TEMPOL TABLETS 500MG

País: Malásia

Língua: inglês

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

Ingredientes ativos:

Paracetamol

Disponível em:

DUOPHARMA (M) SDN. BHD.

DCI (Denominação Comum Internacional):

Paracetamol

Unidades em pacote:

50 x 10 Tablets

Fabricado por:

DUOPHARMA (M) SDN. BHD.

Folheto informativo - Bula

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
TEMPOL TABLET 500MG
Paracetamol (500mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What
TEMPOL
TABLET
is used for
2.
How
TEMPOL
TABLET
works
3.
Before
you use
TEMPOL
TABLET
4.
How
to
use
TEMPOL
TABLET
5.
While
you
are
using
TEMPOL TABLET
6.
Side effects
7.
Storage
and
disposal
of
TEMPOL TABLET
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TEMPOL TABLET IS
USED FOR
TEMPOL TABLET is used to
relieve mild to moderate pain
associated
with
headache,
muscular
aches,
period
pain,
arthritis,
toothache,
migraine,
cold and flu, tension headache
and
sinus
pain/headache
and
for reduction of fever. Also a
suitable alternative for
whom
aspirin is contraindicated, eg.
indigestion,
gastrointestinal
ulcers, aspirin sensitivity.
HOW
TEMPOL
TABLET
WORKS
TEMPOL
TABLET
contains
paracetamol
that
is
a
para-
aminophenol
derivative
that
has analgesic (pain relief) and
antipyretic (anti-fever) actions
similar to those of aspirin.
BEFORE
YOU
USE
TEMPOL
TABLET
_-_
_ _
_When you must not use it _
Do not use TEMPOL TABLET
if
you
are
allergic
to
paracetamol or any of the other
ingredients listed at the end of
the leaflet.
_-_
_ _
_Before you start to use it _
Before
taking
TEMPOL
TABLET, you must tell your
doctor
or
pharmacist
if
you
have, or have had, any of the
following conditions:

An
allergy
(hypersensitivity)
to
Paracetamol
/Acetaminophen

Kidney problems
If you are not sure if you have,
or
have
had,
any
of
these
conditions,
you
should
raise
those
concerns
with
your
doctor or pharmacist.
_Pregnancy _
Ask for your doctor’s advice if
you are pregnant, or likely to
become pregnant during your
course of medication.
_Breastfeeding _
Ask for your doctor’s advice if
you are breastfeeding, or likely
to
breastfeed
during
your
course of medication.
_-_
_ _
_Taking other medicines _
Inform
your
doctor
or
pharmacist
before
taking
TEMPOL TABLET.
Before
using
TEMPOL
TABLET, it is important to tell
your
doctor
or
pharmacist
if
you
are
taking
any
oth

Características técnicas

[DUOPHARMA (M) SDN BHD]
Page 1 of 1
[Revisiion date: 03.09.2019]
TEMPOL TABLET
DESCRIPTION: A white, oblong tablet with marking ‘DUO 861’.
COMPOSITION: Each tablet contains Paracetamol 500mg.
PHARMACODYNAMICS:
Paracetamol is a para-aminophenol derivative that has analgesic and
antipyretic actions similar to those of aspirin, but it has no useful
anti-inflammatory properties.
PHARMACOKINETICS:
After oral administration, paracetamol is absorped rapidly and
complete from the small intestine; peak plasma levels occur 30 -120
minutes after administration. 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. Plasma
protein binding is negligible
at usual therapeutic concentrations but increases with increasing
concentrations.
Paracetamol is metabolized 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 proportion (less than 20%) is metabolized 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 in the urine mainly as the glucuronide and
sulfate conjugates. Less than 5% is excreted as unchanged paracetamol
with 85 to 90% of the administered
dose eliminated in
the urine within 24 hours of ingestion. The elimination half-life
varies from 1 to 3 hours. Food intake delays paracetamol absorption.
INDICATIONS: Indicated for relief of mild to moderate pain associated
with headache, muscular aches, period pain, arthritis, toothache,
migraine, cold & flu, tension headache and sinus
pain/headache, and for reduction of fever. Indicated as a suitable
alternative for whom aspirin is contraindicated, eg. dyspepsia,
gastrointestinal ulcers, aspirin sensivity.
RECOMMENDED DOSAGE:
ADULTS AND CHILDREN OVER 12 YEARS: 500 – 10