Инструкция по применению LYVDELTSI
Содержание инструкции
- What is Seladelpar Gilead and what it is used for
- What you need to know before you take Seladelpar Gilead
- How to take Seladelpar Gilead
- Possible side effects
- How to store Seladelpar Gilead
- Contents of the pack and other information
Seladelpar Gilead 10 mg hard capsules
seladelpar
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. 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 you start to take 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, pharmacist or nurse.
- 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, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Seladelpar Gilead is and what it is used for
- 2. What you need to know before you take Seladelpar Gilead
- 3. How to take Seladelpar Gilead
- 4. Possible side effects
- 5. How to store Seladelpar Gilead
- 6. Contents of the pack and other information
1. What is Seladelpar Gilead and what it is used for
What is Seladelpar Gilead
Seladelpar Gilead contains the active substance seladelpar. It belongs to a group of medicines
called “agonists of the delta receptor activated by peroxisome proliferators.”
This medicine is used in adults to treat primary biliary cholangitis (primary biliary
cholangitis, PBC), a type of liver disease characterized by the progressive destruction of the bile
ducts which obstructs the passage of bile. Bile is a fluid that helps to digest food, especially
fats. If bile cannot reach the digestive tract, it accumulates in the liver (“cholestasis”)
damaging its tissues. This can reduce liver function and cause inflammation.
Seladelpar Gilead can be used together with ursodeoxycholic acid (UDCA) or alone, in
patients who cannot use UDCA.
The active substance of Seladelpar Gilead, seladelpar, works by activating the PPAR delta receptor. This
protein regulates the levels of bile acids, inflammation and fibrosis (formation of scar
tissue). This reduces the production and accumulation of bile in the liver, as well as reducing inflammation
of the liver.
2. What you need to know before you take Seladelpar Gilead
Do not take Seladelpar Gilead:
- if you are allergic to seladelpar or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before you start taking Seladelpar Gilead and during treatment, your doctor may perform blood tests to check your liver function (how your liver is working). If these tests
show a worsening of liver function, your doctor may need to stop treatment, but may restart it later if your liver improves. If your liver function
worsens again after restarting treatment, your doctor may stop treatment
with Seladelpar Gilead permanently. Contact your doctor immediately if you develop symptoms of liver dysfunction (liver inflammation) or complete biliary obstruction
(blocked bile duct) during treatment, including:
- stomach pain (abdominal pain)
- jaundice (yellowing of the skin and whites of the eyes)
- dark urine
- pale stools
Children and adolescents
Seladelpar Gilead should not be given to children and adolescents under the age of
18 years.
Other medicines and Seladelpar Gilead
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines or herbal remedies.
In particular, tell your doctor, pharmacist or nurse if you are taking medicines called:
- probenecid, to treat gout
- cyclosporine, to prevent organ rejection after a transplant.
- “bile acid sequestrants” (such as cholestyramine, colestipol or colesevelam), used to reduce cholesterol levels in the blood. These may reduce the effectiveness of Seladelpar Gilead if taken too close to the time you take Seladelpar Gilead
- if you are taking a “bile acid sequestrant”, you should take Seladelpar Gilead at least 4 hours before or 4 hours after taking a “bile acid sequestrant”. See section 3 for more information.
The following medicines can increase the amount of Seladelpar Gilead in the blood and, therefore, the
risk of side effects with Seladelpar Gilead:
- fluconazole, to treat fungal infections,
- mifepristone, a medicine used for medical termination of pregnancy.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive, ride a bicycle or use
tools or machines.
Seladelpar Gilead contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e.
it is essentially “sodium-free”.
3. How to take Seladelpar Gilead
Take this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, ask your doctor, pharmacist or nurse.
How much medicine to take
The recommended dose is one 10 mg capsule to be taken once a day.
How to take the medicine
- Swallow the capsule whole with water.
- This medicine can be taken with or without food.
- Seladelpar Gilead is taken together with another medicine called “ursodeoxycholic acid” (UDCA, also known as ursodiol) or alone, if you cannot take UDCA. If you are already taking a bile acid sequestrant resin:
- Take Seladelpar Gilead at least 4 hours before or at least 4 hours after taking the bile acid sequestrant resin.
- If you have any doubts, ask your doctor, pharmacist or nurse
If you take more Seladelpar Gilead than you should
If you take more Seladelpar Gilead than you should, inform your doctor, pharmacist or
nurse immediately.
Symptoms of an overdose may include dark urine or muscle pain.
If you forget to take Seladelpar Gilead
If you forget to take Seladelpar Gilead, do not take the missed dose and take the next dose at
the scheduled time.
Do not take a double dose to make up for the missed dose.
If you stop taking Seladelpar Gilead
Do not stop taking this medicine without first talking to your doctor, pharmacist or
nurse.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects.
Very common:may affect more than 1 in 10 people
- stomach pain (abdominal pain)
Common:may affect up to 1 in 10 people
- headache
- feeling unwell (nausea)
- abdominal bloating (abdominal distension)
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side
effects you can help to provide more information on the safety of this medicine.
5. How to store Seladelpar Gilead
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 bottle after “EXP”. The expiry date
refers to the last day of that month.
Do not store this medicine at a temperature above 30 °C.
Do not dispose of any medicine in waste water 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 Seladelpar Gilead contains
- The active substance is seladelpar.
- Each hard capsule of Seladelpar Gilead contains 10 mg of seladelpar.
- The other ingredients are:
- capsule content - microcrystalline cellulose, mannitol, sodium croscarmellose, butylated hydroxytoluene, magnesium stearate, colloidal silicon dioxide
- capsule shell - gelatin, titanium dioxide, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), indigotine (E132)
- black ink used for printing “10” on the body of the capsule shell - shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172)
- white ink used for printing “CBAY” on the capsule cap - shellac (E904), propylene glycol (E1520), sodium hydroxide (E524), povidone (E1201), titanium dioxide
Do not take Seladelpar Gilead if you are allergic to any of the ingredients, as described in section 2.
Description of the appearance of Seladelpar Gilead and contents of the pack
This medicine is presented as a hard capsule with an opaque dark blue cap and
an opaque light grey body, with “CBAY” printed in white ink on the cap and “10”
in black ink on the body. The capsules are packaged in a bottle with a child-resistant closure.
Each bottle contains 30 capsules.
Marketing Authorisation Holder
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland
Manufacturer
Millmount Healthcare Limited
Block 7
City North Business Campus
Stamullen
Co. Meath
K32 YD60
Ireland
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50
Lietuva
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
България
Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888
Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50
Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986
Magyarország
Gilead Sciences Ireland UC
Tel.: + 353 (0) 1 686 1888
Danmark
Gilead Sciences Sweden AB
Tlf.: + 46 (0) 8 5057 1849
Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0
Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98
Eesti
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849
Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100
Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830
España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30
Polska
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 22 262 8702
France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00
Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790
Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
România
Gilead Sciences (GSR) S.R.L.
Tel: + 40 31 631 18 00
Ireland
Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999
Slovenija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849
Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 232 121 210
Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201
Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849
Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100
Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849
Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
An authorisation “subject to conditions” has been granted for this medicine. This means that
further data must be provided on this medicine.
The European Medicines Agency will review the new information at least annually and the product
characterisation document (Product Characterisation Document, PC) will be updated, if necessary.
Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, https://www.ema.europa.eu.
ANNEX IV
CONCLUSIONS RELATING TO THE AUTHORISATION OF THE MARKETING
AUTHORISATION SUBJECT TO CONDITIONS PRESENTED BY THE EUROPEAN
MEDICINES AGENCY
Conclusions presented by the European Medicines Agency on:
- Granting of a marketing authorisation subject to conditions
Following the evaluation of the marketing authorisation application, the Committee
for Medicinal Products for Human Use (Committee for Human Medicinal Products,CHMP) considers that the
benefit/risk ratio is favourable in order to recommend the granting of a marketing
authorisation subject to conditions, as further described in the European Public Assessment Report
(European Public Assessment Report, EPAR).
- Страна регистрации
- Форма выпускаHard capsule, 10 mg
- Код АТХA05AX07
- 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 LYVDELTSIФорма выпуска: Hard capsule, 200 MCGДействующее вещество: odevixibatПроизводитель: IPSEN PHARMAОтпускается по рецептуФорма выпуска: Film-coated tablet, 80 mgДействующее вещество: elafibranorПроизводитель: IPSEN PHARMAОтпускается по рецептуФорма выпуска: Oral solution, 9.5 mg / mLДействующее вещество: Мараликсибат хлоридПроизводитель: Mirum Pharmaceuticals International B.V.Отпускается по рецепту
Аналоги LYVDELTSI в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог LYVDELTSI в Испания
Аналог LYVDELTSI в Украина
Врачи онлайн по LYVDELTSI
Обсудите применение LYVDELTSI и возможные следующие шаги — по оценке врача.
Получите рецепт на LYVDELTSI 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
LYVDELTSI требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество LYVDELTSI — Other drugs for bile therapy. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
LYVDELTSI производится компанией GILEAD SCIENCES IRELAND UC. 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 LYVDELTSI 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 LYVDELTSI 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 (Other drugs for bile therapy) включают BYLVAY, IQIRVO, LIVMARLI. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















