Nilemdo

Patient Information Leaflet

Nilemdo 180 mg film-coated tablets

bempedoic acid
Please read all of this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Nilemdo is and what it is used for
2. What you need to know before you take Nilemdo
3. How to take Nilemdo
4. Possible side effects
5. How to store Nilemdo
6. 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 levels of "bad" cholesterol (also known as "LDL cholesterol"), a type of fat present in the blood. Nilemdo may also help reduce cardiovascular risk by lowering levels of bad cholesterol.
Nilemdo contains the active substance bempedoic acid, which is inactive until it enters the liver, where it is converted into its active form. Bempedoic acid decreases cholesterol production in the liver and increases the removal of LDL cholesterol from the blood by inhibiting an enzyme (ATP citrate lyase) required for cholesterol production.

What Nilemdo is used for

• Adults with primary hypercholesterolaemia or mixed dyslipidaemia, conditions that cause high levels of cholesterol in the blood. It is given as an addition to diet for cholesterol reduction.
• Adults with high levels of cholesterol in the blood who already have cardiovascular disease or who have other conditions that increase their risk of cardiovascular events.

Nilemdo is administered in the following cases:

• if you have taken a statin (such as simvastatin, a medicine commonly used to treat high cholesterol) but LDL cholesterol has not been sufficiently reduced;
• alone or together with other cholesterol-lowering medicines when statins are not tolerated or cannot be used.

2. What you need to know before taking Nilemdo

Do not take Nilemdo

• if you are allergic to bempedoic acid or to any of the other ingredients of this medicine (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 medicine used to lower cholesterol).

Warnings and precautions
Talk to your doctor or pharmacist before taking Nilemdo:

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

Your doctor may prescribe a blood test before starting treatment with Nilemdo to monitor liver function.
If you are taking other medicines called statins (medicines used to lower cholesterol), contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness (see section “Other medicines and Nilemdo”).
If you are planning to become pregnant, consult your doctor, who will advise you on how to stop treatment with Nilemdo before stopping any form of contraception.
Children and adolescents
Do not give Nilemdo to children and adolescents under 18 years of age, as this medicine has not been studied in this age group.
Other medicines and Nilemdo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are taking any medicine containing any of the following active substances:

• atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin (used to lower cholesterol and known as statins). Taking a statin together with Nilemdo may increase the risk of muscle disorders. Inform your doctor immediately of any unexplained muscle pain, tenderness, or weakness;
• bosentan (used to treat a condition called pulmonary arterial hypertension);
• fimasartan (used to treat hypertension and heart failure);
• asunaprevir, glecaprevir, grazoprevir, voxilaprevir (used to treat hepatitis C).

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, if you are trying to become pregnant, or if you suspect you might be pregnant, as it may harm the unborn baby. If you become pregnant while taking this medicine, contact your doctor immediately and stop taking Nilemdo.

• Pregnancy Before starting treatment, ensure that you are not pregnant and that your contraceptive methods are effective, as advised by your doctor. If you are taking oral contraceptives and experience an episode of diarrhea or vomiting lasting more than 2 days, use an alternative contraceptive method (e.g., condoms, diaphragm) for 7 days after symptoms resolve.
  If, after starting treatment with Nilemdo, you decide to become pregnant, inform your doctor, as your treatment will need to be changed.

• Breastfeeding Do not take Nilemdo while breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines
Nilemdo does not affect or has a negligible effect on the ability to drive and use machines.
Nilemdo contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Nilemdo

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
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 realize you have missed:

• a dose on the same day, take the missed dose even if it is later than usual, then take the next dose at the scheduled time the following day;
• the dose for the previous day, take the tablet at the usual time and do not make up for the missed dose.

If you stop taking Nilemdo
Do not stop treatment with Nilemdo without consulting your doctor, as your cholesterol levels may rise again.
If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the following frequencies:
common (may affect up to 1 in 10 people)

• reduction in the number of red blood cells (anaemia)
• increased levels of uric acid in the blood, gout
• shoulder, leg or arm pain
• blood test results indicating liver abnormalities
• reduction in glomerular filtration rate (a measure of kidney function)

uncommon (may affect up to 1 in 100 people)

• decreased haemoglobin (the oxygen-carrying protein in red blood cells)
• increased levels of creatinine and blood urea nitrogen in the blood (laboratory tests to assess kidney function)
• weight loss

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nilemdo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after EXP and on the carton after Scad. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nilemdo contains

• The active substance is bempedoic acid. Each film-coated tablet contains 180 mg of bempedoic acid.
• The other components are:
  • lactose monohydrate (see the end of section 2 “Nilemdo contains lactose and sodium”)
  • microcrystalline cellulose (E460)
  • sodium starch glycolate (type A) (see the end of section 2 “Nilemdo contains lactose and sodium”)
  • hydroxypropylcellulose (E463)
  • magnesium stearate (E470b)
  • anhydrous colloidal silica (E551)
  • partially hydrolysed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol/PEG (E1521)

Description of the appearance of Nilemdo and contents of the pack
The film-coated tablets are white to off-white, oval-shaped, with “180” engraved 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/aluminum blisters in packs of 10, 14, 28, 30, 84, 90, 98 or 100 film-coated tablets, or in unit-dose divisible blisters in packs of 10 × 1, 50 × 1 or 100 × 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Daiichi Sankyo Belgium N.V.-S.A Zentiva, k.s.
Tél/Tel: +32-(0) 2 227 18 80 Tel: +370 52152025

България Luxembourg/Luxemburg
Zentiva, k.s. Daiichi Sankyo Belgium N.V.-S.A
Тел.: +359 24417136 Tél/Tel: +32-(0) 2 227 18 80

Česká republika Magyarország
Zentiva, k.s. Daiichi Sankyo Europe GmbH
Tel: +420 267 241 111 Tel.: +49-(0) 89 7808 0

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

Deutschland Nederland
Daiichi Sankyo Deutschland GmbH Daiichi Sankyo Nederland B.V.
Tel: +49-(0) 89 7808 0 Tel: +31-(0) 20 407 20 72

Eesti Norge
Zentiva, k.s. Daiichi Sankyo Europe GmbH
Tel: +372 52 70308 Tlf: +49-(0) 89 7808 0

Ελλάδα Österreich
Daiichi Sankyo Europe GmbH Daiichi Sankyo Austria GmbH
Τηλ: +49-(0) 89 7808 0 Tel: +43 (0) 1 485 86 42 0

España Polska
Daiichi Sankyo España, S.A. Daiichi Sankyo Europe GmbH
Tel: +34 91 539 99 11 Tel.: +49-(0) 89 7808 0

France Portugal
Daiichi Sankyo France S.A.S. Daiichi Sankyo Portugal, Unip. LDA
Tél: +33 (0) 1 55 62 14 60 Tel: +351 21 4232010

Hrvatska România
Zentiva d.o.o. Daiichi Sankyo Europe GmbH
Tel: +385 1 6641 830 Tel: +49-(0) 89 7808 0

Ireland Slovenija
Daiichi Sankyo Ireland Ltd Daiichi Sankyo Europe GmbH
Tel: +353-(0) 1 489 3000 Tel: +49-(0) 89 7808 0

Ísland Slovenská republika
Daiichi Sankyo Europe GmbH Zentiva, a.s.
Sími: +49-(0) 89 7808 0 Tel: +421 2 3918 3010

Italia Suomi/Finland
Daiichi Sankyo Italia S.p.A. Daiichi Sankyo Europe GmbH
Tel: +39-06 85 2551 Puh/Tel: +49-(0) 89 7808 0

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

Latvija United Kingdom (Northern Ireland)
Zentiva, k.s. Daiichi Sankyo Europe GmbH
Tel: +371 67893939 Tel: +49-(0) 89 7808 0

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/