RABEPRAZOLE SANDOZ®GASTRO-RESISTANT TABLETS 20MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Rabeprazole Sodium

Boleh didapati daripada:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

Rabeprazole Sodium

Unit dalam pakej:

30 Tablets; 60 Tablets; 100 Tablets; 28 Tablets

Dikeluarkan oleh:

LEK PHARMACEUTICALS D.D.

Risalah maklumat

RABEPRAZOLE SANDOZ
® GASRTO-
RESISTANT TABLETS 20MG
Rabeprazole sodium (20mg)
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET:
1.
What Rabeprazole Sandoz is
used for
2.
How Rabeprazole Sandoz
works
3.
Before you use Rabeprazole
Sandoz
4.
How to use Rabeprazole
Sandoz
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Rabeprazole Sandoz
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT RABEPRAZOLE SANDOZ IS
USED FOR
Rabeprazole Sandoz is intended
for:
-
Short-term (4 to 8 weeks)
treatment in the healing of
erosive or ulcerative
Gastroesophageal Reflux
Disease (GERD). For those
people who have not healed
after 8 weeks of treatment, an
additional 8-week course of
Rabeprazole Sandoz may be
considered.
-
For maintaining healing and
reduction in relapse rates of
heartburn symptoms in people
with erosive or ulcerative
Gastroesophageal Reflux
Disease (GERD
maintenance).
-
Short-term (up to four weeks)
treatment in the healing and
symptomatic relief of
duodenal ulcers.
-
Long-term treatment of
pathological hypersecretory
conditions, including
Zollinger-Ellison Syndrome.
-
Symptomatic treatment of
moderate to very severe
GERD.
-
_Helicobacter pylori_
infection
eradication to reduce the risk
of duodenal ulcer recurrence
in adults when used in
combination with amoxicillin
and clarithromycin as a three-
medicine regimen.
GERD is a long-term condition
where acid from the stomach
comes up in to the esophagus
(tube connecting your mouth
and stomach).
HOW RABEPRAZOLE SANDOZ
WORKS
Rabeprazole Sandoz is a
selective “proton pump
inhibitor”, a medicine which
reduces the amount of acid
produced in your stomach.
BEFORE YOU USE RABEPRAZOLE
SANDOZ
-
_When you must not use it _
Do not take Rabeprazole:
-
if you are allergic to
rabeprazole sodium or any of
the other ingredients of this
medicine (see section on
ingredients).
-
if you are pregnant or breast
feeding.
PREGNANCY AND BREAST-FEEDING
_Pregnancy _
There are no adequate
information from

Ciri produk

PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Rabeprazole Sandoz
®
Gastro-Resistant Tablets 20 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg of rabeprazole sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Rabeprazole Sandoz
®
Gastro-Resistant Tablets 20 mg are yellow, round, biconvex, coated
tablets containing
20 mg of rabeprazole sodium.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Healing of erosive or ulcerative gastroesophageal reflux disease
(GERD) _
Rabeprazole Sandoz is indicated for short-term (4 to 8 weeks)
treatment in the healing and symptomatic relief
of erosive or ulcerative gastroesophageal reflux disease (GERD). For
those patients who have not healed after
8 weeks of treatment, an additional 8 -week course of Rabeprazole
Sandoz may be considered.
_Maintenance of healing of erosive or ulcerative gastroesophageal
reflux disease (GERD) _
Rabeprazole Sandoz is indicated for maintaining healing and reduction
in relapse rates of heartburn symptoms
in patients with erosive or ulcerative gastroesophageal reflux disease
(GERD maintenance).
_Healing of duodenal ulcers _
Rabeprazole Sandoz is indicated for short-term (up to four weeks)
treatment in the healing and symptomatic
relief of duodenal ulcers. Most patients heal within four weeks.
_Treatment of pathological hypersecretory conditions, including
Zollinger-Ellison Syndrome _
Rabeprazole Sandoz is indicated for the long-term treatment of
pathological hypersecretory conditions,
including Zollinger-Ellison Syndrome.
_Symptomatic treatment of moderate to very severe gastroesophageal
reflux disease (symptomatic GERD) _
Rabeprazole Sandoz is indicated for the symptomatic treatment of
moderate to very severe GERD.
_Helicobacter pylori eradication to reduce the risk of duodenal ulcer
recurrence in adults _
Rabeprazole Sandoz in combination with amoxicillin and clarithromycin
as a three drug regimen, is indicated
for the treatment of patients with
_H