Anzemet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Dolasetron mesylate

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

ANZEMET
®
 TABLETS

_Dolasetron mesylate_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Anzemet 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 this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ANZEMET TABLETS
ARE USED FOR
Anzemet tablets contain the active
ingredient dolasetron mesylate,
which belongs to a group of
medicines called antiemetics.
Antiemetics are used to help stop
nausea (feeling sick) and vomiting
(being sick).
Anzemet tablets are used to help you
stop feeling or being sick after
surgery.
Anzemet tablets should only be taken
for the nausea and vomiting for
which they have been prescribed.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ANZEMET TABLETS IF YOU:
•
ARE PREGNANT OR MIGHT BE
PREGNANT
•
ARE BREAST-FEEDING OR INTEND TO
BREAST-FEED.
DO NOT TAKE IT IF YOU ARE ALLERGIC TO
IT OR ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
DO NOT GIVE ANZEMET TABLETS TO A
CHILD OR ADOLESCENT UNDER THE AGE
OF 18 YEARS.
DO NOT TAKE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK.
If you take it after the expiry date has
passed, it may not work as well.
DO NOT TAKE IT IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF TAMPERING.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING ANZEMET
TABLETS, TALK TO YOUR DOCTOR OR
PHARMACIST.
BEFORE YOU START TO
TAKE IT
TELL YOUR DOCTOR IF YOU ARE ALLERGIC
TO ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
TELL YOUR DOCTOR OR PHARMACIST IF
YOU ARE PREGNANT OR INTEND TO

Summary of Product characteristics

 
Anzemet CCDS v6 PI v9 15 April 2011 

Page 1 of 9 

PRODUCT INFORMATION 
ANZEMET TABLETS & INJECTIONS 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Dolasetron mesylate 
CHEMICAL STRUCTURE 
Anzemet  is  dolasetron  mesylate  or  (2

,  6

,  8

,  9a

)-octahydro-3-oxo-2,6-methano-2H-
quinolizin-8  yl-1H-indole-3 carboxylate monomethanesulfonate, monohydrate. The empirical 
formula is C
19
H
20
N
2
O
3
•CH
3
SO
3
H•H
2
O (MW = 438.5). The structural formula appears below: 

CAS NUMBER 
CAS number: 115956-13-3 
DESCRIPTION 
Dolasetron mesylate is a white to off-white powder. Freely soluble in water and in propylene 
glycol; slightly soluble in alcohol and in sodium chloride
0.9%. 
Each  Anzemet  tablet  contains  dolasetron  mesylate  (50mg),  lactose,  pregelatinised  maize 
starch, croscarmellose sodium, magnesium stearate, carnauba wax, white beeswax, opadry 
pink YS-1-14555-A and opacode black S-1-8093. 
Each  Anzemet  injection  contains  dolasetron  mesylate(12.5mg),  mannitol,  sodium  acetate 
trihydrate, glacial acetic acid and water for injections. 
PHARMACOLOGY 
Dolasetron  mesylate  and  its  major  metabolite  are  selective  5-HT
3
  antagonists  for  the 
prevention and treatment of nausea and vomiting. They are devoid of activity at most other 
known serotonin receptors, and have no affinity for dopamine or adrenergic receptors.  The 
5-HT
3
  receptors  are  located  on  pre-and  postganglionic  neurones  and  on  neurones  of  the 
sensory  and  enteric  nervous  systems  in  the  periphery  and,  centrally,  in  the  chemoreceptor 
trigger  zone  of  the  area  postrema.  It  is  thought  that  chemotherapeutic  agents  and 
radiotherapy produce nausea and vomiting by releasing serotonin from