OMEPRAZOLE GENERICHEALTH omeprazole 20 mg enteric-coated tablet blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

omeprazole, Quantity: 20 mg

Pieejams no:

Southern Cross Pharma Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Omeprazole

Zāļu forma:

Tablet, enteric coated

Kompozīcija:

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

Ievadīšanas:

Oral

Vienības iepakojumā:

10 Tablets, 5 Tablets, 30 Tablets

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

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.

Produktu pārskats:

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

Autorizācija statuss:

Licence status A

Autorizācija datums:

2015-03-24

Lietošanas instrukcija

CONSUMER MEDICINE INFORMATION
OMEPRAZOLE GENERICHEALTH
(OMEPRAZOLE) ENTERIC-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Omeprazole generichealth.
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
Omeprazole generichealth
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 OMEPRAZOLE
GENERICHEALTH IS USED FOR
_PEPTIC ULCERS _
Omeprazole generichealth 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. Omeprazole
generichealth 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.
Omeprazole generichealth can
be used to heal and prevent
ulcers associated with NSAIDs.
_REFLUX OESOPHAGITIS _
Omeprazole generichealth 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 burnin

Produkta apraksts

AUSTRALIAN PRODUCT INFORMATION – OMEPRAZOLE GENERICHEALTH
(OMEPRAZOLE) ENTERIC-COATED TABLETS
1
NAME OF THE MEDICINE
Omeprazole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in Omeprazole generichealth 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 generichealth v2.2
Page 2 of 18
(omeprazole) enteric-coated tablets
4.2 DOSE AND METHOD OF ADMINISTRATION
_Omeprazole generichealth tablets must be swallowed whole (not broken,
halved or chewed) with liquid. _
_Omeprazole generichealth 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 om