TRADOL TABLET

País: Malasia

Idioma: inglés

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

Ingredientes activos:

Paracetamol; TRAMADOL HYDROCHLORIDE

Disponible desde:

Noripharma Sdn. Bhd.

Designación común internacional (DCI):

Paracetamol; TRAMADOL HYDROCHLORIDE

Unidades en paquete:

10tablet Tablets; 30tablet Tablets; 60tablet Tablets; 100tablet Tablets; 500tablet Tablets; 1000tablet Tablets

Fabricado por:

Noripharma Sdn. Bhd.

Información para el usuario

_Consumer Medication Information Leaflet (RiMUP) _
TRADOL TABLET
Tramadol Hydrochloride / Paracetamol (37.5mg/325mg)
1
What is in this leaflet:
1.
What TRADOL is used for
2.
How does TRADOL works
3.
Before you take TRADOL
4.
How to take TRADOL
5.
While
you
are
using
TRADOL
6.
Side effects
7.
After using TRADOL
8.
Product Description
9.
Manufacturer
10.
Date of Revision
1.
WHAT TRADOL IS USED FOR
TRADOL
is
used
to
treat
moderate to severe pain
when
your doctor recommends that a
combination
of
tramadol
hydrochloride
and
paracetamol
is needed.
2.
HOW TRADOL WORKS
TRADOL
tablets
have
a
combination
of
two
pain
relievers
-
tramadol
hydrochloride
(an
opioid
analgesic)
and
acetaminophen.
You
may
already
be
familiar
with acetaminophen, which acts
quickly
to
relieve
pain.
Tramadol
hydrochloride
is
a
pain
reliever
that
works
over
several hours to maintain pain
relief.
Because
these
two
ingredients
work
together,
TRADOL
tablets
relieve
your
pain quickly and help that pain
relief last longer.
3.
BEFORE YOU USE TRADOL
_When you must not take it_•_ _
•if
you
are
hypersensitive
or
have
had
an
allergic
reaction
(for instance skin rash, swelling
of
the
face,
wheezing
or
difficulty breathing) to tramadol,
paracetamol or any of the other
ingredients in TRADOL
•
in
cases
of
acute
alcohol
poisoning
•
if you are taking sleeping
pills,
pain
relievers
or
medicines that affect mood
and emotions
•
if
you
are
also
taking
medicines
called
monoamine
oxidase
inhibitors (MAOIs) or have
taken MAOIs in the last 14
days before treatment with
TRADOL.

MAOIs
are
used
in
the
treatment of depression or
Parkinson’s disease.
•
if you have a severe liver
disorder
•
If you have epilepsy that is
not
adequately
controlled
by your current medicine.

If
you
are
less
than
12
years old.

If
you
have
slow
or
shallow breathing, or other
breathing problems.

If you are pregnant.

If you are breastfeeding.
_ _
_Before you start to take it _
Before
you
take
TRADOL,
check
with
your
doctor
or
pharmacist if you
•
take
other
medicines
co

Ficha técnica

Page | 1
TRADOL TABLET
COMPOSITION:
Each film-coated tablet contains: Paracetamol 325mg and Tramadol
Hydrochloride
37.5mg
DESCRIPTION:
A beige color oval shaped film coated tablet
PHARMACODYNAMICS:
Tramadol is an opioid analgesic that acts on the central nervous
system. Tramadol is
pure non selective agonists of the μ, δ, and κ opioid receptors
with higher affinity for
the μ receptors. Other mechanisms which contribute to its analgesic
effects are
inhibition of neuronal reuptake of noradrenaline and enhancement of
serotonin
release. Tramadol has an antitussive effect and has no respiratory
depressant effect.
The precise mechanism of the analgesic properties of paracetamol is
unknown and
may involve central and peripheral effects.
PHARMACOKINETICS:
Tramadol is administered in racemic form and the [-] and [+] forms of
tramadol and
its metabolite M1, are detected in the blood. Although tramadol is
rapidly absorbed
after administration, its absorption is slower (and its half-life
longer) than that of
paracetamol.
_Absorption:_
Racemic tramadol is rapidly and almost completely absorbed after oral
administration.
The mean absolute bioavailability of a single 100 mg dose is
approximately 75 %.
After
repeated
administration,
the
bioavailability
is
increased
and
reaches
approximately 90 %.
The oral absorption of paracetamol is rapid and nearly complete and
takes place
mainly in the small intestine. Peak plasma concentrations of
paracetamol are reached
in one hour and are not modified by concomitant administration of
tramadol.
Food
has
no
significant
effect
on
the
peak
plasma
concentration
or
extent
of
absorption
of
either
tramadol
or
paracetamol
so
that
TRADOL
can
be
taken
independently of meal times.
_Distribution:_
Paracetamol appears to be widely distributed throughout most body
tissues except fat.
A
relative
small
portion
(~20%)
of
paracetamol
is
bound
to
plasma
proteins.
_Metabolism:_
Tramadol is extensively metabolized after oral administration. About
30 % of the
dose is excreted in urine as unchanged drug, wher