ESOMAC-20 Gastro Resistant Tablets 20mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Boleh didapati daripada:

CIPLA MALAYSIA SDN BHD

INN (Nama Antarabangsa):

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Unit dalam pakej:

3 x 10 Tablets

Dikeluarkan oleh:

CIPLA LTD

Risalah maklumat

ESOMAC GASTRO RESISTANT TABLETS
CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
ESOMEPRAZOLE (20MG, 40MG)
___________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What ESOMAC is used for
2.
How ESOMAC works
3.
Before you use ESOMAC
4.
How to use ESOMAC
5.
While you are using it
6.
Side effects
7.
Storage and disposal of ESOMAC
8.
Product description
9.
Manufacturer and product holder
10.
Date revision
11.
Serial number
WHAT ESOMAC IS USED FOR
•
‘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.
•
Ulcers in the stomach or upper part of the
gut
(intestine)
that
are
infected
with
bacteria called ‘
_Helicobacter pylori’_
. If
you have this condition, your doctor may
also
prescribe
antibiotics
to
treat
the
infection and allow the ulcer to heal.
•
Stomach
ulcers
caused
by
medicines
called
NSAIDs
(Non-Steroidal
Anti-
Inflammatory Drugs). Esomeprazole can
also be used to stop stomach ulcers from
forming if you are taking NSAIDs.
•
Prolonged treatment after prevention of
rebleeding
of
ulcers
with
intravenous
esomeprazole.
•
Too much acid in the stomach caused by
a
growth
in
the
pancreas
(Zollinger-
Ellison syndrome).
HOW ESOMAC WORKS
ESOMAC
contains
a
medicine
called
esomeprazole. This belongs to a group of
medicines called ‘proton pump inhibitors’.
They work by reducing the amount of acid
that your stomach produces.
BEFORE YOU USE ESOMAC
_-When you must not use it _
•
If you are allergic to esomeprazole or any
of the other ingredients of this medicine.
•
If you are allergic to other proton pump
inhibitor
medicines
(e.g.
pantoprazole,
lansoprazole, rabeprazole, omeprazole).
•
If you are taking a medicine containing
nelfinavir (used to treat HIV).
_ _
_-Before you start to use it _
Talk to your doctor or pharmacist before
taking esomeprazole tablets:
•
If you have severe liver problems.
•
If

Ciri produk

FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A
LABORATORY ONLY OR FOR SPECIALIST USE ONLY
ESOMAC-20 GASTRO RESISTANT TABLETS 20MG
ESOMAC-40 GASTRO RESISTANT TABLETS 40MG
COMPOSITION
ESOMAC-20
Each film coated tablets contains:
Esomeprazole Magnesium Dihydrate equivalent to
Esomeprazole …………….20 mg
(As enteric coated pellets)
Colour: Iron oxide red and Titanium dioxide
ESOMAC-40
Each film coated tablets contains:
Esomeprazole Magnesium Dihydrate equivalent to
Esomeprazole ……………. 40 mg
(As enteric coated pellets)
Colour: Iron oxide red, Iron oxide black, Titanium dioxide &
Erythrosine
DOSAGE FORM
Gastro resistant Tablets
PRODUCT DESCRIPTION
20 mg: Pink, coloured capsule shaped, Biconvex, Film coated tablets,
debossed “20” on one side and plain on other side.
40 mg: Pink, coloured capsule shaped, Biconvex, Film coated tablets,
debossed “40” on one side and plain on other side
PHARMACOLOGY
_PHARMACODYNAMICS_
PHARMACOTHERAPEUTIC GROUP: Drugs for acid-related disorders proton
pump inhibitors.
ATC CODE: A02B C05
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.
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.
PHARMACODYNAMIC EFFECTS
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% when measured 6–7 hours after dosing on
day five.
After five days of oral dosing with 20 mg and 40 mg of esomeprazole,
intragas