APO-OMEPRAZOLE 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:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Omeprazole

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:

10 Tablets, 5 Tablets, 30 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:

Licence status A

Authorization date:

2015-08-24

Patient Information leaflet

APO-OMEPRAZOLE
1
APO-OMEPRAZOLE
_Contains the active ingredient omeprazole _
CONSUMER MEDICINE INFORMATION
For a copy of a large print leaflet, Ph: 1800 195 055
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about omeprazole. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Omeprazole. It contains the active
ingredient omeprazole.
It is used to treat:
•
REFLUX OESOPHAGITIS
Omeprazole is used to treat the
symptoms of reflux oesophagitis
or reflux disease. 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.
Omeprazole is also used to help
stop reflux oesophagitis coming
back or relapsing.
•
PEPTIC ULCERS
Omeprazole is used to treat peptic
ulcers. 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.
These ulcers can be caused by too
much acid being made in the
stomach.
Omeprazole is a

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-OMEPRAZOLE (OMEPRAZOLE) ENTERIC COATED
TABLETS
1
NAME OF THE MEDICINE
Omeprazole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric-coated tablet contains 20 mg omeprazole as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
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
GASTROESOPHAGEAL 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, e.g. the
elderly or ineffective.
ZOLLINGER-ELLISON SYNDROME
The treatment of Zollinger-Ellison syndrome.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Omeprazole enteric-coated tablets are intended for oral
administration. They must be
swallowed whole (not broken or chewed) with liquid.
DOSAGE
APO-Omeprazole is only available as 20 mg enteric coated tablet which
must not be broken.
For 10 mg dosing, another brand of omeprazole with a 10 mg dose
strength should be used.
SYMPTOMATIC GORD
Recommended dose for symptom relief: omeprazole 10–20 mg once daily
for a maximum of
4 weeks.
In most patients symptom relief is rapid. If symptom control has not
been achieved after 4
weeks treatment