Saffid Capsule 300mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GEMFIBROZIL

Boleh didapati daripada:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (Nama Antarabangsa):

GEMFIBROZIL

Unit dalam pakej:

3 x 10s Capsules

Dikeluarkan oleh:

IDAMAN PHARMA MANUFACTURING SDN BHD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
SAFFID CAPSULE 300MG
Gemfibrozil 300mg
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Saffid Capsule 300mg is used
for
2.
How Saffid Capsule 300mg works
3.
Before
you
use
Saffid
Capsule
300mg
4.
How to use Saffid Capsule 300mg
5.
While you are using Saffid Capsule
300mg
6.
Side effects
7.
Storage
and
Disposal
of
Saffid
Capsule 300mg
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT SAFFID CAPSULE 300MG IS USED FOR
Saffid Capsule 300mg is used to treat
hyperlipidaemia (having too much fat in
the blood) and to prevent heart disease in
people with hyperlipidaemia.
Saffid
Capsule
300mg
helps
reduce
cholesterol and triglycerides (fatty acids)
in the blood. High levels of these types
of fat in the blood are associated with an
increased
risk
of
atherosclerosis
(hardening of blood vessels/arteries).
Saffid Capsule 300mg is also used to
lower the risk of stroke, heart attack, or
other heart complications in people with
high cholesterol and triglycerides who
have not responded to dietary and other
measures.
HOW SAFFID CAPSULE 300MG WORKS
_Gemfibrozil_
belongs
to
the
class
of
medications known as
_fibrates_
. It works
by lowering the level of certain types of
fat and cholesterol, especially the type
known as
_triglycerides_
.
BEFORE YOU USE SAFFID CAPSULE 300MG
_When you must not to use it _
Do not take Saffid Capsule 300mg if
you:
•
are
allergic
to
any
medicine
containing gemfibrozil.
•
are allergic to fenofibrate or any other
of
the
class
of
“fibrates”
(e.g.,
clofibrate, bezafibrate)
•
are breast-feeding
•
are pregnant
•
have
severe
liver
disease,
kidney
disease, or gallbladder disease
_Before you start to use it _
Tell
your
pharmacist
if
you
have
allergies to any other medicines, foods,
preservatives or dyes.
Tell your doctor or pharmacist if you are
pregnant or plan to become pregnant or
are
breast-feeding.
Your
doctor
or
pharmacist can discuss with you the risks
and benefits involved.
_Taking other m

Ciri produk

SAFFID CAPSULE 300MG
PRODUCT DESCRIPTION
A maroon and white ‘0’ size elongated capsule
containing white powder.
Each hard capsule contains Gemfibrozil 300mg
PHARMACODYNAMICS
Gemfibrozil
is
a
non-halogenated
phenoxypentanoic
acid.
Gemfibrozil
is
a
lipid
regulating agent which regulates lipid fractions.
Gemfibrozil's mechanism of action has not been
definitively
established.
In
man,
gemfibrozil
stimulates the peripheral lipolysis of triglyceride
rich
lipoproteins
such
as
Very
Low-Density
Lipoprotein
(VLDL)
and
cholymicrons
(by
stimulation of Lipoprotein Lipase). Gemfibrozil also
inhibits synthesis of VLDL in the liver. Gemfibrozil
increases the High-Density Lipoprotein 2 (HDL
2
)
and
High-Density
Lipoprotein
3
(HDL
3
)
subfractions as well as apolipoprotein A-I and A-II.
There is evidence that treatment with fibrates may
reduce coronary heart disease events but they
have
not
been
shown
to
decrease
all-cause
mortality in the primary or secondary prevention of
cardiovascular disease.
PHARMACOKINETICS
_Absorption_
Gemfibrozil
is
well
absorbed
from
the
gastro-intestinal tract after oral administration with
a bioavailability close to 100%. As the presence of
food alters the bioavailability slightly, gemfibrozil
should be taken 30 minutes before a meal. Peak
plasma levels occur in one to two hours. After
administration of 600 mg twice daily, a C
MAX
in the
range of 15 to 25 mg/L is obtained.
_Distribution_
Volume of distribution at steady state is 9-13 L.
The plasma protein binding of gemfibrozil and its
main metabolite are at least 97%.
_Metabolism_
Gemfibrozil undergoes oxidation of a ring methyl
group to form successively a hydroxymethyl and a
carboxyl metabolite (the main metabolite). This
metabolite has a low activity compared to the
parent compound gemfibrozil and an elimination
half-life
of
approximately
20
hours.
Glucuronidation
to
gemfibrozil
1-O-β-glucuronide
is
another
important
elimination pathway for gemfibrozil in man.
The
enzymes
involved
in
the
metabolism
of
gemfibrozil are not known. The interaction