ESOMEPRAZOLE SANDOZ esomeprazole (as magnesium) 20mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

esomeprazole magnesium

Tilgjengelig fra:

Sandoz Pty Ltd

INN (International Name):

Esomeprazole magnesium

Autorisasjon status:

Registered

Informasjon til brukeren

ESOMEPRAZOLE
SANDOZ
_esomeprazole (as magnesium) tablet_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Esomeprazole Sandoz. It does not
contain all the information that is
known about Esomeprazole Sandoz.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking
Esomeprazole Sandoz against the
benefits they expect it will 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 ESOMEPRAZOLE
SANDOZ IS USED FOR
_REFLUX OESOPHAGITIS_
Esomeprazole Sandoz is taken to
treat reflux oesophagitis. This can be
caused by "washing back" (reflux) of
food and acid from the stomach into
the food pipe (oesophagus).
Reflux can cause a burning sensation
in the chest rising up to the throat,
also known as heartburn.
Esomeprazole Sandoz is also taken to
help stop reflux oesophagitis coming
back or relapsing.
_UPPER GASTROINTESTINAL_
_SYMPTOMS ASSOCIATED WITH_
_NON-STEROIDAL ANTI-_
_INFLAMMATORY DRUGS_
_(NSAIDS) THERAPY_
Esomeprazole Sandoz is taken to
treat the symptoms of pain or
discomfort, in the stomach caused by
NSAIDs, a type of medicine for pain
or inflammation.
Esomeprazole Sandoz is also taken to
help heal and prevent ulcers caused
by NSAIDs.
_PEPTIC ULCERS ASSOCIATED_
_WITH HELICOBACTER PYLORI_
_INFECTION_
Most people who have a peptic
(gastric and duodenal) ulcer also
have a bacterium called Helicobacter
pylori in their stomach.
Depending on the position of the
ulcer it is called a gastric or duodenal
ulcer. A gastric ulcer occurs in the
stomach. A duodenal ulcer occurs in
the duodenum which is the tube
leading out from the stomach.
If you have a peptic ulcer, your
doctor will prescribe Esomeprazole
Sandoz with antibiotics. When
Esomeprazole Sandoz and antibiotics
are taken together, they work to kill
the bacterium and let your ulcer h

Preparatomtale

_Product Information Page 1 _
_Esomeprazole Sandoz _
_08/2017 _
_Sandoz Pty Ltd Version 07 _
PRODUCT INFORMATION
ESOMEPRAZOLE SANDOZ20 MG, 40 MG ENTERIC-COATED TABLETS
NAME OF THE MEDICINE
Esomeprazole is a proton pump inhibitor. The active ingredient in
ESOMEPRAZOLE SANDOZ
is esomeprazole magnesium, 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]-
1H-benzimidazole magnesium salt.
The chemical structure of esomeprazole magnesium is:
CAS number: 161973-10-0
Molecular formula: C
34
H
36
N
6
O
6
S
2
Mg
Molecular weight: 713.12
DESCRIPTION
Esomeprazole magnesium is an off white to slight colured powder,
soluble in N,N-Dimethly
formamide.
Esomeprazole Sandoz 20mg and 40mg tablets are comprised of enteric
coated pellets containing
esomeprazole magnesium as the active ingredient as well as the
following inactive (excipient)
ingredients:
Non-pareil seeds 40-50 (ARTG 108808), hyprolose, crospovidone, sucrose
and maize starch,
magnesium oxide light, purified talc, macrogol 6000, methacrylic acid
- ethyl acrylate copolymer
(1:1),
glyceryl
monostearate,
macrogol
400,
polysorbate
80,
hypromellose
phthalate,
microcrystalline cellulose, iron oxide red, povidone, pregelatinised
maize starch– , silicon dioxide,
lactose monohydrate, OPADRY complete film coating system 03B84893 PINK
(ARTG108603)
(20mg), OPADRY complete film coating system 03B54193 PINK (ARTG
108604) (40mg).
PHARMACOLOGY
Esomeprazole magnesium reversibly reduces gastric acid secretion by
specifically inhibiting the
gastric enzyme H
+
, K
+
-ATPase proton pump in the parietal cell.
Both the R- and S-isomer of
omeprazole have similar pharmacodynamic activity. In humans, acid
control with esomeprazole
is dose dependent and is significantly greater, more sustained and
less variable compared to that
obtained with equal doses of omeprazole.
_Product Information Page 2 _
_Esome