OMEPRO-GA omeprazole 20 mg capsules blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

omeprazole, Quantity: 20 mg

Tilgjengelig fra:

Pharmacor Pty Ltd

INN (International Name):

Omeprazole

Legemiddelform:

Capsule

Sammensetning:

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

Administreringsrute:

Oral

Enheter i pakken:

7,14,15,28,30,50,56,60,90,98,100,140,280,&500

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

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.

Produkt oppsummering:

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

Autorisasjon status:

Licence status A

Autorisasjon dato:

2009-07-07

Informasjon til brukeren

October 2019
OMEPRO-GA CAPSULES
OMEPRAZOLE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Omepro-GA. It does not contain all
the information that is known about
Omepro-GA.
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 Omepro-GA
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 OMEPRO-GA IS USED
FOR
REFLUX OESOPHAGITIS
Omepro-GA 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.
Omepro-GA is also taken to help stop
reflux oesophagitis coming back or
relapsing.
PEPTIC ULCERS
Omepro-GA 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.
Omepro-GA 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 Omepro-GA 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 medicine used to treat pain or
inflammation.
Omepro-GA is also used to heal and

Preparatomtale

1
AUSTRALIAN PRODUCT INFORMATION – OMEPRO-GA
(OMEPRAZOLE) CAPSULE
1
NAME OF THE MEDICINE
Omeprazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains omeprazole 20mg
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
T
HERAPEUTIC INDICATIONS
OMEPRO-GA 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 non-steroidal
antiinflammatory drugs.
4.
The prevention of gastric and duodenal ulcers and erosions associated
with non-steroidal
antiinflammatory drugs in patients assessed as being at high risk of
gastroduodenal ulcer or
complications of gastroduodenal ulcer.
2
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
The treatment of Zollinger-Ellison Syndrome.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage
OMEPRO-GA should be swallowed whole (not broken or chewed) with
liquid. It should be noted that
OMEPRO-GA 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 OMEPRO-GA 20 mg daily, further investigation is
recommended.
Erosive oesophagitis
Recommended healing dosage:
Omepra