Nustendi 180 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Nustendi 180mg/10mg film-coated tablets

bempedoic acid/ezetimibe

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

• Keep this 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Nustendi is and what it is used for
2. What you need to know before taking Nustendi
3. How to take Nustendi
4. Possible side effects
5. How to store Nustendi
6. Contents of the pack and other information

1. What Nustendi is and what it is used for

What Nustendi is and how it works

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

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

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

What Nustendi is used for

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

Nustendi is given:

• if you have been taking a statin (such as simvastatin, a medicine commonly used to treat high cholesterol) together with ezetimibe and it has not sufficiently reduced your LDL cholesterol;
• if you have been taking ezetimibe and it has not sufficiently reduced your LDL cholesterol;
• to replace separate tablets of bempedoic acid and ezetimibe if you have been taking these medicines as individual tablets.

2. What you need to know before taking Nustendi

Do not take Nustendi

• if you are allergic to bempedoic acid, ezetimibe, or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant;
• if you are taking more than 40 mg of simvastatin per day (another medicine used to lower cholesterol);
• with a statin if you currently have liver problems.
• Nustendi contains ezetimibe. When Nustendi is administered together with a statin, you must also read all the information regarding ezetimibe in the package leaflet of that specific statin.

Warnings and precautions

Talk to 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 should perform a blood test before you start taking Nustendi with a statin (a medicine used to lower cholesterol) to check how well your liver is functioning.

If you are taking statins, contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness (see Other medicines and Nustendi).

When fibrates are administered concomitantly with Nustendi, your doctor should perform a blood test four weeks after starting Nustendi and periodically thereafter to monitor:

• a type of fat (also called triglycerides) and
• "good" cholesterol (also called "HDL cholesterol").

If you are planning to become pregnant, consult your doctor first. Your doctor will advise you on how to stop taking Nustendi before discontinuing any contraceptive method.

Children and adolescents

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

Other medicines and Nustendi

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor if you are taking medicines containing 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 a statin and Nustendi. 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).
• Fenofibrate or other fibrates or gemfibrozil (also used to lower cholesterol).
• Cyclosporine (frequently used in organ transplant patients).
• Cholestyramine (also used to lower cholesterol), because it affects how ezetimibe works.
• Medicines to prevent blood clots, such as warfarin as well as acenocoumarol, phenindione, and phenprocoumon.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant, planning to become pregnant, or think you might be pregnant, as there is a possibility it could harm the fetus. If you become pregnant while taking this medicine, contact your doctor immediately and stop taking Nustendi.

• Pregnancy

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

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

• Breastfeeding

If you are breastfeeding, consult your doctor before taking this medicine because Nustendi may pass into breast milk.

Driving and using machines

The influence of Nustendi on the ability to drive and use machines is minor.

However, some people may feel dizzy after taking Nustendi. Avoid driving or using machines if you think your reaction ability is impaired.

Nustendi contains lactose and sodium.

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Nustendi

Follow exactly the instructions for administering this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily.

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

Swallow the tablet whole with food or between meals.

If you take more Nustendi than you should

Contact your doctor or pharmacist immediately.

If you forget to take Nustendi

If you realize you have forgotten:

• a dose later on the same day, take the missed dose and then take the next dose at the usual time the following day.
• 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 Nustendi

Do not stop taking Nustendi without permission from your doctor, as your cholesterol levels may rise again.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience any of the following adverse effects (frequency not known):

• muscle pain, tenderness, or weakness (myopathy/rhabdomyolysis)
• yellowing of the skin and eyes, abdominal pain, dark urine, swollen ankles, loss of appetite, and feeling tired, which could be signs of liver problems (hepatitis)
• allergic reactions such as rash and hives; raised red rash, sometimes with target-like lesions (hypersensitivity/erythema multiforme)
• 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, inflammation of the pancreas, often with severe abdominal pain (pancreatitis)
• decrease in platelets, which may cause bruising or bleeding (thrombocytopenia)

Other adverse 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)
• decrease in hemoglobin (the oxygen-carrying protein in red blood cells)
• increased levels of uric acid in the blood
• elevated uric acid levels in blood causing swelling and pain in the joints (gout)
• loss of 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 indicating muscle damage)
• muscle weakness, joint pain (arthralgia)
• increased creatinine and blood urea nitrogen (laboratory tests indicating kidney function)
• unusual tiredness (fatigue) or weakness (asthenia)
• decrease in glomerular filtration rate (a measure of kidney function)

Uncommon (may affect up to 1 in 100 people)

• hot flushes
• upper stomach pain, heartburn, indigestion
• itching
• swelling of the legs or hands
• neck pain, chest pain, pain
• weight loss
• muscle weakness

Frequency not known (cannot be estimated from available data)

• tingling sensation
• depression
• shortness of breath

Reporting of 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 leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nustendi

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 on the carton after EXP/CAD. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nustendi

• The active substances are bempedoic acid and ezetimibe. Each film-coated tablet contains 180 mg of bempedoic acid and 10 mg of ezetimibe.

• The other components are:

• lactose monohydrate (see end of section 2, “Nustendi contains lactose and sodium”)

• microcrystalline cellulose (E 460)

• sodium carboxymethyl starch (type A) (see end of section 2, “Nustendi contains lactose and sodium”)

• hydroxypropyl cellulose (E 463)

• magnesium stearate (E 470b)

• colloidal anhydrous silica (E 551)

• sodium lauryl sulfate (E 487) (see end of section 2, “Nustendi contains lactose and sodium”)

• povidone (K30) (E 1201)

• partially hydrolyzed (poly)vinyl alcohol (E 1203), talc (E 553b), titanium dioxide (E 171), indigo carmine aluminium lake (E 132), glycerol monocaprylocaprate, brilliant blue FCF aluminium lake (E 133)

Appearance of the product and contents of the pack

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

Nustendi 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 × 1, 50 × 1 or 100 × 1 film-coated tablet.

In your country, only certain pack sizes may be marketed.

Marketing Authorization Holder

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48

81379 Munich

Germany

Manufacturer

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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