Summary of Product Characteristics: Information for the Patient

Lydelsi 10 mg Hard Capsules

seladelpar

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help us by reporting any side effects you experience. The final part of section 4 includes information on how to report these side effects.

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

• Keep this leaflet, as 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. It may harm them.
• If you experience side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

What is Lyvdelzi

Lyvdelzi contains the active ingredient seladelpar. It belongs to a group of medications called peroxisome proliferator-activated receptor delta agonists.

This medication 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. Bile is a liquid that helps digest food, especially fats. When bile cannot pass into the digestive tract, it accumulates in the liver (this is called cholestasis) and damages liver tissue. This can decrease liver function and cause inflammation. Lyvdelzi can be used with ursodeoxycholic acid (UDCA) or alone, in patients who cannot tolerate UDCA.

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

Do not take Lyvdelzi:

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

Warnings and precautions

Your doctor may perform blood tests before starting treatment with Lyvdelzi and during treatment to check if your liver is functioning correctly (liver function). If the tests show that your liver function has worsened, your doctor may have to interrupt treatment. If your liver recovers, it may be restarted. If your liver function worsens again after restarting treatment, your doctor may permanently interrupt treatment with Lyvdelzi. Contact your doctor immediately if you develop symptoms of liver dysfunction (inflammation of the liver) or complete bile duct obstruction (blocked bile ducts) during treatment, including:

• abdominal pain
• jaundice (yellowish tone of the skin and the white of the eyes)
• dark urine
• light-colored stools

Children and adolescents

Lyvdelzi should not be administered to children and adolescents under 18 years old.

Other medications and Lyvdelzi

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may have to take any other medication or herbal remedy.

Particularly, inform your doctor, pharmacist, or nurse if you are taking a medication called:

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

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

• Fluconazol, used to treat fungal infections
• Mifepristone, used for medical abortion

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating tools or machines

This medication is unlikely to affect your ability to drive, ride a bike, or use tools or machines.

Lyvdelzi contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

What dose to take

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

How to take

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

If you already take a bile acid sequestrant resin:

• Take Lyvdelzi at least 4 hours before or at least 4 hours after taking the bile acid sequestrant resin
• If in doubt, ask your doctor, pharmacist, or nurse

If you take more Lyvdelzi than you should

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

Among the symptoms of overdose are dark urine or muscle pain.

If you forget to take Lyvdelzi

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lyvdelzi

Do not stop taking this medication without consulting your doctor, pharmacist, or nurse.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse Effects

Inform your doctor, pharmacist, or nurse if you notice any of the following adverse effects.

Very Frequent:may affect more than 1 in 10 people

• Abdominal Pain

Frequent:may affect up to 1 in 10 people

• Headache
• Nausea
• Abdominal Distension (Bloating)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears in the bottle after "CAD". The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Lyvdelzi

• The active ingredient is seladelpar.
• Each hard capsule of Lyvdelzi contains 10 mg of seladelpar.
• The other components are:

• Capsule content: microcrystalline cellulose, mannitol, sodium croscarmellose, butylhydroxytoluene, magnesium stearate, colloidal silicon dioxide
• Capsule coating: 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 capsule body: 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 components, as indicated in section 2.

Appearance of the product and contents of the pack

This medicinal product is a hard capsule with an opaque dark blue cap and an opaque light grey body, and with "CBAY" printed in white ink on the cap and "10" printed in black ink on the body. The capsules are packed in a child-resistant bottle. Each bottle contains 30 capsules.

Marketing Authorization 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

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of the last revision of this leaflet:

This medicinal product has been authorized with a "conditional approval". This type of approval means that more information is expected to be obtained about this medicinal product.

The European Medicines Agency will review the new information about this medicinal product at least once a year and this leaflet will be updated as necessary.

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu.