PANTOPRAZOLE AN pantoprazole (as sodium sesquihydrate) 40 mg enteric-coated tablet blister pack.

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium sesquihydrate

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Authorization status:

Registered

Patient Information leaflet

_Pantoprazole AN tablets – Consumer Medicine Information _
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Pantoprazole AN CMI v1.0
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Page 1_ _
PANTOPRAZOLE AN TABLETS
_Pantoprazole (as sodium sesquihydrate) enteric coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
PANTOPRAZOLE AN.
It
does
not
contain
all
of
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
PANTOPRAZOLE
AN
against
the benefits they expect it will
have 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.
WHAT
PANTOPRAZOLE AN
IS USED FOR
The name of your medicine is
PANTOPRAZOLE
AN.
It
contains
the
active
ingredient
called pantoprazole. It belongs
to a group of medicines called
proton
pump
inhibitors
(PPIs).
PANTOPRAZOLE AN works by
decreasing the amount of acid
the stomach makes to give relief
from
the
symptoms
and
allow
healing to take place.
ULCERS
PANTOPRAZOLE AN is used to
treat and help heal duodenal and
gastric ulcers. Depending on the
position of the ulcer it is called a
gastric
or
duodenal
ulcer.
A
gastric
ulcer
occurs
in
the
stomach.
A
duodenal
ulcer
occurs in the duodenum which is
the
tube
leading
out
of
the
stomach.
PANTOPRAZOLE AN may also
be
used
to
prevent
ulcers
associated with the use of non-
steroidal anti-inflammatory drugs
(NSAIDs). These are
medicines
used
to
relieve
pain,
swelling
and
other
symptoms
of
inflammation,
including
arthritis
(inflammation of the joints).
REFLUX DISEASE
PANTOPRAZOLE
AN
is
also
used to treat reflux oesophagitis
or reflux disease. This can be
caused
by
“washing
back”
(reflux) of food and acid from the
stomach into the food pipe, also
known
as
the
oesophagus.
Reflux
can
cause
a
burning
sensation in the chest rising up
to
the
throat,
also
known
as
heartburn.
PANTOPRAZOLE
AN
is
also
used
to
prevent
reflux
oesophagitis from

Summary of Product characteristics

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_Pantoprazole AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Pantoprazole AN PI v3.0
Page 1 of 13
PANTOPRAZOLE AN
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_(PANTOPRAZOLE SODIUM SESQUIHYDRATE ENTERIC-COATED TABLETS) _
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PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is Pantoprazole sodium (as pantoprazole
sodium sesquihydrate).
Chemical name: Sodium
5-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin-
2-yl)methyl]sulphinyl]benzimidazol-1-ide sesquihydrate
CAS No:
164579-32-2
Molecular formula: C
16
H
14
F
2
N
3
NaO
4
S,1.5H
2
0
MW (sodium salt x 1.5 H
2
O):432.4
DESCRIPTION
Each Pantoprazole AN 40mg enteric coated tablet contains 45.10mg of
pantoprazole sodium
sesquihydrate equivalent to 40mg of pantoprazole.
Each
Pantoprazole
AN
20mg
enteric
coated
tablet
contains
22.55mg
pantoprazole
sodium
sesquihydrate equivalent to 20mg of pantoprazole.
Pantoprazole is a substituted benzimidazole which inhibits basal and
stimulated gastric secretion.
It is a white to off white crystalline powder. Freely soluble in water
and in ethanol (96 per cent),
practically insoluble in hexane. Solubility is low at neutral pH and
increases with increasing pH.
In addition to pantoprazole sodium sesquihydrate, these tablets also
contain mannitol, sodium
carbonate, sodium starch glycollate, crospovidone, colloidal
anhydrous silica,
calcium
stearate,
hypromellose, macrogol 6000, sodium
hydroxide, EUDRAGIT L30-D55 and OPADRY AMB
Aqueous Moisture Barrier Coating System
80W52172 Yellow.
Pantoprazole AN tablets are gluten free.
PHARMACOLOGY
PHARMACODYNAMICS:
Pantoprazole is a proton pump inhibitor. It inhibits specifically and
dose-proportionately H
+
/K
+
-
ATPase, the enzyme which is responsible for gastric acid secretion in
the parietal cells of the
stomach.
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_Pantoprazole AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Pantoprazole AN PI v3.0
Page 2 of 13
The substance is a substituted benzimidazole which accumulates in the
acidic environment of the
parietal cells after absorption. Ther