Uperio 200mg Film-coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

sacubitril/valsartan

Boleh didapati daripada:

ALCON LABORATORIES (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

sacubitril/valsartan

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
UPERIO
® FILM-COATED TABLETS
sacubitril/valsartan (50mg, 100mg, 200mg)
1
WHAT IS IN THIS LEAFLET
1.
What Uperio is used for
2.
How Uperio works
3.
Before you take Uperio
4.
How to use Uperio
5.
While you are using Uperio
6.
Side effects
7.
Storage and Disposal of
Uperio
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT UPERIO IS USED FOR
Uperio is a medicine known as an
angiotensin receptor neprilysin
inhibitor. It dissociates into two
active substances, sacubitril and
valsartan.
Uperio 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.
HOW UPERIO WORKS
Uperio 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.
If you have any questions about
how Uperio works or why this
medicine has been prescribed for
you, ask your doctor or pharmacist.
BEFORE YOU TAKE UPERIO _ _
_When you must not use it: _
DO NOT TAKE UPERIO

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 you
may be allergic to any
component of this medicine,
talk to your doctor before
taking Uperio.

if you are taking another type
of medicine called an
angiotensin converting enzyme
(ACE) inhibitor (for example
enalapril, lisinopril or
ramipril). ACE inhibitors are
used to treat high blood
pressure or heart failure. If you
have been taking an ACE
inhibitor, wait for 36 hours
after taking the last dose before
you start to take Uperio (see
“Taking other medicines”).

if you or a member of your
family have ever had a reaction
called angioedema (swell

Ciri produk

Regulatory Affairs
UPERIO
®
(sacubitril/valsartan)
50, 100, 200 mg film-coated tablets
MALAYSIA PACKAGE LEAFLET
(FEB 19; EU PI JUL 18)
IPL Creator:
Sandhya Sikharam
CDS Author(s):
Mercy Abraham,
Masha Berkhin, Mathieu Weitbruch,
Amol
Parekh, Cecile Hauschka
,
Tom Armstrong
GLC approval:
12 Nov 2014, 21 Nov 2014, 04 Aug 2015, amended 16 May
2017
Effective date:
10-Jul-2017
Safety Label
Change Tracking
Number:
2017-PSB/GLC-0871-s
Document status:
Final
Number of pages:
20
Property of Novartis
Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis
Alcon
Page 2
Malaysia Package Leaflet
10 Jul 2017
UPERIO
UPERIO
®
Uperio 50 mg film-coated tablets (sacubitril/valsartan).
Uperio 100 mg film-coated tablets (sacubitril/valsartan).
Uperio 200 mg film-coated tablets (sacubitril/ valsartan).
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Film-coated tablet.
50 mg: Violet white ovaloid biconvex film-coated tablet with beveled
edges, unscored,
debossed with “NVR” on one side and “LZ” on the other side.
100 mg: Pale yellow ovaloid biconvex film-coated tablet with beveled
edges, unscored,
debossed with “NVR” on one side and “L1” on the other side.
200 mg: Light pink ovaloid biconvex film-coated tablet with beveled
edges, unscored, debossed
with “NVR” on one side and “L11” on the other side.
ACTIVE SUBSTANCE(S)
Sacubitril/valsartan.
Uperio 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 administration,
Uperio dissociates into sacubitril (which is further metabolized to
LBQ657) and valsartan.
Uperio film coated tablets contains 50 mg (sacubitril 24.3 mg /
valsartan 25.7 mg)*.
Uperio film coated tablets contains 100 mg (sacubitril 48.6 mg /
valsartan 51.4 mg)*.
Uperio film coated tablets contains 200 mg (sacubitril 97.2 mg /
valsartan 102.8 mg)*.
* Certain dosage strengths may not be available in all countries.
EXCIPIENTS
microcrystall