Tracidol 100 mg prolonged release capsule

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

TRAMADOL HYDROCHLORIDE

Tilgængelig fra:

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

INN (International Name):

TRAMADOL HYDROCHLORIDE

Enheder i pakken:

50 x 10 Capsules; 100 x 10 Capsules; 3 x 10 Capsules

Fremstillet af:

SMB TECHNOLOGY S.A.

Indlægsseddel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TRACIDOL
® PROLONGED RELEASE CAPSULE
Tramadol Hydrochloride (100mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_Tracidol_
_®_
is used for
2.
How
_Tracidol_
_®_
works
3.
Before you use
_Tracidol_
_®_
4.
How to use
_Tracidol_
_®_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Tracidol_
_®_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _Tracidol_
_®_
IS USED FOR
_Tracidol_
_®_
is indicated for treatment of
moderate to severe pain.
HOW _Tracidol_
_®_
WORKS
Tramadol is a centrally acting analgesic.
Tramadol
is
a
non
–
selective,
pure
agonist in the μ, and K opiate receptors,
and it attaches itself most effectively to
the
μ-receptor.
Other
factors
that
contribute
to
its
analgesic
effects
are
inhibition
of
neuronal
re-uptake
of
noradrenaline and enhancement of 5-HT
release.
Tramadol
has
an
antitussive
effect.
In
opposition to morphine, analgesic doses
of tramadol do not produce respiratory
depression
during
a
wide
interval.
Tramadol
does
not
affect
to
gastrointestinal motility and its effects on
the cardiovascular system are mild.
Antinociceptive
efficacy
of
Tramadol
has
been
shown
with
osteoarthritis
patients.
BEFORE YOU USE _Tracidol_
_®_
-
_When you must not use it _
_ _
Patients
with
severe
renal
or
hepatic
insufficiency,
have
slow
or
shallow
breathing, or other breathing problems,
children under 12 years, hypersensitivity
to
Tramadol
or
to
or
to
any
of
the
excipients,
acute
intoxication
with
alcohol, hypnotics drugs, centrally acting
analgesics,
opioids
or
psychotropic
drugs.
Also contraindicated in patients who are
receiving
monoamine
oxidase
(MAO)
inhibitors or within two weeks of their
withdrawal, epilepsy not controlled by
treatment,
and
breast-feeding
(if
long
term
treatment
is
necessary)
are
not
recommended.
_ _
_Pregnancy and lactation _
Do not take
_Tracidol_
_®_
if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take
_Tracidol_
_®_
if you are brea

Produktets egenskaber

PAGE 1
260 x 220
L
260mm
ACTIVE INGREDIENT:
Each Tracidol Prolonged Release Capsule 100mg contains:
Tramadol Hydrochloride
..............................................................................................................
100mg
PHARMACOLOGY (SUMMARY OF PHARMACODYNAMIC AND PHARMACOKINETIC):
Tramadol is a centrally acting analgesic. Tramadol is a non –
selective, pure agonist in the μ, and K
opiate receptors, and it attaches itself most effectively to the
μ-receptor. Other factors that contribute
to its analgesic effects are inhibition of neuronal re-uptake of
noradrenaline and enhancement of
5-HT release.
Tramadol has an antitussive effect. In opposition to morphine,
analgesic doses of tramadol do not
produce respiratory depression during a wide interval. Tramadol does
not affect to gastrointestinal
motility and its effects on the cardiovascular system are mild. The
potency of tramadol is 1/10- 1/6 of
that of the morphine.
Antinociceptive efficacy of TRACIDOL has been shown with
osteoarthritis patients.
ABSORPTION
Tramadol is absorbed almost completely when administered orally, and
the absolute efficiency is
approximately 70 %. Tramadol metabolises into O-desmethyltramadol,
which has proven to have an
analgesic effect in rodents. The half-life elimination of Tramadol is
approximately 6 hours. The half-life
increases, however, to 9 hours with the capsules of TRACIDOL due to
the long absorption time.
When a single capsule of 200 mg of TRACIDOL was given to a fasting
patient, the average maximum
content concentration of the plasma (Cmax) achieved was 299.59 ng.ml-1
(in the interval 240 -
300ng/ml). A median Tmax 9.59 hours (9 - 12 hours) was related to
this. After the dosage had been
adapted, the efficiency of Tramadol produced by a capsule of TRACIDOL
of 200 mg was complete, in
comparison with 50 mg of immediately liberated Tramadol. In the
presence of food, the availability
and controlled release properties of TRACIDOL capsules were
maintained, with no evidence of dose
dumping. In addition, a steady