Apo-Feno SP 160 mg FC Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FENOFIBRATE

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

FENOFIBRATE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

APOTEX INC. - ETOBICOKE SITE

Risalah maklumat

APO-FENO SP160MG FC TABLETS
Fenofibrate
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
people
ask
about APO-FENO SP. It does not
contain all the information that is
known about APO-FENO SP.
It
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
will
have
weighed the risks of you taking
APO-FENO
SP
against
the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT IS THE MEDICATION FOR
APO-FENO
SP
belongs
to
a
family of medicines called Lipid
Metabolism Regulator.
APO-FENO
SP
has
been
prescribed to you by your doctor
for the treatment of abnormally
high cholesterol, usually in cases
where
hypercholesterolemia
and
hyperglyceridaemia
alone
or
combined (type IIa,IIb, II, IV, and
V dyslipidaemias). It can be also
prescribed
for
the
treatment
of
secondary hyperlipoproteinaemias
if
the
hyperlipoproteinaemia
persist despite effective treatment.
HOW IT WORKS
APO-FENO
SP
is
believed
to
work
by
reducing
the
bad
cholesterol
(low
density
lipoproteins[LDL]
and
very
low
density lipoproteins [VLDL]) and
triglycerides in your blood. It also
increases good cholesterol (High
Density
Lipoproteins
[HDL])
levels.
By
reducing
the
cholesterol
level,
there
will
be
lesser chances of heart disease to
occur, such as heart attack.
BEFORE YOU USE
_WHEN YOU MUST NOT TAKE IT _
_BEFORE YOU START TO TAKE IT _
_TAKING OTHER MEDICINES _
Before
taking
APO-FENO
SP,
your doctor needs to know:
•
Any other medical condition
that you may have, including
severe
liver,
kidney,
gallbladder disease;
•
If
you
are
allergic
to
fenofibrate,
or
any
of
the
ingredients of the medication;
•
Have
had
a
severe
skin
reaction to other fibrates or
ketoprofen;
•
Whether you are planning to
get
pregnant,
are
currently
pregnant
or
are
nursing
an
infant;
•
Any
other
prescription
or
over-the-counter
medication
that you are currently t

Ciri produk

APO-FENO SP 160 MG FC TABLETS
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each tablet contains 160.0 mg fenofibrate.
PRODUCT DESCRIPTION
White, oval, biconvex, film-coated tablet, engraved
APO on one side and FEN160 on the other side.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Fenofibrate is a fibric acid derivative whose lipid
modifying effects reported in humans are mediated
via activation of Peroxisome Proliferator Activated
Receptor type alpha (PPARα).
Through activation of PPARα, fenofibrate increases
the lipolysis and elimination of atherogenic
triglyceride-rich particles from plasma by activating
lipoprotein lipase and reducing production of
apoprotein CIII. Activation of PPARα also induces
an increase in the synthesis of apoproteins AI and
AII.
The above stated effects of fenofibrate on
lipoproteins lead to a reduction in very low- and low
density fractions (VLDL and LDL) containing
apoprotein B and an increase in the high density
lipoprotein fraction (HDL) containing apoprotein AI
and AII.
In addition, through modulation of the synthesis and
the catabolism of VLDL fractions fenofibrate
increases the LDL clearance and reduces small
dense LDL, the levels of which are elevated in the
atherogenic lipoprotein phenotype, a common
disorder in patients at risk for coronary heart
disease.
During clinical trials with fenofibrate, total
cholesterol was reduced by 20 to 25%, triglycerides
by 40 to 55% and HDL cholesterol was increased by
10 to 30%.
In hypercholesterolaemic patients, where LDL
cholesterol levels are reduced by 20 to 35%, the
overall effect on cholesterol results in a decrease in
the ratios of total cholesterol to HDL cholesterol,
LDL cholesterol to HDL cholesterol, or Apo B to
Apo AI, all of which are markers of atherogenic
risk.
Because of its significant effect on LDL cholesterol
and triglycerides, treatment with fenofibrate should
be beneficial in hypercholesterolaemic patients with
or without hypertriglyceridaemia, including
secondary hyperlipoproteinaemia such as type 2
diabetes mellitus