Inspra

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

eplerenone

Available from:

Pfizer PGM

INN (International Name):

eplerenone

Dosage:

25mg

Pharmaceutical form:

tablets film-coated

Prescription type:

Prescription

Summary of Product characteristics

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IN8
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INSPRA
UK
APPROVED
SUMMAR\'
OF
PRODUCT
CHARACIITBRISTICS
1.
NAME
OF
THE
MEDICINAL
PRODUCT
INSPRA'r$
25
urg
film-coated
tablets.
INSPRA€'
50 nrg
fi
lm-coated
tablets.
2.
QUALI.TATIVE
AND
QUANTITATIVE
COMPOSITION
Each
tablet
contzrins
25
mg
of
eplerenone.
Each
tablet
contains
50 mg
of
eplerenone.
Excipients:
Each 25mg
tablet
ooutains
35.7nrg
of
lactose
monohydrate
(see
section
4.4).
Each 50rng,tablet
contains
71.4mg
of
I'actose
monohydrate
(see
section
4'4).
For
a
full
list
of
excipients
see
section
6.1
.
3.
PHARMACIUTTCAL
FORM
Fihr-coated
tablet.
?5 nrg
tablet:
yellow
tatrlet
u,ith
stylized
"Pfizer"
on
one side
of
tablet,
"NSI{"
over
"25"on
the
other
side
of
tablet.
50
mg
tablet;
yellow
tablet
with
stytized
"Pfizer"
on
one
side of
tablet,
"NSR"
over
"50"on
the
other
side
of
tablet.
4.
CLINICAL
I]ARTICULAJTS
I-
.
4.1.
Therapeutic
itrtlications
Eplerenone
is
inclicated:
r
in
zrdclition
to
standarcl
tlielapy
incluclingbeta-blockers,
to
redttce
tlre
risk
of
cardiovascu'lar
rnortalitl,
ancl
n"rorbiclity
in
stable
patients
with lefl
verrtricr-rlar
dysfunction
(LVEF
S
4A
%)
apcl
clirrical
evidence
of
heart
failure
after
recent
uryocardial
iufarction.
.
in
adclition
to
standard
optir,ral
therapy,
to
recluce
tlie
risk
of
cardiovascular
mortality
and
rnorbiclity in
aclLrlt
patients
with
NYIIA
class
ll
(chrorric)
hcart failure
and
left
verrtricular
systolic
clysfunction
(LVEF
-30%)
(see
section
5.1).
4.2.
Posology
ancl
Methocl
of
Atlministratiott
For
the
indivicluat
acljr.rstment
of
dose,
the
strengths
of
25
mg
and
50
nlg
are
available.'l'he
maximum
dose
regimen
is
50
rrrg
daily.
.:1?,rrr!!1:ili{
;s*,'{r{ ${
{t{iiji!
$!1f
l*ttu*ii
?(eHg&l{G?
ln\SPRA
25
nrg and
50
mg filrn-coated
tablets
r:tdit,
*A$:qlg,i'Y*+a
s
rSS
INSPRA
UK
APPROVED
IN
8-I
F
or'
1s
a
s
t
-
ntlt
o
c
ar d
i
ul
in/
a
r
c t
i
o
rt
he
ar
t
fa
i I
ur
e
p
a
t
ie n ts
:
The-recomnenclecl
maintenarrce
dose
of
eplerenoue
is
50
rng
once
daily
(OD).
T