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LYVDELZI 10 mg HARD CAPSULES

Ask a doctor about a prescription for LYVDELZI 10 mg HARD CAPSULES

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Doctor

Alina Tsurkan

Family medicine12 years of experience

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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Doctor

Dmytro Horobets

Family medicine6 years of experience

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use LYVDELZI 10 mg HARD CAPSULES

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.

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.

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.

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Online doctors for LYVDELZI 10 mg HARD CAPSULES

Discuss dosage, side effects, interactions, contraindications, and prescription renewal for LYVDELZI 10 mg HARD CAPSULES – subject to medical assessment and local rules.

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Doctor

Alina Tsurkan

Family medicine12 years of experience

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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Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Dr. Ben Harbi offers reliable, accessible medical support through online consultations, helping patients make informed decisions about their health with a clear, structured, and compassionate approach.

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  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
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  • Interpretation of lab tests and medical reports, therapy adjustment.
  • Second opinion and decision-making support.
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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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