APO-ESOMEPRAZOLE esomeprazole 20 mg enteric-coated tablets blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

esomeprazole magnesium, Quantity: 20.7 mg (Equivalent: esomeprazole, Qty 20 mg)

Tersedia dari:

Arrotex Pharmaceuticals Pty Ltd

INN (Nama Internasional):

Esomeprazole magnesium

Bentuk farmasi:

Tablet, enteric coated

Komposisi:

Excipient Ingredients: hypromellose phthalate; macrogol 4000; crospovidone; macrogol 6000; macrogol 400; microcrystalline cellulose; sodium stearylfumarate; hyprolose; diethyl phthalate; purified talc; povidone; titanium dioxide; hypromellose; iron oxide red; maize starch; sucrose

Rute administrasi :

Oral

Unit dalam paket:

10, 7, 30, 28

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Gastro-Oesophageal Reflux Disease (GORD),- treatment of erosive reflux oesophagitis,- long-term management of patients with healed oesophagitis to prevent relapse,- symptomatic treatment of gastro-oesophageal reflux disease (GORD),Patients requiring NSAID therapy,- short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy,- healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy,- prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk,Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion,Pathological hypersecretory conditions including Zollinger-Ellison Syndrome and idiopathic hypersecretion,In combination with appropriate antibiotics for:,- healing of duodenal ulcer associated with Helicobacter pylori,- eradication of Helicobacter pylori in patients with active or healed peptic ulcer

Ringkasan produk:

Visual Identification: Light brick red to brown, oval, biconvex, film-coated tablets with 'E5' debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2012-02-09

Selebaran informasi

APO-
ESOMEPRAZOLE
TABLETS
ESOMEPRAZOLE MAGNESIUM
_CONSUMER MEDICINE _
_INFORMATION _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APO-ESOMEPRAZOLE.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of you
taking APO-ESOMEPRAZOLE against
the benefits it is expected to 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 APO-
ESOMEPRAZOLE IS USED
FOR
_ _
_REFLUX OESOPHAGITIS _
APO-ESOMEPRAZOLE 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.
APO-ESOMEPRAZOLE is also taken to
help stop reflux oesophagitis coming back
or relapsing.
_UPPER GASTROINTESTINAL SYMPTOMS _
_ASSOCIATED WITH NON-STEROIDAL _
_ANTI-INFLAMMATORY DRUGS (NSAIDS) _
_THERAPY _
APO-ESOMEPRAZOLE is taken to treat
the symptoms of pain or discomfort in the
stomach caused by NSAIDs, a type of
medicine for pain or inflammation.
APO-ESOMEPRAZOLE 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 APO-ESOMEPRAZOLE with
antibiotics. When APO-ESOMEPRAZOLE
and antibiotics are taken together, they
work to kill the bacterium and let your
ulcer heal. You may need further
treatment with antibiotics.
_ZOLLINGER-ELLISON SYND

Karakteristik produk

Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION
APO-ESOMEPRAZOLE
ESOMEPRAZOLE (AS MAGNESIUM) ENTERIC-COATED TABLETS
1
NAME OF THE MEDICINE
Esomeprazole magnesium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Esomeprazole is a proton pump inhibitor. The active ingredient in
APO-ESOMEPRAZOLE
is esomeprazole magnesium, a substituted benzimidazole.
Each
enteric-coated tablet of
APO-ESOMEPRAZOLE
comprises enteric-coated pellets
with esomeprazole magnesium equivalent to esomeprazole 20 mg or 40 mg.
Contains excipient of known effect: sugars.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
APO-ESOMEPRAZOLE
esomeprazole (as magnesium) 20 mg tablets are light brick red to
brown, oval, biconvex, enteric-coated tablets with
‘E5’
debossed on one side and plain on
other side.
APO-ESOMEPRAZOLE
esomeprazole (as magnesium) 40 mg tablets are light brick red to
brown, oval, biconvex, enteric-coated tablets with
‘E6’
debossed on one side and plain on
other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APO-ESOMEPRAZOLE
is indicated for:
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
−
Treatment of erosive reflux oesophagitis
−
Long-term management of patients with healed oesophagitis to prevent
relapse
−
Symptomatic treatment of gastro-oesophageal reflux disease (GORD)
PATIENTS REQUIRING NSAID THERAPY
−
Short-term treatment of upper gastrointestinal symptoms associated
with non-steroidal
anti-inflammatory drug NSAID (non-selective and COX-2 selective)
therapy.
−
Healing of gastric ulcers associated with non-steroidal
anti-inflammatory drug
NSAID (non-selective and COX-2 selective) therapy
Page 2 of 29
−
Prevention of gastric and duodenal ulcers associated with
non-steroidal anti-
inflammatory drug (NSAID) (non-selective and COX-2 selective) therapy
in patients
at risk.
PREVENTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING
TREATMENT WITH
ESOMEPRAZOLE SOLUTION ADMINISTERED BY INTRAVENOUS INFUSION.
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISO