APOTEX-PANTOPRAZOLE pantoprazole (as sodium sesquihydrate) 40 mg enteric coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium sesquihydrate

Available from:

Apotex Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Authorization status:

Registered

Patient Information leaflet

APOTEX-PANTOPRAZOLE
TABLETS
_Contains the active ingredient, pantoprazole (as sodium
sesquihydrate)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about pantoprazole. 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 using this medicine
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 YOUR
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Pantoprazole belongs to a group of
medicines called proton pump
inhibitors (PPIs). PPIs work by
decreasing the amount of acid the
stomach makes, to give relief from
the symptoms and allow healing to
take place.
ULCERS
Pantoprazole 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 pantoprazole is taken with
antibiotics, the combination therapy
will kill the Helicobacter pylori and
let your ulcer heal.
Pantoprazole 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
Pantoprazole 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

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APOTEX-PANTOPRAZOLE (PANTOPRAZOLE SODIUM
SESQUIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Pantoprazole (as sodium sesquihydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric coated tablet contains 20 mg or 40 mg pantoprazole (as
sodium sesquihydrate)
as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
20 MG TABLETS
Yellow, oval, biconvex, enteric-coated tablets engraved “APO” on
one side, “20” on the other
side.
40 MG TABLETS
Yellow, oval, biconvex, enteric-coated tablets engraved “APO” on
one side, “40” on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Symptomatic improvement and healing of gastrointestinal diseases which
require a
reduction in acid secretion:
• Duodenal ulcer.
• Gastric ulcer.
• Gastro-oesophageal reflux disease (GORD).
–
Symptomatic GORD: the treatment of heartburn and other symptoms
associated
with GORD.
–
Reflux oesophagitis.
• Gastrointestinal lesions refractory to H
2
-blockers.
• Zollinger-Ellison syndrome.
_Patients whose gastric or duodenal ulceration is not associated with
ingestion of 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.
For eradication of _ Helicobacter pylori_, treatment with pantoprazole
and one of the
following combinations of antibiotics:
• clarithromycin and amoxycillin or
• clarithromycin and metronidazole or
• amoxycillin 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 microorganism
(see section 4.2 DOSE
AND METHOD OF ADMINISTRATION).
4.
Pantoprazole in combination with bismuth, metronidazole and
tetracycline is indicated
for the era