ACUGESIC CAPSULE 50MG

Country: Malaysia

Language: English

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

Active ingredient:

TRAMADOL HYDROCHLORIDE

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

TRAMADOL HYDROCHLORIDE

Units in package:

10 x 10s Capsules

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ACUGESIC CAPSULE
Tramadol hydrochloride (50mg)
WHAT IS IN THE LEAFLET
1.
What ACUGESIC capsule
is used
2.
How
ACUGESIC
capsule
works
3.
Before
you
use
ACUGESIC capsule
4.
How
to
use
ACUGESIC
capsule
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ACUGESIC capsule
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ACUGESIC CAPSULE IS
USED FOR
ACUGESIC
capsule
is
a
painkiller used for treatment of
severe acute and chronic pain.
ACUGESIC
capsule
is
a
medicine for relief of pain, eg.
in
wound
pain,
fractures,
severe nerve pain, tumor pain,
heart attack. It should not be
used
for
minor
pain.
The
effect sets in quickly and lasts
for some hours.
HOW
ACUGESIC
CAPSULE
WORKS
ACUGESIC
capsule
contains
active
substance
called
Tramadol.
Tramadol
is
a
painkiller
belonging
to
the
class of the opioids that acts on
the central nervous system. It
relieves
pain
by
acting
on
specific
nerve
cells
of
the
spinal cord and brain.
BEFORE YOU USE ACUGESIC
CAPSULE
-
_When you must not use it _
Do
not
use
ACUGESIC
capsule if you have or have had
any of the following condition:

You are less than 12 years
old.

You have slow or shallow
breathing,
or
other
breathing problems.

You are pregnant.

You are breastfeeding.

You
have
recently
taken
large
amounts
of
alcohol,
hypnotics
(sleeping
pills),
analgesics
(painkillers)
or
other medicines that act on
the brain and spinal cord.

You are hypersentitive to,
or
have
had
an
allergic
reaction to tramadol, other
opioids
or
any
of
the
ingredients listed at the end
of this leaflet.
Symptoms
of
an
allergic
reaction
may
include
cough,
shortness of breath, wheezing
or
difficulty
breathing;
swelling
of
the
face,
lips,
tongue, throat or other parts of
the body, rash itching or hives
on
the
skin;
fainting
or
hay
fever like symptoms.
If you think you are having an
allergic
reaction,
stop
taking
the medicine and contact your
doctor immediately or go to the
nearest hospital.

Summary of Product characteristics

[DUOPHARMA (M) SDN BHD]
[Page 1/3]
_ _
[Revision Date: 08.08.2019]
ACUGESIC
DESCRIPTION:
ACUGESIC TABLET 50 MG is a 7 mm square shape, apple green in colour
tablet scored with marking 'duo 861' on one side and plain on the
other side.
ACUGESIC CAPSULE 50 MG is a black/green capsule with marking 'DUO
861'.
COMPOSITION:
ACUGESIC TABLET 50 MG : Each tablet contains Tramadol Hydrochloride 50
mg.
ACUGESIC CAPSULE 50 MG: Each capsule contains Tramadol Hydrochloride
50 mg.
Gelatin for Hard Capsule: Bovine source certified with Malaysia’s
Halal certification
PHARMACODYNAMICS: The side effects of opioid therapy, manifested as
respiratory depression and the development of dependence, which limit
the application of potent
analgesics, continue to impose on the therapist the difficult task of
estimating the benefit-risk relation. Since it has not yet been
possible to separate the therapeutically exploitable
activity and the undesirable side effects of potent analgesics, it was
assumed that the activity and side-effects of potent analgesics were
traceable to a common principle of action.
Increasing knowledge suggests however that it is possible to
distinguish between the therapeutic effects and side effects.
Tramadol (INN)
(±)-trans-2-(dimethylaminomethyl)-1-(methoxy-phenyl)-cyclohexanol
hydrochloride) is classified as a potent centrally active analgesic.
Its structure is related to opiate
alkaloids (eg. codeine) and to synthetic opiate analgesics.
Preclinical and clinical studies have shown that the analgesic action
derives from the reaction of the drug with the specific opioid
receptors of the pain processing system.
Animal experiments led to the assumption that tramadol hydrochloride
is a substance in which the therapeutic effects and side effects can
to a great extent be differentiated.
In tramadol HCl, with its favourable side effect / analgesic action
relation, we now have available for the first time an opioid for the
therapy of severe pain with a minimized abuse and
dependence potential, and which in therapeutic dos