ESOMEPRAZOLE GH esomeprazole (as magnesium trihydrate) 20 mg enteric-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esomeprazole magnesium trihydrate, Quantity: 22.264 mg (Equivalent: esomeprazole, Qty 20 mg)

Available from:

Lupin Australia Pty Limited

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: purified water; purified talc; crospovidone; light magnesium oxide; hyprolose; macrogol 6000; glyceryl monostearate; methacrylic acid - ethyl acrylate copolymer (1:1); polysorbate 80; silicon dioxide; iron oxide red; pregelatinised maize starch; povidone; microcrystalline cellulose; hypromellose phthalate; macrogol 400; titanium dioxide; hypromellose; iron oxide yellow; maize starch; sucrose

Administration route:

Oral

Units in package:

75 CC HDPE with 38 mm neck (with induction sealing liner) containing molecular sieve desiccant canister) of 30's, HDPE bottle pack (120CC HDPE bottle with 38 mm neck (with induction sealing liner) containing molecular sieve desiccant canister.) of 56's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Esomeprazole enteric-coated tablet indicated for:,1] 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),2] 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.,3] Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion.,4] 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

Product summary:

Visual Identification: Light pink coloured, oblong, biconvex, coated tablets debossed with '20' on one side and 'CE' on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-09-27

Patient Information leaflet

Esomeprazole GH CMI v1
Page 1 of 5
CONSUMER MEDICINE INFORMATION
ESOMEPRAZOLE GH
_ESOMEPRAZOLE MAGNESIUM TRIHYDRATE_
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 docto

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ESOMEPRAZOLE GH
(ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) ENTERIC-COATED TABLETS
1
NAME OF THE MEDICINE
Esomeprazole magnesium trihydrate.
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 trihydrate).
List of excipients with known effect: sugars.
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ESOMEPRAZOLE GH 20 MG ENTERIC-COATED TABLETS:
Light
pink
coloured,
oblong,
biconvex,
coated
tablets debossed with '20' on one side and ‘CE’ on the other.
ESOMEPRAZOLE GH 40 MG ENTERIC-COATED TABLETS:
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):
-
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.
Esomeprazole GH v6
Page 2 of 27
(esomeprazole trihydrate) enteric-coated tablets
•
PATHOLOGICAL
HYPERSECRETORY
CONDITIONS
INCLUDING
ZOLLINGER-ELLISON
SYNDROME
AND
IDIOPATHIC
HYPERSECRETION.
•
IN CO