APO-LANSOPRAZOLE lansoprazole 30 mg capsule strip pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lansoprazole, Quantity: 30 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Lansoprazole

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: indigo carmine; Gelatin; hypromellose; macrogol 300; purified talc; maize starch; methacrylic acid - ethyl acrylate copolymer (1:1); titanium dioxide; sucrose; carmoisine; colloidal anhydrous silica; 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:. APO-LANSOPRAZOLE 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:. APO-LANSOPRAZOLE capsules are indicated for. - Treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. . - Healing of erosive oesophagitis.

Product summary:

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: 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:

Registered

Authorization date:

2010-02-12

Patient Information leaflet

APO-LANSOPRAZOLE CAPSULES
1
APO-LANSOPRAZOLE
CAPSULES
_Contains the active ingredient 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 lansoprazole. 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
The name of your medicine is APO-
Lansoprazole. It contains the active
ingredient lansoprazole.
In adults it is used to treat:
•
reflux oesophagitis
•
peptic ulcers
•
Helicobacter pylori infection in
patients with peptic ulcer or
chronic gastritis
•
reflux-like and/or ulcer-like
symptoms associated with acid-
related dyspepsia
In children aged 1-17 years of age it
is used to treat:
•
gastro-oesophageal reflux
disease, including all grades of
oesophagitis
•
erosive oesophagitis
Lansoprazole belongs to a group of
medicines called proton pump
inhibitors (PPIs). It works by
decreasing the amount of acid the
stomach makes, to give relief from
excessive acid and allow healing to
take place.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE ALLERGY TO:
•
lansoprazole or other proton
pump inhibitors
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, cough,
wheezing or difficulty

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-LANSOPRAZOLE (LANSOPRAZOLE) CAPSULES
1
NAME OF THE MEDICINE
Lansoprazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each APO-Lansoprazole enteric capsule contains enteric-coated delayed
release pellets with
15 mg or 30 mg of lansoprazole.
EXCIPIENTS WITH KNOWN EFFECT
Contains sugars as sucrose. Contains sulfites.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-LANSOPRAZOLE 15 MG ENTERIC 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.
APO-LANSOPRAZOLE 30 MG ENTERIC 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
THERAPEUTIC INDICATIONS
ADULTS
APO-Lansoprazole enteric 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 H
2
-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.
2
PAEDIATRIC AND ADOLESCENT PATIENTS 1 TO 17 YEARS OF AGE
APO-Lansoprazole enteric capsules are indicated for:
•
Treatment
of
gastro-oesophageal
reflux
disease,
including
all
grades
of
oesophagitis.
•
Healing of erosive oesophagitis.
4.2
DOSE AND METHOD