BISODAC-HF 10 (BISOPROLOL FUMARATE TABLETS 10MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BISOPROLOL FUMARATE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

BISOPROLOL FUMARATE

Unit dalam pakej:

3x10 Tablets; 28tablet Tablets; 28tablet Tablets; 10x10 Tablets; 3x10 Tablets; 10x10 Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
BISODAC-HF
2.5/5/10MG
(BISOPROLOL
FUMARATE TABLETS 2.5MG/ 5 MG/ 10 MG)
BISOPROLOL FUMARATE (2.5MG, 5MG & 10MG)
WHAT IS IN THIS LEAFLET
1.
What
BISODAC-HF
is
used for
2.
How BISODAC-HF works
3.
Before you use BISODAC-
HF
4.
How to use BISODAC-HF
5.
While you are using it
6.
Side eff
ects
7.
Storage
and
Disposal
of
BISODAC-HF
8.
P
roduct Description
9.
Manufactur
er
10.
Product
Registration
Holder
11.
Date of revision
WHAT BISODAC-HF IS USED
FOR
BISODAC-HF
2.5
MG
IS
USED
FOR:
•
Treatment of stable chronic
heart failure with reduced
systolic
left
ventricular
function
in
addition
to
ACE inhibitors, and
BISODAC-HF 5MG & 10 MG IS
USED FOR:
•
Treatment
of
high
blood
pressure (hypertension)
•
Treatment
of
coronary
heart
disease
(angina
pectoris)
•
Treatment of stable chronic
heart failure with reduced
systolic
left
ventricular
function
in
addition
to
ACE
inhibitors,
and
diuretics,
and
optionally
cardiac glycosides.
HOW BISODAC-HF WORKS
Heart failure occurs when the
heart
muscle
is
weak
and
unable to pump enough blood
around
the
circulation.
This
results
in
breathlessness
and
swelling.
Bisoprolol
slows
down the heart rate and makes
the
heart
more
efficient
at
pumping
blood
around
the
body.
BEFORE YOU USE BISODAC-HF
-
When you must not use i
t
•
are
allergic
(hypersensitivity)
to
bisoprolol or to any of the
other
ingredients
of
BISODAC-HF.
•
have
severe
asthma
or
severe chronic lung disease
•
have
severe
blood
circulation
problems
in
your
limbs
(such
as
Raynaud’s syndrome), that
may cause your fingers and
toes to tingle or turn pale or
blue
•
have
untreated
phaeochromocytoma,
as
rare tumour of the adrenal
gl
and
•
have metabolic acidosis, a
condition when there is t
oo
much acid in the blood.
•
have
heart
failure
that
suddenly
becomes
worse
and / or that may require
hospital treatment
•
have
a
slow
or
irregular
heart rate: ask your doctor
if you are not sure
•
have
very
low
blood
pressure
•
shock induced by disorders
of
cardiac
function
(cardi

Ciri produk

SUMMARY OF PRODUCT
CHARACTERISTICS
BISODAC-HF 2.5 MG,
5 MG & 10 MG
(BISOPROLOL FUMARATE 2.5 MG,
5 MG & 10 MG TABLETS)
R
X ONLY
NAME OF THE DRUG PRODUCT
Bisoprolol Fumarate Tablets 2.5 mg
Bisoprolol Fumarate Tablets 5 mg
Bisoprolol Fumarate Tablets 10 mg
(TRADE) NAME OF
THE PRODUCT
BISODAC-HF 2.5
BISODAC-HF 5
BISODAC-HF 10
STRENGTH:
2.5 mg, 5 mg and 10 mg.
PHARMACEUTICAL DOSAGE FORM: Film-coated tablet
QUALITATIVE AND QUANTITATIVE COMPOSITIONS
_Bisoprolol Fumarate Tablets 2.5 mg_
Ph.Eur. 2.5 mg
_Bisoprolol Fumarate Tablets 5 mg_
Ph.Eur. 5 mg
_Bisoprolol Fumarate Tablets 10 mg_
Ph.Eur. 10 mg
PHARMACEUTICAL FORM
_BISODAC-HF _
_2.5 _
_mg:_
coated tablets debossed with ‘P and break line’ on one
side and ‘2’ on the other side.
_BISODAC-HF 5 mg:_
tablets debossed with ‘P and break line’ on one side and
‘5’ on the other side.
_BISODAC-HF 10 mg:_
tablets debossed with ‘P and break line’ on one side and
‘10’ on the other side.
THERAPEUTIC INDICATIONS
FOR 2.5 MG
•
Treatment of stable chronic heart failure with reduced
systolic left ventricular function in addition to ACE
inhibitors,
and
diuretics,
and
optionally
cardiac
glycosides.
FOR 5MG & 10 MG
•
Treatment of high blood pressure (hypertension)
•
Treatment of coronary heart disease (angina pectoris)
•
Treatment of stable chronic heart failure with reduced
systolic left ventricular function in addition to ACE
inhibitors, and diuretics, and optionally cardiac glycosides.
POSOLOGY AND METHOD OF ADMINISTRATION
RECOMMENDED DOSE FOR 5 MG & 10 MG
TREATMENT OF HYPERTENSION OR ANGINA PECTORIS
In all cases the dose regimen is adjusted individually by
your doctor, in particular according to the pulse rate and
therapeutic success.
The usual initial dose is 5mg bisoprolol fumarate once
daily. If necessary, the dose may be increased to 10mg
bisoprolol fumarate once daily.
The maximum recommended dose is 20mg bisoprolol
fumarate once daily.
BISODAC-HF must be used with caution in patients with
hypertension or angina pectoris and accompanying heart
failure