OZMEP omeprazole 20 mg enteric-coated tablet blister

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

omeprazole, Quantity: 20 mg

Pieejams no:

Medis Pharma Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Omeprazole

Zāļu forma:

Tablet, enteric coated

Kompozīcija:

Excipient Ingredients: purified talc; hypromellose; iron oxide red; Carnauba Wax; sodium stearylfumarate; iron oxide yellow; titanium dioxide; sodium stearate; sodium lauryl sulfate; hypromellose acetate succinate; sodium starch glycollate; propylene glycol; lactose monohydrate; triethyl citrate; monoethanolamine

Ievadīšanas:

Oral

Vienības iepakojumā:

30 tablets

Klase:

Medicine Registered

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

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 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. . Zollinger-Ellison syndrome: The treatment of Zollinger-Ellison syndrome

Produktu pārskats:

Visual Identification: Brownish, capsule-shaped film coated tablets with a debossment of "20" on one side; 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:

2009-05-26

Lietošanas instrukcija

OZMEP ENTERIC-COATED TABLETS
_contains the active ingredient omeprazole _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ozmep.
It does not contain all of the
available information. It does
not take the place of talking
to your doctor or pharmacist.
All medicines have benefits
and risks. Your doctor has
weighed the risks of you
taking Ozmep against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it
again.
WHAT OZMEP IS USED
FOR
PEPTIC ULCERS
Ozmep tablets are 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. Ozmep 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 non-steroidal anti-
inflammatory drugs. These
medicines are commonly
taken to treat arthritis and
other inflammatory
conditions.
Ozmep can be used to heal
and prevent ulcers associated
with NSAIDs.
REFLUX OESOPHAGITIS
Ozmep 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 burning
sensation in the chest rising
up to the throat, also known
as heartburn.
ZOLLINGER-ELLISON SYNDROME
Ozmep is used to treat this
rare conditi

Produkta apraksts

AUSTRALIAN PRODUCT INFORMATION - OZMEP (OMEPRAZOLE) ENTERIC-COATED
TABLETS
1.
NAME OF THE MEDICINE
Omeprazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ozmep enteric-coated tablets contain 20mg of omeprazole.
Excipients with known effect: Contains sugars as lactose.
For the full list of excipients, see Section 6.1
LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
Ozmep 20mg enteric-coated tablets are brown capsule-shaped tablets
debossed with “20” on one
side.
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
_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.
ZOLLINGER-ELLISON SYNDROME
The treatment of Zollinger-Ellison syndrome.
_ Ozmep 20 mg tablets _
_Product Information _
_ _
Ozmep PI Sept 21 Page 2 of 18
4.2
DOSE AND METHOD OF ADMINISTRATION
Ozmep tablets must be swallowed whole (not broken, halved or chewed)
with liquid. Ozmep 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 omeprazole 10 to 20mg once
daily for a maximum of
four weeks.
In most patients symptom relief is rapid. If symptom c