PANTHRON pantoprazole (as sodium sesquihydrate) 40 mg enteric-coated tablet blister pack.

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium sesquihydrate, Quantity: 45.4 mg (Equivalent: pantoprazole, Qty 40 mg)

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; hypromellose; macrogol 6000; sodium starch glycollate; mannitol; calcium stearate; sodium carbonate; crospovidone; sodium hydroxide; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin

Administration route:

Oral

Units in package:

28, 14, 15, 140, 50, 56, 100, 5, 30, 60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. For symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) Duodenal ulcer; ii) Gastric ulcer; iii) Gastro-oesophageal reflux disease (GORD): Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD; Reflux oesophagitis; iv) Gastrointestinal lesions refractory H2 blockers; v) Zollinger-Ellison Syndrome. Patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment.

Product summary:

Visual Identification: Yellow, oval, biconvex enteric-coated tablets, plain on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2010-02-17

Patient Information leaflet

PANTHRON™
®
1
PANTHRON™
_contains the active ingredient pantoprazole _
_(as sodium sesquihydra_
_te)_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PANTHRON™. 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
PANTHRON™ against the benefits
they expect it will 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 IS
PANTHRON™
USED FOR
The name of your medicine is
PANTHRON™.
It
contains
the
active
ingredient
called
pantoprazole
(as
sodium
sesquihydrate).
ULCERS:
PANTHRON™ is used to treat and
help
heal
duodenal
and
gastric
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 can be caused in part by too
much
acid
being
made
in
the
stomach.
PANTHRON™
may
be
used
to
prevent ulcers associated with the use
of
non-steroidal
anti-inflammatory
drugs (NSAIDs). These are medicines
used to relieve pain, swelling and
other
symptoms
of
inflammation,
including arthritis (inflammation of the
joints).
REFLUX DISEASE:
PANTHRON™
is
used
to
treat
reflux
oesophagitis
or
reflux
disease.
This can be caused by
"washing back" (reflux) of food and
acid from the stomach into 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.
PANTHRON™
is
also
used
to
prevent
reflux
oesophagitis
from
coming back.
ZOLLINGER-ELLISON SYNDROME:
PANTHRON™ is used to treat a rare
condition
called
Zollinger-Ellison
syndrome,
where
the
stomach
produces very large amounts of acid,
much more than in ulcers and reflux
disease.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
PANTHRON
TM (PANTOPRAZOLE SODIUM SESQUIHYDRATE) ENTERIC-COATED
DELAYED RELEASE TABLETS
1
NAME OF THE MEDICINE
Pantoprazole sodium sesquihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Panthron™ 40 mg enteric coated tablet contains 45.4 mg of
pantoprazole sodium sesquihydrate
equivalent to 40 mg of pantoprazole.
Each Panthron™ 20 mg enteric coated tablet contains 22.7 mg
pantoprazole sodium sesquihydrate
equivalent to 20 mg of pantoprazole.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Panthron™ is available as 20 mg (yellow, oval shaped, plain on both
sides) and 40 mg (yellow, oval
shaped, plain on both sides) biconvex, enteric-coated tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
1. For symptomatic improvement and healing of the following
gastrointestinal diseases which require
a reduction in acid secretion:
•
duodenal ulcer
•
gastric ulcer
•
gastro-oesophageal reflux disease (GORD):
i. symptomatic GORD. The treatment of heartburn and other symptoms
with GORD
ii. reflux oesophagitis
•
gastrointestinal lesions refractory to H2 blockers
•
Zollinger-Ellison Syndrome.
Patients whose gastric or duodenal ulceration is not associated with
ingestion of non-steroidal anti-
inflammatory drugs (NSAIDs) require treatment with antimicrobial
agents in addition to antisecretory
drugs whether on first presentation or on recurrence.
2. Maintenance of healed reflux oesophagitis in patients previously
treated for moderate to severe
reflux oesophagitis.
2
3. Prevention of gastroduodenal lesions and dyspeptic symptoms
associated with non-selective non-
steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients
with a need for continuous non-
selective NSAID treatment.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS:
Pantoprazole tablets should not be chewed or crushed but swallowed
whole with a little water.
DUODENAL ULCER: Pantoprazole 40 mg (one tablet) should be given once a
day. In most patients freedo