APO-OMEPRAZOLE omeprazole 20 mg capsules bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

omeprazole, Quantity: 20 mg

Available from:

Pharmacor Pty Ltd

INN (International Name):

Omeprazole

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: quinoline yellow; purified water; Gelatin; titanium dioxide; sodium lauryl sulfate; dibasic sodium phosphate; mannitol; hypromellose; macrogol 6000; purified talc; polysorbate 80; methacrylic acid copolymer; maize starch; sucrose

Administration route:

Oral

Units in package:

5,7,14,15,28,30,50,56,60,90,100&500

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The relief of heartburn and other symptoms associated with GORD. The treatment and prevention of relapse in erosive oesophagitis. The treatment of duodenal and gastric ulcer. Combination therapy for the treatment of peptic ulcer disease associated with H. 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 H. pylori negative, or in whom eradication is inappropriate, e.g. the elderly or ineffective. The treatment of Zollinger-Ellison syndrome.

Product summary:

Visual Identification: Opaque yellow cap and body No 2 hard gelatin capsules containing off-white (ivory) to cream-white spherical microgranules; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-04-09

Patient Information leaflet

APO-Omeprazole Capsules
1
APO-OMEPRAZOLE
CAPSULES
_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
This leaflet answers some common
questions about this medicine. 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 this medicine
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 THIS MEDICINE IS
USED FOR
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 taken 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 also used to help stop
gastric or duodenal ulcers coming
back.
PEPTIC ULCERS ASSOCIATED WITH
HELICOBACTER PYLORI INFECTION
Most people who have a peptic ulcer
also have a bacterium called
Helicobacter pylori in their stomach.
When omeprazole is taken with
antibiotics, they work to kill the
bacterium and let your ulcer heal.
You may need further treatment with
antibiotics.
PEPTIC ULCERS ASSOCIATED WITH NON-
STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS)
Some peptic ulcers are caused by
taking medicines called non-steroidal
anti-inflammatory drugs (NSAIDs), a
type of me

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-OMEPRAZOLE (OMEPRAZOLE) CAPSULE
1 NAME OF THE MEDICINE
Omeprazole.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains omeprazole 20 mg
Excipients with known effect
Gelatin, sucrose
For the full list of excipients see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Opaque yellow cap and body No 2 hard gelatin capsules containing
enteric coated off-white
(ivory) to cream-white spherical microgranules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-OMEPRAZOLE is indicated for:
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.
Peptic Ulcers
1.
The treatment of duodenal and gastric ulcer.
2.
Combination therapy for the treatment of peptic ulcer disease
associated with
Helicobacter pylori infection.
3.
The treatment of gastric and duodenal ulcers and erosions associated
with nonsteroidal
anti-inflammatory drugs.
4.
The
prevention
of
gastric
and
duodenal
ulcers
and
erosions
associated
with
nonsteroidal 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 Helicobacter pylori negative, or in whom eradication is
inappropriate, e.g. the
elderly or ineffective.
Zollinger-Ellison Syndrome
2
The treatment of Zollinger-Ellison syndrome.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage
APO-OMEPRAZOLE should be swallowed whole (not broken or chewed) with
liquid. It should
be noted that APO-OMEPRAZOLE is only available in 20 mg.
Symptomatic GORD.
Recommended dose for symptom relief:
Omeprazole 10 mg to 20 mg once daily for a maximum of four weeks.
In most patients, symptom relief is rapid. If symptom control has not
been achieved after four
weeks treatment with APO-OMEPRAZOLE 20 mg daily, further investigation
is recommended.
Erosive oesophagitis.
Recommended