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:

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.