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LYVDELZI 10 mg HARD CAPSULES

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About the medicine

How to use LYVDELZI 10 mg HARD CAPSULES

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Lyvdelzi 10 mg Hard Capsules

seladelpar

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may experience. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Lyvdelzi and what is it used for
  2. What you need to know before you take Lyvdelzi
  3. How to take Lyvdelzi
  4. Possible side effects
  5. Storage of Lyvdelzi
  6. Contents of the pack and further information

1. What is Lyvdelzi and what is it used for

What is Lyvdelzi

Lyvdelzi contains the active substance seladelpar. It belongs to a group of medicines called peroxisome proliferator-activated receptor delta (PPARδ) agonists.

This medicine is used in adults to treat primary biliary cholangitis (PBC), a liver disease in which the bile ducts are slowly destroyed, making it difficult for bile to pass through. Bile is a liquid that helps digest food, especially fats. When bile cannot pass through the digestive tract, it builds up in the liver (this is called cholestasis) and damages liver tissue. This can reduce liver function and cause inflammation. Lyvdelzi can be used alone or with another medicine called ursodeoxycholic acid (UDCA) in patients who cannot tolerate UDCA.

The active substance in Lyvdelzi, seladelpar, works by activating the PPAR delta receptor. This protein regulates bile acid levels, inflammation, and fibrosis (scar tissue formation). This reduces bile production and accumulation in the liver and also reduces liver inflammation.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Lyvdelzi

Do not take Lyvdelzi:

  • if you are allergic to seladelpar or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Your doctor may perform blood tests before you start treatment with Lyvdelzi and during treatment to check if your liver is working properly (liver function). If the tests show that your liver function has worsened, your doctor may need to stop treatment. If your liver recovers, you may be able to start treatment again. If your liver function worsens again after restarting treatment, your doctor may permanently stop treatment with Lyvdelzi. Contact your doctor immediately if you develop symptoms of liver dysfunction (liver inflammation) or complete biliary obstruction (blocked bile ducts) during treatment, including:

  • abdominal pain
  • jaundice (yellowing of the skin and whites of the eyes)
  • dark urine
  • light-colored stools

Children and adolescents

Lyvdelzi should not be given to children and adolescents under 18 years of age.

Other medicines and Lyvdelzi

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 a medicine called:

  • probenecid, used to treat gout
  • cyclosporin, used to prevent the body from rejecting a transplanted organ
  • bile acid sequestrants (such as cholestyramine, colestipol, or colesevelam), used to lower cholesterol levels in the blood. These may reduce the effectiveness of Lyvdelzi if taken too close to Lyvdelzi.
  • If you take a bile acid sequestrant, take Lyvdelzi at least 4 hours before or at least 4 hours after taking the bile acid sequestrant. See section 3 for more information.

The following medicines may increase the risk of side effects with Lyvdelzi, as they increase the amount of Lyvdelzi in the blood:

  • fluconazole, used to treat fungal infections
  • mifepristone, used for medical termination of pregnancy

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use tools or machines.

Lyvdelzi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; this is essentially "sodium-free".

3. How to take Lyvdelzi

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, check with your doctor, pharmacist, or nurse.

How much to take

The recommended dose is one 10 mg capsule once a day.

How to take

  • Swallow the capsule whole with water
  • You can take this medicine with or without food
  • Lyvdelzi is taken with another medicine called ursodeoxycholic acid (UDCA) or alone, if you cannot take UDCA

If you are already taking a bile acid sequestrant:

  • Take Lyvdelzi at least 4 hours before or at least 4 hours after taking the bile acid sequestrant
  • If you are unsure, ask your doctor, pharmacist, or nurse

If you take more Lyvdelzi than you should

If you take more Lyvdelzi than you should, contact your doctor, pharmacist, or nurse immediately.

Symptoms of overdose include dark urine or muscle pain.

If you forget to take Lyvdelzi

If you forget to take Lyvdelzi, skip the missed dose and take the next dose when it is due.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Lyvdelzi

Do not stop taking this medicine without talking to your doctor, pharmacist, or nurse.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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

  • abdominal pain

Common:may affect up to 1 in 10 people

  • headache
  • nausea
  • abdominal distension (swelling of the abdomen)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lyvdelzi

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 after "EXP". The expiry date refers to the last day of the month shown.

Do not store this medicine at a temperature above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lyvdelzi

  • The active substance is seladelpar.
  • Each hard capsule of Lyvdelzi contains 10 mg of seladelpar.
  • The other ingredients are:
  • capsule content: microcrystalline cellulose, mannitol, sodium croscarmellose, butylhydroxytoluene, magnesium stearate, colloidal silicon dioxide
  • capsule shell: gelatin, titanium dioxide, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), indigo carmine (E132)
  • black ink used to print "10" on the body of the capsule: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (E172)
  • white ink used to print "CBAY" on the capsule cap: shellac (E904), propylene glycol (E1520), sodium hydroxide (E524), povidone (E1201), titanium dioxide

Do not take Lyvdelzi if you are allergic to any of the ingredients, listed in section 2.

Appearance and packaging of the product

This medicine is a hard capsule with a dark blue opaque cap and a light gray opaque body, with "CBAY" printed in white ink on the cap and "10" printed in black ink on the body. The capsules are packaged in a child-resistant closure bottle. Each bottle contains 30 capsules.

Marketing authorisation holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business and Technology Park

Carrigtohill

Co. Cork

Ireland

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Belgium/België/Belgien

Gilead Sciences Belgium SRL-BV

Tel: + 32 (0) 24 01 35 50

Lithuania

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Text with contact information of Gilead Sciences Ireland UC including address, phone number, and country Bulgaria

Luxembourg/Luxemburg

Gilead Sciences Belgium SRL-BV

Tel: + 32 (0) 24 01 35 50

Czech Republic

Gilead Sciences s.r.o.

Tel: + 420 910 871 986

Hungary

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Denmark

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Malta

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Germany

Gilead Sciences GmbH

Tel: + 49 (0) 89 899890-0

Netherlands

Gilead Sciences Netherlands B.V.

Tel: + 31 (0) 20 718 36 98

Estonia

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Norway

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Greece

Gilead Sciences Ελλάς Μ.ΕΠΕ.

Tel: + 30 210 8930 100

Austria

Gilead Sciences GesmbH

Tel: + 43 1 260 830

Spain

Gilead Sciences, S.L.

Tel: + 34 91 378 98 30

Poland

Gilead Sciences Poland Sp. z o.o.

Tel: + 48 22 262 8702

France

Gilead Sciences

Tel: + 33 (0) 1 46 09 41 00

Portugal

Gilead Sciences, Lda.

Tel: + 351 21 7928790

Croatia

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Romania

Gilead Sciences (GSR) S.R.L.

Tel: + 40 31 631 18 00

Ireland

Gilead Sciences Ireland UC

Tel: + 353 (0) 214 825 999

Slovenia

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Iceland

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Slovakia

Gilead Sciences Slovakia s.r.o.

Tel: + 421 232 121 210

Italy

Gilead Sciences S.r.l.

Tel: + 39 02 439201

Finland

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Cyprus

Gilead Sciences Ελλάς Μ.ΕΠΕ.

Tel: + 30 210 8930 100

Sweden

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Latvia

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Date of last revision of this leaflet:

This medicine has been authorised with a "conditional approval". This type of approval means that more information on this medicine is expected.

The European Medicines Agency will review new information on this medicine at least once a year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website https://www.ema.europa.eu.

Online doctors for LYVDELZI 10 mg HARD CAPSULES

Discuss questions about LYVDELZI 10 mg HARD CAPSULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (4)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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5.0 (812)
Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55
5.0 (144)
Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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€50

Frequently Asked Questions

Is a prescription required for LYVDELZI 10 mg HARD CAPSULES?
LYVDELZI 10 mg HARD CAPSULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in LYVDELZI 10 mg HARD CAPSULES?
The active ingredient in LYVDELZI 10 mg HARD CAPSULES is Other drugs for bile therapy. This information helps identify medicines with the same composition but different brand names.
Who manufactures LYVDELZI 10 mg HARD CAPSULES?
LYVDELZI 10 mg HARD CAPSULES is manufactured by Gilead Sciences Ireland Unlimited Company. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of LYVDELZI 10 mg HARD CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether LYVDELZI 10 mg HARD CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to LYVDELZI 10 mg HARD CAPSULES?
Other medicines with the same active substance (Other drugs for bile therapy) include BYLVAY 1200 micrograms hard capsules, BYLVAY 200 micrograms HARD CAPSULES, BYLVAY 400 micrograms hard capsules. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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