LANSOPRAZOLE ODT GH lansoprazole 15 mg orally disintegrating tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lansoprazole, Quantity: 15 mg

Available from:

Lupin Australia Pty Limited

INN (International Name):

Lansoprazole

Pharmaceutical form:

Tablet, orally disintegrating

Composition:

Excipient Ingredients: mannitol; citric acid; hypromellose; aspartame; microcrystalline cellulose; methacrylic acid - ethyl acrylate copolymer (1:1); titanium dioxide; iron oxide yellow; triethyl citrate; purified talc; purified water; magnesium carbonate hydrate; polysorbate 80; hyprolose; polyacrylate dispersion (30 per cent); magnesium stearate; glyceryl monostearate; crospovidone; iron oxide red; macrogol 6000; xylitol; calcium hydrogen phosphate; Flavour

Administration route:

Oral

Units in package:

Alu/Alu blister (with Peelable Al foil) 7's and 28's, Alu/Alu blister (with push through Al foil) 7's and 28's, Cold form dessicant blister (with Peelable Al foil) 7's and 28's, Cold form dessicant blister (with push through Al foil) 7's and 28's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults:,1.Healing and long-term management of reflux oesophagitis.,2.Healing and long-term management for patients with duodenal ulcer.,3.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.,4.Lansoprazole is also effective in patients with benign peptic lesions that do not respond to H2-receptor antagonists.,5.Eradication of H. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics (see Clinical Trials).,6.Relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia.,Paediatric patients 6 to 17 years of age.,1.Treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis.,2.Healing of erosive oesophagitis.

Product summary:

Visual Identification: White to yellowish white uncoated tablets,speckled with orange to dark brown pellets debossed with 'I5' on one side and plain on the other side; 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

Authorization status:

Licence status A

Authorization date:

2014-11-19

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
LANSOPRAZOLE ODT GH
(LANSOPRAZOLE) ORALLY DISINTEGRATING TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Lansoprazole ODT GH. It does
not contain all 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
Lansoprazole ODT GH against
the benefits this medicine is
expected to have.
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 LANSOPRAZOLE ODT
GH IS USED FOR
_PEPTIC ULCERS _
Lansoprazole ODT GH 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.
Too much acid being made in
the stomach can cause these
ulcers. Lansoprazole ODT GH is
also used to help stop duodenal
ulcers from coming back.
_REFLUX OESOPHAGITIS _
Lansoprazole ODT GH is used
to treat the symptoms of reflux
oesophagitis or reflux disease in
adults and in children from 6 to
17 years of age.
This can be caused by backflow
(reflux) of food and acid from the
stomach into the food pipe or
gullet, also known as the
oesophagus.
Reflux can cause a burning
sensation in the chest rising up
to the throat, also known as
heartburn.
_HEARTBURN AND STOMACH _
_PAIN ASSOCIATED WITH _
_REFLUX OR PEPTIC ULCER _
Lansoprazole ODT GH is used
for the short-term treatment of
heartburn and peptic ulcer
symptoms in adults.
_PEPTIC ULCERS ASSOCIATED _
_WITH HELICOBACTER PYLORI _
_INFECTION _
Most people who have a peptic
ulcer also have bacteria called
_Helicobacter pylori_ in their
stomach. Lansoprazole ODT GH
can be taken in conjunction with
certain antibiotics to help
eradicate _Helicobacter pylori_
and let your peptic ulcer heal.
However, it is possible that the
antibiotics may not always

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – LANSOPRAZOLE ODT GH
(LANSOPRAZOLE) ORALLY DISINTEGRATING TABLET
1
NAME OF THE MEDICINE
Lansoprazole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lansoprazole ODT GH contains 15 mg or 30 mg of lansoprazole.
List of excipients with known effects: aspartame.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Lansoprazole ODT GH 15 mg: White to yellowish white, uncoated tablets
speckled with orange to dark
brown pellets, with “I5” debossed on one side of the tablet and
plain on the other side.
Lansoprazole ODT GH 30 mg: White to yellowish white, uncoated tablets
speckled with orange to dark
brown pellets debossed with “30” on one side and plain on the
other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
•
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 (NSAIDs) require
treatment with antimicrobial
agents in addition to antisecretory drugs whether on first
presentation or on recurrence.
•
Lansoprazole ODT GH is also effective in 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 (see
SECTION 5.1 PHARMACODYNAMIC
PROPERTIES – CLINICAL TRIALS).
•
Relief of reflux-like and/or ulcer-like symptoms associated with
acid-related dyspepsia.
PAEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE
•
Treatment of gastro-oesophageal reflux disease (GORD), including all
grades of oesophagitis.
•
Healing of erosive oesophagitis.
Lansoprazole ODT GH v8
Page 2 of 17
(lansoprazole) orally disintegrating tablet
4.2 DOSE AND METHOD OF ADMINISTRATION
For oral administration.
Lansoprazole ODT GH is strawberry f