ESOMEPRAZOLE APOTEX esomeprazole magnesium dihydrate 20mg enteric coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

07-03-2022

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

esomeprazole magnesium dihydrate, Quantity: 21.75 mg (Equivalent: esomeprazole, Qty 20 mg)

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Esomeprazole

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: triethyl citrate; purified talc; hypromellose; sodium stearylfumarate; glyceryl monostearate; microcrystalline cellulose; hyprolose; methacrylic acid - ethyl acrylate copolymer (1:1); crospovidone; magnesium stearate; povidone; polysorbate 80; macrogol 6000; titanium dioxide; macrogol 400; iron oxide red; iron oxide yellow; maize starch; sucrose

Administration route:

Oral

Units in package:

7, 100, 14, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

It is indicated for:,Gastro-Oesophageal Reflux Disease (GORD): treatment of erosive reflux oesophagitis, long-term management of patients with healed oesophagitis to prevent relapse and 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 and 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 IV Esomeprazole solution by intravenous infusion (intravenous dosage form can be available from other brands).,Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion, in combination with appropriate antibiotics for: healing of duodenal ulcer associated with Helicobacter pylori and eradication of Helicobacter pylori in patients with active or healed peptic ulcer.

Product summary:

Visual Identification: elliptically shaped, biconvex, light pink enteric coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2014-07-30

Patient Information leaflet

Medis Pharma Pty Ltd
Version 01
1
ESOMEPRAZOLE APOTEX_ _
ESOMEPRAZOLE MAGNESIUM DIHYDRATE_ _
(ES-oh-MEP-ra-zole) -
enteric coated tablets
_ _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions people ask about
ESOMEPRAZOLE APOTEX. It does
not contain all the information that is
known about ESOMEPRAZOLE
APOTEX.
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
APOTEX 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
APOTEX IS USED FOR
_REFLUX OESOPHAGITIS _
_ _
ESOMEPRAZOLE APOTEX 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 APOTEX 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 APOTEX 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 APOTEX 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 APOTEX with
antibi

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Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - ESOMEPRAZOLE APOTEX
(EOMEPRAZOLE (AS MAGNESIUM DIHYDRATE)) 20MG AND 40MG ENTERIC-COATED
TABLET
1.
NAME OF THE MEDICINE
Esomeprazole (as magnesium dihydrate)
2.
QUANTITATIVE AND QUALITATIVE COMPOSITION
The ESOMEPRAZOLE APOTEX 20 mg and 40 mg tablet are enteric coated and
contain
esomeprazole (as magnesium dihydrate).
ESOMEPRAZOLE APOTEX 20 mg tablet: Each enteric-coated tablet contains
esomeprazole
magnesium dihydrate 21.75 mg (equal to 20 mg esomeprazole).
ESOMEPRAZOLE APOTEX 40 mg tablet: Each enteric-coated tablet contains
esomeprazole
magnesium dihydrate 43.50 mg (equal to 40 mg esomeprazole).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
ESOMEPRAZOLE APOTEX 20 mg tablet: light pink, elliptically shaped,
biconvex, enteric coated
tablet.
ESOMEPRAZOLE APOTEX 40 mg tablet: pink, elliptically shaped, biconvex,
enteric-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ESOMEPRAZOLE APOTEX 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 IV
ESOMEPRAZOLE SOLUTION BY INTRAVENOUS INFUSION (INTRAVENOUS DOSAGE FORM
CAN BE AVAILABLE
FROM OTHER BRANDS).
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME AND IDIOPATHIC
HYPERSECRETION

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