Kanarb Film-Coated Tablets 120mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Fimasartan Potassium Trihydrate

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

Fimasartan Potassium Trihydrate

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Boryung Corporation

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
KANARB
®
Fimasartan Potassium trihydrate/ Fimasartan (60 mg, 120 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Kanarb
®
is used for
2.
How Kanarb
®
works
3.
Before you use Kanarb
®
4.
How to use Kanarb
®
5.
While you are using it
6.
Side Effects
7.
Storage and disposal of Kanarb
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
1.
WHAT KANARB
®
IS USED FOR
Kanarb
®
(Fimasartan
potassium
trihydrate) is indicated for the treatment
of essential hypertension.
2.
HOW KANARB
®
WORKS
Kanarb
®
is an angiotensin
II receptor
antagonist, which selectively binds to
the
AT
1
receptor with a high affinity,
giving
very potent anti-hypertensive effect.
3.
BEFORE YOU USE KANARB
®
-
_When you must not use it _
_ _
Kanarb
®
is
contraindicated
in
the
following patients:
a)
Patients who are hypersensitive to
any component in this product
b)
Pregnant or nursing mothers
c)
Hemodialysis
patients
(no
experience in this population)
d)
Patients
with
moderate
to
severe
hepatic impairment
e)
Patients
with
hepatobiliary
obstruction
f)
Patients
with
diabetes
or
renal
impairment (GFR <60 mL/min) who
are taking aliskiren
g)
Patients with diabetic nephropathy
who
are
taking
angiotensin
converting enzyme (ACE) inhibitors
h)
Patients with genetic disorders such
as
galactose
intolerance,
Lapp
lactose
deficiency,
or
glucose-
galactose
malabsorption
(since
Kanarb
®
contains lactose)
i)
Drugs directly acting on the rennin-
angiotensin system may cause injury
or death to the developing fetus when
administered to a pregnant woman
during
the
second
and
third
trimesters.
Therefore,
Kanarb
®
should
be
discontinued
when
pregnancy
is
detected
in
female patients.
-
_Taking other medicines _
_ _
A)
_POTASSIUM _
_SUPPLEMENTS _
_AND _
_POTASSIUM-SPARING _
_ DIURETICS_:
Serum potassium can be increased
by
Kanarb
®
and
other
drugs
that
exert
effects
on
the
renin-
angiotensin
system
when
co-
administered
with
potassium-
sparing
diuretics
(e.g.,
spirinolactone),
pota

Ciri produk

0422/
말레이시아
_Read package insert carefully before use._
_Consult your doctor for more information._
_Prescription medicine only. Keep out of reach of children._
Brand or Product Name
Kanarb
®
Film Coated Tablets 60mg and 120mg
Name and Strength of Active Substance(s)
Fimasartan 60 mg contains 66.01 mg of fimasartan potassium trihydrate
(or 60 mg as fimasartan potassium.
Fimasartan 120 mg contains 132.02 mg of fimasartan potassium
trihydrate (or 120 mg as fimasartan potassium.
Product Description
Kanarb
®
Film Coated Tablet 60mg is a yellow film-coated hexagonal tablet, the
front side of which is engraved with “FMS6”. The backside of
Kanarb
®
Film Coated
Tablet 60mg is engraved with “BR” and there is a split line in the
middle.
Kanarb
®
Film Coated Tablet 120 mg is an orange film-coated hexagonal tablet,
the front side of which is engraved with “FMS12”. The backside of
Kanarb
®
Film Coated
Tablet 120mg is engraved with “BR” and there is a split line in
the middle.
Pharmacodynamics/Pharmacokinetics
_Pharmacokinetic Characteristics of Fimasartan_
_Absorption_
Time to peak plasma concentration (Tmax) following single oral
administration of fimasartan at doses of 20 – 480 mg in healthy
subjects ranged 0.5 – 3 hours with the
terminal half-life (t1/2) being 5 – 16 hours. Similar results were
obtained in patients with hypertension, i.e., Tmax ranged 0.5 – 1.3
hours and t1/2 were 7 – 10 hours
following fimasartan administration at doses 20 – 180 mg. Several
subjects showed a second peak, and the total systemic exposure as
assessed by the area under the
concentration-time curve was linear (i.e., dose-independent).
Accumulation index was 1.20 – 1.26 and 1.02 – 1.08 for healthy
subjects and patients, respectively. The
absolute bioavailability of fimasartan in healthy subjects following
60 mg oral administration compared to 30 mg intravenous infusion was
estimated to be 19%.
These results support the notion that oral fimasartan is rapidly
absorbed, have linear pharmacokinetic pro