NEXIUM MUPS TABLET 20MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Unit dalam pakej:

14Tablet Tablets

Dikeluarkan oleh:

AstraZeneca AB

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NEXIUM MUPS
® TABLET
_ _
Esomeprazole (20mg, 40mg)
1
WHAT IS IN THIS LEAFLET
1.
What Nexium MUPS is used for
2.
How Nexium MUPS works
3.
Before you use Nexium MUPS
4.
How to use Nexium MUPS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Nexium
MUPS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT NEXIUM MUPS IS USED FOR
Nexium MUPS is used to treat and
prevent relapse of the following
conditions:
Adults and young people aged 12
years and above:
•
‘Gastro-oesophageal reflux
disease’ (GERD). This is where
acid from the stomach escapes
into the oesophagus (the tube
which connects your throat to
your stomach) causing pain,
inflammation and heartburn.
•
Ulcers in the stomach or upper
part of the gut (duodenum) 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.
Adults
•
Stomach ulcers caused by
medicines called NSAIDs (Non-
Steroidal Anti-Inflammatory
Drugs). Nexium MUPS can also
be used to stop stomach ulcers
from forming if you are taking
NSAIDs.
•
Too much acid in the stomach
caused by a growth in the
pancreas (Zollinger-Ellison
syndrome).
•
Prolonged treatment after
prevention of re-bleeding of
ulcers with Nexium injection.
HOW NEXIUM MUPS WORKS
Nexium MUPS 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 NEXIUM MUPS
_- When you must not use it _
•
You are allergic (hypersensitive)
to esomeprazole or any of the
other ingredients of this
medicine.
•
You are allergic to other proton
pump inhibitor medicines (e.g.
pantoprazole, lanzoprazole,
rabeprazole, omeprazole).
•
You are taking a medicine
containing nelfinavir (used to
treat HIV).
If you are not sure, talk to your
doctor or pharmacist be

Ciri produk

1
NEXIUM MUPS
®
ESOMEPRAZOLE
Delayed-Release Tablets 20 mg and 40 mg
COMPOSITION
Each tablet contains: 20 mg or 40 mg esomeprazole (as magnesium
trihydrate).
Excipients: Nexium 20 mg: Sucrose 28 mg. Nexium 40 mg: Sucrose 30 mg.
For excipients see "List of excipients".
PHARMACEUTICAL FORM
Gastro-resistant tablets
20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20
mg on one side and
A
EH
on
the other side.
40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on
one side and
A
EI
on the other
side.
Each tablet contains esomeprazole as enteric-coated pellets (MUPS).
DESCRIPTION
Nexium MUPS is a proton pump inhibitor. The active ingredient in
Nexium MUPS is esomeprazole
magnesium trihydrate, a substituted benzimidazole. Esomeprazole is the
S-isomer of omeprazole.
It is optically stable
_in vivo_
, with negligible conversion to the R-isomer. The chemical name is di-
(S)-5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]
sulfinyl]
1
_H_
-
benzimidazole
magnesium salt trihydrate.
The chemical structure of esomeprazole magnesium trihydrate is:
CAS Number:
217087-09-7
Molecular formula:
C
34
H
36
N
6
O
6
S
2
Mg.3H
2
O
Molecular weight:
767.2 (trihydrate)
N
C
H
3
O
C
H
3
C
H
2
N
N
O
S
O
-
2
Mg
2+
. 3 H
2
O
CH
3
CH
3
2
THERAPEUTIC INDICATION
Nexium MUPS tablets are indicated for:
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
-
treatment of erosive reflux esophagitis
-
long-term management of patients with healed esophagitis to prevent
relapse -
symptomatic treatment of gastroesophageal reflux disease (GERD)
IN COMBINATION WITH AN APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMEN
FOR THE ERADICATION OF
_HELICOBACTER PYLORI_ AND
-
healing of
_Helicobacter pylori_
associated duodenal ulcer and
-
prevention of relapse of peptic ulcers in patients with
_Helicobacter pylori_
associated ulcers
PATIENTS REQUIRING CONTINUED NSAID THERAPY
-
healing of gastric ulcers associated with NSAID therapy
-
prevention of gastric and duodenal ulcers associated with NSAID
therapy in patients at risk
PROLONGED TREATMEN