ESOMEPRAZOLE VIATRIS esomeprazole (as magnesium dihydrate) 40 mg enteric coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

16-03-2021

Summary of Product characteristics (SPC)

18-06-2021

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

esomeprazole magnesium dihydrate, Quantity: 43.5 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

esomeprazole magnesium dihydrate

Pharmaceutical form:

Tablet, enteric coated

Composition:

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

Administration route:

Oral

Units in package:

7, 100, 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, 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:

Licence status A

Authorization date:

2014-07-30

Patient Information leaflet

ESOMEPRAZOLE
MYLAN
_esomeprazole (as magnesium dihydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ESOMEPRAZOLE
MYLAN. 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
ESOMEPRAZOLE MYLAN 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
MYLAN IS USED FOR
_REFLUX OESOPHAGITIS_
ESOMEPRAZOLE MYLAN 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 MYLAN 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 MYLAN 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 MYLAN 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 MYLAN with
antibiotics. When
ESOMEPRAZOLE MYLAN and
antibiotics are taken together, they
work to kill the bacterium and let
your ulcer heal. You may need
further treatment with antibiotics.
_ZOLLIN

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Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ESOMEPRAZOLE MYLAN
_esomeprazole (as magnesium dihydrate) enteric-coated tablet _
1
NAME OF THE MEDICINE
Esomeprazole (as magnesium dihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ESOMEPRAZOLE MYLAN 20 mg tablet: each enteric-coated tablet contains
21.75 mg of esomeprazole
magnesium dihydrate (equal to 20 mg base) as the active ingredient.
ESOMEPRAZOLE MYLAN 40 mg tablet: each enteric-coated tablet contains
43.50 mg of esomeprazole
magnesium dihydrate (equal to 40 mg base) as the active ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ESOMEPRAZOLE MYLAN 20 mg is a light pink, elliptically shaped,
biconvex, enteric-coated tablet.
ESOMEPRAZOLE MYLAN 40 mg is a pink, elliptically shaped, biconvex,
enteric-coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ESOMEPRAZOLE MYLAN 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 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

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