NILEMDO 180 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Nilemdo 180 mg Film-Coated Tablets

bempedoic acid

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 Nilemdo and what is it used for

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

1. Possible side effects
2. Storage of Nilemdo

1. Contents of the pack and other information

1. What is Nilemdo and what is it used for

What is Nilemdo and how does it work

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

Nilemdo contains the active substance bempedoic acid, which remains inactive until it enters the liver, where it is converted into its active form. Bempedoic acid reduces the production of cholesterol 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 cardiovascular disease or have other conditions that put them at higher risk of having cardiovascular events.

Nilemdo is administered:

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

• alone or with other cholesterol-reducing medicines when statins are not tolerated or cannot be used.

2. What you need to know before you take Nilemdo

Do not take Nilemdo

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

• if you are pregnant;
• if you are breast-feeding;

• if you take more than 40 mg of simvastatin per day (another medicine 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 perform a blood test before you start taking Nilemdo to check how your liver is working.

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

If you plan to become pregnant, consult your doctor before stopping any contraceptive method.

Children and adolescents

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

Other medicines and Nilemdo

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 reduce cholesterol and known as statins).

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

Pregnancy and breast-feeding

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

• Pregnancy

Before starting treatment, you must confirm that you are not pregnant and are using an effective contraceptive, as advised by your doctor. If you are using the pill and experience an episode 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 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.

• Breast-feeding

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

Driving and using machines

Nilemdo has no or negligible influence on the ability to drive and use machines.

Nilemdo 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 Nilemdo

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are 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:

• 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 from 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 Nilemdo

Do not stop taking Nilemdo without your doctor's permission, as your cholesterol levels 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.

Side effects may occur with the following frequencies:

Common(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 problems
• decrease in glomerular filtration rate (a measure of kidney function)

Uncommon(may affect up to 1 in 100 people)

• decrease in hemoglobin (a protein in red blood cells that carries oxygen)
• increase in creatinine and urea in the blood (laboratory tests of kidney function)

• weight loss

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 Nilemdo

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 storage conditions.

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

6. Contents of the pack and other information

Composition of Nilemdo

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

• microcrystalline cellulose (E460)
• sodium carboxymethyl starch (type A) (see end of section 2 "Nilemdo contains lactose and sodium")
• hydroxypropyl cellulose (E463)
• magnesium stearate (E470b)

• colloidal anhydrous silica (E551)
• partially hydrolyzed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol/PEG (E1521)

Appearance of the product and pack size

The film-coated tablets are white or almost white, oval, 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 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 obtain further information on this medicine by contacting 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.