SEEBRI BREEZHALER glycopyrronium (as bromide) 50 microgram powder for inhalation (in capsule) blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glycopyrronium bromide, Quantity: 63 microgram (Equivalent: glycopyrronium, Qty 50 microgram)

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

glycopyrronium bromide (glycopyrrolate)

Pharmaceutical form:

Inhalation, powder for

Composition:

Excipient Ingredients: hypromellose; carrageenan; potassium chloride; magnesium stearate; purified water; sunset yellow FCF; lactose monohydrate; strong ammonia solution; ethanol absolute; propylene glycol; potassium hydroxide; butan-1-ol; Shellac; iron oxide black; isopropyl alcohol

Administration route:

Inhalation

Units in package:

3 X (30 capsules + 1 device) = 90 capsules + 3 devices, 30 capsules+1 device, 10 capsules + 1 device (sample pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SEEBRI BREEZHALER is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).

Product summary:

Visual Identification: Transparent orange capsules containing a white powder with product code GPL50; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2012-11-12

Patient Information leaflet

SEEBRI
®
BREEZHALER
®
CAPSULES FOR INHALATION
_Glycopyrronium bromide (glycopyrrolate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Seebri Breezhaler.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP-TO-DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP-TO-
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates 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 having Seebri
Breezhaler against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SEEBRI
BREEZHALER IS USED FOR
Seebri capsules are for the treatment
of chronic obstructive pulmonary
disease, also called COPD. COPD is
a serious lung condition that can
cause difficulty in breathing, and
constant coughing. Symptoms of
COPD include shortness of breath,
cough, chest discomfort and
coughing up phlegm.
Seebri capsules for inhalation belong
to a group of medicines called
bronchodilators. These medicines are
used to keep the air passages in the
lungs open and make breathing
easier.
Seebri Breezhaler block tightening of
these muscles in the lungs, making it
easier for air to get in and out of the
lungs.
Seebri capsules for inhalation contain
the active ingredient, glycopyrronium
bromide (glycopyrrolate) in a capsule
form.
The capsules are for oral inhalation
only. The powder from the capsule is
inhaled (breathed into the lungs),
using the Breezhaler
®
inhalation
device provided with the medicine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS AB

Summary of Product characteristics

1
AUSTRALIAN PI – SEEBRI
 BREEZHALER

(GLYCOPYRRONIUM) POWDER FOR INHALATION IN CAPSULE
1
NAME OF THE MEDICINE
_Glycopyrronium bromide is now known as glycopyrrolate. _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEEBRI hard capsules are for oral inhalation only. SEEBRI is also
supplied with a BREEZHALER inhalation
device to permit oral inhalation of the contents of the capsule shell.
Each capsule contains 63 microgram glycopyrronium bromide
(glycopyrrolate) equivalent to 50
microgram glycopyrronium.
The delivered dose (the dose that leaves the mouthpiece of the SEEBRI
BREEZHALER inhaler) is
equivalent to 44 microgram glycopyrronium.
EXCIPIENTS: Lactose monohydrate
For the full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Inhalation powder, hard capsule
Transparent orange capsules containing a white powder, with the
product code GPL50 printed in black
above a black bar and the company logo (
) printed under a black bar.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SEEBRI BREEZHALER is indicated as a once-daily maintenance
bronchodilator treatment to relieve
symptoms of patients with chronic obstructive pulmonary disease
(COPD).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage
The recommended dosage of SEEBRI BREEZHALER is once-daily inhalation
of the content of one 50 μg
SEEBRI capsule using the BREEZHALER inhaler.
Method of administration
SEEBRI
capsules
must
be
administered
only
by
the
oral
inhalation
route
and
only
using
the
BREEZHALER inhaler. SEEBRI capsules must not be swallowed.
2
SEEBRI BREEZHALER is recommended to be administered at the same time
of the day each day. If a
dose is missed, the missed dose should be taken as soon as possible.
Patients should be instructed not
to take more than one dose in a day.
SEEBRI capsules must always be stored in the blister to protect from
moisture, and only removed
IMMEDIATELY BEFORE USE.
Patients who do not experience improvement in breathing should be
asked if they are swallowing the
medicine rather than inhaling it.
When prescribing SEEBR