Инструкция по применению OSTIDIL-D3
Содержание инструкции
OSTIDIL-D3 0.25 micrograms soft capsules, 1 microgram soft capsules
Alfacalcidol
Generic medicine
Read this leaflet carefully before taking this medicine as 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 for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What OSTIDIL-D3 is and what it is used for.
- 2. What you need to know before you take OSTIDIL-D3
- 3. How to take OSTIDIL-D3
- 4. Possible side effects
- 5. How to store OSTIDIL-D3
- 6. Contents of the pack and other information
1. What is OSTIDIL-D3 and what is it used for
OSTIDIL-D3 contains the active ingredient alfacalcidol, a precursor of vitamin D3.
OSTIDIL-D3 is used to treat:
- 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, which control calcium metabolism (Hypoparathyroidism).
- bone diseases characterized by a defect in bone mineralization (caused by poor vitamin D metabolism and resistant to vitamin D (Rickets and osteomalacia D-resistant or D-dependent (pseudo-deficient)).
- (Rickets and osteomalacia due to kidney alterations due to vitamin D metabolism).
- loss of bone consistency after menopause (Postmenopausal osteoporosis).
2. What you need to know before taking OSTIDIL-D3
Do not take OSTIDIL-D3:
- if you are allergic or hypersensitive to Vitamin D or to any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant or breastfeeding
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- if you suffer from high levels of calcium in the blood (hypercalcemia) if you suffer from established vitamin D toxicity/excessive vitamin intake (hypervitaminosis).
Warnings and precautions
Talk to your doctor or pharmacist before taking OSTIDIL-D3
Throughout the treatment period, the doctor will ask you/the child to undergo
blood tests to monitor the following values:
- calcium levels as Ostidil-d3 can cause high levels of calcium in the blood (hypercalcemia) and increased calcium excretion in the urine (hypercalciuria). In this way, they will assess the most suitable dosage for you and monitor any toxicity of the medicine in case of symptoms. Tell your doctor if you are breastfeeding as infants will also need to be monitored. If calcium levels are high (hypercalcemia), the doctor will stop the treatment until values return to normal, generally quickly, and will prescribe the medicine at a lower dosage.
- phosphate levels to reduce the risk of calcium deposits in the bones (ectopic calcifications)
- alkaline phosphatase levels as this anticipates hypercalcemia
Also, tell your doctor if you/the child are taking:
- digitalis glycosides, medicines for treating heart disorders. You may experience increased calcium levels in the blood while taking these medicines and consequently increases the possibility of heart rhythm disturbances.
- phosphate-binding substances as OSTIDIL-D3 influences the transport of phosphates in the intestine, kidney and bones and simultaneous administration should be evaluated by the doctor based on the concentration of phosphate in the blood (phosphatemia)
- an adequate intake of vitamin D from the diet and exposure to sunlight as vitamin D supplementation in this case may be harmful.
Tell your doctor before taking OSTIDIL-d3 if:
- you are breastfeeding as infants may be sensitive
- you suffer from a kidney disease (kidney impairment or stones), or
- you suffer from a heart disease.
- you are taking vitamin D or its derivatives as an overdose of vitamin D causes even serious effects such as increased calcium levels in the blood (hypercalcemia) which, if chronic, could cause widespread calcification in blood vessels, calcification at the kidney level (nephrocalcinosis) and calcification of other soft tissues, which may also require emergency therapy.
Other medicines and OSTIDIL-D3
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
In particular, tell your doctor if you/the child are taking:
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- anticonvulsants (e.g. barbiturates, diphenylhydantoin), medicines for treating uncontrolled body movements, as it may be necessary to increase the doses of OSTIDIL-D3;
- magnesium-based drugs to avoid increased magnesium in the blood (hypermagnesemia);
- (medicines for treating high blood pressure (thiazide diuretics) or preparations containing calcium as they can increase calcium levels in the blood. The doctor may ask you/the child to undergo blood tests;
- other preparations containing vitamin D due to the possibility of an additive effect and increased risk of increased calcium in the blood (hypercalcemia);
- preparations containing aluminum because they can interfere with the effectiveness of the drug;
- bile acid sequestrants, such as cholestyramine, medicines for treating high levels of fat in the blood as it may reduce the intestinal absorption of Ostidil-d3;
- an anticoagulant drug called warfarin as its action may be potentiated;
- drugs used in infectious diseases (Rifampicin and isoniazid) as they can reduce the effectiveness of vitamin D;
- drugs used in inflammation (corticosteroids) can counteract the effect of vitamin D.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The product should be administered during pregnancy and breastfeeding only in case of actual
need under direct medical supervision who will establish the risk/benefit.
Driving and operating machinery
OSTIDIL-D3 does not alter or negligibly alters the ability to drive vehicles and operate
machinery,
3. How to take OSTIDIL-D3
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is:
Adults and adolescents:
weighing over 20 Kg: 1 microgram per day.
Children:
weighing under 20 kg: 0.05 micrograms/Kg per day.
Subsequently the dose may be adjusted according to the response. Depending on the needs
and the weight of the patients.
If you take more OSTIDIL-D3 than you should
If you take more OSTIDIL-D3than prescribed by your doctor, contact your doctor or pharmacist immediately.
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Excessive intake of vitamin D leads to an increase in calcium levels in the blood (hypercalcemia). Overdose symptoms are: loss of appetite (anorexia), fatigue, nausea and vo-
miting, constipation or diarrhea, increased urine production (polyuria), need
to urinate at night (nocturia), sweating, headache, thirst, drowsiness and dizziness. If toxicity occurs, your doctor will tell you to stop treatment with OSTIDIL-D3 and will adopt some sup-
portive measures.
In case of a severe increase in blood calcium levels (hypercalcemia) due to accidental overdose, you must stop the medicine and go to the nearest hospital where you will be given
diuretics, along with intravenous fluids or cortisone and similar drugs.
In acute overdose, the doctor will evaluate treatment with gastric lavage and/or the administration of mineral oils to reduce absorption and promote fecal elimination.
Hypercalcemia caused by an excess dose of vitamin D or its metabolites may also require emergency therapies.
If you forget to use OSTIDIL-D3
If you forget to take OSTIDIL-D3do not take a double dose to make up for the missed
dose.
If you stop taking OSTIDIL-D3
If you have any doubts about the use of Alfacalcidol, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the dosage is in accordance with actual individual needs, OSTIDIL-D3 is well tolerated.
Otherwise, as the product has a D-vitaminic activity, side effects similar to those due to an excess of vitamin D (hypervitaminosis D) may appear,
i.e. a syndrome due to increased calcium levels (hypercalcemia), or toxic manifestations of calcium depending on the severity and duration of the hypercalcemia.
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)
- increased levels of calcium in the urine (hypercalciuria) rare (may affect up to 1 in 1,000 people)
- high levels of phosphate in the blood (hyperphosphatemia) frequency not known(the frequency cannot be estimated from the available data)
- allergic reactions
The symptoms of high levels of calcium in the blood (hypercalcemia) are
of both acute and chronic type. The former include increased levels of calcium in the urine
(hypercalciuria), ectopic calcifications, kidney and cardiovascular damage, weakness, headache,
drowsiness, nausea, vomiting, dry mouth, constipation, bone and muscle pain. In a later
stage, urinary disorders (micturition), conjunctivitis (due to calcification), photophobia (light intolerance), inflammation of the pan-
creas (pancreatitis), rhinorrhea (runny nose), itching, hyperthermia (increased body
temperature), decreased libido, albuminuria (protein loss in the urine), hypercholes-
terolemia (increased cholesterol levels in the blood), increased SGOT and SGPT (liver
enzymes), calcium deposition in the bones outside the usual sites (ectopic calcification), increased blood pressure (hypertension), heart rhythm disturbances (cardiac arrhythmias) and, rarely, altered sense of reality (psychosis). Since the half-life of
calcitriol is short, normalization of any hypercalcemia occurs within a few days
of stopping treatment with OSTIDIL-D3, however more quickly than during therapy with vitamin D or its metabolites.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 OSTIDIL-D3
Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date which is stated on the label after “Exp.”
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored away from sources of heat, humidity and light.
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. Package contents and other information
What OSTIDIL-D3 contains
OSTIDIL-D3 0.25 mcg soft capsules:
Each capsule contains:
Active ingredient: Alfacalcidol (1 α -Hydroxy vitamin D3) mcg 0.25.
Excipients: Tocopherol mixture (E306), Medium chain triglycerides, Gelatin, Glycerol, Purified water, Titanium dioxide (E171), Iron oxide (E172)
OSTIDIL-D3 1.0 mcg soft capsules:
Each capsule contains:
Active ingredient: Alfacalcidol (1 α -Hydroxy vitamin D3) mcg 1.0.
Excipients:Tocopherol mixture (E306), Medium chain triglycerides, Gelatin, Glycerol, Purified water, Titanium dioxide (E171), Iron oxide (E172).
Description of the appearance of OSTIDIL-D3 and package contents
OSTIDIL-D3 0.25 mcg soft capsules - 30 capsules of 0.25 mcg.
OSTIDIL-D3 1.0 mcg soft capsules - 30 capsules of 1.0 mcg
Marketing Authorisation Holder and Manufacturer
MAH
Laboratorio Farmaceutico SIT S.r.l. – via Cavour, 70 – 27035 Mede (PV)
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MANUFACTURER
Curtis Health Caps S.A.
ul. Batorowska 52, Wysogotowo
62-081 Przeźmierowo – Poland
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- Страна регистрации
- Форма выпускаSoft capsule, 0.25 MICROGRAMS
- 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 OSTIDIL-D3Форма 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 OSTIDIL-D3 в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог OSTIDIL-D3 в Польша
Аналог OSTIDIL-D3 в Испания
Врачи онлайн по OSTIDIL-D3
Обсудите применение OSTIDIL-D3 и возможные следующие шаги — по оценке врача.
Получите рецепт на OSTIDIL-D3 онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
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Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
OSTIDIL-D3 требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество OSTIDIL-D3 — Альфа-кальцидол. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
OSTIDIL-D3 производится компанией LABORATORIO FARMACEUTICO SIT SPECIALITA IGIENICO TERAPEUTICHE 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 OSTIDIL-D3 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 OSTIDIL-D3 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.
















