OMEPRAZOLE RANBAXY

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Omeprazole

Available from:

Ranbaxy Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

 
Omeprazole Ranbaxy CMI V2 Jun 2009 

OMEPRAZOLE 
RANBAXY  
OMEPRAZOLE TABLETS 

CONSUMER MEDICINE 
INFORMATION 

WHAT IS IN THIS LEAFLET 

This leaflet answers some of the 
common questions about 
OMEPRAZOLE RANBAXY. 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 
OMEPRAZOLE RANBAXY against 
the benefits it is expected to 
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 OMEPRAZOLE RANBAXY 
IS USED FOR 

_Peptic Ulcers _

OMEPRAZOLE RANBAXY is used 
to treat peptic 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 from the 
stomach. 

These ulcers can be caused by 
too much acid being made in the 
stomach. 

OMEPRAZOLE RANBAXY is also 
used to help stop peptic or 
duodenal ulcers coming back. 

_Peptic Ulcers Associated with _
_Helicobacter pylori Infection _

Most peptic ulcers are caused 
by an infection with the 
bacterium  _Helicobacter pylori_ in 
the stomach. _H. pylorus_ 
weakens the protective mucous 
coating of the stomach and 
duodenum, which allows acid to 
get through to the sensitive 
lining beneath
. 
Both the acid 
and the bacteria irritate the lining 
and cause a sore, or ulcer. 

When  OMEPRAZOLE RANBAXY is 
taken together with an antibiotic, 
the combination will kill _H. pylori_ 
and let your peptic ulcer heal.  

_Peptic Ulcers Associated with _
_Non-Steroidal Anti-Inflammatory _
_Drugs (NSAIDs) _

Some peptic ulcers are caused 
by medicines called non-
steroidal anti-inflammatory 
drugs. These medicines are 
co

Summary of Product characteristics

OMEPRAZOLE RBX PI V2 Jun09

Page 1 of 10

OMEPRAZOLE RANBAXY 
_PRODUCT INFORMATION _

OMEPRAZOLE RANBAXY (omeprazole) 20 mg tablets 

DESCRIPTION 

Chemical name: 5-methoxy-2-[(_RS_)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]-sulphinyl]-1_H_-
benzimidazole.  Omeprazole is a white or almost white
powder, very slightly soluble in water, 
soluble in methylene chloride, sparingly soluble in
alcohol and in methanol. It dissolves in dilute 
solutions of alkali hydroxides. 

Each tablet contains 20 mg of omeprazole and
the following excipients: ascorbyl palmitate, 
cellulose-  microcrystalline, crospovidone, magnesium stearate, povidone, lactose, talc  purified, 
hypromellose phthalate, glycerol triacetate, iron oxide red
(CI77491), iron oxide black (CI77499). 

Omeprazole has the empirical formula of C
17
H
19
N
3
O
3
S,  a molecular weight of 345.4  and CAS 
number 73590-58-6.  

Structurally it is represented as: 

PHARMACOLOGY 

Omeprazole reversibly reduces gastric acid secretion
by specifically inhibiting the gastric 
enzyme H+, K+-ATPase, the proton pump, in the acid
environment of the intracellular canaliculi 
within the parietal cell. This effect of omeprazole on
the final step of the gastric acid formation 
process is dose dependent and effectively inhibits both
basal acid secretion and stimulated acid 
secretion, irrespective of the stimulus to acid production. 

Omeprazole has no effect on acetylcholine
or histamine receptors. No clinically significant 
pharmacodynamic effects, other than those explained by the effect on acid secretion, have been 
observed. 

_EFFECT ON GASTRIC ACID SECRETION:_ Oral dosing with omeprazole 20 mg once daily provides rapid 
and effective reduction of gastric acid secretion. After a single dose the onset of antisecretory 
effect occurs within one hour and is