PARZOL 20 rabeprazole sodium 20 mg enteric coated tablets blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

rabeprazole sodium, Quantity: 20 mg

Disponible desde:

Medis Pharma Pty Ltd

Designación común internacional (DCI):

Rabeprazole sodium

formulario farmacéutico:

Tablet, enteric coated

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

30 tablets

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, 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

Estado de Autorización:

Registered

Fecha de autorización:

2013-03-06

Información para el usuario

PARZOL 20/PI/14092018 v3
AUSTRALIAN PRODUCT INFORMATION - PARZOL 20 (RABEPRAZOLE SODIUM)
1.
NAME OF THE MEDICINE
Rabeprazole sodium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PARZOL 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
PARZOL 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.
PARZOL 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 relapse of gastro-o

Ficha técnica

PARZOL 20/PI/02072019 v4
AUSTRALIAN PRODUCT INFORMATION - PARZOL 20 (RABEPRAZOLE SODIUM)
1.
NAME OF THE MEDICINE
Rabeprazole sodium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PARZOL 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
PARZOL 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.
PARZOL 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 relapse of gastro-