NEXOLE esomeprazole magnesium dihydrate 20mg tablet enteric blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
esomeprazole magnesium dihydrate
Available from:
Arrow Pharma Pty Ltd
INN (International Name):
esomeprazole magnesium dihydrate
Authorization status:
Registered
Patient Information leaflet
Medis Pharma Pty Ltd
Version 01
1
NEXOLE_ _
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
enteric coated tablets
_ _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions people ask about
NEXOLE. It does not contain all the
information that is known about
NEXOLE.
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 NEXOLE 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 NEXOLE IS
USED FOR
_REFLUX OESOPHAGITIS _
_ _
NEXOLE 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.
NEXOLE is also taken to help stop
reflux oesophagitis coming back or
relapsing.
_ _
_ _
_UPPER GASTROINTESTINAL SYMPTOMS _
_ASSOCIATED WITH NON-STEROIDAL ANTI-_
_INFLAMMATORY DRUGS (NSAIDS) _
_THERAPY _
_ _
NEXOLE is taken to treat the
symptoms of pain or discomfort, in the
stomach caused by NSAIDs, a type of
medicine for pain or inflammation.
NEXOLE 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 NEXOLE with
antibiotics. When NEXOLE and
antibiotics are taken together, they
work to kill the bacterium and let
your ulcer heal. You may need
further treatment with antibio
Read the complete document
Summary of Product characteristics
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PRODUCT INFORMATION
NEXOLE 20MG AND 40MG ENTERIC-COATED TABLET
NAME OF THE MEDICINE
NEXOLE is a proton pump inhibitor. The active ingredient in NEXOLE is
esomeprazole
magnesium dihydrate, 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-pyridyl)methyl]sulfinyl]-1
_H_
-
benzimidazole]magnesium salt dihydrate.
The chemical structure of esomeprazole magnesium dihydrate is:
2
Mg
2+
. 2H
2
O
CAS number: 217087-10-0
Molecular formula: C
34
H
36
N
6
O
6
S
2
Mg.2H
2
O
Molecular weight: 749.2 (dihydrate)
DESCRIPTION
The NEXOLE 20 mg and 40 mg tablet are enteric coated and contain
esomeprazole (as
magnesium dihydrate). The tablets contain the following inactive
ingredients: methacrylic acid
polymer, purified talc, triethyl citrate, hypromellose, sucrose, maize
starch, magnesium stearate,
hydroxypropyl cellulose, glyceryl monostearate, polysorbate 80,
microcrystalline cellulose,
povidone, macrogol 6000, crospovidone, sodium stearylfumarate,
titanium dioxide, macrogol
400, iron oxide red and iron oxide yellow.
_ _
PHARMACOLOGY
Esomeprazole 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.
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.
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EFFECT ON GASTRIC ACID SECRETION
After oral dosing with esomeprazole 20 mg and 40 mg the onset of
effect occurs within one h
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