GA TRAMADOL tramadol hydrochloride 50 mg capsule blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

tramadol hydrochloride

MAH:

Medis Pharma Pty Ltd

INN:

Tramadol hydrochloride

authorization_status:

Registered

PIL

GA TRAMADOL CAPSULES
_Tramadol hydrochloride_
Page 1 of 3
GA Tramadol V2 100528
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GA Tramadol. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking GA
Tramadol against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT GA TRAMADOL IS
USED FOR
GA Tramadol is used to relieve
moderate to severe pain and
belongs to a group of medicines
called analgesics (pain relievers).
Your doctor may have prescribed
GA Tramadol for another reason.
Ask your doctor why GA Tramadol
has been prescribed for you.
This medicine is available only with
a doctor's prescription.
GA Tramadol is not normally
addictive although some cases
have been reported.
BEFORE YOU USE GA
TRAMADOL
_When you must not use it _
_ _
Do not use GA Tramadol if:
•
YOU HAVE A KNOWN ALLERGY
TO GA TRAMADOL OR ANY
OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Some of the symptoms of
an allergic reaction may
include skin rash, itching,
difficulty breathing and
swelling of the face
(including lips, tongue,
throat etc)
•
YOU ARE TAKING MEDICINE
FOR DEPRESSION
CONTAINING A "MONOAMINE
OXIDASE INHIBITOR" (SUCH
AS NARDIL, PARNATE), OR
HAVE TAKEN ONE WITHIN THE
PAST TWO WEEKS.
DO NOT USE GA TRAMADOL AFTER
THE EXPIRY DATE PRINTED ON THE
PACK.
If you take this medicine after the
expiry date has passed, it may not
work as well.
DO NOT USE GA TRAMADOL IF THE
PACKAGING IS TORN OR SHOWS SIGNS
OF TAMPERING.
DO NOT GIVE GA TRAMADOL TO
CHILDREN.
There is no experience with the use
of GA Tramadol in children.
If you are not sure whether you
should be using GA Tramadol, talk
to your doctor.
_ _
_Before you use it _
_ _
YOU MUST TELL YOUR DOCTOR IF:
1. you have a known allergy to
G

SPC

GA Tramadol V3 140916
Page 1 of 12
PRODUCT INFORMATION
GA TRAMADOL 50 MG CAPSULES
NAME OF THE MEDICINE
The product, GA Tramadol 50 mg capsules, contains tramadol
hydrochloride as the
active ingredient.
The chemical structure of tramadol hydrochloride is:
CAS number: 36282-47-0
DESCRIPTION AND COMPOSITION
The chemical name of tramadol hydrochloride is (1
_RS_
,2
_RS_
)-2-
[(dimethylamino)methyl)]-1-(3-methoxyphenyl)cyclohexanol
hydrochloride.
Molecular formula: C
16
H
25
NO
2
.HCl. MW: 299.84.
Tramadol hydrochloride is an odourless, white to off white crystalline
powder that is
readily soluble in both water and ethanol and has a pKa of 9.41. The
water/n-octanol
partition coefficient is 1.35 at pH 7.
The excipients contained in the product include croscarmellose sodium,
povidone,
microcrystalline cellulose, colloidal anhydrous silica, magnesium
stearate, gelatin,
titanium dioxide, quinoline yellow, iron oxide yellow, Brilliant Blue
FCF.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS:
Tramadol is a centrally acting synthetic analgesic of the
aminocyclohexanol group with opioid-like effects. It is not derived
from natural
sources, nor is it chemically related to opiates.
GA Tramadol V3 140916
Page 2 of 12
Although the mode of action is not completely understood, at least two
complementary mechanisms appear applicable: binding to
_µ_
-opioid receptors and
inhibition of re-uptake of noradrenaline and serotonin. The opioid
like activity of
tramadol derives from low affinity binding of the parent compound to
_µ_
-opioid
receptors and higher affinity binding of the principal active
metabolite, mono O-
desmethyl tramadol, denoted M1, to
_µ_
-opioid receptors. In animal models, M1 is up
to six times more potent than tramadol in producing analgesia and 200
times more
potent in
_µ_
-opioid binding. The contribution of tramadol to human analgesia,
relative
to M1, is unknown.
Both human and animal studies have shown that antinociception induced
by tramadol
is only partially antagonised by the opiate antagonist naloxone. In
addition