RABEPRAZOLE GH rabeprazole sodium 20mg enteric coated tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

rabeprazole sodium

Disponible depuis:

Generic Health Pty Ltd

DCI (Dénomination commune internationale):

Rabeprazole sodium

Statut de autorisation:

Registered

Notice patient

Rabeprazole GH CMI v1
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CONSUMER MEDICINE INFORMATION
RABEPRAZOLE GH
_RABEPRAZOLE SODIUM TABLETS_
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Rabeprazole GH 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 GH against the
benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING RABEPRAZOLE GH ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to read
it again.
WHAT RABEPRAZOLE GH IS USED
FOR
The name of your medicine is
Rabeprazole GH. It contains the
active ingredient rabeprazole
sodium.
_Reflux Oesophagitis:_
Rabeprazole GH 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 GH is also used to
help stop reflux oesophagitis
from coming back or relapsing.
_Peptic Ulcers:_
Rabeprazole GH 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 Rabeprazole GH
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 Rabeprazole GH

Résumé des caractéristiques du produit

131211 Rabeprazole GH PI_v1.1
Page 1 of 12
PRODUCT INFORMATION
RABEPRAZOLE GH
RABEPRAZOLE SODIUM 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 GH 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
GH
tablets
contain
the
inactive
ingredients
mannitol,
light
magnesium
oxide,
hydroxypropylcellulose,
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
131211 Rabeprazole GH PI_v1.1
Page 2 of 12
_ _
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 effec