PANTOPRAZOLE GH pantoprazole (as sodium sesquihydrate) 20 mg enteric coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium sesquihydrate

Available from:

Torrent Australasia Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Authorization status:

Registered

Patient Information leaflet

Pantoprazole GH CMI v1.0 December 2014
Page 1 of 5
CONSUMER MEDICINE INFORMATION
PANTOPRAZOLE GH
_PANTOPRAZOLE (AS SODIUM SESQUIHYDRATE) 20 & 40MG ENTERIC-COATED
TABLETS _
_WHAT IS IN THIS LEAFLET _
This leaflet answers some
common questions about
pantoprazole.
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
pantoprazole against the benefits
this medicine is expected to have
for you.
Use pantoprazole as directed and
follow the advice given in the
leaflet.
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 PANTOPRAZOLE GH IS USED _
_FOR _
The name of your medicine
is PANTOPRAZOLE GH
pantoprazole (as sodium
sesquihydrate) enteric-coated
tablets. It contains the active
ingredient called pantoprazole
20mg or 40mg.
ULCERS
Pantoprazole 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).
REFLUX DISEASE
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, also known as
heartburn.
Pantoprazole is also used to
prevent reflux oesophagitis from
coming back.
ZOLLINGER-ELLISON SYNDROME
Pantoprazole is used to tr

Summary of Product characteristics

1
PRODUCT INFORMATION
PANTOPRAZOLE GH
PANTOPRAZOLE (AS SODIUM SESQUIHYDRATE) 20 MG AND 40 MG ENTERIC COATED
TABLETS
NAME OF THE MEDICINE
Pantoprazole (as sodium sesquihydrate)
.1.5H
2
O
Chemical
name
:
Sodium
5-(difluoromethoxy)-2-[(_RS_)-[3,4-dimethoxypyridin-2-
yl)methyl]sulfinyl]-1_H_-benzimidazol-1-ide sesquihydrate.
Molecular Formula: C
16
H
14
F
2
N
3
NaO
4
S
. 1.5 H
2
O
CAS number (pantoprazole sodium sesquihydrate): 164579-32-2
DESCRIPTION
Pantoprazole is a substituted benzimidazole which inhibits basal and
stimulated gastric
secretion. It is a white to off white crystalline hygroscopic powder.
Solubility is low at
neutral pH and increases with increasing pH.
Each tablet core contains the active ingredient, pantoprazole (as
sodium sesquihydrate)
20
mg
or
40
mg,
mannitol,
crospovidone,
sodium
carbonate
anhydrous,
hydroxypropylcellulose, calcium stearate.
Tablet
film
coating
contains
hypromellose,
iron
oxide
yellow,
titanium
dioxide,
propylene glycol, Eudragit L30 D-55, triethyl citrate and purified
talc
2
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 stomach.
Following oral administration, pantoprazole accumulates in the acidic
environment of
the parietal cells where it is converted into the active form, a
cyclic sulfenamide which
binds to the H
+
/K
+
-ATPase thus inhibiting the proton pump. This causes potent and
long-lasting suppression of basal and stimulated gastric acid
secretion. As it acts distal to
the receptor level it can influence gastric acid secretion
irrespective of the nature of the
stimulus (acetylcholine, histamine, gastrin).
Since pantoprazole' only exerts its full effect in a highly acidic
environment (pH < 3),
remaining mostly inactive at higher pH values, it is considered a
selective inhibitor in the
acid secretory parietal cells. This effect is diminished at the same
rate as acid secretion
is inhibited by means of a feedback mechanism.