APO-Pantoprazole

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

Apotex Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

APO-PANTOPRAZOLE

_Contains the active ingredient, pantoprazole (as sodium
sesquihydrate)_
CONSUMER MEDICINE INFORMATION

_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE ASK YOUR
DOCTOR OR PHARMACIST IF YOU DO NOT
UNDERSTAND ANYTHING OR ARE
WORRIED ABOUT TAKING YOUR
MEDICINE.
This leaflet answers some common
questions about your medicine.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. Some more recent
information on your medicine may
be available. Speak to your
pharmacist or doctor to obtain the
most up-to-date information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT PANTOPRAZOLE IS
USED FOR
The name of your medicine is APO-
Pantoprazole. It contains the active
ingredient, pantoprazole (as sodium
sesquihydrate).
It 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. These
can be caused in part by too much
acid being made in the stomach.
Pantoprazole 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).
Pantoprazole 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

Summary of Product characteristics

Product Information 
– Australia 
APO-Pantoprazole Tablets 
Page 1 
APO-PANTOPRAZOLE TABLETS 

NAME OF THE MEDICINE 
Pantoprazole sodium sesquihydrate. 

Chemical Name: 
1) 
1_H_-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-
pyridinyl)methyl]-sulfinyl]-, sodium salt, hydrate (2:3) 

2)   5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridyl)methyl] 
sulfinyl]benzimidazole, sodium salt, sesquihydrate 

Structural Formula: 

Molecular Formula: 
C
16
H
14
F
2
N
3
NaO
4
S.1.5 H
2
O 

Molecular Weight: 
432.4 

CAS Registry Number:  164579-32-2 

DESCRIPTION 
Pantoprazole sodium sesquihydrate is very soluble in water, methanol, ethanol, freely soluble in acetone, 
soluble  in  phosphate  buffers  within  the  pH  6.0-7.5  range,  and  practically  insoluble  in  chloroform, 
dichloromethane, diethyl ether and n-hexane. 
Pantoprazole  is  a  substituted  benzimidazole  which  inhibits  basal  and  stimulated  gastric  secretion. 
Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder. Solubility is low at neutral 
pH and increases with increasing pH. 

Each enteric coated tablet contains the active ingredient pantoprazole (as sodium sesquihydrate). In 
addition,  each  enteric  coated  tablet  contains  the  following  inactive  ingredients:  lactose  anhydrous, 
crospovidone,  microcrystalline  cellulose,  magnesium  stearate,  hypromellose,  macrogol  8000, 
anhydrous  sodium  carbonate,  methacrylic  acid  copolymer,  triethyl  citrate,  talc-purified,  titanium 
dioxide and iron oxide yellow. 

PHARMACOLOGY 
PHARMACODYNAMICS 
Pantoprazole  inhibits  specifically  and  dose  proportionately  H
+
/K
+
-ATPase,  the  enzyme  which  is 
responsible for gastric acid secretion in the parietal cells of the