I-PANTOPRAZOLE 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:

Pharmacor Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: mannitol; sodium carbonate; sodium starch glycollate; crospovidone; colloidal anhydrous silica; calcium stearate; hypromellose; macrogol 6000; 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:

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

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 to pale yellow coloured 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:

2010-02-17

Patient Information leaflet

I-Pantoprazole (V – 02)
1
I-Pantoprazole
Pantoprazole (as sodium sesquihydrate) delayed release tablets
Consumer Medicine Information (CMI)
Please read this information before you start taking this medicine.
What is in this CMI
This leaflet answers some
common questions about I-
PANTOPRAZOLE. 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 I-
PANTOPRAZOLE against the
benefits this medicine 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 is I-PANTOPRAZOLE
used for
Ulcers
I-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 Somac is taken with antibiotics
the combination therapy will kill the
Helicobacter pylori and let your ulcer
heal.
I-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
I-PANTOPRAZOLE is also used to
treat reflux oesophagitis or reflux
disease. This can be caused by
“washing back” (reflux) of food and
acid from the stoma

Summary of Product characteristics

I-PANTOPRAZOLE (V – 03)
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION –
I-PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) ENTERIC
COATED DELAYED RELEASE TABLETS
1
NAME OF THE MEDICINE
Pantoprazole (as sodium sesquihydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
I-Pantoprazole
40
mg
enteric
coated
tablet
contains
45.10
mg
of
pantoprazole
sodium
sesquihydrate equivalent to 40 mg of pantoprazole.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
40 mg enteric coated tablets are yellow to pale yellow coloured oval,
biconvex enteric coated tablets
plain on both sides.
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): 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults:
I-PANTOPRAZOLE (V – 03)
Page 2 of 16
I-Pantoprazole tablets should not be chewed or crushed but swallowed
whole with a little water. I-
Pantoprazole tablets are only available as 40 mg tablets. Where dosing
requires the dose range of
pantoprazole 20 to 40 mg, there are alternative brands available as 20
mg tablets.
Duodenal ulcer: I-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 treatment is not sufficient, healing will be achieved
in almost all cases within a further
two weeks