PANTO pantoprazole 20mg (as sodium sesquihydrate) enteric-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium sesquihydrate

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Authorization status:

Registered

Patient Information leaflet

_Panto_
_®_
_ CMI AU_
_ _
Page 1 _ _
_ _
PANTO
®
TABLETS
_PANTOPRAZOLE _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Panto.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
this medicine.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Panto 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 PANTO IS USED
FOR
ULCERS
Panto 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.
Most people who have a peptic ulcer
also
have
bacteria
called
_Helicobacter pylori_
in their stomach.
When Panto is taken with antibiotics
the combination therapy will kill the
_Helicobacter _
_pylori_
and
let
your
ulcer heal.
Panto may also 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
Panto is also 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.

Summary of Product characteristics

PANTO TABLETS V12 (CCDS V7.0)
_ _
_Page 1 _
AUSTRALIAN PRODUCT INFORMATION
PANTO
® (PANTOPRAZOLE SODIUM SESQUIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Pantoprazole (as pantoprazole sodium sesquihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PANTO
20
mg
enteric
coated
tablets,
each
tablet
contains
22.6
mg
pantoprazole
sodium
sesquihydrate equivalent to 20 mg pantoprazole.
PANTO
40
mg
enteric
coated
tablets,
each
tablet
contains
45.1
mg
pantoprazole
sodium
sesquihydrate equivalent to 40 mg pantoprazole.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The 20 mg tablets are yellow and oval shaped, marked with the letter
"P20" on one side.
The 40 mg tablets are yellow and oval shaped, marked with the letter
"P40" on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
1. Symptomatic improvement and healing of gastrointestinal diseases
which require a reduction in
acid secretion:
•
Duodenal ulcer
•
Gastric ulcer
•
Gastro-oesophageal reflux disease (GORD)
o
Symptomatic GORD. The treatment of heartburn and other symptoms
associated with
GORD
o
Reflux oesophagitis
•
Gastrointestinal lesions refractory to H
2
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
3.
For eradication of _ Helicobacter pylori_, treatment with pantoprazole
and one of the following
combinations of antibiotics:
•
Clarithromycin and amoxicillin or
•
Clarithomycin and metronidazole or
PANTO TABLETS V12 (CCDS V7.0)
_ _
_Page 2 _
•
Amoxicillin and metronidazole
is recommended in cases of duodenal ulcer and gastric ulcer with the
objective of reducing the
recurrence of duodenal and gastric ulcers caused by this microorgan