Stemetil

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Prochlorperazine maleate; Prochlorperazine mesylate

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Listed (Export Only)

Patient Information leaflet

STEMETIL
®

_(S-TEM-E-TIL)_
_Prochlorperazine (pro-klor-per-a-zeen)_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Stemetil.
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 Stemetil
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 STEMETIL IS USED
FOR
Stemetil belongs to a group of
medicines called phenothiazines. It
helps to correct chemical imbalances
in the brain, allowing it to function
correctly. These chemicals may also
affect the parts of the brain which
control nausea (feeling sick) and
vomiting.
Stemetil is used to treat nausea,
vomiting and dizziness due to
various causes, including migraine
(severe headache).
Your doctor may have prescribed
Stemetil for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY STEMETIL HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Stemetil is not recommended for use
in children (under the age of 2 years
or children under 10kg in weight).
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE STEMETIL IF YOU HAVE AN
ALLERGY TO:
•
Stemetil
•
the group of medicines called
phenothiazines
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction to
Stemetil may include:
•
shortness of breath, wheezing or
difficulty in breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
YOU SHOULD NOT TAKE STEMETIL IF YOU
HAVE ANY OF THE FOLLOWING MEDICAL
CONDITIONS:
•
shock
•
disease of the blood with a low
number of blood cells
•
yellowing of the skin and/or eye,
also called jaundice
STEMETIL MUST NOT BE GIVEN TO
ANYONE WHO IS UN

Summary of Product characteristics

 
Stemetil GLUv6 PIv12 21 Aug 13

1 
PRODUCT INFORMATION 
STEMETIL
®
_ _
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Tablets 

prochlorperazine maleate 
Molecular Formula: C
20
H
24
ClN
3
S.2C
4
H
4
O
4 
CAS number: 84-02-6

Injection 
  [http://www.genome.ad.jp/Fig/compound/C13524.gif]
prochlorperazine mesylate 
Molecular formula: C
20
H
24
ClN
3
S.2CH
3
SO
3
H 
CAS number: 5132-55-8

Suppositories 

prochlorperazine base 
Molecular Formula: C
20
H
24
ClN
3
S 
CAS number: 58-38-8 
DESCRIPTION 
Prochlorperazine  is  2  chloro-10-(3-(4-methyl  piperazinyl)-propyl)  phenothiazine.    Prochlorperazine 
maleate  contains  62%  of  the  active  base;  prochlorperazine  mesylate  contains  66%  of  the  active 
base. 

The  maleate  is  an  odourless,  nonhydroscopic,  white  or  almost  white,  fine  granular  powder,  which 
becomes  coloured  on  exposure  to  light.    It  is  sparingly  soluble  (about  0.1%)  in  water,  ethanol  or 
methanol and is insoluble in ether or chloroform. 

The  mesylate  is  an  odourless,  nonhydroscopic,  almost  white,  crystalline  solid  which  becomes 
coloured  on  exposure  to  light.      It  is  very  soluble  in  water  (more  than  2  g/mL)  but  is  only  slightly 
soluble  in  ethanol  or  chloroform  and  is  insoluble  in  ether  or  benzene.    The  pH  of  a  2%  aqueous 
solution is between 2 and 3. 
PHARMACOLOGY 
Prochlorperazine is a phenothiazine with a piperazine moiety in
the side chain.  It possesses strong 
antiemetic and antipsychotic activity with less sedative
action than chlorpromazine. 
PHARMACODYNAMICS 
As with other phenothiazines, prochlorperazine has actions
on several neurotransmitter systems: 
1. 
Antidopamine action, which probably contributes