Nilemdo

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Bempedoic acid

Available from:

Daiichi Sankyo Europe GmbH

ATC code:

C10AX

INN (International Name):

bempedoic acid

Therapeutic group:

Lipid modifying agents

Therapeutic area:

Hypercholesterolemia; Dyslipidemias

Therapeutic indications:

Nilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin (see sections 4.2, 4.3, and 4.4) or,alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.

Product summary:

Revision: 6

Authorization status:

Authorised

Authorization date:

2020-04-01

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
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.
WHAT IS IN 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 NILEMDO IS AND WHAT IT IS USED FOR
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 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
Nilemdo is given to 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.
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.
26
2.
WHAT YOU NEED TO KNOW BEFORE YOU TA

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nilemdo 180 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 180 mg of bempedoic acid.
Excipient(s) with known effect
Each 180 mg film-coated tablet contains 28.5 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, oval, film-coated tablet of approximately 13.97 mm
× 6.60 mm × 4.80 mm
debossed with “180” on one side and “ESP” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nilemdo is indicated in adults with primary hypercholesterolaemia
(heterozygous familial and
non-familial) or mixed dyslipidaemia, as an adjunct to diet:
•
in combination with a statin or statin with other lipid-lowering
therapies in patients unable to
reach LDL-C goals with the maximum tolerated dose of a statin (see
sections 4.2, 4.3, and 4.4)
or,
•
alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant,
or for whom a statin is contraindicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Nilemdo is one film-coated tablet of 180 mg
taken once daily.
_Concomitant simvastatin therapy _
When Nilemdo is coadministered with simvastatin, simvastatin dose
should be limited to 20 mg daily
(or 40 mg daily for patients with severe hypercholesterolaemia and
high risk for cardiovascular
complications, who have not achieved their treatment goals on lower
doses and when the benefits are
expected to outweigh the potential risks) (see sections 4.4 and 4.5).
_Special populations _
_Elderly patients _
No dose adjustment is necessary in elderly patients (see section 5.2).
_ _
3
_Patients with renal impairment _
No dose adjustment is necessary in patients with mild or moderate
renal impairment. There are limited
data available in patients with severe renal impairment (defined as
estimated glomerular filtration rate
[eGFR] < 30 mL/min/1.73 m
2
), and p