APX-PANTOPRAZOLE pantoprazole (as sodium sesquihydrate) 40 mg enteric-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

10-11-2021

Summary of Product characteristics (SPC)

10-11-2021

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

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

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Pharmaceutical form:

Tablet, enteric coated

Composition:

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

Administration route:

Oral

Units in package:

30, 5

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

Authorization status:

Licence status A

Authorization date:

2013-10-15

Patient Information leaflet

PANTOPRAZOLE APOTEX TABLETS
1
PANTOPRAZOLE APOTEX
TABLETS
_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
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.
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 chest rising up to the throat,
also known as heartburn.
Pantoprazole is also used to prevent
reflux oesophagitis from coming
back.
ZOLLINGER-ELLISON SYNDROME
Pantoprazole is used to treat a rare
condition called Zollinger-Ellison
syndr

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Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION PANTOPRAZOLE APOTEX
TABLETS (PANTOPRAZOLE SODIUM SESQUIHYDRATE)
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.
EXCIPIENT OF KNOWN EFFECT: soya bean products.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PANTOPRAZOLE
APOTEX
Tablets
20
mg
(AUST
R
213715)
and
PANTOPRAZOLE
APOTEX Tablets 40 mg (AUST R 213716) are yellow to pale yellow, oval,
biconvex enteric-
coated tablets, plain on both sides.
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.
3.
Prevention
of
gastroduodenal
lesions and dyspeptic symptoms
associated
with
nonselective NSAIDs in increased risk patients with a need for
continuous nonselective
NSAID treatment.
4.2
DOSE AND METHOD OF ADMINISTRATION
The enteric coated tablets are intended for oral administration.
Pantoprazole tablets should not be chewed or crushed, but swallowed
whole with a little water.
2
DOSAGE
DUODENAL ULCER
Pantoprazole 40 mg (one tablet) should be given once a day. In most
patients, freedom from
symptoms is achieved rapidly and healing generally occurs within two
weeks. If a two week
period of treat

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