Milosec Capsule 20 mg

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

Omeprazole Pellets 8.5%

Dostupné s:

MILRIN PHARMACEUTICAL CO. (M) SDN BHD

INN (Mezinárodní Name):

Omeprazole Pellets 8.5%

Jednotky v balení:

14Capsule Capsules

Výrobce:

The United Drug (1996) Co., Ltd.

Informace pro uživatele

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MILOSEC
® CAPSULE
Omeprazole (20mg)
1
WHAT IS IN THIS LEAFLET
1.
What MILOSEC
®
is used for
2.
How MILOSEC
®
works
3.
Before you use MILOSEC
®
4.
How to use MILOSEC
®
5.
While you are using MILOSEC
®
6.
Side effects
7.
Storage
and
disposal
of
MILOSEC
®
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT MILOSEC
® IS USED FOR
MILOSEC
®
is
used
to
reduce
the
amount of acid in your stomachs such
as
gastric,
duodenal
ulcers,
or
gastroesophageal
reflux
disease
or
Zollinger-Ellison
syndrome.
This
medicine
can
also
be
used
to
treat
stomach
infections
caused
by
_Helicobacter pylori_
bacteria.
HOW MILOSEC
® WORKS
MILOSEC
®
contains
Omeprazole
which works by reducing gastric acid
secretion.
BEFORE YOU USE MILOSEC
®
-
_When you must not use it _
Do NOT take MILOSEC
®
if you are
allergic
(hypersensitive)
to
omeprazole
or
any
of
the
other
ingredients.
-
_Before you start to use it_
Tell your doctor if you are
-
having liver problems
-
due to having a specific blood test
(Chromogranin A)
-
_Taking other medicines_
Please tell your doctor or pharmacist if
you are taking or have recently taken
any
other
medicines,
including
medicines
obtained
without
a
prescription especially:
-
diazepam (use to treat anxiety)
-
warfarin (use to treat blood clots)
-
phenytoin
(use
to
prevent
and
control seizure)
PREGNANCY AND BREASTFEEDING
It is preferable not to take this product
during pregnancy.
If you are pregnant or suspect that you
are
pregnant,
you
should
tell
your
doctor
or
your
pharmacist
before
taking MILOSEC
®
.
You
should
not
breastfeed
while
taking
this
medicine.
If
you
are
breastfeeding
or
planning
to
breastfeed, talk to your doctor before
taking this medicine.
HOW TO USE MILOSEC
®
-
_How much to use_
Follow the directions given to you by
your doctor and pharmacist carefully.
These directions may differ from the
information contained in this leaflet.
DUODENAL
ULCER
TREATMENT
OR
PREVENTION:
Recommended
Dosage:
MILOSEC
®
20

Charakteristika produktu

MILOSEC
® Capsule 20 mg
(
Omeprazole
20 mg)
Composition:
Each capsule contains Omeprazole Pellets equivalent to Omeprazole 20
mg
Product Description:
Opaque pink-reddish brown capsule No.2, imprinted “Frx Frx” in
black color, containing off-white enteric coated pellet.
Pharmacodynamics:
Omeprazole reduces gastric acid secretion through a highly selective
mechanism of action. It produces specific dose-
dependent inhibition of the enzyme H
+
, K
+
-ATPase (the proton pump) in the parietal cell. As this action
inhibits the final
stage of gastric acid formation, there is an effective inhibition of
both basal and stimulated acid secretion irrespective of
the stimulus to acid formation. Omeprazole has no effect on
acetylcholine or histamine receptors and no clinically
significant pharmacodynamic effects have been observed other than
those explained by the effect of omeprazole on
acid secretion. The onset of action is rapid and reversible control of
gastric secretion is achieved with once-daily
dosing.
During treatment with antisecretory medicinal products, serum gastrin
increase 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 tumors.
Available published evidence suggested 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 but variably absorbed after oral doses.
Absorption is not affected by food.
Omeprazole is acid-labile and pharmacokinetics may vary between the
various formulations developed to improve oral
bioavailability. The absorption of omeprazole also appears to be
dose-dependent; increasing the dosage above 40 mg
has been reported to increase the plasma concentrations in a
non-linear fashion because of saturable first-pass
hepatic-metabolism.
In
addition,
absorption
is
highe