Tramedo SR

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Tramadol hydrochloride

Available from:

Alphapharm Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

TRAMEDO SR
1
TRAMEDO SR
_Tramadol hydrochloride modified release tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tramedo SR.
It does not contain all the available
information.  It does not take the
place of talking to your doctor or
pharmacist. 
All medicines have benefits and
risks.  Your doctor has weighed the
risks of you taking Tramedo SR
against the benefits expected for you. 
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. 
You may need to read it again. 
THE INFORMATION SUPPLIED IN THIS
LEAFLET RELATES ONLY TO TRAMEDO SR
TABLETS. 
It is not to be used in relation to any
other product, which may also
contain the same active ingredient. 
WHAT TRAMEDO SR IS
USED FOR
Tramedo SR is used to relieve
moderate to severe pain. 
Tramedo SR belongs to a group of
medicines called analgesics, also
known as "pain relievers" or "pain
killers". 
Tramedo SR tablets are designed to
release the pain reliever gradually
over several hours. 
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TRAMEDO SR
HAS BEEN PRESCRIBED FOR YOU. 
Your doctor may have prescribed
Tramedo SR for another reason. 
Tramedo SR is not recommended for
use in children below 12 years, as its
safety and effectiveness has not been
established in this age group. 
Tramedo SR is available only with a
doctor's prescription. 
When used as prescribed by your
doctor, addiction to Tramedo SR is
very unlikely. 
BEFORE YOU TAKE
TRAMEDO SR
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TRAMEDO SR IF YOU
ARE: 
*
sensitive to opioids
*
allergic to any other medicines
containing tramadol
hydrochloride (eg. Tramal) 
*
allergic to any of the ingredients
listed at the end of this leaflet. 
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives; swelling of the face,
lips o

Summary of Product characteristics

TRAMEDO SR 
_Tramadol hydrochloride _

PRODUCT INFORMATION 

NAME OF THE MEDICINE 

Active ingredient: Tramadol hydrochloride 

Chemical name:
(+)-_cis_-2-[(dimethylamino)methyl]-1-(3-methyoxyphenyl)cyclohexanol
hydrochloride 

Structural formula: 

Molecular formula: C
16
H
25
NO
2
.HCl 
Molecular weight:  299.84        
CAS Registry No.: 36282-47-0 

DESCRIPTION

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.  It 
belongs to the analgesics class and has an opioid-like activity.  

Tramedo SR modified release preparations contain
tramadol hydrochloride in the following dose strengths: 
100mg, 150mg amd 200mg.  The tablets also contain
the following inactive ingredients: glyceryl behenate, 
calcium hydrogen phosphate, povidone and colloidal anhydrous
silica.  

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.  Although pre-clinical testing 
has not completely explained the mode of action, 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_-desmethyltramadol, denoted M1, to µ-
opioid receptors.  In animal models, M1 is up to 6 times more
potent than tramadol in producing analgesia 
TRAMEDO SR– Product Information 
2 

and 200 times more potent in µ-opioid binding.  The
contribution of tramadol to human analgesia, relative to