Package Leaflet: Information for the Patient

Nilemdo 180 mg Film-Coated Tablets

Acid Bempedoic

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

1. What you need to know before taking Nilemdo
2. How to take Nilemdo

1. Possible side effects
2. Storage of Nilemdo

1. Contents of the pack and additional information

What is Nilemdo and how it works

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

Nilemdo contains the active ingredient bempedoic acid, which remains inactive until it enters the liver, where it changes to its active form. Bempedoic acid reduces cholesterol production in the liver and increases the elimination of LDL cholesterol from the blood by blocking an enzyme (ATP-citrate lyase) necessary for cholesterol production.

What is Nilemdo used for

• 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 put them at a higher risk of experiencing cardiovascular events.

Nilemdo is administered:

• if you have been using a statin (such as simvastatin, a medication commonly used to treat high cholesterol) and it does not sufficiently reduce your LDL cholesterol;

• alone or with other medications to reduce cholesterol when statins cannot be tolerated or used.

Do not take Nilemdo

• if you are allergic to bempedoic acid or any of the other ingredients of this medication (listed in section 6);

• if you are pregnant;
• if you are breastfeeding;

• if you are taking more than 40 mg of simvastatin per day (another medication used to reduce cholesterol).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nilemdo:

• if you have ever had gout;
• if you have severe kidney problems;
• if you have severe liver problems.

Your doctor may do a blood test before you start taking Nilemdo. This is to check how your liver is working.

If you are taking other medications called statins (medications used to reduce cholesterol), consult your doctor immediately if you notice unexplained muscle pain, tenderness or weakness (see Other medications and Nilemdo).

If you intend to become pregnant, consult your doctor first. Your doctor will instruct you on how to stop taking Nilemdo before stopping any form of contraception.

Children and adolescents

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

Other medications and Nilemdo

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 reduce cholesterol and known as statins).

The risk of muscle disease may increase when taking a statin and Nilemdo. Inform 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).

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 Nilemdo.

• Pregnancy

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

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

• Breastfeeding

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

Driving and operating machinery

The influence of Nilemdo on the ability to drive and operate machinery is negligible or small.

Nilemdo 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.

Swallow the tablet whole with food or between meals.

If you take more Nilemdo than you should

Consult your doctor or pharmacist immediately.

If you forget to take Nilemdo

If you realize you have forgotten:

• to take a dose later the same day, take the missed dose and take the next dose at the usual time the following 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 Nilemdo

Do not stop taking Nilemdo 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 medications, this medication may produce adverse effects, although not everyone will experience them.

Adverse effects may occur at the following frequencies:

Frequent(may affect up to 1 in 10 people)

• decrease in the number of red blood cells (anemia)
• increase in uric acid levels in the blood, gout
• pain in the shoulders, legs, or arms
• blood tests indicating liver abnormalities
• decrease in glomerular filtration rate (measure of kidney function)

Infrequent(may affect up to 1 in 100 people)

• decrease in hemoglobin (protein in red blood cells that transports oxygen)
• increase in creatinine and urea nitrogen in the blood (laboratory test of kidney function)

• weight loss

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on 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 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 special storage conditions.

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. By doing so, you will help protect the environment.

Nilemdo Composition

• The active ingredient is bempedoic acid. Each film-coated tablet contains 180 mg of bempedoic acid.
• The other components are:
• • monohydrate lactose (see end of section 2 “Nilemdo contains lactose and sodium”)

Appearance of the product and contents of the pack

The film-coated tablets are white or off-white, oval-shaped, with the inscription “180” on one side and “ESP” on the other side. Tablet size: 13.97 mm × 6.60 mm × 4.80 mm.

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

Only some pack sizes may be marketed in your country.

Marketing Authorization Holder

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48

81379 Munich

Germany

Responsible Person

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

For further information about this medicinal product, please consult the representative of the marketing authorization holder in your country.

Last update of the summary of product characteristics: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.