PARBEZOL rabeprazole sodium 20mg enteric-coated tablet bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
10-07-2017
Summary of Product characteristics
(SPC)
12-07-2017
Public Assessment Report
(PAR)
10-11-2017
Active ingredient:
Rabeprazole sodium
Available from:
Arrow Pharma Pty Ltd
INN (International Name):
Rabeprazole sodium
Patient Information leaflet
PARBEZOL
CONSUMER MEDICINE INFORMATION
Ver 1.1
Page 1 of 5
PARBEZOL 10 & 20
Rabeprazole sodium
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PARBEZOL tablets.
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 PARBEZOL
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 PARBEZOL IS USED FOR
The
name
of
your
medicine
is
PARBEZOL
TM
.
It
contains
the
active
ingredient
rabeprazole sodium.
WHAT IT DOES
This
medicine
is
used
to
treat,
_- Reflux Oesophagitis _
_- Peptic Ulcers _
_- Chronic Gastritis _
_ _
_Reflux Oesophagitis:_
This medicine is used to treat reflux
oesophagitis or reflux disease. This
can be caused by food and acid from
the stomach flowing the wrong way
(reflux) back up 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.
This medicine is also used to help
stop
reflux
oesophagitis
from
coming back or relapsing.
_ _
_Peptic Ulcers: _
This medicine 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
of
the
stomach. These ulcers can be caused
by too much acid being made in the
stomach.
Most people who have a peptic ulcer
also
have
a
bacteria
called
Helicobacter pylori in their stomach.
Your
doctor
may
also
prescribe
a
course of antibiotics (clarithromycin
and
amoxycillin)
for
you.
When
PARBEZOL
is
taken
with
antibiotics, the combination therapy
will kill the Helicobacter pylori and
let your ulcer heal.
_ _
_Chronic Gastritis: _
The
presence
of
the
bacteria
Helicobacter
pylori
may
cau
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Summary of Product characteristics
PARBEZOL- Product Information
Page 1 of 13
PRODUCT INFORMATION
PARBEZOL 10 (10 MG RABEPRAZOLE SODIUM TABLETS)
PARBEZOL 20 (20 MG RABEPRAZOLE SODIUM TABLETS)
NAME OF THE MEDICINE
The name of the medicine is rabeprazole as rabeprazole sodium.
The chemical name for rabeprazole sodium is (±)
2-[{4-(3-methoxypropoxy)-3- methylpyridin-2-
yl}-methylsulphinyl]-1H-benzimidazole sodium. Rabeprazole has one
chiral centre and is a
racemate of two enantiomers. It has the following structural formula:
CAS Registration No.:
CAS-117976-89-3 (rabeprazole)
CAS-117976-90-6 (rabeprazole sodium)
DESCRIPTION
Rabeprazole sodium is a substituted benzimidazole and belongs to the
class of proton pump
inhibitors. It is a white to off-white hydroscopic powder.
Its solubility in water is pH dependent, being very soluble in water
at pH 9 to 11, and only slightly
soluble in water at pH 8. It is very soluble in methanol, freely
soluble in dichloromethane and
practically insoluble in hexane.
PARBEZOL
is
available
as
enteric
coated
tablets
containing
10
mg
rabeprazole
sodium
(equivalent to 9.42 mg rabeprazole) or 20 mg rabeprazole sodium
(equivalent to 18.85 mg
rabeprazole).
PARBEZOL tablets contain the inactive ingredients mannitol, heavy
magnesium oxide, light
magnesium oxide, hydroxypropylcellulose, crospovidone, magnesium
stearate, ethylcellulose,
hypromellose phthalate, diacetylated monoglycerides, purified talc and
titanium dioxide. The 20
mg tablet also contains iron oxide yellow.
PHARMACOLOGY
Rabeprazole sodium suppresses gastric acid secretion by the specific
inhibition of the H
+
/K
+
-
ATPase enzyme (proton pump) at the secretory surface of the gastric
parietal cell thereby blocking
the final step of acid production. This effect is dose-related and
leads to inhibition of both basal
and stimulated acid secretion irrespective of the stimulus. Animal
studies indicate that after
administration, rabeprazole sodium rapidly disappears from both the
plasma and gastric mucosa.
PARBEZOL- Product Information
Page 2 of 13
PHARMACODYNAMICS
_ _
_An
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