FEPRIL SUSPENSION 250MG/5ML

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
06-02-2018
Ciri produk Ciri produk (SPC)
04-11-2019

Bahan aktif:

Paracetamol

Boleh didapati daripada:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (Nama Antarabangsa):

Paracetamol

Unit dalam pakej:

120 ml; 100 ml; 90 ml; 60 ml

Dikeluarkan oleh:

IDAMAN PHARMA MANUFACTURING SDN BHD

Risalah maklumat

                                FEPRIL SUSPENSION 250MG/5ML
Paracetamol (250mg /5mL)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What FEPRIL is used for
2.
How FEPRIL works
3.
Before you use FEPRIL
4.
How to use FEPRIL
5.
While you are using FEPRIL
6.
Side effects
7.
Storage and disposal of FEPRIL
8.
Product description
9.
Product
Registration
Holder
&
Manufacturer
10.
Date of revision
WHAT FEPRIL IS USED FOR
FEPRIL
is
used
for
relief
of
mild
to
moderate
pain
and
to
reduce
fever.
It
provides
symptomatic
relief
only;
additional therapy to treat the cause of
the
pain
or
fever
should
be
instituted
when necessary.
HOW FEPRIL WORKS
FEPRIL has analgesic (pain relief) and
antipyretic (anti-fever) properties.
BEFORE YOU USE FEPRIL
-
_When you must not use it _
Do not take FEPRIL if you are allergic to
Paracetamol or Acetaminophen.
Do not take FEPRIL if you are pregnant,
trying to get pregnant or think you may
be pregnant without discussing with your
doctor first.
Do not take FEPRIL if you are breast-
feeding.
If you are not sure whether you should
start taking this medicine, talk to your
doctor or pharmacist.
-
_Before you start to use it _
Tell your doctor if you have allergies to
Paracetamol or Acetaminophen.
Your doctor needs to know before you
take FEPRIL if you have kidney or liver
problem. FEPRIL should be given with
care to patients with impaired kidney or
liver function.
FEPRIL should also be
given with care to patients taking other
drugs that affect the liver.
Your doctor needs to know if you are
intolerant of aspirin. Patient intolerant of
aspirin may not be intolerant of FEPRIL,
however
mild
bronchospastic
reactions
with FEPRIL have been reported in some
aspirin-sensitive asthmatics.
Discuss with your doctor or pharmacist
first if you are pregnant or breastfeeding.
-
_Taking other medicines _
Tell
your
doctor
or
pharmacist
before
taking
FEPRIL,
if
you
are
taking
any
other medicines, including any that you
buy
without
a
prescription
from
pharmacy,
supermarket
or
health
food
shop. The effects of some medicine
                                
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Ciri produk

                                IDAMAN PHARMA MANUFACTURING
FEPRIL SUSPENSION 250MG/5ML
DESCRIPTION
Viscous, opaque liquid and free from visible impurities. Colour:
Orange to orange brownish. Odour: Fruity odour.
Each 5ml contains Paracetamol 250mg.
PRESERVATIVES
Methyl Paraben
:
10mg
Propyl Paraben
:
2.5mg
ROUTE OF ADMINISTRATION
Oral
PHARMACODYNAMICS
Paracetamol is a centrally acting analgesic and antipyretic with
minimal
anti-inflammatory
properties.
The
mechanism
of
analgesic action has not been fully determined. Paracetamol may
act
predominantly
by
inhibiting
prostaglandin
synthesis
in
the
central nervous system (CNS) and, to a lesser extent, through a
peripheral
action
by
blocking
pain
impulse
generation.
The
peripheral action may also be due to inhibition of prostaglandin
synthesis or to inhibition of the synthesis or actions of other
substances that sensitise pain receptors to mechanical or chemical
stimulation.
Paracetamol probably produces antipyresis by acting centrally on
the hypothalamic heat regulating centre to produce peripheral
vasodilation resulting in increased blood flow through the skin,
sweating
and
heat
loss.
The
central
action
probably
involves
inhibition of prostaglandin synthesis in the hypothalamus.
PHARMACOKINETICS_ _
ABSORPTION:
Rapid
and
almost
complete
following
oral
administration. Paracetamol absorption takes place mainly in the
small intestine and therefore the rate of absorption is depending
on the rate of gastric emptying. It has been shown that drugs
which
delay
gastric
emptying
also
delay
the
absorption
of
paracetamol whereas metoclopramide accelerates absorption of
the
analgesic
through
the
total
amount
absorbed
doses
not
increase. The rate of absorption may be decreased if paracetamol
is taken following a high carbohydrate meal. Alterations in gastric
pH have no appreciable effect on paracetamol absorption. During
absorption, the amount of paracetamol which is inactivated is
negligible and it has been shown that paracetamol does not affect
gastric
mucosal
permeability
and
does
not
produce
mucosal
bleeding
                                
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