LANZOPRAN lansoprazole 15 mg capsule strip pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lansoprazole, Quantity: 15 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Lansoprazole

Pharmaceutical form:

Capsule

Composition:

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

Administration route:

Oral

Units in package:

28 and 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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 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.

Product summary:

Visual Identification: Yellow cap/yellow body, self-locked hard gelatine capsules of size '3' imprinted 'L15' on both cap and body, containing white to off-white pellets; Container Type: Strip Pack; Container Material: Other composite material; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2010-02-12

Summary of Product characteristics

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
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4.2
D
OSE AND METHOD OF ADMINISTRATION
LANZOPRAN capsules contain15 or 30 mg of lansoprazole as
enteric-coated delayed release
capsules.
To achieve