TRD Contin 100mg controlled release tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TRAMADOL HYDROCHLORIDE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

TRAMADOL HYDROCHLORIDE

Unit dalam pakej:

50Tablet Tablets

Dikeluarkan oleh:

MODI-MUNDIPHARMA PRIVATE LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TRD-CONTIN
TM CONTROLLED RELEASE
TABLETS
Tramadol hydrochloride (100 mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What TRD-Contin
TM
is used for
2.
How TRD-Contin
TM
works
3.
Before you use TRD-Contin
TM
4.
How to use TRD-Contin
TM
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
TRD-
Contin
TM
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TRD-CONTIN
TM
IS USED FOR
TRD-Contin
TM
is
used
for
relieving
moderate to severe pain.
HOW TRD-CONTIN
TM WORKS
TRD-Contin
TM
contains
tramadol
which is in a class of medications called
opiods pain killer. It relieves pain by
acting
on
specific
nerve
cells
of
the
brain and nervous system.
BEFORE YOU USE TRD-CONTIN
TM
-
_When you must not use it _
Do not take TRD-Contin
TM
tablets if:

you are allergic to tramadol, other
opioid pain killers e.g., morphine
or
codeine
or
any
other
ingredients of this medicine (listed
in Product Description).

you
have
taken
monoamine
oxidase
inhibitors
(medicine
to
treat
depression)
within
the
last
two weeks.

you
have
epilepsy
which
inadequately
controlled
by
treatment

you have taken large amounts of
alcohol or other substances which
can
affect
your
level
of
consciousness.

you are less than 12 years old.

adolescent
between
12
and
18
years who are obese or have slow
or
shallow
breathing,
or
other
breathing problems.

children
or
adolescent
younger
than 18 years to treat pain after
surgery
to
remove
the
tonsils
and/or adenoids.
-
_Before you start use it _
Tell your doctor if

you have or ever had any:
-
liver, heartor kidneyproblems
-
lung or breathing problems
-
severe stomach problems
-
a serious head injury
-
fits or convulsions/epilepsy

you are taking medicine to treat
depression

you have or have had any problem
with
substances
or
alcohol
dependence.

you are undergoing treatment for
withdrawal from narcotics.
_Pregnancy and lactation _
This medicine is not recommended for
use in pregnancy.
Do no

Ciri produk

For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory.
R
x
Controlled Release Tablets of Tramadol Hydrochloride
TRD-CONTIN
TM
100
CONTINUS
TM CONTROLLED RELEASE SYSTEM
DESCRIPTION
Each white, biconvex, scored, film-coated caplet engraved with
“MM” logo on one of the facets of
TRD-CONTIN
TM
100 Continus contains Tramadol Hydrochloride BP 100 mg in the Continus
TM
controlled release system.
INDICATION
Treatment of moderate to severe pain.
PHARMACODYNAMICS PROPERTIES
Pharmacotherapeutic group: analgesics, other opioids; ATC code:
N02AX02
Mechanism of action
Tramadol is a centrally acting synthetic opioid analgesic. It is a
non-selective pure agonist at µ, δ and
κ opioid receptors with a higher affinity to the µ receptor. Other
mechanisms which contribute to its
analgesic effect are inhibition of neuronal re-uptake of noradrenaline
and enhancement of serotonin
release.
Clinical efficacy and safety
Tramadol hydrochloride has an antitussive effect. In contrast to
morphine, analgesic doses of
tramadol hydrochloride over a wide range have no
respiratory-depressant effect. Also
gastrointestinal motility is less affected. Effects on the
cardio-vascular system tend to be slight. The
potency of tramadol hydrochloride is reported to be 1/10(one tenth) to
–1/6(one sixth) that of
morphine.
Paediatric population
The safety profile of tramadol was similar in adult and paediatric
patients older than 1 year (see
section Dosage & Administration).
PHARMACOKINETIC PROPERTIES
Absorption
More than 90% of tramadol is absorbed after oral administration. The
mean absolute bioavailability
is approximately 70%, irrespective of concomitant intake of food. The
difference between absorbed
and non-metabolised available tramadol is probably due to low
first-pass-effect. The first-pass-effect
after oral administration is a maximum of 30%.
Tramadol has a high tissue affinity (V
d,β
= 203 ± 40 l). Protein binding is about 20%.
After administration of tramadol 100 mg prolonged release tablets the
peak plasma