Axiago MUPS Tablet 40mg

Land: Maleisië

Taal: Engels

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

Werkstoffen:

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Beschikbaar vanaf:

ZUELLIG PHARMA SDN BHD

INN (Algemene Internationale Benaming):

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Eenheden in pakket:

14tablet Tablets; 14tablet Tablets

Geproduceerd door:

ASTRAZENECA AB

Bijsluiter

AXIAGO MUPS
®
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ESOMEPRAZOLE (20MG, 40MG)
WHAT IS IN THIS LEAFLET
1.
What Axiago MUPS is used
for
2.
How Axiago MUPS works
3.
Before you use Axiago
MUPS
4.
How to use Axiago MUPS
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
Axiago MUPS
8.
Product Description
9.
Manufacturer & Product
Registration Holder
10.
Date of Revision
WHAT AXIAGO MUPS IS USED FOR
Axiago MUPS is used to treat the
following conditions in 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.
Axiago MUPS is used for
symptomatic and long-term
management of patients with
healed esophagitis to prevent
recurrence.
Axiago MUPS is also used to treat
the following conditions in
Adults:
•
In combination with an
appropriate antibacterial
medication to eradicate
_Helicobacter pylori_
, promote
healing of these duodenal ulcers
and prevent relapse of peptic
ulcers in patients with
_Helicobacter pylori _
associated
ulcers.
•
Patients who need continued
(Non-Steroidal Anti-
Inflammatory Drugs) NSAID
therapy for the healing of
stomach ulcers associated with
NSAID therapy and to prevent
stomach and duodenal ulcers
associated with NSAID therapy
in patients at risk.
•
Prolonged treatment after
intravenous induced prevention
of re-bleeding of peptic ulcers.
•
Zollinger Ellison Syndrome,
which is a rare condition where
one or more tumors form in the
pancreas or upper part of the
small intestine (duodenum).
These tumors, called
gastrinomas, secrete large
amounts of the hormone gastrin,
which causes the stomach to
produce too much acid.
HOW AXIAGO MUPS WORKS
Axiago 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 AXIAGO MUPS
_-_
_

Productkenmerken

1
AXIAGO MUPS
® TABLET 20 MG & 40 MG
Esomeprazole
COMPOSITION
Each tablet contains: 20 mg or 40 mg esomeprazole (as magnesium
trihydrate).
Excipients: Axiago MUPS Tablet 20 mg: Sucrose 28 mg. Axiago MUPS
Tablet 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
AXIAGO
MUPS
is
a
proton
pump
inhibitor.
The
active
ingredient
in
Axiago
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)
THERAPEUTIC INDICATION
Axiago MUPS are indicated for:
2
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 TREATMENT AFTER I.V. INDUCED PREVENTION OF REBLEEDING OF
PEPTIC ULC