Zydol SR

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

Tramadol hydrochloride

Verfügbar ab:

Aspen Pharma Pty Ltd

Klasse:

Medicine Registered

Gebrauchsinformation

Zydol™ SR- Consumer
Medicine Information                                                                                  
                              Page 1 of 4 

ZYDOL
™
 SR
_ _
_tramadol hydrochloride_

_ _
CONSUMER MEDICINE INFORMATION (CMI) 

WHAT IS IN THIS LEAFLET 

This leaflet answers some 
common questions about 
Zydol Sustained Release 
tablets.  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 Zydol SR 
against the benefits this 
medicine is expected to have 
for you. 

TALK TO YOUR DOCTOR OR 
PHARMACIST IF YOU HAVE ANY 
CONCERNS ABOUT TAKING THIS 
MEDICINE. 

KEEP THIS LEAFLET. 
You may need to read it again. 

WHAT ZYDOL IS USED 
FOR 

Zydol SR is used to relieve 
moderate to severe pain and 
belongs to a group of 
medicines called analgesics 
(pain relievers). 

ASK YOUR DOCTOR WHY ZYDOL 
HAS BEEN PRESCRIBED FOR 
YOU.  Your doctor may have 
prescribed it for another 
reason.   

This medicine is available only 
with a doctor’s prescription. 

It is not normally addictive 
although some cases have 
been reported. 

BEFORE YOU USE IT 

_WHEN YOU MUST NOT USE IT _

DO NOT USE ZYDOL SR IF: 

  you have a known allergy 
to Zydol SR 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 have an allergy to any 
other medicines known

Fachinformation

ZYDOL SR- Product Information 

Page 1 of 12 
PRODUCT INFORMATION 

ZYDOL
™ 
SR  

NAME OF PREPARATION 

Zydol SR (tramadol hydrochloride) 50 mg, 100 mg, 150 mg & 200
mg sustained release tablets. 

DESCRIPTION AND COMPOSITION 

Zydol SR preparations contain tramadol hydrochloride which
is (1_RS_, 2_RS_)-2-
[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol
hydrochloride.  It is an odourless, 
white to off-white crystalline powder that is readily soluble in
both water and methanol and has a 
pKa of 9.41.  The water/n-octanol partition coefficient is 1.35
at pH 7.  It belongs to the synthetic 
analgesics class and has opioid-like activity, with the formula:  C
16
 H
25
 NO
2
. HCl.  MW = 299.84. 

The structural formula of tramadol hydrochloride is:- 

The CAS Registry Number is 36282-47-0. 

The composition of Zydol

 SR preparations is as follows: 
Zydol SR sustained release tablets contain tramadol
hydrochloride in the following dose strengths: 
50, 100, 150 and 200 mg.  Excipients are: hypromellose 10
5
 mPa.s, silica- colloidal anhydrous, 
magnesium stearate, microcrystalline cellulose.  Excipients in the
film coat are: hypromellose 6 
mPa.s, lactose, macrogol 6000, propylene glycol, talc-purified,
titanium dioxide, quinoline yellow 
aluminium lake CI47005 (150 and 200 mg tablets only), iron oxide red
CI77491 (150 and 200 mg 
tablets only), iron oxide yellow C177492 (50 and 200 mg tablets only)
and iron oxide black 
C177499 (200 mg tablet only). 

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. Although its 
mode of action is not completely understood, from animal tests, at
least two complementary 
mechanisms appear applicable: binding to µ-opioid receptors and
inhibition o