ESOMEPRAZOLE SZ esomeprazole (as magnesium) 20 mg enteric-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
20-10-2017
Active ingredient:
esomeprazole magnesium
Available from:
Sandoz Pty Ltd
INN (International Name):
Esomeprazole magnesium
Authorization status:
Registered
Patient Information leaflet
ESOMEPRAZOLE SZ
1
ESOMEPRAZOLE SZ
_esomeprazole (as magnesium) enteric-coated tablet _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Esomeprazole SZ enteric-coated
tablet. It does not contain all the
information that is known about
Esomeprazole SZ enteric-coated
tablet.
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 SZ enteric-coated
tablet 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
SZ ENTERIC-COATED
TABLET IS USED FOR
_REFLUX OESOPHAGITIS _
Esomeprazole SZ enteric-coated
tablet 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 SZ enteric-coated
tablet 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 SZ enteric-coated
tablet 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 SZ enteric-coated
tablet 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 ulc
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Summary of Product characteristics
_Product Information Page 1 _
_Esomeprazole SZ 20 mg and 40 mg enteric coated tablets _
_10/2017 _
Sandoz Pty Ltd
Version 01
PRODUCT INFORMATION
ESOMEPRAZOLE SZ 20 MG AND 40 MG ENTERIC COATED TABLETS
NAME OF MEDICINE
Esomeprazole magnesium
Esomeprazole SZ (esomeprazole enteric-coated tablet) is a proton pump
inhibitor. The active ingredient in
Esomeprazole SZ (esomeprazole enteric-coated tablet) is esomeprazole
magnesium amorphous, 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.
The chemical structure of esomeprazole magnesium amorphous is:
CAS number: [161973-10-0]
Molecular formula: C
34
H
36
N
6
O
6
S
2
Mg
Molecular weight: 713.12 (amorphous)
DESCRIPTION
Esomeprazole SZ (esomeprazole enteric-coated 20 mg and 40 mg tablets)
is comprised of enteric-coated
pellets containing esomeprazole (as magnesium amorphous). The tablets
contain the following inactive
ingredients: Non Pareil seeds 40-50 (which contain maize starch and
sucrose), hypolose, crospovidone,
sucrose, light magnesium oxide, purified talc, macrogol 6000,
Methacrylic acid- ethyl acrylate copolymer
(1:1), glyceryl monostearate, macrogol 400, polysorbate 80,
hypromellose phthalate, microcrystalline
cellulose, povidone, pregelatinised maize starch, silicon dioxide,
hypromellose and lactose monohydrate.
The 20 mg and 40 mg tablets are coloured with titanium dioxide, iron
oxide red, and 20mg tablet also
contain iron oxide yellow.
PHARMACOLOGY
Esomeprazole magnesium amorphous 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 obta
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