Инструкция по применению ORPAKOL
Содержание инструкции
Orphacol 50 mg hard capsules, 250 mg hard capsules
Cholic acid
Medicinal product subject to additional monitoring. This will allow the rapid identification of new
information on safety. You can contribute by reporting any adverse effects experienced
during the use of this medicine. See the end of section 4 for information on how
to report adverse effects.
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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Orphacol is and what it is used for
- 2. What you need to know before you take Orphacol
- 3. How to take Orphacol
- 4. Possible side effects
- 5. How to store Orphacol
- 6. Contents of the pack and other information
1. What is Orphacol and what is it used for
Orphacol contains cholic acid, a bile acid normally produced by the liver. Some diseases are
caused by defects in the production of bile acids and Orphacol is used to treat infants from 1 month to 2 years
of age, children, adolescents and adults with these diseases. The cholic acid contained in Orphacol replaces
the missing bile acids due to the defect in the production of the bile acids themselves.
2. What you need to know before you take Orphacol
Do not take Orphacol
- if you are allergic to cholic acid or to any of the other ingredients of this medicine (listed in section 6).
- if you are taking phenobarbital or primidone, a medicine to treat epilepsy.
Warnings and precautions
During treatment, the doctor will perform various blood and urine tests at different times to see
how your body reacts to the medicine and to help calculate the dose you need. If
you are growing rapidly or if you become ill (e.g. if you have liver problems) more frequent tests will be necessary.
Other medicines and Orphacol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Some medicines used to reduce cholesterol levels, so-called bile acid sequestrants (cholestyramine,
colestipol, colesevelam) and medicines used to treat heartburn containing aluminium,
can reduce the effect of Orphacol. If you are taking these medicines, take Orphacol at least 5 hours
before or at least 5 hours after taking the other medicines. Cyclosporine (a medicine used
to suppress the immune system) can also change the effect of Orphacol. Tell your doctor if you are
taking cyclosporine.
Ursodeoxycholic acid can reduce the effect of Orphacol if both medicines are taken at the
same time. If you are prescribed ursodeoxycholic acid together with Orphacol in single doses, take
one medicine in the morning and the other in the evening. If you are prescribed separate doses of
ursodeoxycholic acid and/or Orphacol, ask your doctor or pharmacist for advice on the correct sequence of
administration as these medicines must be administered several hours apart.
Pregnancy and breastfeeding
Ask your doctor for advice if you are planning a pregnancy. Take a pregnancy test as soon as
you suspect you are pregnant. It is very important to continue taking Orphacol during pregnancy.
If you become pregnant during treatment with Orphacol, the doctor will decide which treatment and dose
are best in your situation. As a precaution, you and the baby should be carefully
monitored during pregnancy.
Orphacol can be used during breastfeeding. Before starting to take Orphacol
tell your doctor if you are planning to breastfeed or if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Orphacol is unlikely to affect your ability to drive or operate machinery.
Orphacol contains lactose
Orphacol contains a certain sugar (lactose monohydrate). If your doctor has told you that you are intolerant
to some sugars, contact your doctor before taking Orphacol.
3. How to take Orphacol
Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor.
The usual dose is from 5 to 15 mg per kg of body weight each day in infants, children, adolescents and
adults.
Before therapy, your doctor will check laboratory tests to establish the correct dose for
you. The dose will then be further adjusted by the doctor depending on the body's response.
Orphacol capsules must be taken orally with food approximately at the
same time each day, in the morning and/or evening. Taking Orphacol at regular intervals with food will
help you remember to take this medicine and may help your body absorb it better. The
capsules must be swallowed whole with water. Do not chew them.
If your doctor has prescribed a dose that requires taking more than one capsule a day, you and your doctor
can decide how this dose will be taken during the day. You may, for example, take one
capsule in the morning and one in the evening. This way you will have to take fewer capsules at a time. However, this
may not be possible if you have been prescribed another medicine containing
ursodeoxycholic acid at the same time. In this case, you should ask your doctor or pharmacist for advice on the correct
sequence of administration as ursodeoxycholic acid and Orphacol must be administered several
hours apart (see paragraph 2).
Use in children
For infants and children who cannot swallow the capsules, the capsules can be opened and their
contents added to infant formula or apple/orange or apple/apricot juice for children.
If you take more Orphacol than you should
If you have taken more Orphacol than you should, contact your doctor as soon as possible. He will evaluate the laboratory
tests and advise you on when to resume therapy at the normal dose.
If you forget to take Orphacol
Take the next dose when you should normally take it. Do not take a double dose to
compensate for missing the dose.
If you stop taking Orphacol
If you stop therapy with Orphacol, there is a risk of irreversible damage to the liver. You
should never stop taking Orphacol unless your doctor advises you to do so.
If you have any doubts about the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some patients have suffered from itching and/or diarrhoea, however it is not known how likely this is to happen (the
frequency cannot be estimated from the available data). Tell your doctor if the itching and/or diarrhoea lasts more
than three days.
An increase in liver enzymes (serum transaminases) has been reported in some patients during treatment with
Orphacol (the frequency cannot be defined based on the available data). The doctor will decide what to do if this
happens.
Gallstones have been described after long-term therapy with Orphacol.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor. You can also report side effects
directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Orphacol
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 carton and blister after “Exp.”.
The expiry date refers to the last day of that month.
Store at a temperature below 25 C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Orphacol contains
- The active ingredient is cholic acid. Orphacol 50 mg: each hard capsule contains 50 mg of cholic acid.Orphacol 250 mg: each hard capsule contains 250 mg of cholic acid.
- The other excipients are: Capsule content: lactose monohydrate (for more information see section 2 in “Orphacol contains lactose”), anhydrous colloidal silica, magnesium stearate Capsule shell: Orphacol 50 mg: gelatin, titanium dioxide (E171), indigo carmine (E132); Orphacol 250 mg: gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172).
Description of the appearance of Orphacol and contents of the pack
Orphacol is available in oblong hard capsules. The 50 mg cholic acid capsules are blue and
white and the 250 mg cholic acid capsules are green and white. They are contained in blisters of 10
capsules each.
The packs are available in packs of 30, 60 and 120 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
THERAVIA
16 Rue Montrosier
92200 Neuilly-sur-Seine
France
Manufacturer
THERAVIA
16 Rue Montrosier
92200 Neuilly-sur-Seine
France
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien
THERAVIA
Tél/Tel: +32 (0)2 808 2973
[email protected]
Lietuva
Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 500
[email protected]
България
THERAVIA
Teл.: +33 (0)1 72 69 01 86
[email protected]
Luxembourg/Luxemburg
THERAVIA
Tél/Tel: +352 278 62 329
[email protected]
Česká republika
THERAVIA
Tel.: +33 (0)1 72 69 01 86
[email protected]
Magyarország
Medis Hungary Kft
Tel: +36 (2) 380 1028
[email protected]
Danmark
Immedica Pharma AB
Tlf: +46 (0)8 533 39 500
[email protected]
Deutschland
THERAVIA
Tel: 08001090001
[email protected]
Nederland
THERAVIA
Tel : +31 (0)20 208 2161
[email protected]
Eesti
Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 500
[email protected]
Norge
Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 500
[email protected]
Ελλάδα
THERAVIA
Τηλ:
+33 (0)1 72 69 01 86
[email protected]
España
THERAVIA
Tel: + (34) 914 146 613
[email protected]
Polska
THERAVIA
Tel.: +33 (0)1 72 69 01 86
[email protected]
France
THERAVIA
Tél: +33 (0)1 72 69 01 86
[email protected]
Portugal
THERAVIA
Tel: 800210571
[email protected]
Hrvatska
Medis Adria d.o.o.
Tel: +385 (1) 230 3446
[email protected]
România
THERAVIA
Tel: +33 (0)1 72 69 01 86
[email protected]
Ireland
THERAVIA
Tel : +353-(0)1-903 8043
[email protected]
Slovenija
Medis d.o.o.
Tel: +386 (1) 589 6900
[email protected]
Ísland
Immedica Pharma AB
Sími: + 46 (0)8 533 39 500
[email protected]
Slovenská republika
THERAVIA
Tel: +33 (0)1 72 69 01 86
[email protected]
Italia
THERAVIA
Tel : 800 959 161
[email protected]
Suomi/Finland
Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 500
[email protected]
Κύπρος
THERAVIA
Τηλ: +33 (0)1 72 69 01 86
[email protected]
Sverige
Immedica Pharma AB
Tel: +46 (0)8 533 39 500
[email protected]
Latvija
Immedica Pharma AB
Tel: +46 (0)8 533 39 500
[email protected]
An authorisation for this medicinal product has been granted in “exceptional circumstances”. This means that
due to the rarity of the disease and for ethical reasons, complete information on
this medicinal product could not be obtained.
The European Medicines Agency will annually review any new information on this
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu /. Furthermore, links to other websites on rare diseases and
related therapeutic treatments are provided.

- Страна регистрации
- Форма выпускаHard capsule, 50 MG
- Код АТХA05AA03
- 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 ORPAKOLФорма выпуска: Hard capsule, 250 MGДействующее вещество: chenodeoxycholic acidПроизводитель: LEADIANT GMBHОтпускается по рецептуФорма выпуска: Hard capsule, 250 MGДействующее вещество: урсодезоксихолевая кислотаПроизводитель: ABC FARMACEUTICI S.P.A.Отпускается по рецептуФорма выпуска: Hard capsule, 300 MGДействующее вещество: урсодезоксихолевая кислотаПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается по рецепту
Аналоги ORPAKOL в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог ORPAKOL в Испания
Врачи онлайн по ORPAKOL
Обсудите применение ORPAKOL и возможные следующие шаги — по оценке врача.
Получите рецепт на ORPAKOL 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
ORPAKOL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ORPAKOL — Холевая кислота. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ORPAKOL производится компанией THERAVIA. 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 ORPAKOL 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 ORPAKOL 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 (Холевая кислота) включают AKIDO KENODESOSSIKOLIKO LEADIANT, AKIDO URSODESOSSIKOLIKO ABK, AKIDO URSODESOSSIKOLIKO AUROBINDO. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















