Інструкція із застосування SEFAL
Зміст інструкції
SEFAL 1 microgram soft capsules
Alfacalcidol
Read this leaflet carefully before you start 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 they have the same symptoms as you, as it may 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 SEFAL is and what it is used for
2 What you need to know before you take SEFAL
3 How to take SEFAL
4 Possible side effects
5 How to store SEFAL
6 Contents of the pack and other information
1. What is SEFAL and what is it for
The active ingredient of SEFAL is alfacalcidol, also known as 1 alpha-hydroxycholecalciferol, a synthetic product
derived from vitamin D that exerts the same effects as common vitamin D.
SEFAL can be used for the treatment of the following conditions: renal osteodystrophy
(a condition characterized by bone problems caused by renal insufficiency), hypoparathyroidism (defects in the
production of hormones by certain glands called parathyroid glands), rickets and osteomalacia (diseases
of the skeleton that make bones weak and fragile) D–resistant or D–dependent (pseudo-deficient),
rickets and osteomalacia due to renal alterations related to vitamin D metabolism, osteoporosis
(a disease characterized by the weakening of the bones) following menopause.
2. What you need to know before taking SEFAL
Do not take SEFAL
if you are allergic to alfacalcidol or any of the other ingredients of this medicine (listed in
section 6);
if you have high levels of calcium in your blood (hypercalcemia)
if you are pregnant or breastfeeding
Warnings and precautions
Talk to your doctor or pharmacist before taking SEFAL.
Since alfacalcidol is an analogue of vitamin D, during treatment with SEFAL you should not take
vitamin D or its derivatives as excessive doses of vitamin D can cause you serious harm.
Since excessive doses of SEFAL can cause an increase in calcium levels in the blood and sometimes in the
urine, your doctor will ask you to undergo tests to monitor calcium levels in the blood and to establish the
dose of SEFAL suitable for you.
High concentrations of calcium in the blood can in fact cause serious reactions that in some cases may
require emergency therapies. Furthermore, the presence of high concentrations of calcium in the blood for
prolonged periods can lead to calcification.
Other symptoms of increased calcium levels in the blood are muscle and bone pain, muscle weakness, confusion, dehydration, anorexia, fatigue, nausea, vomiting, constipation, increased
urine production, sweating, headache, intense thirst, increased blood pressure,
drowsiness.
If you experience an increase in calcium content in your blood, your doctor will tell you to stop
treatment with SEFAL until the situation normalizes. Afterwards, they may decide to lower the dose
of SEFAL for your treatment.
If you are being treated with digitalis (a drug extracted from a plant that contains substances that stimulate the
heart muscle) your doctor will be cautious when prescribing SEFAL to you as the increase in calcium concentrations
resulting from taking SEFAL can cause heart rhythm disturbances.
If you are taking phosphorus-binding substances, your doctor may decide to adjust their dose as
SEFAL influences the transport of phosphates in the intestine, kidney and bones.
Other medicines and SEFAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you take other medicines while taking SEFAL, the therapeutic action may be affected.
In particular, taking SEFAL together with the following medicines is not recommended:
- Thiazide diuretics (medicines used to increase urine production) and calcium-containing preparations. These medicines can cause an increase in calcium levels in the blood.
- Vitamin D-containing preparations. They can increase calcium levels in the blood.
- Anticonvulsants such as barbiturates, phenytoin, carbamazepine or primidone (medicines used to treat seizures). These medicines can reduce your body's response to taking SEFAL, resulting in a need to increase your dose.
- Magnesium-based antacids (medicines that counteract stomach acidity). Taking them at the same time as SEFAL can cause an increase in magnesium levels in the blood.
- Aluminum-containing preparations as the simultaneous administration of SEFAL can cause an increase in aluminum levels in the blood.
- Cholestyramine (a medicine used to lower cholesterol levels in the blood) and orlistat (a medicine used to treat obesity) as they can reduce the intestinal absorption of SEFAL.
- Digitalis (a medicine used for heart problems). This combination should be carefully monitored.
- Warfarin (an anticoagulant medicine). This combination requires particular caution.
.
Pregnancy and breastfeeding
If you are pregnant, suspect you are 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.
SEFAL should not be used if you are pregnant or breastfeeding.
If you are a woman of childbearing age, you should use effective contraceptive measures during treatment with SEFAL.
Driving and using machines
SEFAL does not alter or negligibly alters the ability to drive vehicles and use machinery.
However, you may experience dizziness during treatment with SEFAL.
3. How to take SEFAL
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Regardless of the condition for which you are taking SEFAL, the recommended dose is 1 microgram per day.
Use in children and adolescents
For children weighing more than 20 kg the recommended dose is 1 microgram per day.
For children weighing less than 20 kg the recommended dose is 0.05 micrograms per kg per day.
In any case, the recommended dose may be modified by the doctor depending on your response to the
medicine.
If you take more SEFAL than you should
If you accidentally take an excessive amount of SEFAL, contact your doctor.
If, following an overdose, calcium levels in the blood should increase excessively, your doctor will
tell you to stop treatment and will adopt some supportive measures.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you take the recommended dose of SEFAL, the medicine will generally be well tolerated.
In the event that you take excessive doses of SEFAL, you may experience side effects similar to those caused by an
excess of vitamin D and related to the accumulation of calcium in the blood.
These effects include: increased levels of calcium and phosphate in the blood, confusion, headache,
dizziness, nausea, vomiting, diarrhea, constipation, abdominal pain, rash, itching, urticaria, muscle
pain, high concentrations of calcium in the urine, formation of kidney stones, calcium accumulation at the
kidney level, kidney failure, malaise, fatigue, calcium deposition at the tissue level.
Reporting of side effects
If you get any side effects, even if 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 to provide
more information on the safety of this medicine.
5. How to store SEFAL
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 pack after Exp. The expiry date
refers to the last day of that month.
Keep the medicine in its outer packaging to protect it from light and moisture.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What SEFAL contains
- The active ingredient is alfacalcidol (1 α-Hydroxy vitamin D3). Each capsule contains 1 microgram of alfacalcidol.
- 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 SEFAL and contents of the pack
Pack containing 30 soft capsules in blisters.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder:
FARMA GROUP S.r.l.
Via Strampelli, 18
63074 San Benedetto del Tronto (AP)
Manufacturer responsible for batch release:
I.BIR.N. – Istituto Bioterapico Nazionale s.r.l.
Via Vittorio Grassi nn. 9/15
00155 Roma
- Країна реєстрації
- Лікарська формаSoft capsule, 1 MICROGRAMMO
- Код АТХA11CC03
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до SEFALЛікарська форма: Soft capsule, 1 MICROGRAMДіюча речовина: Альфа-кальцидолВиробник: DOC GENERICI SRLПотрібен рецептЛікарська форма: Soft capsule, 0.25 microgramsДіюча речовина: Альфа-кальцидолВиробник: ZENTIVA ITALIA S.R.L.Потрібен рецептЛікарська форма: Soft capsule, 0.25 MCGДіюча речовина: Альфа-кальцидолВиробник: THERAMEX IRELAND LIMITEDПотрібен рецепт
Аналоги SEFAL в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог SEFAL у Польща
Аналог SEFAL у Іспанія
Лікарі онлайн щодо SEFAL
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на SEFAL онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
SEFAL потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у SEFAL — Альфа-кальцидол. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
SEFAL виробляється компанією FARMA GROUP S.R.L.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування SEFAL з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати SEFAL у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Альфа-кальцидол) включають ALFAKALKIDOLO DOK, ALFAKALKIDOLO TSENTIVA, ALPA D3. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















