RABEPRAZOLE SUN rabeprazole sodium 20 mg enteric coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rabeprazole sodium, Quantity: 20 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Rabeprazole sodium

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: heavy magnesium oxide; diacetylated monoglycerides; mannitol; iron oxide yellow; hypromellose phthalate; titanium dioxide; light magnesium oxide; purified talc; magnesium stearate; ethylcellulose; hyprolose; propylene glycol; butan-1-ol; allura red AC aluminium lake; industrial methylated spirit; ethanol; Shellac; strong ammonia solution; sulfuric acid

Administration route:

Oral

Units in package:

28, 30, 10, 14, 7

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment and prevention of relapse of gastro-oesophageal reflux disease. Symptomatic treatment of gastro-oesophageal reflux disease. Treatment of duodenal ulcers. Treatment of gastric ulcers.,Patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,Also indicated, in combination with clarithromycin and amoxycillin, for: - Eradication of Helicobacter pylori in patients with peptic ulcer disease or chronic gastritis - Healing of peptic ulcers in patients with Helicobacter pylori associated ulcers.

Product summary:

Visual Identification: Yellow coloured, circular shaped biconvex, coated tablets imprinted with RA on one side and plain on other side.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-08-21

Patient Information leaflet

RABEPRAZOLE SUN CMI September 2019 v2 Page
1 of 5
RABEPRAZOLE SUN
_Rabeprazole sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
RABEPRAZOLE SUN. It does not
contain
all
the
available
information. It does not take the
place of talking to your doctor or
pharmacist.
This leaflet was last updated on
the date at the end of this leaflet.
More recent information may be
available.
The
latest
Consumer
Medicine Information is available
from
https://www.ebs.tga.gov.au/
and
may
contain
important
information
about
the
medicine
and its use of which you should be
aware.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
taking
RABEPRAZOLE SUN against the
benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING RABEPRAZOLE SUN ASK
YOUR DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
YOUR
MEDICINE.
You may need to read it again.
WHAT
RABEPRAZOLE
SUN IS USED FOR
The
name
of
your
medicine
is
RABEPRAZOLE SUN. It contains
the active ingredient rabeprazole
sodium.
_ _
RABEPRAZOLE SUN belongs to
a group of medicines called proton
pump
inhibitors
(PPIS).
RABEPRAZOLE
SUN
works
by
decreasing the amount of acid the
stomach makes, to give relief from
the symptoms and allow healing to
take place. Your food will still be
digested in the normal way.
_Gastro-oesophageal _
_reflux _
_disease: _
RABEPRAZOLE SUN is used to
treat
gastro-oesophageal
reflux
disease
(GORD),
commonly
known as ‘reflux’. . 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.
RABEPRAZOLE SUN is also used
to
help
stop
reflux
oesophagitis
from coming back or relapsing.
_Peptic Ulcers: _
RABEPRAZOLE SUN 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 occ

Summary of Product characteristics

RABEPRAZOLE SUN PI July 2019 v2
Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION -
RABEPRAZOLE SUN
rabeprazole sodium 20 mg enteric-coated tablets
1. NAME OF THE MEDICINE
Rabeprazole sodium
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
RABEPRAZOLE SUN: Each enteric-coated tablets contains 20 mg
rabeprazole sodium
(equivalent to 18.85 mg rabeprazole).
For the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS
.
3. PHARAMCEUTICAL FORM
RABEPRAZOLE SUN 20 mg: Yellow, circular-shaped, biconvex,
enteric-coated tablets
imprinted with “RA” on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rabeprazole enteric coated tablets are indicated for:

Treatment and prevention of relapse of gastro-oesophageal reflux
disease

Symptomatic treatment of gastro-oesophageal reflux disease

Treatment of duodenal ulcers

Treatment of gastric ulcers.
Patients whose gastric and duodenal ulceration is not associated with
ingestion of non-steroidal
anti-inflammatory drugs (NSAIDs) usually require treatment with
antimicrobial agents in
addition to antisecretory drugs whether on first presentation or on
recurrence.
Rabeprazole enteric coated tablets are also indicated, in combination
with clarithromycin and
amoxycillin, for:

Eradication of
_Helicobacter pylori _
in patients with peptic ulcer disease or chronic gastritis

Healing of peptic ulcers in patients with
_Helicobacter pylori _
associated ulcers.
RABEPRAZOLE SUN PI July 2019 v2
Page 2 of 21
4.2 DOSE AND METHOD OF ADMINISTRATION
RABEPRAZOLE SUN tablets should not be chewed or crushed, but should be
swallowed
whole. RABEPRAZOLE SUN tablets should be taken at the same time each
day to facilitate
treatment compliance. Rabeprazole was taken with or without food in
the pivotal clinical trials.
ADULTS
Treatment of active Gastro-Oesophageal Reflux Disease (GORD): The
recommended oral dose
for this condition is one 20 mg tablet to be taken once daily for four
to eight weeks.
Prevention of Relapse of Gastro-oesophageal Reflux Disease (