GA Tramadol

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Tramadol hydrochloride

Available from:

Actavis Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

 
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

Summary of Product characteristics

PR
RODUCT
T INFOR
RMATIO
ON

G
GA TRAMA
ADOL 50 M
MG CAPSULEES 

NA
AME OF T
THE MEDICINE 

The
activ
e product, G
ve ingredien
GA Tramado
nt.   
ol 50 mg cap
psules, conttains tramad
dol hydroch
hloride as th
he 

Thee chemical sstructure of tramadol hy
ydrochlorid
de is: 

[http://www.pharmacopoeia.co.uk/ixbin/bp.cgi?a=imagezoom&file=bp2008_v2_09_medicinal_and_pharmaceutical_substances_09/large/5_tram1.png]

CAS
S number: 3
36282-47-0 

DESCRIPTIO
ON AND COMPOS
SITION 

The
[(dim

Mol

Tram
read
part

The
cellu
titan

CL

PHA
ami
sour

Tramadol V2 
e chemical n
methylamin
lecular form
madol hydr
dily soluble 
tition coeffi
e excipients 
ulose – mic
nium dioxid
LINICAL P
ARMACODYN
inocyclohex
rces, nor is 
 100528  
name of tram
no)methyl)]
mula: C
16
H
2
rochloride is
in both wat
cient is 1.35
contained i
crocrystallin
de, quinolin
PHARMA
NAMICS: Tram
xanol group 
it chemical
madol hydro
-1-(3-metho
ochloride is
oxyphenyl)
s (1_RS_,2_RS_)
cyclohexan
-2-
nol hydrochlloride.  
5
NO
2
.HCl. MW: 299.8
84.  
s an odourle
ter and etha
5 at pH 7. 
ess, white to
anol and has
o off white c
s a pKa of 9
crystalline p
9.41. The w
powder that
ater/n-octan
t is 
nol 
in the produ
ne, silica – c
e yellow, ir
uct include c
colloidal anh
ron oxide ye
croscarmell
hydrous, m
ellow, Brilli
lose sodium
agnesium st
iant Blue FC
m, povidone,
tearate, gela
CF. 
, 
atin, 
ACOLOGY
Y 
madol is a c
with opioid
ly related to
centrally ac
d-like effect
o opiates. 
ting synthet
ts.  It is not 
tic analgesi
derived fro
c of the 
om natural 
GA T
Page 1 of 11
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 princi