Entresto 50mg Film-coated Tablets

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv bestanddel:

sacubitril/valsartan

Tilgængelig fra:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

sacubitril/valsartan

Enheder i pakken:

28tablet Tablets; 30tablet Tablets

Fremstillet af:

NOVARTIS FARMA S.P.A.

Indlægsseddel

_Consumer Medication Information Leaflet (RiMUP) _
ENTRESTO
® FILM-COATED TABLETS
sacubitril/valsartan (50mg, 100mg, 200mg)
1
WHAT IS IN THIS LEAFLET
1.
What Entresto is used for
2.
How Entresto works
3.
Before you take Entresto
4.
How to use Entresto
5.
While you are using Entresto
6.
Side effects
7.
Storage and Disposal of
Entresto
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ENTRESTO IS USED FOR
Entresto is a medicine known as an
angiotensin receptor neprilysin
inhibitor. It dissociates into two
active substances, sacubitril and
valsartan. They both help to treat
heart failure and control high blood
pressure.
Entresto is used to treat a type of
long-term heart failure in adults.
This type of heart failure occurs
when the heart is weak and cannot
pump enough blood to the lungs
and the rest of the body. The most
common symptoms of heart failure
are breathlessness, fatigue,
tiredness and ankle swelling.
Entresto is also used to treat high
blood pressure in adults. High
blood pressure increases the
workload of the heart and arteries.
If it continues for a long time, it
can damage the blood vessels of the
brain, heart, and kidneys, and may
result in a stroke, heart failure, or
kidney failure. High blood pressure
increases the risk of heart attacks.
Lowering your blood pressure to
normal reduces the risk of
developing these disorders.
HOW ENTRESTO WORKS
Entresto works by blocking the
effects of neprilysin via sacubitril
and angiotensin-II receptor via
valsartan. As a result, blood vessels
relax and less water is retained by
the body which is beneficial to treat
heart failure and high blood
pressure.
If you have any questions about
how Entresto works or why this
medicine has been prescribed for
you, ask your doctor or pharmacist.
BEFORE YOU TAKE ENTRESTO _ _
_When you must not use it: _
DO NOT TAKE ENTRESTO
•
if you are allergic to sacubitril,
valsartan or any of the other
ingredients of this medicine
(listed in section 8 “Product
description”). If you think

Produktets egenskaber

Novartis
Page 2
Malaysia Package Leaflet
19 May 2021
ENTRESTO
®
2
ENTRESTO
®
1.
NAME OF THE MEDICINAL PRODUCT
Entresto
®
50 mg film-coated tablets
Entresto
®
100 mg film-coated tablets
Entresto
®
200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entresto
®
50 mg film-coated tablets
Each film-coated tablet contains 24.3 mg sacubitril and 25.7 mg
valsartan (as sacubitril valsartan
sodium salt complex).
Entresto
®
100 mg film-coated tablets
Each film-coated tablet contains 48.6 mg sacubitril and 51.4 mg
valsartan (as sacubitril valsartan
sodium salt complex).
Entresto
®
200 mg film-coated tablets
Each film-coated tablet contains 97.2 mg sacubitril and 102.8 mg
valsartan (as sacubitril valsartan
sodium salt complex).
Entresto
®
contains a salt complex of the anionic forms of sacubitril and
valsartan, sodium cations, and
water molecules in the molar ratio of 1:1:3:2:5 respectively.
Following oral adminstration, Entresto
®
dissociates into sacubitril (which is further metabolized to LBQ657
[sacubitrilat]) and valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Entresto
®
50 mg film-coated tablets
Violet white ovaloid biconvex film-coated tablet with bevelled edges,
unscored, debossed with “NVR”
on one side and “LZ” on the other side. Approximate tablet
dimensions 13.1 mm x 5.2 mm.
Entresto
®
100 mg film-coated tablets
Pale yellow ovaloid biconvex film-coated tablet with bevelled edges,
unscored, debossed with “NVR”
on one side and “L1” on the other side. Approximate tablet
dimensions 13.1 mm x 5.2 mm.
Entresto
®
200 mg film-coated tablets
Light pink ovaloid biconvex film-coated tablet with bevelled edges,
unscored, debossed with “NVR”
on one side and “L11” on the other side. Approximate tablet
dimensions 15.1 mm x 6.0 mm.
Novartis
Page 3
Malaysia Package Leaflet
19 May 2021
ENTRESTO
®
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS HEART FAILURE
Entresto is indicated to reduce the risk of cardiov