OLMESAR 40 (Olmesartan Medoxomil Tablets 40mg)

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
19-04-2018
Ciri produk Ciri produk (SPC)
19-04-2018

Bahan aktif:

OLMESARTAN MEDOXOMIL

Boleh didapati daripada:

CAMBER LABORATORIES SDN. BHD.

INN (Nama Antarabangsa):

OLMESARTAN MEDOXOMIL

Unit dalam pakej:

10x10tablet Tablets

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

                                OLMESAR 20 (OLMESARTAN MEDOXOMIL
TABLETS 20MG)/OLMESAR 40 (OLMESARTAN
MEDOXOMIL TABLETS 40MG)
®
Olmesartan Medoxomil (20mg & 40mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_OLMESAR _
_20 _
_& _
_40 _
_(Olmesartan _
_Medoxomil _
_tablets _
_20mg & 40mg) _
is used for
2.
How
_OLMESAR _
_20 _
_& _
_40 _
_(Olmesartan Medoxomil)_
works
3.
Before you use
_OLMESAR 20 & 40 _
_(Olmesartan Medoxomil)_
4.
How to use
_OLMESAR 20 & 40 _
_(Olmesartan Medoxomil) _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_OLMESAR _
_20 & 40 (Olmesartan Medoxomil) _
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT _OLMESAR 20 & 40 (OLMESARTAN _
_MEDOXOMIL) _IS USED FOR
Olmesartan
Medoxomil
belongs
to
a
group of medicines called angiotensin-II
receptor antagonists. They are used to
lower blood pressure.
HOW _OLMESAR 20 & 40 (OLMESARTAN _
_MEDOXOMIL)_ WORKS
Olmesartan
Medoxomil
lowers
blood
pressure by relaxing the blood vessels by
blocking the angiotensin-II receptors.
BEFORE YOU USE
_OLMESAR 20 & 40 _
_(OLMESARTAN MEDOXOMIL)_
-
_When you must not use it _
_ _
-
if
you
are
allergic
to
olmesartan
medoxomil
or
any
of
the
other
ingredients of this medicine.
_Pregnancy and lactation _
Do
not
take
_OLMESAR _
_20 _
_& _
_40 _
_(OLMESARTAN _
_MEDOXOMIL)_
if you are
pregnant,
trying
to
get
pregnant
or
think you may be pregnant.
Do
not
take
_OLMESAR _
_20 _
_& _
_40 _
_(OLMESARTAN _
_MEDOXOMIL)_
if you are
breast-feeding.
Ask
your
doctor
or
pharmacist
for
advice
before
taking
any medicine.
-
_Before you start to use it _
Tell your doctor
if you have any of the
following health problems:
-
Kidney problems
-
Liver disease
-
Heart failure or problems with your
heart.
As with any medicine which reduces
blood pressure, an excessive drop in
blood pressure in patients with blood
flow disturbances of the heart or brain
could lead to a heart attack or stroke.
Your doctor will therefore check your
blood pressure carefully.
-
_Taking other medicine
                                
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Ciri produk

                                8
OLMESARTAN MEDOXOMIL TABLETS 20MG&40 MG
NAME OF THE PRODUCT
OLMESAR 20 (Olmesartan Medoxomil Tablets 20mg)
OLMESAR 40 (Olmesartan Medoxomil Tablets 40mg)
NAME AND STRENGTH OF ACTIVE INGREDIENT
Name
: Olmesartan Medoxomil
Strength
: 20mg &40 mg
PRODUCT DESCRIPTION
OLMESARTAN MEDOXOMIL TABLETS 20MG
White to off white round, biconvex film coated tablets debossed with
‘H’ on one side and ‘O3” on the other side.
OLMESARTAN MEDOXOMIL TABLETS 40MG
White to off white oval, biconvex film coated tablets debossed with
'H' on one side and 'O4' on the other side.
DOSAGE FORM:
Tablet in the form of film coated
PHARMACODYNAMICS/PHARMACOKINETICS
PHARMACODYNAMICS:
PHARMACOLOGY:
MECHANISM OF ACTION:
Olmesartan medoxomil is a prodrug, which is hydrolysed to the active
metabolite
olmesartan during absorption from the gastrointestinal tract.
Olmesartan is a selective AT
1
subtype angiotensin
II receptor antagonist.
Angiotensin II is formed from angiotensin I in a reaction catalyzed by
angiotensin-converting enzyme (ACE,
kininase II). Angiotensin II is the principal pressor agent of the
renin-angiotensin system, with effects that
include vasoconstriction, stimulation of synthesis and release of
aldosterone, cardiac stimulation and renal
reabsorption of sodium. Olmesartan blocks the vasoconstrictor effects
of angiotensin II by selectively blocking
the binding of angiotensin II to the AT
1
receptor in vascular smooth muscle. Its action is, therefore,
independent
of the pathways for angiotensin II synthesis.
An
AT
2
receptor
is
found
also
in many
tissues,
but
this
receptor
is not
known
to
be
associated
with
cardiovascular homeostasis. Olmesartan has more than a 12,500-fold
greater affinity for the AT
1
receptor than
for the AT
2
receptor.
Blockade of the renin-angiotensin system with
ACE inhibitors, which inhibit the
9
biosynthesis of angiotensin II from angiotensin I, is a mechanism of
many drugs used to treat hypertension.
ACE inhibitors also inhibit the degradation of bradykinin, a reaction
also catalyzed by ACE. Because
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