ESOMEPRAZOLE GENERICHEALTH esomeprazole (as magnesium) 40 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)
24-11-2020
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
esomeprazole magnesium
Available from:
Lupin Australia Pty Limited
INN (International Name):
Esomeprazole magnesium
Authorization status:
Registered
Patient Information leaflet
Esomeprazole GH CMI v2 Sep2017
Page 1 of 5
CONSUMER MEDICINE INFORMATION
ESOMEPRAZOLE GH
esomeprazole
What is in this leaflet
This leaflet answers some of
the common questions
people ask about
Esomeprazole GH enteric-
coated tablet. It does not
contain all the information
that is known about
Esomeprazole GH 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 GH
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 GH
is used for
Reflux Oesophagitis
Esomeprazole GH 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 GH 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 GH 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 GH 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 ulcer,
your doctor will prescribe
Esomeprazole GH enteric-
c
Read the complete document
Summary of Product characteristics
AUSTRALIAN PI - ESOMEPRAZOLE GH
(ESOMEPRAZOLE MAGNESIUM) ENTERIC-COATED TABLETS
1
NAME OF THE MEDICINE
Esomeprazole magnesium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Esomeprazole GH (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: Sugar Spheres
(non-pareil seeds 40-50),
hydroxypropylcellulose, crospovidone, sucrose, maize starch, magnesium
oxide-light, purified talc,
macrogol 6000, Methacrylic acid- ethyl acrylate copolymer (1:1),
glycerol monostearate (40-55),
macrogol 400, polysorbate 80, hypromellose phthalate, microcrystalline
cellulose, povidone,
pregelatinised maize starch, silicon dioxide. The 20 mg and 40 mg
tablets are coloured with
titanium dioxide, iron oxide red, and 20mg tablet also contain iron
oxide yellow.
3
PHARMACEUTICAL FORM
ESOMEPRAZOLE GH 20 MG:
Light pink coloured, oblong, biconvex, coated tablets debossed with
'20' on one side and ‘CE’ on the other.
ESOMEPRAZOLE GH 40 MG:
Pink coloured, oblong, biconvex, coated tablets debossed with '40'
on one side and ‘CE’ on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esomeprazole GH (esomeprazole enteric-coated 20 mg and 40 mg tablet)
is indicated for:
•
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD):
o
treatment of erosive reflux oesophagitis.
o
long-term management of patients with healed oesophagitis to prevent
relapse.
o
symptomatic treatment of gastro-oesophageal reflux disease (GORD).
•
PATIENTS REQUIRING NSAID THERAPY:
o
short-term treatment of upper gastrointestinal symptoms associated
with non-steroidal
anti-inflammatory drug NSAID (non-selective and COX-2 selective)
therapy.
o
healing of gastric ulcers associated with non-steroidal
anti-inflammatory drug NSAID (non-
Esomeprazole GH PI v3
Page 2 of 32
selective and COX-2 selective) therapy.
o
prevention of gastric and duodenal ulcers associated with
non-steroidal anti inflammatory
drug NSAID (non-selective and COX
Read the complete document
