APO-PANTOPRAZOLE pantoprazole (as sodium sesquihydrate) 20 mg enteric coated tablets bottle

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

pantoprazole sodium sesquihydrate, Quantity: 22.6 mg (Equivalent: pantoprazole, Qty 20 mg)

Pieejams no:

Arrotex Pharmaceuticals Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Pantoprazole sodium sesquihydrate

Zāļu forma:

Tablet, enteric coated

Kompozīcija:

Excipient Ingredients: methacrylic acid copolymer; magnesium stearate; titanium dioxide; purified talc; lactose; sodium carbonate; triethyl citrate; crospovidone; macrogol 8000; iron oxide yellow; hypromellose; microcrystalline cellulose

Ievadīšanas:

Oral

Vienības iepakojumā:

100, 500, 30

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Symptomatic improvement and healing of the following gastrointestinal diseases which require a reduction in acid secretion. - Duodenal ulcer. - Gastric ulcer. - Gastroesophageal 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.. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with nonselective NSAIDs in increased risk patients with a need for continuous nonselective NSAID treatment.

Produktu pārskats:

Visual Identification: Yellow, oval, biconvex, enteric-coated tablets engraved "APO" on one side, "20" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizācija statuss:

Registered

Autorizācija datums:

2009-12-09

Lietošanas instrukcija

APO-PANTOPRAZOLE TABLETS
1
APO-PANTOPRAZOLE
TABLETS
_Contains the active ingredient, 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
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
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children.
BEFORE YOU TAKE THIS
MEDICINE
against the benefits they expect it
inflammation, including arthritis
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
the 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
(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 se

Produkta apraksts

1
AUSTRALIAN PRODUCT INFORMATION
APO-PANTOPRAZOLE (PANTOPRAZOLE SODIUM
SESQUIHYDRATE) TABLETS
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.
EXCIPIENTS WITH KNOWN EFFECT
Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
20 MG TABLETS
Yellow, oval, biconvex, enteric-coated tablets engraved “APO” on
one side, “20” on the other
side.
40 MG TABLETS
Yellow, oval, biconvex, enteric-coated tablets engraved “APO” on
one side, “40” on the other
side.
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.
2
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.
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.