PHARMACOR OMEPRAZOLE omeprazole 20 mg capsule bottle

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

omeprazole, Quantity: 20 mg

可用日期:

Pharmacor Pty Ltd

INN（国际名称）:

Omeprazole

药物剂型:

Capsule

组成:

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

给药途径:

Oral

每包单位数:

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

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

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.

產品總結:

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

授权状态:

Licence status A

授权日期:

2010-04-09

资料单张

October 2019
PHARMACOR OMEPRAZOLE CAPSULES
OMEPRAZOLE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Pharmacor Omeprazole. It does not
contain all the information that is
known about Pharmacor Omeprazole.
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 Pharmacor
Omeprazole 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 PHARMACOR
OMEPRAZOLE IS USED FOR
REFLUX OESOPHAGITIS
Pharmacor 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.
Pharmacor Omeprazole is also taken
to help stop reflux oesophagitis
coming back or relapsing.
PEPTIC ULCERS
Pharmacor 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.
Pharmacor 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 Pharmacor 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-inflammat

产品特点

1
AUSTRALIAN PRODUCT INFORMATION –
PHARMACOR OMEPRAZOLE (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
PHARMACOR 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 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
PHARMACOR OMEPRAZOLE should be swallowed whole (not broken or chewed)
with liquid. It should
be noted that PHARMACOR 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 PHARMACOR OMEPRAZOLE 20 mg daily, further investigation
is recommended.