ZABEP 20 rabeprazole sodium 20 mg enteric coated tablets blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

rabeprazole sodium, Quantity: 20 mg

Commercializzato da:

Medis Pharma Pty Ltd

INN (Nome Internazionale):

Rabeprazole sodium

Forma farmaceutica:

Tablet, enteric coated

Composizione:

Excipient Ingredients: iron oxide yellow; propylene glycol; povidone; sodium lauryl sulfate; magnesium stearate; titanium dioxide; methacrylic acid - ethyl acrylate copolymer (1:1); mannitol; light magnesium oxide; purified talc; hyprolose; polysorbate 80; ethylcellulose

Via di somministrazione:

Oral

Confezione:

30 tablets

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Rabeprazole is indicated for: ,? treatment and prevention of relapse of gastro-oesophageal reflux disease ,? symptomatic treatment of gastro-oesophageal reflux disease ,? treatment of duodenal ulcers ,? treatment of gastric ulcers. ,Patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,Rabeprazole is also indicated, in combination with clarithromycin and amoxycillin, for: ,? eradication of Helicobacter pylori in patients with peptic ulcer disease or chronic gastritis ,? healing of peptic ulcers in patients with Helicobacter pylori associated ulcers.

Dettagli prodotto:

Visual Identification: Yellow, elliptical, biconvex shaped tablet with no markings; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2013-03-06

Foglio illustrativo

Zabep/180215/CMI-08
1
ZABEP 20
_contains the active ingredient rabeprazole sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZABEP 20.
It does not contain all of the available
information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have benefits and risks.
Your doctor has weighed the risks of
you taking ZABEP 20 against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT ZABEP 20 IS USED
FOR
ZABEP 20 is used to:

treat reflux oesophagitis or reflux
disease. This can be caused by
food and acid from the stomach
flowing the wrong way (reflux)
back up the food pipe, also known
as the oesophagus.
Reflux can cause a burning
sensation in the chest rising up the
throat, also known as heartburn.

help stop reflux oesophagitis from
coming back or relapsing

treat peptic ulcers. Depending on
the position of the ulcer it is called
a gastric or duodenal ulcer occurs
in the stomach. A duodenal ulcer
occurs in the duodenum which is
the tube leading out of the
stomach.
These ulcers can be caused by too
much acid being made in the
stomach.
Most people who have a peptic
ulcer also have a bacteria called
Helicobacter pylori in their
stomach. Your doctor may also
prescribe a course of antibiotics
(clarithromycin and amoxicillin) for
you. When ZABEP 20 is taken with
antibiotics, the combination therapy
will kill the Helicobacter pylori and
let your ulcer heal.
The presence of the bacteria
Helicobacter pylori may cause the
stomach to become inflamed,
resulting in pain, nausea and
vomiting. When ZABEP 20 is taken
with antibiotics, they will help kill
Helicobacter pylori and allow the
stomach to heal.
ZABEP 20 belongs to a group of
medicines called proton pump
inhibitors (PPIs). ZABEP 20 works by
decreasing the amount of acid the
stomach makes, to give relief from the
sympto

Scheda tecnica

ZABEP 20 – Product information
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION - ZABEP 20 (RABPRAZOLE SODIUM)
1.
NAME OF THE MEDICINE
Rabeprazole sodium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZABEP 20 enteric coated tablets contain 20 mg of rabeprazole sodium.
The tablets also contain
povidone,
hydroxypropyl
cellulose,
magnesium
oxide,
mannitol,
magnesium
stearate,
ethylcellulose, methacrylic acid - ethyl acrylate copolymer (1:1),
polysorbate 80, sodium lauryl
sulfate, propylene glycol, iron oxide yellow, titanium dioxide and
purified talc. The tablets are
gluten free.
3.
PHARMACEUTICAL FORM
Rabeprazole sodium 20 mg enteric-coated tablet; Yellow, elliptical,
biconvex shaped tablet with
no markings.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZABEP 20 is indicated for:

treatment and prevention of relapse of gastro-oesophageal reflux
disease

symptomatic treatment of gastro-oesophageal reflux disease

treatment of duodenal ulcers

treatment of gastric ulcers.
Patients whose gastric and duodenal ulceration is not associated with
ingestion of non-steroidal
anti-inflammatory drugs (NSAIDs) usually require treatment with
antimicrobial agents in addition
to antisecretory drugs whether on first presentation or on recurrence.
ZABEP 20 is also indicated, in combination with clarithromycin and
amoxycillin, for:

eradication of _Helicobacter pylori_ in patients with peptic ulcer
disease or chronic gastritis

healing of peptic ulcers in patients with _Helicobacter pylori_
associated ulcers.
4.2
DOSE AND METHOD OF ADMINISTRATION
Rabeprazole sodium tablets should not be chewed or crushed, but should
be swallowed whole.
Rabeprazole sodium tablets should be taken at the same time each day
to facilitate treatment
compliance. Rabeprazole sodium was taken with or without food in the
pivotal clinical trials.
ADULTS
Treatment of active gastro-oesophageal reflux disease (GORD)
The recommended oral dose for this condition is one 20 mg tablet to be
taken once daily for four
to eight weeks.
Prevention of rel