Nexpro Tablets 40mg

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
22-01-2021
Ciri produk Ciri produk (SPC)
16-06-2020

Bahan aktif:

ESOMEPRAZOLE MAGNESIUM

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ESOMEPRAZOLE MAGNESIUM

Unit dalam pakej:

14tablet Tablets; 28tablet Tablets

Dikeluarkan oleh:

TORRENT PHARMACEUTICALS LTD

Risalah maklumat

                                NEXPRO TABLETS
_ _
Esomeprazole Magnesium (20 mg, 40 mg)
_ _
_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Nexpro used for
2.
How Nexpro works
3.
Before you use Nexpro
4.
How to use Nexpro
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Nexpro
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT NEXPRO IS USED FOR
_Gastro-Oesophageal _
_Reflux _
_Disease _
_(GERD): _
Nexpro
is
taken
to
treat
reflux
oesophagitis.
This
can
be
caused
by
"washing
back"
(reflux)
of food
and
acid from the stomach into the food
pipe (oesophagus).
_Peptic _
_Ulcers _
_Associated _
_with _
_Helicobacter pylori Infection: _
Most people who have a peptic (gastric
and
duodenal)
ulcer
also
have
a
bacterium called Helicobacter pylori in
their stomach.
Depending on the position of the ulcer
it is called a gastric or duodenal ulcer.
A gastric ulcer occurs in the stomach. If
you have a peptic ulcer, your doctor
will prescribe Nexpro with antibiotics.
When Nexpro and antibiotics are taken
together,
they
work
to
kill
the
bacterium and let your ulcer heal.
_Patients _
_requiring _
_continued _
_NSAID _
_therapy: _
Nexpro is taken to treat the symptoms
of pain or discomfort, in the stomach
caused by NSAIDs, a type of medicine
for pain or inflammation.
Nexpro is also taken to help heal and
prevent ulcers caused by NSAIDs.
_Prolonged treatment after IV induced _
_prevention _
_of _
_rebleeding _
_of _
_peptic _
_ulcers: _
When
peptic
ulcers
become
severe
enough, they start to bleed. You may
receive
treatment
injected
into
your
veins initially. This treatment may be
followed
with
Nexpro
tablets
prescribed by your doctor for a longer
period of time. This is to help your
ulcer/s to heal.
_Treatment _
_of _
_Zollinger _
_Ellison _
_Syndrome: _
Nexpro
is
also
used
to
treat
a
rare
condition
called
Zollinger-Ellison
syndrome, where the stomach produces
large amounts of acid, much more than
in ulcers or reflux disease.
HOW NEXPRO
                                
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Ciri produk

                                PRODUCT NAME
:
ITEM / PACK
:
DESIGN STYLE
:
CODE
:
DIMENSIONS (MM)
:
ART WORK SIZE
:
DATE
:
Reviewed By
NO. OF COLORS: 1
COUNTRY : Malaysia
Front/Back
Nexpro Tablets
Insert
S/S
180 x 340
xxxxxxxxxx-5253
Black
04-06-2020
PANTONE SHADE NOS.:
ACTIVITIES
DEPARTMENT
NAME
SIGNATURE
DATE
Prepared By
PKG.DEV
PKG.DEV
LOCATION :
Chhatral
QUALITY
Approved By
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
NEXPRO TABLETS 20 MG
Each gastro- resistant tablet contains
Esomeprazole magnesium equivalent to Esomeprazole ............. 20 mg
Colours: Red oxide of Iron and Titanium Dioxide
NEXPRO TABLETS 40 MG
Each gastro-resistant tablet contains
Esomeprazole magnesium equivalent to Esomeprazole ............. 40 mg
Colours: Red oxide of Iron and Titanium Dioxide
PRODUCT DESCRIPTION
Esomeprazole Tablets 20 mg are brick red colored, round shape,
biconvex,
film coated tablets, imprinted with “20” on one side with black
ink and plain
on other side.
Esomeprazole Tablets 40 mg are brick red colored, round shape, beveled
edge, biconvex, film coated tablets, imprinted with “40” on one
side with
black ink and plain on other side.
DOSAGE FORM
Gastro resistant Tablets
PHARMACODYNAMICS
PHARMACODYNAMICS
Esomeprazole is the S-isomer of omeprazole and reduces gastric acid
secretion through a specific targeted mechanism of action. It is a
specific
inhibitor of the acid pump in the parietal cell. Both the R- and
S-isomer of
omeprazole have similar pharmacodynamic activity.
SITE AND MECHANISM OF ACTION
Esomeprazole is a weak base and is concentrated and converted to the
active form in the highly acidic environment of the secretory
canaliculi of the
parietal cell, where it inhibits the enzyme H+K+-ATPase - the acid
pump and
inhibits both basal and stimulated acid secretion.
EFFECT ON GASTRIC ACID SECRETION
After oral dosing with esomeprazole 20 mg and 40 mg the onset of
effect
occurs
within
one
hour.
After
repeated
administration
with
20
mg
esomeprazole
once
daily
for
five
days,
mean
peak
acid
output
after
pentagastrin stimulation is decreased 90% wh
                                
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