OZPAN pantoprazole 20mg Enteric Coated Tablets Blister Pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium, Quantity: 22.557 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Pantoprazole sodium

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: purified talc; microcrystalline cellulose; sodium carbonate; sodium lauryl sulfate; iron oxide yellow; titanium dioxide; triethyl citrate; mannitol; crospovidone; hyprolose; methacrylic acid - ethyl acrylate copolymer (1:1); calcium stearate; hypromellose; propylene glycol; povidone; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

30 tablets

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.e for duodenal ulcer, gastric ulcer, gastro-oesophageal reflux disease (GORD) including - symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD; - reflux oesophagitis; gastrointestinal lesions refractory to H2 blockers, and Zollinger-Ellison Syndrome. Patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal 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 coloured, enteric coated, oval shaped, biconvex tablet printed with 'II' on one side and plain on other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-07-13

Patient Information leaflet

Ozpan CMI V3 Sep 2019
Page 1 of 9
OZPAN
PANTOPRAZOLE ENTERIC-COATED TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about OZPAN (PANTOPRAZOLE
ENTERIC-COATED TABLETS 20/40 MG).
It does not contain all the available information. It does not take
the
place of talking to your doctor or pharmacist.
This leaflet was last updated on the date at the end of this leaflet.
More recent information may be available. The latest Consumer Medicine
Information is available from https://www.ebs.tga.gov.au/ and may
contain important information about the medicine and its use of which
you should be aware.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking pantoprazole 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 OZPAN IS USED FOR
The name of your medicine is OZPAN. It contains the active ingredient
pantoprazole.
ULCERS
OZPAN 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 OZPAN is taken with
antibiotics the combination therapy will kill the Helicobacter pylori
and let your ulcer heal.
Ozpan CMI V3 Sep 2019
Page 2 of 9
OZPAN 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
OZPAN is also used to treat reflux oesophagitis or reflux disease.
This
can be caused by “washing back” (refl

Summary of Product characteristics

Ozpan PI V6 Aug 2022
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION
OZPAN
(PANTOPRAZOLE ENTERIC-COATED TABLETS)
1.
NAME OF MEDICINE
Pantoprazole sodium sesquihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of OZPAN contains Pantoprazole sodium sesquihydrate
equivalent to 20mg
or 40mg of Pantoprazole.
For the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
OZPAN 20 mg tablets are available as yellow-coloured, enteric-coated
oval-shaped,
biconvex tablets imprinted with ‘
II
’
in black ink on one side and plain on other side.
OZPAN 40 mg tablets are available as yellow coloured, enteric-coated
oval shaped,
biconvex tablets imprinted with ‘
IV
’
in black ink on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
OZPAN
is indicated for:
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
Ozpan PI V6 Aug 2022
Page 2 of 26

Gastrointestinal lesions refractory to H2 blockers

Zollinger-Ellison Syndrome
Patients whose gastric or duodenal ulceration is not associated with
ingestion of
nonsteroidal
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.
4.2.
DOSE AND METHOD OF ADMINISTRATION
OZPAN
tablets should not be chewed or crushed but swallowed whole with a
little
water.
In
_H. pylori_
negative patients, the following dosage guid