FENOLIP CAPSULE 300MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FENOFIBRATE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

FENOFIBRATE

Unit dalam pakej:

500 Capsule Capsules; 100 Capsule Capsules; 60 Capsule Capsules; 1000 Capsule Capsules; 30 Capsule Capsules; 250 Capsule Capsules

Dikeluarkan oleh:

Noripharma Sdn. Bhd.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
_ _
FENOLIP CAPSULE 300MG
Fenofibrate (300mg)
Page | 1
WHAT IS IN THIS LEAFLET
1.
What Fenolip is used for
2.
How Fenolip works
3.
Before you use Fenolip
4.
How to use Fenolip
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Fenolip
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT FENOLIP IS USED FOR
Fenofibrate is indicated in
appropriate cases of type IIa,
IIb, III, IV and V
hyperlipidemia (elevated
lipid/fat levels in the blood)
HOW IS FENOLIP WORKS
Fenofibrate reduces elevated
blood cholesterol and
triglycerides (a type of fat) and
is of benefit in the treatment of
severe hyperlipidemias found
in some patients, in whom
dietary measures alone have
failed to produce an adequate
response.
BEFORE YOU USE FENOLIP
-
_When you must not use it _
Do not take Fenolip if
•
You are allergic
(hypersensitive) to
fenofibrate, or any of the
other ingredients of
Fenolip.
•
You suffer from liver or
kidney disease or
gallbladder disease.
-
_Before you start to use it _
Tell your doctor before you
start to take this medicine:
•
If you have any kidney
problem.
•
If you have diabetes,
especially Type 2
diabetes that is not well
controlled.
•
If you have liver
problems.
•
You are taking other
medicines.
•
If you or your family
have had muscle
problems.
•
If you are over 70 years
of age
-
_Taking other medicines _
Please tell your doctor if you
are taking or fany other
medicines, including medicines
obtained without a
prescription. In particular
please let your doctor know if
you already take:
•
Anticoagulants to thin
your blood (for example,
warfarin).
•
Other drugs to control
lipid (fat) levels in the
blood (for example, drugs
known as “statins” or
“fibrates”). Taking a
“statin” (e.g.simvastatin,
atorvastatin) at the same
time as Fenolip
can
increase the risk of
muscle problems.
•
Oral antidiabetic agents
like glitazone
HOW TO USE FENOLIP
-
_How much to use _
The recommended initia

Ciri produk

FENOLIP CAPSULE
DESCRIPTION:
Opaque white hard gelatin capsules.
COMPOSITION:
Each capsule contains Fenofibrate 300mg.
ACTIONS
&
PHARMACOLOGY:
Hypolipidemic.
Studies
with
fenofibrate
on
lipoprotein fractions show decrease in levels of LDL- and
VLDL-cholesterol. HDL-
cholesterol levels are frequently increased; LDL- and
VLDL-triglycerides are reduced.
The overall effect is a decrease in the ratio of low and very low
density lipoproteins to
high density lipoproteins, which epidemiological studies have
correlated with a decrease
in atherogenic risk. Fenofibrate has a uricosuric effect and is
therefore of additional
benefit to type IV hyperlipidemic patients. Poorly and less well
absorbed from an empty
stomach, hence should always be taken with food. The plasma half-life
of elimination of
fenofibric acid is approximately 20 hours, Kinetic studies after
multiple dosing show the
absence of accumulation of the product.
INDICATIONS: Fenofibrate reduces elevated serum cholesterol and
triglycerides and is
of benefit in the treatment of severe hyperlipidemias found in some
patients, in whom
dietary measures alone have failed to produce an adequate response.
Fenofibrate is
therefore indicated in appropriate cases of type IIa, IIb, III, IV and
V hyperlipidemia.
CONTRAINDICATION: Contraindicated in patients with severe liver
dysfunction,
existing gall bladder disease, severe renal disorders and in patients
hypersensitive to
fenofibrate.
SIDE
EFFECTS:
Adverse
reactions
observed
during
fenofibrate
treatment
are
infrequent, and are generally minor, transient and do not interfere
with treatment.
Most commonly reported are mild gastrointestinal disturbances, skin
reactions, headache,
fatigue, and vertigo. Sexual asthenia and muscle cramps are less
frequently reported.
Probably causally related: Hepatitis, rhabdomyolysis.
PRECAUTIONS: Dose reduction should be considered in elderly patients
and those
with
impaired
renal
and
hepatic
functions.
If
satisfactory
reduction
of
serum
concentration of lipids is not obtained after 3 to 6 mont