PROCHLORPERAZINE AN prochlorperazine maleate 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prochlorperazine maleate

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Prochlorperazine maleate

Authorization status:

Registered

Patient Information leaflet

_Prochlorperazine AN tablets – Consumer Medicine Information _
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_Doc ID: 90.AN.M.1.0 _
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_Page 1 _
PROCHLORPERAZINE AN TABLETS
_Prochlorperazine maleate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Prochlorperazine AN.
It
does
not
contain
all
the
available
information
that
is
known
about
Prochlorperazine
AN.
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 using
this
medicine
against
the
benefits
he/she
expects
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
PROCHLORPERAZINE AN
IS USED FOR
Prochlorperazine AN 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.
Prochlorperazine AN is used to
treat
nausea,
vomiting
and
dizziness due to various causes,
including
migraine
(severe
headache).
Your
doctor
may
have
prescribed Prochlorperazine AN
for another reason
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
PROCHLORPERAZINE AN HAS BEEN
PRESCRIBED TO YOU.
This medicine is available only
with a doctor’s prescription.
Prochlorperazine
AN
is
not
recommended for use in children
*under
the
age
of
2
years
or
children under 10 kg in weight).
BEFORE YOU TAKE
PROCHLORPERAZINE AN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PROCHLORPERAZINE
AN IF YOU HAVE AN ALLERGY TO:

prochlorperazine;

the
group
of
medicines
called phenothiazines;

any of the ingredients listed
at the end of this leaflet.
Symptoms of an allergic reaction
to
Prochlorperazine
AN
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

Summary of Product characteristics

Doc ID: 90.AN.P.1.1
Page 1
_Prochlorperazine AN tablets Product Information _
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_ Scentia Pharmaceuticals Pty Ltd _
PROCHLORPERAZINE AN
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_(PROCHLORPERAZINE MALEATE TABLETS) _
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PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is prochlorperazine maleate
CHEMICAL NAME:
2-chloro-10-[3-(4-methylpiperazin-1-yl)propyl]-10_H_-phenothiazide
bis[hydrogen
(_Z_)-butenedioate]
MOLECULAR FORMULA: C
20
H
24
CIN
3
S.2C
4
H
4
O
4
MOLECULAR WEIGHT: 606.2
CAS REGISTRY NUMBER: _[84-02-6] _
DESCRIPTION
Prochlorperazine
maleate
contains
62%
of
the
active
base
prochlorperazine.
It
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.
Prochlorperazine AN tablets contain 5mg of prochlorperazine maleate.
The tablets also
contain
the following excipients: lactose, maize starch, purified water,
colloidal anhydrous
silica and
magnesium stearate.
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 to both the
therapeutic effect and
unwanted effects including extrapyramidal disorders and endocrine
disturbances.
2.
α-Adrenoreceptor antagonism, which contributes to cardiovascular side
effects such
as orthostatic hypotension and reflex tachycardia.
3.
Potentiation of noradrenaline by blocking its reuptake into nerve
terminals.
4.
Weak anticholinergic action.
Doc ID: 90.AN.P.1.1
Page 2
_Prochlorperazine AN tablets Product Information _
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_ Scentia Pharmaceuticals Pty Ltd _
5.
Weak antihistamine action.
6.
Weak serotonin antagonism.
Prochlorperazine
also
has
an
effect
on
temperature
control
and
blocks
conditioned
avoidance responses.