PORO SUPPOSITORY

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Paracetamol

Boleh didapati daripada:

Y.S.P. INDUSTRIES (M) SDN BHD

INN (Nama Antarabangsa):

Paracetamol

Unit dalam pakej:

5Units Units; 10Units Units; 100Units Units

Dikeluarkan oleh:

Y.S.P. INDUSTRIES (M) SDN BHD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
_ _
1 |
PORO SUPPOSITORY
Paracetamol (Acetaminophen) (125mg, 250mg)
WHAT IS IN THIS LEAFLET
1.
What
PORO
SUPPOSITORY
is
used for
2.
How PORO SUPPOSITORY works
3.
Before
you
use
PORO
SUPPOSITORY
4.
How to use PORO SUPPOSITORY
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
PORO
SUPPOSITORY
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT PORO SUPPOSITORY IS USED FOR
PORO
SUPPOSITORY
is
used
for
the
symptomatic relief of fever, minor aches, pain
and headaches.
HOW PORO SUPPOSITORY WORKS
PORO SUPPOSITORY consists of analgesic-
antipyretic (an agent that relieves pain and
reduces fever) effect.
BEFORE YOU USE PORO SUPPOSITORY
_-When you must not use it _
Do
not
use
PORO
suppository
if
you
are
allergic to paracetamol or other ingredients in
it.
_-Before you start to use it _
Tell your doctor or pharmacist if
-
you are allergic to any medicines, foods,
preservatives or dyes;
-
you have any other medical conditions such
as heart, liver or kidney problems;
-
you have alcohol abuse problems
-
you are allergic to Paracetamol. Paracetamol
may cause severe skin reactions.
-
you are taking other Paracetamol containing
products
_-Taking other medicines _
Do
not
take
other
paracetamol
containing
medicines
at
the
same
time.
Avoid
taking
Aspirin with paracetamol as it may increase
blood
concentrations
of
unhydrolysed
Aspirin. Besides, you must also inform them
about
all
the
medicines
you
are
taking,
including those without a prescription.
HOW TO USE PORO SUPPOSITORY
_-How much to use _
To be inserted deep into rectum every 4 hours
as needed, up to four times daily.
Children 1-2 years: 1 suppository of 125mg.
Children
2-6
years:
1-2
suppositories
of
125mg.
Children
6-12
years:
1-2
suppositories
of
250mg.
_-When to use it _
PORO
SUPPOSITORY
should
be
taken
according to the time advised by your doctor
or
pharmacist.
It
can
be
taken
with
or
without food.
_-How long to use it _
PORO SUPPOSITORY should be inserted
into

Ciri produk

PORO
®
SUPPOSITORY
INGREDIENT(S):
Poro suppository 125mg
Each suppository contains:
Paracetamol(Acetaminophen)
………..……….................…………...…… 125mg
Poro suppository 250mg
Each suppository contains:
Paracetamol(Acetaminophen)
………..……………..……..................…… 250mg
PHARMACOLOGY (SUMMARY OF PHARMACODYNAMIC AND PHARMACOKINETIC):
1. Paracetamol may act by inhibiting prostaglandin synthesis in the
central
nervous system and through a peripheral action by blocking pain
impulse
generation. The peripheral action may also be due to inhibition of the
synthesis of prostaglandins which sensitize pain receptors to
mechanical or
chemical stimulation.
2. Paracetamol produces antipyresis by acting centrally on the
hypothalamic
heat-regulation
center
to
produce
peripheral
vasodilation
resulting
in
increase blood flow through the skin, sweating and heat loss. The
central
action
probably
involved
inhibition
of
prostaglandin
synthesis
in
the
hypothalamus.
3. Paracetamol is uniformly distributed throughout most body fluids,
the
apparent volume of distribution is 1 to 1.2 L/kg. Paracetamol can
cross the
placenta and is excreted in milk. At therapeutic plasma levels no
protein
binding occurs. Paracetamol is metabolised by the hepatic microsomal
enzyme system. In adults at therapeutic doses, paracetamol is mainly
conjugated with glucuronide (45-55%) or sulphate (20-30%). A minor
propor-
tion (less than 20%) is metabolised to catechol derivatives, and
mercapturic
acid compounds via oxidation. Paracetamol is metabolized differently
by
infants and children compared to adults, the sulphate conjugate being
predominant. Paracetamol is excreted by active tubular secretion:
85-90% of
the administered dose is eliminated in the urine within 24 hours of
administration. Paracetamol has a half-life of 1 to 3.5 hours.
INDICATION(S):
For the symptomatic relief of fever and pain (headache, muscle ache)
associated
with common cold.
DOSAGE AND ADMINISTRATION:
Children 1-2 years: 1 suppository of 125