SARANTO 50 mg (Losartan Potassium Tablets 50 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LOSARTAN POTASSIUM

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

LOSARTAN POTASSIUM

Unit dalam pakej:

30 Tablets; 100 Tablets; 30 Tablets; 100 Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

SARANTO
_Consumer Medication Information Leaflet (RiMUP)_
Losartan Potassium Tablet (50 mg, 100 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Saranto is used for
2.
How Saranto works
3.
Before you use Saranto
4.
How to use Saranto
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Saranto
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS SARANTO USED FOR

Hypertension
(High
Blood
Pressure)

Hypertensive Patients with Left
Ventricular
Hypertrophy
(Enlargement of Left Ventricle of
the Heart).
Losartan
Potassium
is
indicated
to
reduce the risk of stroke in patients
with hypertension and left ventricular
hypertrophy.

Nephropathy
(Appearance
of
Low
but
abnormal
levels
of
albumin in the urine) in Type 2
Diabetic Patients
Losartan Potassium may also be used
to treat other conditions, for
example,
heart
failure
and
kidney
disease in diabetic patients with high
blood pressure.
HOW SARANTO WORKS
Saranto
belongs
to
a
group
of
medicines
known
as
angiotensin-II
receptor antagonists. Angiotensin- II
is a substance produced in the body
which
binds
to
receptors
in
blood
vessels, causing them to tighten. This
results
in
an
increase
in
blood
pressure. Saranto prevents the binding
of angiotensin-II to these receptors,
causing
the
blood
vessels
to
relax
which
in
turn
lowers
the
blood
pressure. Saranto slows the decrease
of kidney function in patients with
high
blood
pressure
and
type
2
diabetes.
BEFORE YOU USE SARANTO
_-When you must not use it _

You are allergic (hypersensitive)
to losartan or any of its other
ingredients,

You
are
more
than
3
months
pregnant.
(It
is
also
better
to
avoid
Saranto
in
early
pregnancy)
_-Before you start to use it _
It
is
important
to
tell
your
doctor
before taking Saranto if :-

You
have
a
history
of
angioedema (swelling of the face,
lips, throat, mouth and/or tongue)
as you may be more likely to
develop an allergic reaction.

You
think
you
are
(or
might
become) pregnant. Saranto is not
recommended
in

Ciri produk

Additional Information :
TEAM LEADER
Lova Raju
INITIATOR
Bharath
Saranto 50
PRODUCT NAME
CUSTOMER / COUNTRY
Malaysia
DIMENSIONS
110 x 230 mm
PHARMACODE
14417
COMPONENT
04
Leaflet
VERSION NO.
REASON OF ISSUE
Revision
P1514417
ITEM CODE
REVIEWED / APPROVED BY
DATE & TIME
05.06.2018 & 5:25 PM
SIGN / DATE
Artist:
NO. OF COLOURS :
01
Supersede item Code: P1510049
WOS-17-000125
NAME OF THE PRODUCT:
SARANTO 50 (Losartan Potassium Tablets 50 mg)
NAME AND STRENGTH OF ACTIVE
INGREDIENT :
Losartan Potassium Ph.Eur. and 50 mg.
DOSAGE FORM: Tablet.
PRODUCT DESCRIPTION:
White to off-white, oval shaped, biconvex film-
coated tablets debossed with 'E' on one side and '4'
and '6' separated by a scoreline on other side.
PHARMACODYNAMICS/PHARMACOKINETICS
PHARMACODYNAMICS:
Losartan is an oral, specific angiotensin-II receptor
(type AT1) antagonist. Angiotensin II binds to the
AT1 receptor found in many tissues (e.g. vascular
smooth muscle, adrenal gland, kidneys, and the
heart)
and
elicits
several
important
biological
actions, including vasoconstriction and the release
of
aldosterone.
Angiotensin
II
also
stimulates
smooth-muscle proliferation. Based on binding and
pharmacological bioassays, it binds selectively to
the AT1 receptor.
During
Losartan
administration,
removal
of
angiotensin-II negative feedback on renin secretion
leads to increased plasma renin activity. Increases
in
plasma
renin
activity
lead
to
increases
in
angiotensin II in plasma. Even with these increases,
antihypertensive activity and suppression of plasma
aldosterone
concentration
are
maintained,
indicating
effective
angiotensin-II
receptor
blockade.
Losartan binds selectively to the AT1 receptor and
does not bind to or block other hormone receptors or
ion channels important in cardiovascular regulation.
Furthermore,
Losartan
does
not
inhibit
ACE
(kininase II), the enzyme that degrades bradykinin.
Losartan block responses to angiotensin I and
angiotensin
II
without
affecting
responses
to
bradykinin.
In
non-diabetic
hypertensive
patients
with
proteinuria,
the
admin