Verquvo Film Coated Tablet 10mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Vericiguat Micronized

Boleh didapati daripada:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Vericiguat Micronized

Unit dalam pakej:

14 Tablets; 28 Tablets; 14 Tablets; 28 Tablets

Dikeluarkan oleh:

BAYER AG

Risalah maklumat

VERQUVO
®
Verquvo® (Vericiguat) Film Coated Tablet 2.5 mg, 5mg, 10mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Verquvo_
is used for
2.
How
_Verquvo_
works
3.
Before you use
_Verquvo_
4.
How to use
_Verquvo_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Verquvo_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT _VERQUVO_ IS USED FOR
Verquvo is used to treat adults with long-
term heart failure who recently have had
an increase in heart failure symptoms.
Therefore, you may have gone to
hospital and/or received a medicine
(diuretic) given in a vein to help you pass
more urine than usual.
Heart failure is when your heart is weak
and cannot pump enough blood to your
body. Some common symptoms of heart
failure are shortness of breath, tiredness,
or swelling caused by a build-up of fluid.
HOW _VERQUVO_ WORKS
Verquvo
contains
the
active
substance
vericiguat,
which
is
a
type
of
heart
medicine
called
soluble
guanylate
cyclase stimulator. It works by widening
the arteries to make it easier for the heart
to get more blood and oxygen throughout
the body.
BEFORE YOU USE _VERQUVO _
- When you must not use it
DO NOT TAKE _VERQUVO _IF YOU ARE:
-
ALLERGIC
to vericiguat or any of the
other ingredients of this medicine
-
taking any medicine that contains
another
SOLUBLE GUANYLATE CYCLASE
STIMULATOR
, e.g. riociguat used to treat
high blood pressure in lungs.
If any of the above applies to you,
TALK
TO YOUR DOCTOR FIRST
and do not take this
medicine.
- Before you start to use it
Talk to your doctor or pharmacist before
taking Verquvo if you have
-
LOW BLOOD PRESSURE
with symptoms
like dizziness or light-headedness,
-
SEVERE KIDNEY PROBLEMS
or are
ON
DIALYSIS.
-
SEVERE LIVER PROBLEMS.
CHILDREN AND ADOLESCENTS
Do not give this medicine to children and
adolescents aged under 18 years because
it has not been studied yet in this age
group.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding,

Ciri produk

1
Vericiguat 2.5mg,5mg,10mg_Malaysia_SmPC_Aug 22
1.
NAME OF THE MEDICINAL PRODUCT
Verquvo
®
film coated tablet 2.5 mg
Verquvo
®
film coated tablet 5 mg
Verquvo
®
film coated tablet 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Verquvo
®
film coated tablet 2.5 mg
Each film coated tablet contains 2.5 mg vericiguat.
_Excipient with known effect _
Each film coated tablet contains 58.14 mg lactose (as monohydrate),
see section 4.4.
Verquvo
®
film coated tablet 5 mg
Each film coated tablet contains 5 mg vericiguat.
_Excipient with known effect _
Each film coated tablet contains 55.59 mg lactose (as monohydrate),
see section 4.4.
Verquvo
®
film coated tablet 10 mg
Each film coated tablet contains 10 mg vericiguat.
_Excipient with known effect _
Each film coated tablet contains 111.15 mg lactose (as monohydrate),
see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet (tablet)
Verquvo
®
film coated tablet 2.5 mg
Round, biconvex, white film coated tablet with a diameter of 7 mm,
marked with “2.5” on one side
and “VC” on the other side.
Verquvo
®
film coated tablet 5 mg
Round, biconvex, brown-red film coated tablet with a diameter of 7 mm,
marked with “5” on one side
and “VC” on the other side.
Verquvo
®
film coated tablet 10 mg
Round, biconvex, yellow-orange film coated tablet with a diameter of 9
mm, marked with “10” on one
side and “VC” on the other side.
2
Vericiguat 2.5mg,5mg,10mg_Malaysia_SmPC_Aug 22
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Verquvo
®
is indicated to reduce the risk of cardiovascular death and heart
failure (HF) hospitalization
in adult patients with chronic heart failure and reduced ejection
fraction who are stabilised after a
recent decompensation event requiring IV therapy. (See section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Vericiguat is administered in conjunction with other heart failure
therapies.
Before starting vericiguat, care should be taken to optimise volume
status and d