RABEPRAZOLE AN rabeprazole sodium 20mg enteric coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

11-09-2020

Public Assessment Report (PAR)

28-11-2017

Active ingredient:

rabeprazole sodium, Quantity: 20 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Rabeprazole sodium

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: diacetylated monoglycerides; heavy magnesium oxide; light magnesium oxide; hyprolose; ethylcellulose; magnesium stearate; purified talc; crospovidone; mannitol; titanium dioxide; hypromellose phthalate; iron oxide yellow

Administration route:

Oral

Units in package:

30, 90

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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. ,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: Round, yellow, biconvex enteric-coated tablets; Container Type: Bottle; Container Material: HDPE; Container Life Time: 21 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:

2012-04-05

Patient Information leaflet

_Rabeprazole AN tablets – Consumer Medicine Information _
_ _
_Doc ID: 92.AN.M.1.0 _
_ _
_ _
_Page 1 _
RABEPRAZOLE AN TABLETS
_Rabeprazole sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Rabeprazole AN.
It
does
not
contain
all
of
the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the
risks
of
you
taking
Rabeprazole
AN
against
the
benefits they expect it will have
for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
TALK
TO
YOUR
DOCTOR
OR
PHARMACIST.
Keep
this
leaflet
with
your
medicine.
You may need to read it again.
WHAT RABEPRAZOLE AN
IS USED FOR
The name of your medicine is
Rabeprazole AN.
It contains the active ingredient
rabeprazole sodium.
Rabeprazole is used to treat
-
Reflux oesophagitis
-
Peptic ulcers
-
Chronic Gastritis
_Reflux Oesophagitis: _
Rabeprazole AN 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.
Rabeprazole AN is also used to
help
stop
reflux
oesophagitis
from coming back or relapsing
_Peptic Ulcers _
Rabeprazole AN is used to treat
peptic ulcers. Depending on the
position of the ulcer, it is called a
gastric ulcer 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.
The
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 Rabeprazole AN
is
taken
with
antibiotics,
the
combination therapy will kill the
Helicobacter pylori and let your
ulcer heal.
_Chronic Gastritis _
The
pr

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Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – RABEPRAZOLE AN
(RABEPRAZOLE SODIUM) TABLETS
1
NAME OF THE MEDICINE
rabeprazole sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RABEPRAZOLE AN 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).
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
RABEPRAZOLE AN 10 mg tablets are round, white, biconvex enteric-coated
tablets.
RABEPRAZOLE AN 20 mg tablets are round, yellow, biconvex
enteric-coated
tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
RABEPRAZOLE AN is 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 AN is also indicated, in combination with clarithromycin
and amoxycillin, for:
•
Eradication of Helicobacter pylori in patients with peptic ulcer
disease or chronic
2
gastritis
•
Healing of peptic ulcers in patients with Helicobacter pylori
associated ulcers.
4.2
D
OSE AND METHOD OF ADMINISTRATION
RABEPRAZOLE AN tablets should not be chewed or crushed, but should be
swallowed whole.
RABEPRAZOLE AN tablets should be taken at the same time each day to
facilitate treatment
compliance.
Rabeprazole tablets were taken with or without food in the pivotal
clinical trials.
A
DULTS
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 (GORD): The
recommended
oral
dose for preventing re

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