BRIMICA GENUAIR 340/12 aclidinium bromide and formoterol fumarate dihydrate powder for inhalation dry powder inhaler

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aclidinium bromide, Quantity: 0.4 mg/actuation; formoterol fumarate dihydrate, Quantity: 0.012 mg/actuation

Available from:

A Menarini Australia Pty Ltd

INN (International Name):

aclidinium bromide,formoterol (eformoterol) fumarate dihydrate

Pharmaceutical form:

Inhalation, powder for

Composition:

Excipient Ingredients: lactose monohydrate

Administration route:

Oral

Units in package:

Carton containing 1 inhaler with 30 unit doses, Sample Pack containing 1 inhaler with 30 unit doses, Carton containing 3 inhalers each with 60 unit doses., Carton containing 1 inhaler with 60 unit doses.

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BRIMICA GENUAIR 340/12 is indicated as a long-term twice daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Product summary:

Visual Identification: The inhalation powder is white or almost white, and is delivered from a white inhaler with an integral dose indicator and an orange dosage button.; Container Type: Inhaler - dry powder; Container Material: Plastic; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-05-01

Patient Information leaflet

BRIMICA
® GENUAIR
®
340/12
_aclidinium bromide / formoterol (eformoterol) fumarate dihydrate_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BRIMICA
GENUAIR 340/12.
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 pharmacist or doctor
will be able to advise you about the
risks and benefits of using BRIMICA
GENUAIR 340/12.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BRIMICA
GENUAIR 340/12 IS
USED FOR
BRIMICA GENUAIR 340/12
contains two different medicines
called aclidinium bromide and
formoterol (eformoterol) fumarate
dihydrate.
Both belong to a group of medicines
known as bronchodilators.
Bronchodilators relax airways and
help keep bronchioles open.
BRIMICA GENUAIR 340/12 is a
dry powder inhaler that uses your
breath to deliver the medicine
directly into your lungs. This makes
it easier for chronic obstructive
pulmonary disease (COPD) patients
to breathe.
BRIMICA GENUAIR 340/12 is used
to help open the airways and relieve
symptoms of COPD, a serious long-
term lung disease characterised by
breathing difficulties. Regular use of
BRIMICA GENUAIR 340/12 can
help you when you have ongoing
shortness of breath related to your
disease and will help you to minimise
the effects of the disease on your
everyday life.
BRIMICA GENUAIR 340/12 is
indicated for maintenance treatment
of your COPD; it should not be used
to treat a sudden attack of
breathlessness or wheezing. If your
COPD symptoms (breathlessness,
wheezing, cough) do not improve or
get worse you should contact your
doctor for advice as soon as possible.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY BRIMICA
GENUAIR 340/12 HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor’s prescription.
It is not addictive.
BEFORE YOU USE
BRIMICA GENUAIR
340/12
_WHE

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION –
BRIMICA
® GENUAIR
® 340/12
ACLIDINIUM BROMIDE AND FORMOTEROL (EFORMOTEROL) FUMARATE
DIHYDRATE POWDER FOR INHALATION
_Brimica Genuair PI vA04-0 _
_Page 1_
1
NAME OF THE MEDICINE
aclidinium bromide and formoterol (eformoterol) fumarate dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BRIMICA GENUAIR 340/12 contains an adhesive mixture of micronised
aclidinium bromide,
formoterol (eformoterol) fumarate dihydrate (hereafter referred to as
formoterol (eformoterol))
and α-lactose monohydrate, contained in a metered device, dry powder
inhaler.
Each
metered
dose
is
equal
to
400
micrograms
aclidinium
bromide
(equivalent
to
343 micrograms aclidinium) and 12 micrograms formoterol (eformoterol)
fumarate dihydrate.
Each delivered dose (the dose leaving the mouthpiece) contains 396
micrograms aclidinium
bromide
(equivalent
to
340
micrograms
aclidinium)
and
11.8
micrograms
formoterol
(eformoterol) fumarate dihydrate.
EXCIPIENTS WITH KNOWN EFFECT: Each dose contains lactose monohydrate.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
The inhalation powder is white or almost white, and is delivered from
a white inhaler with an
integral dose indicator and an orange dosage button.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BRIMICA GENUAIR 340/12 is indicated as a long-term twice daily
maintenance bronchodilator
treatment to relieve symptoms in adult patients with chronic
obstructive pulmonary disease
(COPD).
4.2
DOSE AND METHOD OF ADMINISTRATION
Use in adults
The recommended dose is one inhalation of BRIMICA GENUAIR 340/12 twice
daily, once in
the morning and once at night.
Method of Administration
BRIMICA GENUAIR 340/12 must be administered only by the oral
inhalation route. BRIMICA
GENUAIR 340/12 should be administered in the morning and at night and
should be taken
12 hours apart. If a dose is missed the next dose should be taken as
soon as possible.
However, if it is nearly time for the next dose, the missed dose
should be skipped.
Use