RIZIL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

Aurobindo Pharma Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

                                RIZIL
 
CONSUMER MEDICINE INFORMATION
     
            
Ver 1.3
Page 1 of 4 
RIZIL 40 
Pantoprazole (as Sodium Sesquihydrate) 
CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about RIZIL. 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 RIZIL against the benefits 
this medicine is expected to have for 
you.  
Use RIZIL 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 RIZIL IS USED FOR 
The name of your medicine is RIZIL. 
It contains the active ingredient called 
pantoprazole.  
ULCERS 
RIZIL 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. 
Most people who have a peptic ulcer 
also have bacteria called _Helicobacter _
_pylori  _in their stomach. When RIZIL 
is taken with antibiotics the 
combination therapy will kill the 
_Helicobacter pylori _and let your ulcer 
heal.
RIZIL 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 
RIZIL 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 fo
                                
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Summary of Product characteristics

                                 
Product Information:   
RIZIL (Pantoprazole Enteric-Coated Tablets 40 mg)        
                                      
                                      
     Ver 1.3 
 
Page 1 of 18 
 
PRODUCT INFORMATION 
RIZIL 40
(40 MG PANTOPRAZOLE AS SODIUM SESQUIHYDRATE ENTERIC COATED TABLETS) 
NAME OF THE MEDICINE 
Pantoprazole (as sodium sesquihydrate). 
 
CHEMICAL NAME: Sodium
5-(difluoromethoxy)-2-[(_RS_)-[(3,4-dimethoxypyridin-2-
yl)methyl]sulphinyl]benzimidazol-1-ide sesquihydrate 
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 is a substituted benzimidazole which inhibits basal and
stimulated gastric secretion. 
Pantoprazole sodium sesquihydrate is a white to off-white crystalline
powder. It is freely soluble 
in water, soluble in methanol & practically insoluble in methylene
chloride. 
 
RIZIL 40 is available as enteric coated tablets containing 40 mg
pantoprazole (as sodium 
sesquihydrate). 
 
RIZIL enteric coated tablets contain the following inactive
ingredients: sodium carbonate 
anhydrous, mannitol, crospovidone, calcium stearate, hypromellose,
iron oxide yellow (CI 
77492), hydroxypropylcellulose, methacrylic acid-ethyl acrylate
copolymer (1:1), triethyl citrate 
and opacode monogramming ink S-1-16530 brown (PI ARTG-106601). 
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. 
 
The substance is a substituted benzimidazole which accumulates in the
acidic environment of the 
parietal cells after absorption. There, it is converted into the
active form, a cyclic sulphenamide 
which binds to the H
+
/K
+
-ATPase, thus inhibiting the proton pump and causing potent and
long- 
 
Product Information:   
RIZIL (
                                
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