other medicines and DERIL
Inform your doctor or pharmacist if you/the child are taking, have recently taken or may
take any other medicine.
In particular, inform your doctor if you/the child are taking:
- anticonvulsants (e.g. barbiturates, phenytoin, carbamazepine or primidone), medicines to treat uncontrolled body movements, as it may be necessary to increase the doses of DERIL;
- magnesium-based antacids, medicines to treat heartburn;
- thiazide diuretics (medicines to treat high blood pressure) or preparations containing calcium. The doctor may ask you/the child to undergo blood tests;
- other preparations containing vitamin D;
- preparations containing aluminum (e.g. aluminum hydroxide, sucralfate);
- bile acid sequestrants, such as cholestyramine, medicines to treat high levels of fat in the blood. Take/give DERIL at least 1 hour before, or 4 to 6 hours after the bile acid sequestrant.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
DERIL should not be used during pregnancy unless your doctor deems it strictly
necessary.
Breastfeeding
Alfacalcidol is excreted in human milk. The doctor will decide whether to stop breastfeeding or
stop therapy with DERIL taking into account the benefit of breastfeeding for the child
and the benefit of therapy for you.
The doctor will carefully monitor the breastfed baby during your treatment with DERIL.
Driving and using machines
Alfacalcidol does not alter or alters negligibly the ability to drive vehicles and use machines.
However, dizziness may occur during treatment and therefore take this into account while driving or
using machinery.
3. How to take/give DERIL to the child
Take/give this medicine to the child following the doctor's or pharmacist's instructions exactly at all times. If you have any doubts, consult your doctor or pharmacist.
Throughout the treatment period, the doctor will ask that you/the child undergo blood tests and regular check-ups.
The recommended dose is 1 mcg per day.
The recommended maintenance dose is between 0.25 and 1 mcg per day based on the results obtained with therapy and from the laboratory tests that the doctor will ask you to undergo during treatment.
In case of osteoporosis, the doctor will indicate the most suitable dose for you based on your state of health.
In patients with severe bone dysfunction (with the exception of those with renal insufficiency), the doctor may increase the dosage between 1 and 3 mcg per day.
In patients with severe hypocalcemia, the doctor may increase the dosage between 3 and 5 mcg per day. In such patients, the doctor may also prescribe other medicines containing calcium.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experience any of the following symptoms, stop usingDERIL immediately and
consult a doctor or the nearest hospital where you will be given appropriate and specific treatment:
- High levels of calcium in the blood (hypercalcemia); your doctor will then have you resume therapy with a halved dose;
- High levels of phosphorus in the blood (hyperphosphoremia);
- High levels of calcium in the urine (hypercalciuria exceeding 6 mg/kg/24 h).
Possible side effects are listed below according to the following frequency:
common (may affect up to 1 in 10 people)
- high levels of calcium in the blood (hypercalcemia)
- high levels of phosphate in the blood (hyperphosphatemia)
- increased levels of calcium in the urine (hypercalciuria)
- abdominal pain and discomfort
- skin rash (various types of rash have been reported, such as erythematous, maculo-papular and pustular)
- itching uncommon (may affect up to 1 in 100 people)
- headache
- diarrhoea
- vomiting
- constipation
- nausea
- muscle pain (myalgia)
- stones (pebbles) in the kidney (nephrolithiasis/nephrocalcinosis)
- fatigue/weakness/malaise
- formation of calcium deposits in tissues (calcinosis) rare (may affect up to 1 in 1,000 people)
- dizziness frequency not known (the frequency cannot be estimated from available data)
- kidney damage (including acute renal failure)
- confusional state
Additional side effects in children
The safety profile observed is similar between adults and children
Reporting of side effects
If you/the child experience any side effects, including those not listed in this leaflet,
please inform your doctor or pharmacist. You can also report side effects directly through the
national reporting system at “https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse”.
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store DERIL
Keep away from sources of heat, humidity and light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after SCAD. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What DERIL contains
- The active ingredient is alfacalcidol 1 mcg.
- The other ingredients are: Covi-ox T70 (E306), Fractionated coconut oil, Gelatin, Glycerol, Purified water, Titanium dioxide (E171), Iron oxide (E172)
Description of the appearance of DERIL and contents of the pack
DERIL is presented as capsules.
It is available in packs of 30 capsules containing 1 mcg of active ingredient.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
LANOVA FARMACEUTICI S.r.l.
Via Conca D’Oro n. 212 – 00141 Rome
Manufacturer
LABORATORIOS ALCALA‘ FARMA S.L. – C/Nunneaton, 85 – Guadalajara, 19004 Guadalajara –
Spain
Primary and secondary packaging
LABORATORIOS ALCALA‘ FARMA S.L. – Avenida De Madrid, 82 – Alcalà De Henares – Madrid
- 28802 – Spain
Controlled by:
LABORATORIOS ALCALA’ FARMA S.L. - Avenida De Madrid, 82 – Alcalà De Henares – Madrid
- 28802 – Spain

- Страна регистрации
- Форма выпускаSoft capsule, 1 MCG
- Код АТХA11CC03
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги DERILФорма выпуска: Soft capsule, 1 MICROGRAMДействующее вещество: Альфа-кальцидолПроизводитель: DOC GENERICI SRLОтпускается по рецептуФорма выпуска: Soft capsule, 0.25 microgramsДействующее вещество: Альфа-кальцидолПроизводитель: ZENTIVA ITALIA S.R.L.Отпускается по рецептуФорма выпуска: Soft capsule, 0.25 MCGДействующее вещество: Альфа-кальцидолПроизводитель: THERAMEX IRELAND LIMITEDОтпускается по рецепту
Аналоги DERIL в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог DERIL в Польша
Аналог DERIL в Испания
Врачи онлайн по DERIL
Обсудите применение DERIL и возможные следующие шаги — по оценке врача.
Получите рецепт на DERIL онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
DERIL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество DERIL — Альфа-кальцидол. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
DERIL производится компанией LANOVA FARMACEUTICI S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения DERIL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить DERIL в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Альфа-кальцидол) включают ALFAKALKIDOLO DOK, ALFAKALKIDOLO TSENTIVA, ALPA D3. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















