APO-LANSOPRAZOLE ODT lansoprazole 15 mg orally disintegrating tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Buy It Now

Patient Information leaflet (PIL)

14-12-2021

Summary of Product characteristics (SPC)

06-12-2021

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

lansoprazole, Quantity: 15 mg

Available from:

Lupin Australia Pty Limited

INN (International Name):

Lansoprazole

Pharmaceutical form:

Tablet, orally disintegrating

Composition:

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

Administration route:

Oral

Units in package:

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

APO-LANSOPRAZOLE ODT®
1
APO-LANSOPRAZOLE ODT
_Lansoprazole _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APO-Lansoprazole
ODT. 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 THIS MEDICINE IS
USED FOR
PEPTIC ULCERS
APO-Lansoprazole ODT 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.
APO-Lansoprazole ODT is also used
to help stop duodenal ulcers from
coming back.
REFLUX OESOPHAGITIS
APO-Lansoprazole ODT 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
APO-Lansoprazole ODT 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.
APO-Lansoprazole ODT 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
antibiotic

Read the complete document

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – APO-LANSOPRAZOLE ODT
(LANSOPRAZOLE) ORALLY DISINTEGRATING TABLET
1
NAME OF THE MEDICINE
Lansoprazole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each APO-Lansoprazole ODT 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
APO-Lansoprazole ODT 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.
APO-Lansoprazole ODT 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.
•
APO-Lansoprazole ODT 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.
APO-Lansoprazole ODT v8
Page 2 of 17
(lansoprazole) orally disintegrating tablet
4.2 DOSE AND METHOD OF ADMINISTRATION
For oral administration.
APO-Lansoprazole ODT is strawberry fl

Read the complete document