bempedoic acid: package leaflet

What Nilemdo is and how it works

Nilemdo is a medicine that lowers levels of ‘bad’ cholesterol (also called “LDL-cholesterol”), a type of fat, in the blood. Nilemdo also can help reduce cardiovascular risk through lowering the levels of bad cholesterol.

Nilemdo contains the active substance bempedoic acid, which is inactive until it enters the liver where it is changed to its active form. Bempedoic acid decreases the production of cholesterol in the liver and increases the removal of LDL-cholesterol from the blood by blocking an enzyme (ATP citrate lyase) needed for the production of cholesterol.

What Nilemdo is used for

• Adults with primary hypercholesterolaemia or mixed dyslipidaemia, which are conditions that cause a high cholesterol level in the blood. It is given in addition to a cholesterol-lowering diet.
• Adults with high cholesterol levels in their blood who already have cardiovascular disease or have other conditions that put them at a higher risk of cardiovascular events.

Nilemdo is given:
- if you have been using a statin (such as simvastatin, a commonly used medicine that treats high cholesterol) and this does not lower your LDL-cholesterol sufficiently;
- alone or together with other cholesterol-lowering medicines when statins are not tolerated or cannot be used.

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 take more than 40 mg of simvastatin daily (another medicine used to lower cholesterol).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nilemdo:
- if you 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 well your liver is working.

If you are taking other medicines called statins (medicines used to lower cholesterol), talk promptly to your doctor about any unexplained muscle pain, tenderness, or weakness ( see ‘Other medicines and Nilemdo’).

In case of concomitant administration of fibrates with Nilemdo, your doctor should do a blood test at four weeks after starting Nilemdo and periodically thereafter to monitor:
- a type of fat (also called triglycerides) and
- ‘good’ cholesterol (also called “HDL-cholesterol”).

If you plan to become pregnant, talk to your doctor first.Your doctor will advise you how to stop taking Nilemdo before stopping any form of contraception.

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 medicine(s) with 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 both a statin and Nilemdo. Tell your doctor immediately about any unexplained muscle pain, tenderness or weakness.
- bosentan (used to manage a condition called pulmonary artery hypertension).
- fimasartan (used to treat high blood pressure and heart failure).
- asunaprevir, glecaprevir, grazoprevir, voxilaprevir (used to treat hepatitis C).
- fenofibrate or other fibrates (used to lower cholesterol).

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant, trying to get pregnant, or think you may be pregnant, as there is a possibility that it could harm an unborn baby. If you get pregnant while taking this medicine, call your doctor immediately and stop taking Nilemdo.

- Pregnancy
Before starting treatment, you should confirm you are not pregnant and are using effective contraception, as advised by your doctor. If you use contraceptive pills and suffer from an episode of diarrhoea or vomiting that lasts more than 2 days, you must use an alternative method of contraception (e.g. condoms, diaphragm) for 7 days following resolution of symptoms.

If, after you have started treatment with Nilemdo, you decide that you would like to become pregnant, tell your doctor, as your treatment will need to be changed.

- Breast-feeding
If you are breast-feeding, ask your doctor for advice before taking this medicine because Nilemdo may pass into your breast-milk.

Driving and using machines

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

Nilemdo contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet once daily.

Swallow the tablet whole with food or between meals.

If you take more Nilemdo than you should

Contact your doctor or pharmacist immediately.

If you forget to take Nilemdo

If you notice that you forgot:
- a dose late in a day, take the missed dose and take the next dose at your regular time the next day.
- the previous day’s dose, take your tablet at the regular time and do not make up for the forgotten dose.

If you stop taking Nilemdo

Do not stop taking Nilemdo without your doctor’s permission as your cholesterol may rise again.

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

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

Side effects can occur with the following frequencies:

Common (may affect up to 1 in 10 people)
- lower number of red blood cells (anaemia)
- increased levels of uric acid in blood, gout
- pain in shoulders, legs, or arms
- blood test results indicating liver abnormalities
- decreased glomerular filtration rate (a measure of how well your kidneys are working)

Uncommon (may affect up to 1 in 100 people)
- decreased haemoglobin (a protein in red blood cells that carries oxygen)
- raised creatinine and blood urea nitrogen (laboratory tests of kidney function)
- weight loss

Reporting of side effects

If you get 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.

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. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Nilemdo contains

• 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 under ‘Nilemdo contains lactose and sodium’)
• microcrystalline cellulose (E460)
• sodium starch glycolate (Type A grade) (see end of section 2 under ‘Nilemdo contains lactose and sodium’)
• hydroxypropyl cellulose (E463)
• magnesium stearate (E470b)
• silica, colloidal anhydrous (E551)
• partially hydrolysed poly(vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171), macrogol/PEG (E1521)

What Nilemdo looks like and contents of the pack

Film-coated tablets are white to off-white, oval, debossed with “180” on one side and “ESP” on the other side. Tablet dimensions: 13.97 mm × 6.60 mm × 4.80 mm.

Nilemdo is supplied in plastic/aluminium blisters in cartons of 10, 14, 28, 30, 84, 90, 98 or 100 film- coated tablets or unit dose blisters in cartons of 10 x 1, 50 x 1 or 100 x 1 film-coated tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Daiichi Sankyo Europe GmbH
Zielstattstrasse 48
81379 Munich
Germany

Manufacturer

Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Daiichi Sankyo Belgium N.V.-S.A
Tél/Tel: +32-(0) 2 227 18 80

Lietuva
Zentiva, k.s.
Tel: +370 52152025

България
Zentiva, k.s.
Тел.: + 359 24417136

Luxembourg/Luxemburg
Daiichi Sankyo Belgium N.V.-S.A
Tél/Tel: +32-(0) 2 227 18 80

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111

Magyarország
Daiichi Sankyo Europe GmbH
Tel.: +49-(0) 89 7808 0

Danmark
Organon Denmark ApS
Tlf.: +45 4484 6800

Malta
Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0

Deutschland
Daiichi Sankyo Deutschland GmbH
Tel: +49-(0) 89 7808 0

Nederland
Daiichi Sankyo Nederland B.V.
Tel: +31-(0) 20 4 07 20 72

Eesti
Zentiva, k.s.
Tel: +372 52 70308

Norge
Organon Norway AS
Tlf: +47 24 14 56 60

Ελλάδα
Daiichi Sankyo Europe GmbH
Τηλ: +49-(0) 89 7808 0

Österreich
Daiichi Sankyo Austria GmbH
Tel: +43 (0) 1 485 86 42 0

España
Daiichi Sankyo España, S.A.
Tel: +34 91 539 99 11

Polska
Daiichi Sankyo Europe GmbH
Tel.: +49-(0) 89 7808 0

France
Organon France
Tél: +33 (0) 1 57 77 32 00

Portugal
Daiichi Sankyo Portugal, Unip. LDA
Tel: +351 21 4232010

Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830

România
Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0

Ireland
Daiichi Sankyo Ireland Ltd
Tel: +353-(0) 1 489 3000

Slovenija
Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010

Italia
Daiichi Sankyo Italia S.p.A.
Tel: +39-06 85 2551

Suomi/Finland
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520

Κύπρος
Daiichi Sankyo Europe GmbH
Τηλ: +49-(0) 89 7808 0

Sverige
Organon Sweden AB
Tel: +46 8 502 597 00

Latvija
Zentiva, k.s.
Tel: +371 67893939

This leaflet was last revised in

Other sources of information

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