NILEMDO 180 мг Фильм-coated таблетки

Содержание инструкции

1. Nilemdo 180 mg film-coated tablets
   1. What is Nilemdo and what is it 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

Nilemdo 180 mg film-coated tablets

bempedoic acid

Read 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 called “LDL cholesterol”), a type of fat, in the blood. Nilemdo can also help reduce cardiovascular risk by reducing levels of bad cholesterol.
Nilemdo contains the active ingredient bempedoic acid, which is inactive until it enters the
liver where it is converted into 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) necessary for cholesterol production.

What is Nilemdo used for

• Adults with primary hypercholesterolemia or mixed dyslipidemia, conditions that cause high cholesterol levels in the blood. It is administered in addition to diet for cholesterol reduction.
• Adults with high cholesterol levels in the blood who already have cardiovascular disease or who have other conditions that expose them to a higher risk of cardiovascular events.

Nilemdo is administered in the following cases:

• if you have used a statin (such as simvastatin, a medicine commonly used for the treatment of high cholesterol) but have not reduced LDL cholesterol sufficiently;
• alone or together with other medicines to reduce cholesterol 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 breastfeeding;
• if you are taking more than 40 mg of simvastatin per day (another medicine used to reduce 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.

The doctor may prescribe a blood test before starting treatment with Nilemdo, in
order to check your liver function.
If you are taking other medicines called statins (medicines used to reduce 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 first, who will explain 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
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 medicine containing
one of the following active ingredients:

• atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin (used to reduce cholesterol and known as statins). Taking a statin together with Nilemdo may increase the risk of muscle disease. Tell 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 may be pregnant, as there is a possibility that it may harm the fetus. If you become pregnant
during treatment with this medicine, contact your doctor immediately and stop
taking Nilemdo.

• PregnancyBefore starting treatment, check that you are not pregnant and that the contraceptive methods you are using are effective, as recommended by your doctor. If you are using contraceptive pills and experience an episode of diarrhea or vomiting that lasts more than 2 days, use a

alternative method of contraception (e.g., condoms, diaphragm) for the 7 days following
the resolution of the symptoms.
If, after starting treatment with Nilemdo, you decide you want to become pregnant,
tell your doctor, because the treatment will need to be changed.

• BreastfeedingDo not take Nilemdo if you are breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines
Nilemdo does not alter or alters negligibly 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, 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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once a day.
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 realise you have forgotten:

• a dose on the same day, take the forgotten dose even if at a later time than usual and then take the next dose at the scheduled time of the following day;
• the dose of the previous day, take the tablet at the scheduled time and do not compensate for the forgotten dose.

If you stop taking Nilemdo
Do not stop treatment with Nilemdo without your doctor's consent, as your cholesterol
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 can occur with the following frequencies:

common(may affect up to 1 in 10 people)

• reduction in the number of red blood cells (anemia)
• increased levels of uric acid in the blood, gout
• pain in the shoulders, legs or arms
• 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 hemoglobin (protein in red blood cells that carries oxygen)
• increased levels of creatinine and blood urea nitrogen (laboratory tests to check kidney function)
• weight loss

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
described 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 which is stated on the blister after EXP and on the package
after Scad. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nilemdo contains

• The active ingredient is bempedoic acid. Each film-coated tablet contains 180 mg of bempedoic acid.
• The other ingredients are:
• lactose monohydrate (see the end of paragraph 2 “Nilemdo contains lactose and sodium”)
• microcrystalline cellulose (E460)
• sodium starch glycolate (type A) (see the end of paragraph 2 “Nilemdo contains lactose and sodium”)
• hydroxypropylcellulose (E463)
• magnesium stearate (E470b)
• anhydrous colloidal silicon dioxide (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 in colour, oval, with “180” embossed 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 in unit-dose divisible blisters in cartons 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, contact the local representative of the marketing
authorisation holder:

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

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

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

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

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

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
Daiichi Sankyo France S.A.S.
Tél: +33 (0) 1 55 62 14 60

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

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

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

Suomi/Finland
Daiichi Sankyo Europe GmbH
Puh/Tel: +49-(0) 89 7808 0

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

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

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

United Kingdom (Northern Ireland)
Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0

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