RABEPRAZOLE RBX rabeprazole sodium 10mg enteric coated tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

rabeprazole sodium, Quantity: 10 mg

Disponibil de la:

Dr Reddys Laboratories Australia Pty Ltd

INN (nume internaţional):

Rabeprazole sodium

Forma farmaceutică:

Tablet, enteric coated

Compoziție:

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

Calea de administrare:

Oral

Unități în pachet:

2,7,10,28,30 tablets

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

? 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.

Rezumat produs:

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

Statutul autorizaţiei:

Registered

Data de autorizare:

2013-05-27

Prospect

1
RABEPRAZOLE RBX
TABLETS
_RABEPRAZOLE RBX draft CMI Version 03_11/2013 _
_Rabeprazole sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
RABEPRAZOLE RBX 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
RABEPRAZOLE
RBX against the benefits this medicine is expected to
have for you.
_Chronic Gastritis:_
The presence of the bacteria Helicobacter pylori may
cause the stomach to become inflamed, resulting in
pain, nausea and vomiting.
When RABEPRAZOLE RBX tablets are taken with
antibiotics, they will help kill Helicobacter pylori and
allow the stomach to heal.
IF YOU HAVE ANY CONCERNS ABOUT USING
RABEPRAZOLE RBX ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need
to read it again.
WHAT
RABEPRAZOLE RBX
IS
USED
FOR
The name of your medicine is RABEPRAZOLE
RBX.
It contains the active ingredient rabeprazole
sodium.
_Reflux Oesophagitis:_
RABEPRAZOLE
RBX
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.
RABEPRAZOLE RBX is also used to help stop
reflux oesophagitis from coming back or relapsing.
_Peptic Ulcers:_
RABEPRAZOLE RBX 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
RA

Caracteristicilor produsului

Product Information
RABEPRAZOLE RBX_V2 Jan 2014
Page 1 of 9
RABEPRAZOLE RBX TABLETS
NAME OF THE MEDICINE
Rabeprazole sodium
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:
C
18
H
20
N
3
NaO
3
S
MW: 381.43
CAS-117976-90-6 (rabeprazole sodium)
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.
RABEPRAZOLE
RBX
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).
RABEPRAZOLE
RBX
tablets
contain
the
inactive
ingredients
mannitol,
light
magnesium
oxide,
hydroxypropylcellulose,
magnesium
stearate,
ethylcellulose,
hypromellose
phthalate,
diacetylated
monoglycerides, purified talc, purified water, absolute ethanol,
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 f