Omesec Capsule 20mg

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

OMEPRAZOLE

Tersedia dari:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN (Nama Internasional):

OMEPRAZOLE

Unit dalam paket:

28Capsule Capsules; 14Capsule Capsules; 70Capsule Capsules

Diproduksi oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Selebaran informasi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
OMESEC CAPSULE
Omeprazole (20mg)
WHAT IS IN THE LEAFLET
1.
What Omesec Capsule is used
for
2.
How Omesec Capsule works
3.
Before
you
use
Omesec
Capsule
4.
How to use Omesec Capsule
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Omesec Capsule
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT OMESEC CAPSULE IS USED
FOR
Omesec
is
used
to
treat
the
following conditions:
•
‘Gastro-oesophageal
reflux
disease’
(GERD).
This
is
a
condition where
the acid from
the
stomach
escapes
into
the
throat.
•
Ulcers in the upper part of the
intestine
(duodenal
ulcer)
or
stomach (gastric ulcer).
•
Ulcers
associated
with
‘
_Helicobacter _
_pylori’_
infection
in
combination
with
other
medications such as antibiotics.
•
Zollinger-Ellison
syndrome
(overproduction
of gastric acid
due to tumours).
HOW OMESEC WORKS
Omesec
contains
the
active
substance omeprazole. It belongs
to
a
group
of
medicines
called
‘proton
pump
inhibitors’.
They
work by reducing the amount of
acid produced by your stomach.
BEFORE YOU USE OMESEC
-
_When you must not use it_
Do not use Omesec if you are
•
allergic to omeprazole or any of
the other ingredients of Omesec.
•
pregnant or planning to become
pregnant
•
breast-feeding
_ _
-
_Before you start to use it _
_ _
Inform your doctor if:
•
you have any liver disease.
Tell your doctor before taking this
medicine, if you are due to have a
specific blood test (Chromogranin
A).
Omesec
Capsule
treatment
should be stopped for at least 5
days before the test.
Your doctor will prepare test to
exclude cancer since Omeprazole
may
mask
symptoms
and
delay
diagnosis.
-
_Taking other medicines _
_ _
Please inform your doctor if you
are taking or have recently taken
any other medications, as well as
those
you
bought
without
a
prescription,
including
but
not
limited to:
•
Ketoconazole
(for
fungal
infection)
•
Digoxin (for heart problems)
•
Diazepam (for anxiety)
•
Phenytoin (for

Karakteristik produk

20 mg Capsules
PRODUCT DESCRIPTION
Hard gelatin capsule with pink body and caramel cap, each half
printed with ‘OMESEC 20’ in black, holding enteric-coated
mini-tablets.
COMPOSITION
Active Ingredient : Omeprazole 20 mg/capsule
Preservatives : None
PHARMACODYNAMICS
Omeprazole is a proton-pump inhibitor and thus prevents the
secretion of gastric acid. Omeprazole is a weak base and is
activated in acidic pH to a sulphonamide derivative that binds
irreversibly
to
Hydrogen/Potassium Adenosine Triphosphatase
(H+/K+ ATPase) enzyme system, the so called 'proton pump' that
is found at the secretory surface of parietal cells. It thereby
inhibits
the final transport of hydrogen ions (via exchange with potassium
ions) into the gastric lumen. Omeprazole inhibits both basal and
stimulated
acid
secretion
irrespective
of
the
stimulus.
It also inhibits hepatic cytochrome P-450 mixed function oxidase
system.
During treatment with antisecretory medicinal products, serum
gastrin increases in response to the decreased acid secretion.
Also
CgA
increases
due
to
decreased
gastric
acidity.
The
increased
CgA
level
may
interfere
with
investigations
for
neuroendocrine tumours.
Available
published
evidence
suggests
that
proton
pump
inhibitors should be discontinued between 5 days and 2 weeks
prior to CgA measurements. This is to allow CgA levels that might
be
spuriously
elevated
following
PPI
treatment
to
return
to
reference range.
PHARMACOKINETICS
Omeprazole is rapidly absorbed, but to a variable extent following
oral
administration.
The
absorption
of
Omeprazole
is
formulation-dependent and dose-dependent but it is not affected
by food. Omeprazole in the form of enteric-coated mini-tablets is
absorbed
from
the
small
intestines
and
delivered
via
the
bloodstream
to
the
parietal
cell.
Oral
absorption
of
the
enteric-coated formulation is relatively slow and may be further
influenced as a result of delayed gastric emptying.
Omeprazole is distributed in tissue, particularly gastric parietal
cells. It is highly bound to plasma proteins, approx