MICARDIS PLUS

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Unit dalam paket:

DUS, 2 ALU-BLISTER @ 10 TABLET

Tanggal Otorisasi:

2022-09-24

Karakteristik produk

Red font:
Proposed
CCDS
0252-13; Blue
F
on
t:
Editorial; Y
e
llow
mark: Additional from BPOM
DISETUJUI OLEH BPOM : 15/10/2021
EREG10036412000538 - 39
M
I
C
A
R
D
I
S
P
LUS
C
OM
P
OS
I
T
I
ON
1 tablet
c
on
ta
i
ns
:
[
1
,
1
’
-
b
iph
e
n
yl]
-
2
-
car
b
o
xyl
i
caci
d
,
4
’
-
[
(1
,
4
’
d
i
m
e
t
h
yl
-
2
’
-
p
ro
p
yl[
2
,
6
-
bi
-
1
H
-
b
en
z
i
m
i
d
a
z
ol
e]
-
1
’
-
yl)methyl] (=
telmisartan)
40 or 80
m
g
Hydrochlorothiazide
12.5
m
g
Excipients:
**
povidone, meglumine,
sodium hydroxide, sorbitol,
magnesium stearate, microcristalline c
e
ll
u
l
ose
,
ferric oxide red (E172), sodium starch glycolate, lactose
monohydrate,
maize
st
a
rc
h
Sodium
MIC
A
R
D
IS
®
PLUS
t
a
b
l
e
t
s
40/12.5
mg
contain
less than 1 mmol
sodium
(23 mg) per tablet, that is to
sa
y
essentially
‘
s
o
di
um
-
f
ree’.
Sodium
M
I
C
A
R
D
I
S
®
PLUS
tablets 80/12.5
mg
contain
less than 1 mmol sodium (23 mg) per tablet, that is to
sa
y
essentially
‘
s
o
di
um
-
f
ree’.
I
ND
I
CAT
I
O
NS
T
r
ea
t
m
en
t
of
essen
t
i
a
l
h
y
p
er
t
ens
i
on
.
As fixed dose
combination
MICARDIS PLUS
is
indicated
in
patients
whose blood
pressure
is
not
adequately controlled
on
telmisartan
or
hydrochlorothiazide
a
l
on
e.
DOSAGE AND
A
D
M
IN
IST
R
A
T
IO
N
MICARDIS PLUS
may be taken with or
without
f
ood
.
Ad
u
l
ts
MICARDIS PLUS
should be taken once daily. The dose of
telmisartan
could be
up-titrated b
ef
or
e
switching to
MICARDIS
PLUS. Direct change from
monotherapy
to the fixed
combinations
may
be
c
ons
i
d
er
ed
.
•
MICARDIS
PLUS
40/12.5
mg may be
administered
in
patients
whose blood
pressure
is
no
t
adequately controlled
by
MICARDIS
40 mg or
hy
dr
o
chl
o
r
o
t
hi
a
z
i
de
.
•
MICARDIS
PLUS
80/12.5
mg may be
administered
in
patients
whose blood
pressure
is
no
t
adequately controlled
by
MICARDIS
80 mg or by
MICARDIS PLUS
40/12.5
m
g
.
Sodium or volume
d
ep
l
e
t
i
on
should be
corrected
before
treatment commencement
with
Mi
c
a
r
d
i
s
P
lu
s
.
The
maximum
antihypertensive
effect
is
generally
attained
with
MICARDIS
P
L
U
S
4 – 8 weeks