SALPRAZ 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: 45.12 mg (Equivalent: pantoprazole, Qty 40 mg)

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: crospovidone; triethyl citrate; purified water; calcium stearate; Carnauba Wax; methacrylic acid - ethyl acrylate copolymer (1:1); sodium carbonate; mannitol; povidone; purified talc; macrogol 6000; hypromellose; titanium dioxide; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin

Administration route:

Oral

Units in package:

Blister of 30 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults 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 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. For eradication of Helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: Clarithromycin and amoxicillin or Clarithomycin 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 microorganism (see ?DOSAGE AND ADMINISTRATION?). 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 nonselective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment. Children aged from 5 to 17 years Gastro-oesophageal reflux disease (GORD) ? Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD ? Reflux oesophagitis The treatment duration should not exceed 8 weeks.

Product summary:

Visual Identification: Yellow coloured, oval, biconvex enteric coated tablets plain on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-06-23

Patient Information leaflet

SALPRAZ
_pantoprazole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SALPRAZ. 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 SALPRAZ
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 SALPRAZ IS
USED FOR
The name of your medicine is
SALPRAZ. It contains the active
ingredient pantoprazole.
ULCERS
SALPRAZ 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 SALPRAZ is taken with
antibiotics, the combination therapy
will kill the Helicobacter pylori and
let your ulcer heal.
SALPRAZ may 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
SALPRAZ 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.
SALPRAZ is also used to prevent
reflux oesophagitis from coming
back.
ZOLLINGER-ELLISON SYNDROME
SALPRAZ is used to treat a rare
condition called Zollinger-Ellison
syndrome, where the stomach
produces very large amounts of acid,
much more than i

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
SALPRAZ
_ _
_Pantoprazole (as pantoprazole sodium sesquihydrate) tablets_
_ _
1
NAME OF THE MEDICINE
Pantoprazole (as pantoprazole sodium sesquihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SALPRAZ 20 mg enteric coated tablets contain 22.560 mg pantoprazole
sodium sesquihydrate equivalent to
20 mg pantoprazole.
SALPRAZ 40 mg enteric coated tablets contain 45.120 mg pantoprazole
sodium sesquihydrate equivalent to
40 mg pantoprazole.
Excipients with known effects: Salpraz also contains traces of soya
bean products.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Salpraz tablets are yellow coloured, oval, biconvex enteric coated
tablets plain on both the sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
1.
Symptomatic improvement and healing of 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 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 microorganism (see
Section 4.2 Dose and Method of
Administration).
SALPRAZ
– PRODUCT INFORMATIO