PRABEZ rabeprazole sodium 10mg enteric coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rabeprazole sodium, Quantity: 10 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Rabeprazole sodium

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: diacetylated monoglycerides; hyprolose; magnesium stearate; purified water; light magnesium oxide; iron oxide red; hypromellose phthalate; Carnauba Wax; ethanol absolute; mannitol; titanium dioxide; purified talc; ethylcellulose

Administration route:

Oral

Units in package:

2,7,10,28,30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

? 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 antiinflammatory,drugs (NSAIDs) usually require treatment with antimicrobial agents in addition to,antisecretory drugs whether on first presentation or on recurrence.,It 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.

Product summary:

Visual Identification: Pink, round, biconvex coated tablets and plain on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2013-05-27

Patient Information leaflet

PRABEZ TABLETS
_Rabeprazole sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PRABEZ 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 PRABEZ
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING PRABEZ ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT PRABEZ IS USED
FOR
The name of your medicine is
PRABEZ. It contains the active
ingredient rabeprazole sodium.
Reflux Oesophagitis:
PRABEZ 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 to the throat,
also known as heartburn.
PRABEZ is also used to help stop
reflux oesophagitis from coming
back or relapsing.
Peptic Ulcers:
PRABEZ 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 a bacteria called
Helicobacter pylori in their stomach.
Your doctor may also prescribe a
course of antibiotics (clarithromycin
and amoxycillin) for you. When
PRABEZ is taken with antibiotics,
the combination therapy will kill the
Helicobacter pylori and let your ulcer
heal.
Chronic Gastritis:
The presence of the bacteria
Helicobacter pylori may cause the
stomach to become inflamed,
resulting in pain, nausea and
vomiting.
When PRABEZ tablets are taken
with antibiotics, they will help kill
Helicobacter pylori and allow the
stomach to heal.
HOW PRABEZ WORKS
PRABEZ belongs

Summary of Product characteristics

PRODUCT INFORMATION
PRABEZ
_Rabeprazole _
NAME OF THE MEDICINE
The
chemical
name
for
rabeprazole
sodium
is
(±)
2-[{4-(3-methoxypropoxy)-3-methylpyridin-2-
yl}-
methylsulphinyl]-1_H_-benzimidazole sodium. Rabeprazole has one chiral
centre and is a racemate of two
enantiomers. It has the following structural formula:
DESCRIPTION
Rabeprazole sodium is a substituted benzimidazole and belongs to the
class of proton pump inhibitors.
Rabeprazole sodium is soluble in water. pH dependent solubility of
Rabeprazole sodium shows that it is
highly soluble in water.
Prabez is available as enteric coated tablets containing 10 mg
rabeprazole sodium (equivalent to 9.42 mg
rabeprazole) and 20 mg rabeprazole sodium (equivalent to 18.85 mg
rabeprazole).
Prabez tablets contain the inactive ingredients mannitol, light
magnesium oxide, hyprolose, magnesium
stearate,
ethylcellulose,
hypromellose
phthalate,
diacetylated
monoglycerides,
purified
talc,
titanium
dioxide and carnauba wax. The 10 mg tablet also contains iron oxide
red and the 20 mg tablet contains
iron oxide yellow.
PHARMACOLOGY
Rabeprazole sodium suppresses gastric acid secretion by the specific
inhibition of the H
+
/K
+
- ATPase
enzyme (proton pump) at the secretory surface of the gastric parietal
cell thereby blocking the final step of
acid production. This effect is dose-related and leads to inhibition
of both basal
and stimulated acid
secretion irrespective of the stimulus. Animal studies indicate that
after administration, rabeprazole sodium
rapidly disappears from both the plasma and gastric mucosa.
PHARMACODYNAMICS
_Anti-Secretory Activity: _ Oral administration of a 20 mg dose of
rabeprazole sodium provides rapid and
effective reduction of gastric acid secretion. The onset of the
anti-secretory effect occurs within one hour
with the maximum effect occurring within two to four hours. Inhibition
of basal and food-stimulated acid
secretion 23 hours after the first dose of rabeprazole sodium is 69%
and 82% respectively, and the
duration of inhibition lasts up to 48 hou