PANTOPRAZOLE SANDOZ pantoprazole 20 mg (as sodium sesquihydrate) enteric coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium sesquihydrate, Quantity: 22.55 mg (Equivalent: pantoprazole, Qty 20 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: hyprolose; crospovidone; triethyl citrate; sodium carbonate; microcrystalline cellulose; colloidal anhydrous silica; calcium stearate; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; hypromellose; iron oxide yellow; quinoline yellow aluminium lake; macrogol 400; brilliant scarlet 4R aluminium lake

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: Duodenal ulcer; Gastric ulcer; Gastro-oesophageal reflux disease (GORD) i. Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD ii. 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. 3. For eradication of Helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: Clarithromycin and amoxicillin or; Clarithromycin and metronidazole or; 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 micro-organism. 4. Pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of Helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. 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 coated tablet.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2009-04-21

Patient Information leaflet

PANTOPRAZOLE SANDOZ
®
1
PANTOPRAZOLE SANDOZ
®
_Pantoprazole (as sodium sesquihydrate) enteric coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pantoprazole
Sandoz.
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 taking 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 THE MEDICINE.
You may need to read it again.
WHAT
PANTOPRAZOLE
SANDOZ IS USED
FOR
This medicine contains the active
ingredient pantoprazole. It belongs to
a group of medicines called proton
pump inhibitors (PPIs).
It works by decreasing the amount of
acid the stomach makes to give relief
from the symptoms and allow
healing to take place.
ULCERS
Pantoprazole Sandoz 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.
Ulcers 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 Sandoz is taken
with antibiotics the combination
therapy will kill the Helicobacter
pylori and let your ulcer heal.
This medicine 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 Sandoz 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.
Refl

Summary of Product characteristics

221013-pantoprazole-sandoz-pi
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
PANTOPRAZOLE SANDOZ
® (PANTOPRAZOLE SODIUM SESQUIHYDRATE)
ENTERIC COATED TABLETS
1.
NAME OF THE MEDICINE
Pantoprazole sodium sesquihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Pantoprazole Sandoz 20 mg enteric coated tablet contains 22.55 mg
pantoprazole sodium
sesquihydrate equivalent to 20 mg of pantoprazole.
Each Pantoprazole Sandoz 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
Pantoprazole Sandoz 20 mg tablets are yellow and oval shaped
enteric-coated tablets.
Pantoprazole Sandoz 40 mg tablets are yellow and oval shaped
enteric-coated tablets.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
_ADULTS _
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):
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
•
Clarithromycin and metronidazole or
•
Amoxicillin and metronidazole.
221013-pantoprazole-sandoz-pi
Page 2 of 22
is recommended in cases of duodenal ulcer and gastric ulcer with the
objective of reducing the
recurrence