ESOZ Esomeprazole Magnesium Gastro-Resistant Tablets 40 mg

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

ESOMEPRAZOLE MAGNESIUM

Tilgjengelig fra:

RANBAXY (MALAYSIA) SDN. BHD.

INN (International Name):

ESOMEPRAZOLE MAGNESIUM

Enheter i pakken:

3 x 10 Tablets

Produsert av:

Sun Pharmaceutical Industries Limited

Informasjon til brukeren

ESOZ 40 MG
Page 1
ESOZ
_ _
(Esomeprazole Magnesium Gastro Resistant Tablets 40 mg)
_Consumer Medication Information Leafleat (RiMUP)_
_ _
WHAT IS IN THIS LEAFLET
1. What
ESOZ
is used for
2. How
ESOZ
works
3. Before you use
ESOZ
4. How to use
ESOZ
5. While you are using
ESOZ
6. Side Effects
7. Storage and Disposal of
ESOZ
8. Product Description
9. Manufacturer
10. Product Registration Holder
11. Date of Revision
This
leaflet
answers
some
common
questions about
ESOZ
.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking
ESOZ
against the benefits
it is expected to have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ESOZ IS USED FOR
ESOZ
is used to treat the following
conditions:

‘Gastroesophageal
reflux
disease’
(GERD). This is where acid from the
stomach escapes into the gullet (the
tube which connects your throat to
your
stomach)
causing
pain,
inflammation and heartburn. It also
helps
to
stop
reflux
oesophagitis
from coming back or relapsing.

A rare condition where the stomach
produces
large
amounts
of
acid,
much more than in ulcers or reflux
disease
(Zollinger-Ellison
syndrome).

Prevention
of
rebleeding
of
ulcers
following
treatment
with
esomeprazole
IV
solution
by
intravenous infusion.
HOW ESOZ WORKS
ESOZ
contains
a
medicine
called
esomeprazole. Esomeprazole is a type
of
medicine
called
a
proton-pump
inhibitor. It works by decreasing the
amount of acid made by the stomach to
relieve symptoms and allow healing to
take place.
This does not stop food
being digested in the normal way.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS ABOUT WHY ESOZ HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
This
product
is
available
in
40
mg
strength.
BEFORE YOU USE ESOZ
_WHEN YOU MUST NOT USE IT _
IF YOU HAVE AN ALLERGY TO:

Esomeprazole or any ingredient of
ESOZ
listed at the end of this leaflet
(see
PRODUCT DESCRIPTION
)

Any

Preparatomtale

2+
_For the use of a Registered Medical Practitioner only_
PRESCRIBING INFORMATION
ESOZ TABLETS
(Esomeprazole Magnesium Gastro Resistant 40 mg)
COMPOSITION
ESOZ 40 MG
Each gastro-resistant tablet contains: Esomeprazole Magnesium
Amorphous equivalent to
Esomeprazole……..………40 mg
_Inactive components:_
Sugar spheres , Hydroxyl propyl cellulose (HPC-L), Crospovidone
PPXL-10, Povidone (PVP K-
30), Macrogol 400, Purified talc, Isopropyl alcohol, Hypromellose
phthalate(HP-55S), Hypromellose
phthalate(HP-50), Diethylphalate, Acetone, Macrogol 6000, Methylene
chloride, Microcrystalline
cellulose PH101, Microcrystalline cellulose PH112, Sodium stearyl
fumerate Macrogol 4000, and
Opadry
03B86651
brown(HPMC
2910/Hypromellose
6cP,Tiatanium
dioxide,Macrogol/PEG
400,Talc, Iron oxide red)
PRODUCT DESCRIPTION
ESOZ 40 MG: Light brick red to brown colored, oval, biconvex, film
coated tablets with ‘E6’
debossed on one side and plain on other side.
DESCRIPTION
ESOZ TABLETS contain esomeprazole magnesium. Chemically it is,
(T-4)-Bis[5-methoxy-2-[(S)-
[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazolato]magnesium
,
a
compound that inhibits gastric acid secretion. Esomeprazole is the
S-isomer of omeprazole. Its
molecular formula is C
34
H
36
Mg N
6
O
6
S
2
with molecular weight of 713.12. The structural formula is:
H
3
CO
N
-
CH
3
N
S
O
N
OCH
3
Mg
CH
3
2
ESOMEPRAZOLE MAGNESIUM
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
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