Label: information for the patient

Nustendi 180mg/10mg film-coated tablets

acid bempedoic/ezetimibe

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

What is Nustendi and how it works

Nustendi is a medication that reduces levels of "bad" cholesterol (also known as "LDL cholesterol"), a type of fat, in the blood. Nustendi may also help reduce cardiovascular risk by decreasing levels of bad cholesterol.

Nustendi contains two active principles that reduce cholesterol in two ways:

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

For what Nustendi is used

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

Nustendi is administered:

• if you have been using a statin (such as simvastatina, a medication commonly used to treat high cholesterol), along with ezetimiba and do not reduce your LDL cholesterol sufficiently;
• if you have been using ezetimiba and do not reduce your LDL cholesterol sufficiently;
• to replace bempedoic acid and ezetimiba if you have been using these medications in separate tablets.

Do not take Nustendi

• if you are allergic to bempedoic acid, ezetimibe, or any of the other components of this medication (listed in section6);
• if you are pregnant;
• if you are breastfeeding;
• if you are taking more than 40mg of simvastatin per day (another medication used to lower cholesterol);
• with a statin if you currently have liver problems.
• Nustendi contains ezetimibe. When Nustendi is administered with a statin, you must read all the information related to ezetimibe in the prospectus 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 must perform a blood test before you start taking Nustendi with a statin (a medication used to lower cholesterol). It is done to check how your liver is functioning.

If you are taking statins, consult your doctor immediately if you observe unexplained muscle pain, sensitivity, or weakness (see Other medications and Nustendi).

If you intend to become pregnant, consult your doctor first. Your doctor will instruct you on how to stop taking Nustendi before interrupting any contraceptive method.

Children and adolescents

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

Other medications and Nustendi

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. In particular, inform your doctor if you are taking any of the following active ingredients:

• 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. Inform your doctor immediately about any unexplained muscle pain, sensitivity, 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 hepatitisC).
• Fenofibrate or gemfibrozil (also used to lower cholesterol).

No information is available on the effects of using Nustendi with medications that lower cholesterol, called fibrates.

• Ciclosporin (frequently used in transplant patients).
• Colestiramine (also used to lower cholesterol), because it affects how ezetimibe works.
• Blood thinners, such as warfarin, acenocoumarol, fluindione, and phenprocoumon.

Pregnancy and breastfeeding

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

• Pregnancy

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

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

• Breastfeeding

Do not take Nustendi if you are breastfeeding, as it is not known if Nustendi passes into breast milk.

Driving and operating machinery

The influence of Nustendi on the ability to drive and operate machinery is small.

However, some people may feel dizzy after taking Nustendi. Avoid driving or operating machinery if you think your reaction time is impaired.

Nustendi contains lactose and sodium.

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

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

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

The recommended dose is one tablet per day.

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

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

If you interrupt treatment with Nustendi

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Immediately contact your doctorif you have any of the following side effects (unknown frequencies):

• Muscle pain, sensitivity, or weakness (myopathy/rhabdomyolysis)
• Yellowing of the skin and eyes, abdominal pain, dark urine, swollen ankles, decreased appetite, and a feeling of fatigue, which may be signs of liver problems (hepatitis)
• Allergic reactions, such as rashes and urticaria; raised red rash, sometimes with target-shaped lesions (hypersensitivity/multiforme erythema)
• 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, pancreatitis, often with intense abdominal pain
• Decreased platelets, which may cause bruises/bleeding (thrombocytopenia)

Other side effects may appear with the following frequencies:

Frequent(may affect up to 1 in 10 people)

• Decreased red blood cell count (anemia)
• Decreased 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 bloating and gas, inflammation of the stomach lining (gastritis)
• Blood tests indicating liver abnormalities
• Muscle spasms, muscle pain, shoulder, leg, or arm pain, back pain
• Blood tests showing increased creatine kinase (laboratory test for muscle damage)
• Muscle weakness, joint pain (arthralgia)
• Increased creatinine and urea nitrogen 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)

• Seizures
• Upper stomach pain, stomach burning, indigestion
• Itching
• Swelling of the legs or hands
• Neck pain, chest pain, pain
• Weight loss
• Muscle weakness

Unknown frequency(cannot be estimated from available data)

• Tickling sensation
• Depression
• Shortness of breath

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the box after EXP/CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medications 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 Nustendi

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

• monohydrate lactose (see end of section2 “Nustendi contains lactose and sodium”)
• microcrystalline cellulose (E460)
• sodium carboxymethylcellulose (type A) (see end of section2 “Nustendi contains lactose and sodium”)
• hydroxypropylcellulose (E463)
• magnesium stearate (E470b)
• anhydrous colloidal silica (E551)
• sodium lauryl sulfate (E487) (see end of section2 “Nustendi contains lactose and sodium”)
• povidone (K30) (E1201)
• partially hydrolyzed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), aluminum lake of indigo carmine (E132), monocaprilocaprate of glycerol, aluminum lake FCF brilliant blue (E133)

Appearance of the product and contents of the package

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

Nustendi is presented in plastic/aluminum blisters in boxes of 10, 14, 28, 30, 84, 90, 98 or 100film-coated tabletsor in single-dose blisters in boxes of 10×1, 50×1 or 100×1film-coated tablet.

It may only be marketed in some sizes in your country.

Marketing authorization holder

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48

81379 Munich

Germany

Responsible for manufacturing

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

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

Last update of this leaflet:11/2024.

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.