PROBITOR omeprazole 20 mg enteric capsule blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

omeprazole, Quantity: 20 mg

Pieejams no:

Sandoz Pty Ltd

Zāļu forma:

Capsule

Kompozīcija:

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

Ievadīšanas:

Oral

Vienības iepakojumā:

6 capsules (sample pack), 28 capsules, 30 capsules, 35 capsules, 7 capsules (sample pack)

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

The relief of heartburn and other symptoms associated with gastro-oesophageal reflux disease (GORD). Treatment and prevention of relapse in erosive oesophagitis. Treatment of duodenal and gastric ulcer. Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter pylori infection. Treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs (NSAIDs). Prevention of gastric and duodenal ulcers and erosions associated with NSAIDs 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 (eg. the elderly) or ineffective. Treatment of Zollinger-Ellison syndrome.

Produktu pārskats:

Visual Identification: Opaque, unprinted capsules with a yellow cap and a yellow body.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorizācija statuss:

Registered

Autorizācija datums:

2002-06-25

Lietošanas instrukcija

PROBITOR
®
1
PROBITOR
®
_omeprazole enteric capsules _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Probitor.
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 PROBITOR IS
USED FOR
The name of your medicine is
Probitor. It contains the active
ingredient omeprazole.
PEPTIC ULCERS
This medicine 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 of the stomach.
Ulcers can be caused by too much
acid being made in the stomach.
This medicine is also used to stop
gastric or duodenal ulcers from
coming back.
REFLUX OESOPHAGITIS
This medicine is used to treat the
symptoms of reflux oesophagitis and
reflux disease. This can be caused by
"washing back" (reflux) of food and
acid from the stomach into the
oesophagus (food pipe).
Reflux can cause a burning sensation
in the chest rising up to the throat,
also known as heartburn.
PEPTIC ULCERS ASSOCIATED WITH
HELICOBACTER PYLORI
Many people who have a peptic ulcer
also have bacteria called
Helicobacter pylori in their stomach.
When Probitor is taken together with
antibiotics, it will help kill the
bacteria and allow your peptic ulcer
to heal. However, it is possible that
the antibiotics might not always be
able to kill Helicobacter pylori. 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. These
medicines are

Produkta apraksts

_Product Information _
_ _
_Page 1 _
_Probitor 20 mg enteric capsules _
_06/2021 _
_ _
AUSTRALIAN PRODUCT INFORMATION
PROBITOR
® (OMEPRAZOLE) ENTERIC CAPSULES
1.
NAME OF THE MEDICINE
Omeprazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Probitor enteric capsule contains omeprazole 20 mg.
_Excipient with known effect:_
Sucrose.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Probitor are enteric-coated, off-white to cream-white spherical
pellets. The pellets are contained
in an opaque yellow cap & body, unprinted, hard gelatin capsules.
Note: Probitor
is available in 20 mg enteric capsules only.
4.
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Probitor enteric capsules are indicated for:
•
The relief of heartburn and other symptoms associated with GORD.
•
Treatment and prevention of relapse in erosive oesophagitis.
•
Treatment of duodenal and gastric ulcer.
•
Combination therapy for the treatment of peptic ulcer disease
associated with
_Helicobacter _
_pylori_
infection.
•
Treatment of gastric and duodenal ulcers and erosions associated with
non-steroidal anti-
inflammatory drugs (NSAIDs).
•
Prevention of gastric and duodenal ulcers and erosions associated with
NSAIDs 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.
•
Treatment of Zollinger-Ellison syndrome.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_SYMPTOMATIC GORD _
_Recommended dose for symptom relief _
Omeprazole 10 mg to 20 mg once daily for a maximum of four weeks.
_Product Information _
_ _
_Page 2 _
_Probitor 20 mg enteric capsules _
_06/2021 _
_ _
In most patients, symptom relief is rapid. If symptom control has not
been achieved after four
weeks treatment with Probitor
20 mg daily, further investigation is recommended.
_EROSIVE OESOPH