ESOMEPRAZOLE RBX esomeprazole 20 mg enteric-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esomeprazole magnesium, Quantity: 20.7 mg (Equivalent: esomeprazole, Qty 20 mg)

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Esomeprazole magnesium

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: hyprolose; sodium stearylfumarate; hypromellose phthalate; macrogol 6000; diethyl phthalate; crospovidone; macrogol 400; microcrystalline cellulose; povidone; macrogol 4000; purified talc; titanium dioxide; hypromellose; iron oxide red; maize starch; sucrose

Administration route:

Oral

Units in package:

10, 30, 28, 7

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Gastro-Oesophageal Reflux Disease (GORD),- treatment of erosive reflux oesophagitis,- long-term management of patients with healed oesophagitis to prevent relapse,- symptomatic treatment of gastro-oesophageal reflux disease (GORD),Patients requiring NSAID therapy,- short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy,- healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy,- prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk,Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion,Pathological hypersecretory conditions including Zollinger-Ellison Syndrome and idiopathic hypersecretion,In combination with appropriate antibiotics for:,- healing of duodenal ulcer associated with Helicobacter pylori,- eradication of Helicobacter pylori in patients with active or healed peptic ulcer

Product summary:

Visual Identification: Light brick red to brown, oval, biconvex, film-coated tablets with 'E5' debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-02-09

Patient Information leaflet

ESOMEPRAZOLE RBX
TABLETS
ESOMEPRAZOLE MAGNESIUM
_CONSUMER MEDICINE _
_INFORMATION _
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about ESOMEPRAZOLE RBX.
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
ESOMEPRAZOLE
RBX
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 ESOMEPRAZOLE
RBX IS USED FOR
_ _
_REFLUX OESOPHAGITIS _
ESOMEPRAZOLE RBX is taken to treat
reflux oesophagitis. This can be caused
by "washing back" (reflux) of food and
acid from the stomach into the food pipe
(oesophagus).
Reflux can cause a burning sensation in
the
chest
rising up
to
the
throat, also
known as heartburn.
ESOMEPRAZOLE RBX is also taken to
help stop reflux oesophagitis coming back
or relapsing.
_UPPER GASTROINTESTINAL SYMPTOMS _
_ASSOCIATED WITH NON-STEROIDAL _
_ANTI-INFLAMMATORY DRUGS (NSAIDS) _
_THERAPY _
ESOMEPRAZOLE RBX is taken to treat
the symptoms of pain or discomfort in the
stomach caused by NSAIDs, a type of
medicine for pain or inflammation.
ESOMEPRAZOLE RBX is also taken to
help heal and prevent ulcers caused by
NSAIDs.
_PEPTIC ULCERS ASSOCIATED WITH _
_HELICOBACTER PYLORI INFECTION _
Most people who have a peptic (gastric
and
duodenal)
ulcer
also
have
a
bacterium
called
_Helicobacter _
_pylori_
in
their stomach. 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.
If you have a peptic ulcer, your doctor will
prescribe
ESOMEPRAZOLE
RBX
with
antibiotics. When ESOMEPRAZOLE RBX
and antibiotics are taken together, they
work to kill the bacterium and let your
ulcer
heal.
You
may
need
further
treatment with antibiotics.
_ZOLLINGER-ELLISON SYN

Summary of Product characteristics

Page 3 of 28
AUSTRALIAN PRODUCT INFORMATION
ESOMEPRAZOLE RBX
ESOMEPRAZOLE (AS MAGNESIUM) ENTERIC-COATED TABLETS
1
NAME OF THE MEDICINE
Esomeprazole magnesium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Esomeprazole is a proton pump inhibitor. The active ingredient in
ESOMEPRAZOLE RBX
is
esomeprazole magnesium, a substituted benzimidazole.
Each enteric-coated tablet of
ESOMEPRAZOLE RBX
comprises enteric-coated pellets with
esomeprazole magnesium equivalent to esomeprazole 20 mg or 40 mg.
Contains excipient of known effect: sucrose.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
ESOMEPRAZOLE RBX
esomeprazole (as magnesium) 20 mg tablets are light brick red to
brown,
oval, biconvex, enteric-coated tablets with
‘E5’
debossed on one side and plain on
other side.
ESOMEPRAZOLE RBX
esomeprazole (as magnesium) 40 mg tablets are light brick red to
brown,
oval, biconvex, enteric-coated tablets with
‘E6’
debossed on one side and plain on
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ESOMEPRAZOLE RBX
is indicated for:
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
−
Treatment of erosive reflux oesophagitis
−
Long-term management of patients with healed oesophagitis to prevent
relapse
−
Symptomatic treatment of gastro-oesophageal reflux disease (GORD)
PATIENTS REQUIRING NSAID THERAPY
−
Short-term treatment of upper gastrointestinal symptoms associated
with non-steroidal
anti-inflammatory drug NSAID (non-selective and COX-2 selective)
therapy.
−
Healing of gastric ulcers associated with non-steroidal
anti-inflammatory drug
NSAID (non-selective and COX-2 selective) therapy
−
Prevention of gastric and duodenal ulcers associated with
non-steroidal anti-
inflammatory drug (NSAID) (non-selective and COX-2 selective) therapy
in patients
at risk.
Page 3 of 28
PREVENTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING
TREATMENT WITH
ESOMEPRAZOLE SOLUTION ADMINISTERED BY INTRAVENOUS INFUSION.
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISO