MEPRESIN 40 (OLMESARTAN MEDOXOMIL TABLETS 40MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

OLMESARTAN MEDOXOMIL

Boleh didapati daripada:

Ascend Laboratories Sdn Bhd

INN (Nama Antarabangsa):

OLMESARTAN MEDOXOMIL

Unit dalam pakej:

3 X 10 Tablets

Dikeluarkan oleh:

Alkem Laboratories Limited

Risalah maklumat

MEPRESIN 20 (OLMESARTAN MEDOXOMIL 20MG TABLET) MEPRESIN 40 (OLMESARTAN MEDOXOMIL 40MG TABLET)
Olmesartan Medoxomil 20mg/40mg Tablet
1
_Consumer Medication Information Leaflet (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What MEPRESIN is used for
2.
How MEPRESIN works
3.
Before you use MEPRESIN
4.
How to use MEPRESIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of MEPRESIN
8.
Product Description
9.
Manufacturer and
Product
Registration Holder
10.
Date of revision
WHAT MEPRESIN
IS USED FOR
Olmesartan Medoxomil is used to treat
essential
hypertension
(high
blood
pressure)
in
adults.
‘Essential’
means
that
the
high
blood
pressure
is
not
caused by any other condition.
HOW MEPRESIN_ _WORKS
Olmesartan
Medoxomil
belongs
to
a
class of medicines known as angiotensin
II receptor antagonists. Angiotensin II is
a
substance
produced
in
your
body
which
causes
your
blood
vessels
to
narrow,
thus
increasing
your
blood
pressure. Olmesartan blocks the effect
of
angiotensin
II
so
that
the
blood
vessels relax, and your blood pressure is
lowered.
BEFORE YOU USE MEPRESIN_ _
-
_When you must not use it_
Do not take MEPRESIN if you:
• are allergic to olmesartan medoxomil
or to any of the other ingredients of
MEPRESIN.
• are in the second and third trimesters
of pregnancy.
• suffer from problems with drainage of
the bile from the gallbladder (biliary
obstruction).
• have diabetes or impaired kidney
function and you are treated with a
blood pressure lowering medicine
containing aliskiren.
_Pregnancy and lactation _
Do
not
take
MEPRESIN
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant.
Do
not
take
MEPRESIN
if
you
are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
-
_Before you start to use it_
Before you take MEPRESIN, tell your
doctor.if you:
• have diarrhoea, vomiting, or you are on
a treatment with high doses of diuretics or
on a low salt diet
• are taking medicinal products that affect
the renin-angiotensin-aldosterone system
•
have kidney proble

Ciri produk

COMPOSITION
MEPRESIN 20: Each film coated tablet contains: Olmesartan Medoxomil
Ph.Eur .......... 20 mg
MEPRESIN 40: Each film coated tablet contains: Olmesartan Medoxomil
Ph.Eur .......... 40 mg
PRODUCT DESCRIPTION
MEPRESIN 20: White to off white coloured, 8.60 mm ± 0.3 mm round
shape film coated tablets debossed with OLM on side &
20 on other side.
MEPRESIN 40: White to off white coloured, 15.10 ± 0.3 mm x 7.10 mm ±
0.3 mm oval shape film coated tablets debossed with
OLM on one side & 40 on other side.
PHARMACODYNAMICS
Pharmacotherapeutic group: Angiotensin II antagonists Mechanism of
action / Pharmacodynamic effects
Olmesartan medoxomil is a potent, orally active, selective angiotensin
II receptor (type AT1) antagonist. It is expected to
block all actions of angiotensin II mediated by the AT1 receptor,
regardless of the source or route of synthesis of angiotensin
II. The selective antagonism of the angiotensin II (AT1) receptors
results in increases in plasma renin levels and angiotensin I
and II concentrations, and some decrease in plasma aldosterone
concentrations.
Angiotensin II is the primary vasoactive hormone of the
renin-angiotensin-aldosterone system and plays a significant role in
the pathophysiology of hypertension via the type 1 (AT1) receptor.
PHARMACOKINETICS
_Absorption and distribution_
Olmesartan medoxomil is a prodrug. It is rapidly converted to the
pharmacologically active metabolite, olmesartan, by
esterases in the gut mucosa and in portal blood during absorption from
the gastrointestinal tract.
No intact olmesartan medoxomil or intact side chain medoxomil moiety
have been detected in plasma or excreta. The mean
absolute bioavailability of olmesartan from a tablet formulation was
25.6%.
The mean peak plasma concentration (C
) of olmesartan is reached within about 2 hours after oral dosing with
olmesartan
max
medoxomil, and olmesartan plasma concentrations increase approximately
linearly with increasing single oral doses up to
about 80 mg.Food had minimal effect on the bioavailability of
o