NUSTENDI 180 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Nustendi 180mg/10mg film-coated tablets

bempedoic acid/ezetimibe

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Nustendi and what is it used for

What is Nustendi and how does it work

Nustendi is a medicine that reduces the levels of "bad" cholesterol (also called "LDL cholesterol"), a type of fat, in the blood. Nustendi may also help reduce the risk of cardiovascular disease by lowering the levels of bad cholesterol.

Nustendi contains two active substances that lower cholesterol in two ways:

• bempedoic acid reduces the production of cholesterol in the liver and increases the elimination of LDL cholesterol from the blood;
• ezetimibe acts in the intestine, reducing the amount of cholesterol absorbed from food.

What is Nustendi used for

• Adults with primary hypercholesterolemia or mixed dyslipidemia, which are diseases that produce high levels of cholesterol in the blood. It is given in addition to a cholesterol-reducing diet.
• Adults with high blood cholesterol levels who already have cardiovascular disease or have other conditions that put them at higher risk of having cardiovascular events.

Nustendi is given:

• if you have been using a statin (such as simvastatin, a medicine commonly used to treat high cholesterol), along with ezetimibe and it does not sufficiently lower your LDL cholesterol;
• if you have been using ezetimibe and it does not sufficiently lower your LDL cholesterol;
• to replace bempedoic acid and ezetimibe if you have been taking these medicines in separate tablets.

2. What you need to know before you take Nustendi

Do not take Nustendi

• if you are allergic to bempedoic acid, ezetimibe or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant;
• if you are breast-feeding;
• if you are taking more than 40 mg of simvastatin per day (another medicine used to lower cholesterol);
• with a statin if you currently have liver problems.
• Nustendi contains ezetimibe. When Nustendi is given with a statin, you should read all the information about ezetimibe in the package leaflet of that specific statin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nustendi:

• if you have ever had gout;
• if you have severe kidney problems;
• if you have moderate or severe liver problems. Nustendi is not recommended in this case.

Your doctor will do a blood test before you start taking Nustendi with a statin (a medicine used to lower cholesterol). This is to check how your liver is working.

If you are taking statins, consult your doctor immediately if you notice unexplained muscle pain, tenderness or weakness (see Other medicines and Nustendi).

If you plan to become pregnant, consult your doctor before stopping any contraceptive method. Your doctor will tell you how to stop taking Nustendi before stopping any contraceptive method.

Children and adolescents

Do not give Nustendi to children and adolescents under 18 years of age. The use of Nustendi has not been studied in this age group.

Other medicines and Nustendi

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking any of the following active substances:

• Atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin (used to lower cholesterol and known as statins).

The risk of muscle disease may increase when taking a statin and Nustendi. Tell your doctor immediately about any unexplained muscle pain, tenderness or weakness.

• Bosentan (used to treat a disease called pulmonary arterial hypertension).
• Fimasartan (used to treat high blood pressure and heart failure).
• Asunaprevir, glecaprevir, grazoprevir, voxilaprevir (used to treat hepatitis C).
• Fenofibrate or gemfibrozil (also used to lower cholesterol).

There is no information available on the effects of using Nustendi with cholesterol-lowering medicines called fibrates.

• Ciclosporin (often used in patients who have had transplants).
• Colestyramine (also used to lower cholesterol), because it affects how ezetimibe works.
• Medicines to prevent blood clots, such as warfarin as well as acenocoumarol, fluindione and phenprocoumon.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant, plan to become pregnant or think you may be pregnant, as there is a possibility that it may harm the fetus. If you become pregnant while taking this medicine, call your doctor immediately and stop taking Nustendi.

• Pregnancy

Before starting treatment, you must confirm that you are not pregnant and that you are using an effective contraceptive, as advised by your doctor. If you are using the pill and suffer from a bout of diarrhea or vomiting that lasts more than 2 days, you should use an alternative contraceptive method (e.g. condoms, diaphragm) for 7 days after the symptoms have resolved.

If, after starting treatment with Nustendi, you decide you would like to become pregnant, tell your doctor, as you will need to change your treatment.

• Breast-feeding

Do not take Nustendi if you are breast-feeding because it is not known whether Nustendi passes into breast milk.

Driving and using machines

Nustendi has a minor influence on the ability to drive and use machines.

However, some people feel dizzy after taking Nustendi. Avoid driving or using machines if you think your reaction ability is reduced.

Nustendi contains lactose and sodium.

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Nustendi

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one tablet per day.

If you are taking colestyramine, take Nustendi at least 2 hours before or at least 4 hours after taking colestyramine.

Swallow the tablet whole with food or between meals.

If you take more Nustendi than you should

Consult your doctor or pharmacist immediately.

If you forget to take Nustendi

If you realize you have:

• missed a dose later the same day, take the missed dose and take the next dose at the usual time the next day.
• missed the dose the previous day, take your tablet at the usual time and do not take a double dose to make up for the missed dose.

If you stop taking Nustendi

Do not stop taking Nustendi without your doctor's permission, as your cholesterol may increase again.

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

4. Possible side effects

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

Contact your doctor immediatelyif you have any of the following side effects (frequency not known):

• Muscle pain, tenderness or weakness (myopathy/rhabdomyolysis)
• Yellowing of the skin and eyes, abdominal pain, dark urine, swollen ankles, decreased appetite and feeling of tiredness, which may be signs of liver problems (hepatitis)
• Allergic reactions, such as rash and hives; red elevated rash, sometimes with target-like lesions (hypersensitivity/erythema multiforme)
• Difficulty breathing or swelling of the face, lips, throat or tongue (anaphylaxis/angioedema)
• Gallstones or inflammation of the gallbladder (cholelithiasis/cholecystitis), which may cause abdominal pain, nausea and vomiting, inflammation of the pancreas, often with severe abdominal pain (pancreatitis)
• Decrease in platelet count, which may cause bruising/bleeding (thrombocytopenia)

Other side effects may appear with the following frequencies:

Common(may affect up to 1 in 10 people)

• Decrease in the number of red blood cells (anemia)
• Decrease in hemoglobin (protein in red blood cells that carries oxygen)
• Increased levels of uric acid in the blood
• High levels of uric acid in the blood that cause swelling and pain in the joints (gout)
• Decreased appetite
• Dizziness, headache
• High blood pressure
• Cough
• Constipation, diarrhea, abdominal pain
• Nausea
• Dry mouth
• Abdominal swelling and gas, inflammation of the stomach lining (gastritis)
• Blood tests that indicate liver problems
• Muscle spasms, muscle pain, pain in the shoulders, legs or arms, back pain
• Blood tests that show increased creatine kinase (laboratory test for muscle damage)
• Muscle weakness, joint pain (arthralgia)
• Increased creatinine and urea in the blood (laboratory test for kidney function)
• Unusual fatigue or weakness (asthenia)
• Decreased glomerular filtration rate (measure of kidney function)

Uncommon(may affect up to 1 in 100 people)

• Hot flushes
• Pain in the upper abdomen, heartburn, indigestion
• Itching
• Swelling of the legs or hands
• Neck pain, chest pain, pain
• Weight loss
• Muscle weakness

Frequency not known(cannot be estimated from the available data)

• Numbness
• Depression
• Shortness of breath

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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 Nustendi

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 blister and carton after EXP/CAD. The expiry date is the last day of the month stated.

This medicine does not require any special temperature storage conditions. Store in the original package to protect from moisture.

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

6. Contents of the pack and other information

What Nustendi contains

• The active substances are bempedoic acid and ezetimibe. Each film-coated tablet contains 180 mg of bempedoic acid and 10 mg of ezetimibe.
• The other ingredients are:

Appearance and packaging

The film-coated tablets are blue, oval, with the inscription "818" on one side and "ESP" on the other side. Tablet size: 15 mm x 7 mm x 5 mm.

Nustendi is available in plastic/aluminum blisters in packs of 10, 14, 28, 30, 84, 90, 98 or 100 film-coated tablets or in unit dose blisters in packs of 10 x 1, 50 x 1 or 100 x 1 film-coated tablet.

Not all pack sizes may be marketed in your country.

Marketing authorization holder

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48

81379 Munich

Germany

Manufacturer

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

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

Date of last revision of this leaflet:05/2025.

Other sources of information

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