FENO-TG 160mg tablet

Country: Malasía

Tungumál: enska

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

Kauptu það núna

Vara einkenni Vara einkenni (SPC)
24-01-2022

Virkt innihaldsefni:

FENOFIBRATE

Fáanlegur frá:

UNIMED SDN BHD

INN (Alþjóðlegt nafn):

FENOFIBRATE

Einingar í pakka:

3x10'stablet Tablets

Framleitt af:

Troikaa Pharmaceuticals Ltd

Upplýsingar fylgiseðill

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FENO-TG 160 MG TABLET
Fenofibrate 160 mg
WHAT IS IN THIS LEAFLET
1.
What Feno-TG is used for
2.
How Feno-TG works
3.
Before you use Feno-TG
4.
How to use Feno-TG
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Feno-TG
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT FENO-TG IS USED FOR
FENO-TG is used to lower the level of
fats (lipids) in the blood. For example the
fats known as triglycerides. It is used,
alongside
a
low
fat
diet
and
other
nonmedical treatments such as exercise
and weight loss, to lower levels of fats in
the blood.
HOW WORKS
FENO-TG works through the activation
of
a
cell
nuclear
receptor
called
peroxisome
proliferator-activated
receptor alpha, which reduces the amount
of triglycerides and bad cholesterol made
in
the
body
and
increases
the
good
cholesterol.
BEFORE YOU USE FENO-TG
-
_When you must not use it _
_ _
Do not take Feno-TG if:
•
You have an allergy to FENO-TG or
any ingredients of it and
Gemfibrozil
-
_Before you start use it _
Tell your doctor if:
•
You have any allergies to any other
medicines or any other substances,
such as food, preservatives or dyes.
•
You are pregnant or intend to become
pregnant and breast-feeding or intend
to breast-feed.
•
You
have
or
have
had
any
other
medical
conditions,
including:
Kidney
problems
and
muscular
aching, tenderness or weakness not
caused by exercise.
PREGNANCY AND LACTATION
Ask your doctor or pharmacist for advice
before taking this medicine if you are
pregnant or breast-feeding.
-
_Taking other medicines _
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription.
In particular please let your doctor know
if you already take:
•
Anti-coagulants to thin your blood ,
other drugs used to control lipid (fat)
levels in the blood and Ciclosporin
(an immunosuppressant)
HOW TO USE FENO-TG
-
_How much to use _
_ _
Always take FENO-TG 160 mg exactl
                                
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Vara einkenni

                                FRONT
DESCRIPTION :
FENO-TG 160 mg Tablets (Fenofibrate Tablets), is a lipid regulating
agent available as tablets for oral administration.
Elevated levels of total cholesterol (total-C), low density
lipoprotein
cholesterol (LDL-C), and apolipoprotein B (apo B), an LDL membrane
complex, are associated with human atherosclerosis. Similarly,
decreased levels of high density lipoprotein cholesterol (HDL-C) and
its
transport complex, apolipoprotein A (apo AI and apo AII) are
associated
with the development of atherosclerosis.
COMPOSITION :
Fenofibrate BP 160 mg.
The effects of fenofibric acid have been explained by the activation
of
peroxisome proliferator activated receptor
α
(PPAR
α
). Through this
mechanism, fenofibrate increases lipolysis and elimination of
triglyceride-rich particles from plasma by activating lipoprotein
lipase
and reducing production of apoprotein C-III (an inhibitor of
lipoprotein
lipase activity). The resulting fall in triglycerides produces an
alteration
in the size and composition of LDL from small, dense particles (which
are thought to be atherogenic due to their susceptibility to
oxidation), to
large buoyant particles. These larger particles have a greater
affinity for
cholesterol receptors and are catabolized rapidly. Activation of PPAR
α
also induces an increase in the synthesis of apoproteins A-I, A-II and
HDL-cholesterol.
Absorption : Fenofibrate is well absorbed from the gastrointestinal
tract.
Following oral administration, approximately 60% of a single dose of
radiolabelled fenofibrate appeared in urine, primarily as fenofibric
acid
Each film coated tablet contains :
Orange coloured, round shape, biconvex film coated tablets.
Fenofibric acid, the active metabolite of fenofibrate, produces
reductions in total cholesterol, LDL cholesterol, apolipoprotein B,
total
triglycerides and triglyceride rich lipoprotein (VLDL). In addition,
treatment with fenofibrate results in increases in high density
lipoprotein (HDL) and apoproteins apoAI and apoAII.
Fenofibrate also reduces serum uric 
                                
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