Livdelzi 10 mg capsules

• 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Livdelzi contains the active substance seladelpar. This belongs to a group of medicines called peroxisome proliferator-activated receptor delta agonists.

This medicine is used to treat adults who have a liver illness called ‘primary biliary cholangitis’ (PBC). Livdelzi can also reduce itching that is linked to PBC.

This medicine works by controlling liver problems in the body and making the liver less inflamed.

Livdelzi can be taken:

• together with another medicine called ‘ursodeoxycholic acid’ (called UDCA or ‘urso’ or ‘ursodiol’)
• or by itself – if you cannot take urso or ursodiol

• you are allergic to seladelpar or any of the other ingredients of this medicine (listed in section 6)
• you have something called ‘complete biliary obstruction,’ – this is a blockage of your bile duct which prevents bile flow from the liver into your gut.

Do not take Livdelzi if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.

Your doctor may need to stop your Livdelzi treatment if your liver starts to not work as well. They may then start it again if your liver recovers.

Do not give this medicine to children and adolescents below 18 years of age.

Your doctor may do regular blood tests to check your liver health when you start Livdelzi and while you are taking it.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:

• 'bile acid binding resins’ (such as cholestyramine, colestipol, or colesevelam adsorb) - used to lower blood cholesterol levels oritching caused by PBC. These may make Livdelzi work less well if taken too close to when you take Livdelzi.
  If you are taking a ‘bile acid binding resin’, you will need to take Livdelzi at least 4 hours before or at least 4 hours after taking a ‘bile acid binding resin’. See section 3 for more information.
• Ciclosporin, used to prevent the body from rejecting a transplanted organ.
• Fluconazole, used to treat fungal infections.
• Mifepristone, used for the medical termination of a pregnancy.
• Probenecid, used to treat gout.

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

This medicine is not likely to affect you being able to drive, cycle or use any tools or machines.

The recommended dose of Livdelzi is 10 mg taken once daily.

• You can take this medicine with or without food.
• Livdelzi is taken either together with another medicine called ‘ursodeoxyycholic acid’ (UDCA, also called urso or ursodiol) – or by itself if you cannot have urso or ursodiol.

If you are already taking a bile acid binding resin:

• Take Livdelzi at least 4 hours before – or at least 4 hours after – taking the bile acid binding resin.
• If you are unsure, ask your doctor, pharmacist or nurse.

If you take more Livdelzi than you should, tell your doctor, pharmacist or nurse straight away.

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

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

Tell your doctor, pharmacist or nurse if you notice any of the following side effects.

Common: may affect up to 1 in 10 people

• headache
• feeling sick (nausea)
• tummy pain or swelling

If you get 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 Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or search MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you help provide more information about the safety of taking this medicine.

• The active substance is seladelpar.
• Each capsule of Livdelzi contains 10 mg of seladelpar.
• The other ingredients are:
  • capsule content – microcrystalline cellulose, mannitol, croscarmellose sodium, butyl hydroxytoluene, magnesium stearate, colloidal silicon dioxide
  • capsule shell – gelatine, titanium dioxide, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), indigo carmine (E132)
  • black ink used to imprint “10” on the body of the capsule shell – Shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172)
  • white ink used to imprint “CBAY” on the cap of the capsule – Shellac (E904), propylene glycol (E1520), sodium hydroxide (E524), povidone (E1201), titanium dioxide

This medicine is a capsule with a light grey body and a dark blue cap, printed with “CBAY” on the cap and “10” on the body. The capsules are packaged in a bottle with a child resistant cap with an outer carton. Each bottle contains 30 capsules.