LANZOPRAN lansoprazole 30 mg capsule blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

lansoprazole, Quantity: 30 mg

Fáanlegur frá:

Sun Pharma ANZ Pty Ltd

INN (Alþjóðlegt nafn):

Lansoprazole

Lyfjaform:

Capsule

Samsetning:

Excipient Ingredients: methacrylic acid - ethyl acrylate copolymer (1:1); hypromellose; indigo carmine; colloidal anhydrous silica; titanium dioxide; maize starch; purified talc; macrogol 300; sucrose; carmoisine; Gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid

Stjórnsýsluleið:

Oral

Einingar í pakka:

28 and 30

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Adults:. LANZOPRAN capsules are indicated for. - Healing and long-term management of reflux oesophagitis. . - Healing and long-term management for patients with duodenal ulcer.. - Healing of benign gastric ulcer. Patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. . - Patients with benign peptic lesions that do not respond to H2-receptor antagonists.. - Eradication of H. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics. . - Relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia. . Paediatric and adolescent patients I to 17 years of age:. LANZOPRAN capsules are indicated for. - Treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. . - Healing of erosive oesophagitis.

Vörulýsing:

Visual Identification: Purple cap/lavender body, self-locked hard gelatin capsules of size '1' imprinted 'L30' on both cap and body, containing white to off-white pellets; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Leyfisstaða:

Licence status A

Leyfisdagur:

2010-02-12

Upplýsingar fylgiseðill

LANZOPRAN
®
_Lansoprazole_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
LANZOPRAN.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
This leaflet was last updated on
the date at the end of this leaflet.
More recent information may be
available. The latest Consumer
Medicine Information is available
from https://www.ebs.tga.gov.au/
and may contain important
information about the medicine
and its use of which you should be
aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
LANZOPRAN against the benefits
it is expected to 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 LANZOPRAN IS
USED FOR
The name of your medicine is
LANZOPRAN.
LANZOPRAN contains
lansoprazole as active ingredient.
Lansoprazole belongs to a group
of medicines called proton pump
inhibitors (PPIs). Lansoprazole
works by decreasing the amount of
acid the stomach makes, to give
relief from the symptoms and allow
healing to take place.
REFLUX OESOPHAGITIS
(INFLAMMATION OF OESOPHAGUS):
LANZOPRAN is used to treat the
symptoms of reflux oesophagitis or
reflux disease in adults and in
children from 1 to 17 years of age.
This can be caused by backflow
(reflux) of food and acid from the
stomach into the food pipe, also
known as the oesophagus. Reflux
can cause a burning sensation in
the chest rising up to the throat,
also known as heart burn.
PEPTIC ULCERS (ULCERS OF
STOMACH OR DUODENUM):
LANZOPRAN is used to treat
peptic ulcers in adults. 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. These
can be caused in part by too much
acid being made in the stomach.
LANZOPRAN is also used to stop
duodenal ulcers from c

Vara einkenni

AUSTRALIAN PRODUCT INFORMATION – LANZOPRAN
(LANSOPRAZOLE) CAPSULES
1
NAME OF THE MEDICINE
Lansoprazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each LANZOPRAN capsule contains enteric-coated delayed release pellets
with 15 mg or 30 mg
of lansoprazole.
Contains excipients with known effects: sucrose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
LANZOPRAN 15 mg capsules - Yellow cap/yellow body, self-locked hard
gelatin capsules of size
‘3’ imprinted with ‘L 15’ on both cap and body, containing
white to off-white pellets.
LANZOPRAN 30 mg capsules - Purple cap/lavender body, self-locked hard
gelatin capsules of
size ‘1’ imprinted with ‘L 30’ on both cap and body,
containing white to off-white pellets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_ADULTS _
LANZOPRAN capsules are indicated for
•
Healing and long-term management of reflux oesophagitis.
•
Healing and long-term management for patients with duodenal ulcer.
•
Healing of benign gastric ulcer. Patients whose gastric or duodenal
ulcer is not
associated with ingestion of non-steroidal anti-inflammatory drugs
require treatment
with antimicrobial agents in addition to antisecretory drugs whether
on first
presentation or on recurrence.
•
Patients with benign peptic lesions that do not respond to H2-receptor
antagonists.
•
Eradication of _H. pylori_ from the upper gastrointestinal tract in
patients with peptic
ulcer or chronic gastritis when used in combination with appropriate
antibiotics.
•
Relief of reflux-like and/or ulcer-like symptoms associated with
acid-related dyspepsia.
_PAEDIATRIC AND ADOLESCENT PATIENTS 1 TO 17 YEARS OF AGE _
LANZOPRAN capsules are indicated for
•
Treatment of gastro-oesophageal reflux disease, including all grades
of oesophagitis.
•
Healing of erosive oesophagitis.
Lanzopran PI v6 Sep 2019
Page 1 of 14
4.2
D
OSE AND METHOD OF ADMINISTRATION
LANZOPRAN capsules contain15 or 30 mg of lansoprazole as
enteric-coated delayed release
capsules.
To achieve