Parbezol rabeprazole sodium 20mg enteric coated tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

rabeprazole sodium, Quantity: 20 mg

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

Designación común internacional (DCI):

Rabeprazole sodium

formulario farmacéutico:

Tablet, enteric coated

Composición:

Excipient Ingredients: ethylcellulose; iron oxide yellow; mannitol; diethyl phthalate; hypromellose phthalate; sodium starch glycollate type A; light magnesium oxide; magnesium stearate; titanium dioxide; purified talc; povidone

Vía de administración:

Oral

Unidades en paquete:

30

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

Visual Identification: Yellow coloured, round, biconvex, delayed release tablet, plain on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2012-07-09

Información para el usuario

_PARBEZOL tablets – Consumer Medicine Information _
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_Page 1 _
PARBEZOL TABLETS
_Rabeprazole sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PARBEZOL tablets. 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 PARBEZOL
against the benefits this medicine
is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING PARBEZOL ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT PARBEZOL IS
USED FOR
The name of your medicine is
PARBEZOL. It contains the active
ingredient rabeprazole sodium.
PARBEZOL belongs to a group of
medicines called proton pump
inhibitors (PPIs). PARBEZOL
works by decreasing the amount of
acid the stomach makes, to give
relief from the symptoms and allow
healing to take place. Your food
will still be digested in the same
way.
GASTRO-OESOPHAGEAL REFLUX
DISEASE:
PARBEZOL is used to treat gastro-
oesophageal reflux disease
(GORD), commonly known as
'reflux'. 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 to
the throat, also known as
heartburn. PARBEZOL is also
used to help stop gastro-
oesophageal reflux disease from
coming back or relapsing.
PEPTIC ULCERS:
PARBEZOL is used to treat peptic
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 ulcers can be caused 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. Your doctor may also
prescribe a course of antibiotics
(clarithromycin and amoxycillin) for
you. When

Ficha técnica

1
AUSTRALIAN PI – PARBEZOL (RABEPRAZOLE SODIUM) TABLETS
1
NAME OF THE MEDICINE
Rabeprazole sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PARBEZOL tablets are enteric coated tablets containing 10 mg
rabeprazole sodium (equivalent to
9.42 mg rabeprazole) or 20 mg rabeprazole sodium (equivalent to 18.85
mg rabeprazole).
Rabeprazole sodium is a substituted benzimidazole and belongs to the
class of proton pump
inhibitors.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PARBEZOL 10 mg are pink, biconvex tablets blank on both sides.
PARBEZOL 20 mg are light yellow, biconvex tablets, blank on both
sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PARBEZOL 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.
PARBEZOL is also indicated, in combination with clarithromycin and
amoxycillin, for:
•
Eradication of _Helicobacter pylori _in patients with peptic ulcer
disease or chronic gastritis
2
•
Healing of peptic ulcers in patients with _Helicobacter pylori
_associated ulcers.
4.2
D
OSE AND METHOD OF ADMINISTRATION
PARBEZOL tablets should not be chewed or crushed, but should be
swallowed whole. PARBEZOL
tablets should be taken at the same time each day to facilitate
treatment compliance. Rabeprazole
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 Relapse of Gastro-Oesophageal Reflux Disease (GORD):
_The recommended oral dose
fo