MAXOR EC TABS omeprazole 20 mg enteric-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

omeprazole, Quantity: 20 mg

Available from:

Southern Cross Pharma Pty Ltd

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: iron oxide black; microcrystalline cellulose; povidone; iron oxide red; crospovidone; purified talc; lactose monohydrate; hypromellose phthalate; magnesium stearate; triacetin; ascorbyl palmitate

Administration route:

Oral

Units in package:

30 tablets, 10 tablets, 5 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Omeprazole Tablets are indicated for: A. Gastro-Oesophageal Reflux Disease (GORD): 1. Symptomatic GORD: The relief of heartburn and other symptoms associated with GORD. 2. Erosive Oesophagitis: The treatment and prevention of relapse. B. Peptic Ulcers: 1. The treatment of duodenal and gastric ulcer. 2. Combination therapy for the treatment of peptic ulcer disease associated with Heliobacter pylori infection. 3. The treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. The prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. Long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be Heliobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. C. Zollinger-Ellison Syndrome: The treatment of Zollinger-Ellison Syndrome.

Product summary:

Visual Identification: Red brown, oblong, enteric coated tablets.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-11-03

Patient Information leaflet

MAXOR EC TABS
1
MAXOR EC TABS
_omeprazole _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Maxor EC Tabs. 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 Maxor EC
Tabs 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 MAXOR EC TABS
IS USED FOR
PEPTIC ULCERS
Maxor EC Tabs is used to treat
peptic ulcers and also to help prevent
them from coming back.
These ulcers can be caused by the
stomach producing too much acid.
Depending on the location of the
ulcer it is called a gastric or duodenal
ulcer. A gastric ulcer occurs in the
stomach and a duodenal ulcer occurs
in the tube leading out of the
stomach, also known as the
duodenum.
PEPTIC ULCERS ASSOCIATED WITH
HELICOBACTER PYLORI INFECTION
Most people with a peptic ulcer have
been found to have the bacteria
Helicobacter pylori in their stomach.
Maxor EC Tabs taken together with
two antibiotics will kill the bacteria
and let your ulcer heal. It is possible
that the antibiotics may not always
kill Helicobacter pylori.
PEPTIC ULCERS ASSOCIATED WITH NON-
STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS)
Some peptic ulcers are caused by
taking medicines known as
nonsteroidal anti-inflammatory
drugs. These medicines are
commonly taken to treat arthritis and
other inflammatory conditions.
Maxor EC Tabs can be used to heal
and prevent ulcers associated with
NSAIDs.
REFLUX OESOPHAGITIS
Maxor EC Tabs is used to treat and
prevent the symptoms of reflux
oesophagitis. This condition is
caused by the washing back, or
reflux, of food and acid from the
stomach into the oesophagus.
Symptoms include a burning
sensation in the chest rising up to the
throat, also known as heartburn.
Maxor EC Tabs is also taken to help
stop ref

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – MAXOR EC TABS
(OMEPRAZOLE) ENTERIC-COATED TABLETS
1
NAME OF THE MEDICINE
Omeprazole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in Maxor EC Tabs 20 mg enteric-coated tablets is
omeprazole.
Each tablet contains 20 mg of omeprazole.
List of excipients with known effects: sugars as lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Red brown, oblong, enteric -coated tablet.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD_) _
•
_Symptomatic GORD: _The relief of heartburn and other symptoms
associated with GORD.
•
_Erosive oesophagitis: _The treatment and prevention of relapse.
PEPTIC ULCERS
•
The treatment of duodenal and gastric ulcer.
•
Combination therapy for the treatment of peptic ulcer disease
associated with _Helicobacter pylori _
infection.
•
The treatment of gastric and duodenal ulcers and erosions associated
with non-steroidal anti-
inflammatory drugs.
•
The prevention of gastric and duodenal ulcers and erosions associated
with non-steroidal anti-
inflammatory
drugs
in
patients
assessed
as
being
at
high
risk
of
gastroduodenal
ulcer
or
complications of gastroduodenal ulcer.
•
Long-term prevention of relapse in gastric and duodenal ulceration, in
patients proven to be
_Helicobacter pylori _negative, or in whom eradication is
inappropriate, eg. the elderly or ineffective.
ZOLLINGER-ELLISON SYNDROME
The treatment of Zollinger-Ellison syndrome.
Omeprazole mylan v2
Page 2 of 18
(omeprazole) enteric-coated tablets
4.2 DOSE AND METHOD OF ADMINISTRATION
_Maxor EC Tabs tablets must be swallowed whole (not broken, halved or
chewed) with liquid. Maxor EC _
_Tabs is only available as 20 mg strength. For 10 mg dosing, other
brands of omeprazole available as the _
_10 mg strength should be used. _
ADULTS
Symptomatic gastro-oesophageal reflux disease (GORD)
Recommended dose for symptom relief is omeprazole 10 mg to 20mg once
daily for a maximum of fou