Hirobriz Breezhaler

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

indacaterol maleate

Available from:

Novartis Europharm Limited

ATC code:

R03AC18

INN (International Name):

indacaterol

Therapeutic group:

Drugs for obstructive airway diseases,

Therapeutic area:

Pulmonary Disease, Chronic Obstructive

Therapeutic indications:

Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Product summary:

Revision: 18

Authorization status:

Authorised

Authorization date:

2009-11-30

Patient Information leaflet

56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE USER
HIROBRIZ BREEZHALER 150 MICROGRAM INHALATION POWDER, HARD CAPSULES
HIROBRIZ BREEZHALER 300 MICROGRAM INHALATION POWDER, HARD CAPSULES
indacaterol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Hirobriz Breezhaler is and what it is used for
2.
What you need to know before you use Hirobriz Breezhaler
3.
How to use Hirobriz Breezhaler
4.
Possible side effects
5.
How to store Hirobriz Breezhaler
6.
Contents of the pack and other information
1.
WHAT HIROBRIZ BREEZHALER IS AND WHAT IT IS USED FOR
WHAT HIROBRIZ BREEZHALER IS
Hirobriz Breezhaler contains the active substance indacaterol which
belongs to a group of medicines
called bronchodilators. When you inhale it, it relaxes the muscles in
the walls of the small air passages
in the lungs. This helps open up the airways, making it easier to get
air in and out.
WHAT HIROBRIZ BREEZHALER IS USED FOR
Hirobriz Breezhaler is used to make breathing easier for adult
patients who have breathing difficulties
due to a lung disease called chronic obstructive pulmonary disease
(COPD). In COPD the muscles
around the airways tighten. This makes breathing difficult. This
medicine relaxes these muscles in the
lungs, making it easier for air to get in and out of the lungs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HIROBRIZ BREEZHALER
DO NOT USE HIROBRIZ BREEZHALER
-
if you are allergic to indacaterol or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains indacaterol maleate equivalent to 150 microgram
indacaterol.
The delivered dose leaving the mouthpiece of the inhaler is
indacaterol maleate equivalent to
120 microgram indacaterol.
Excipient with known effect
Each capsule contains 24.8 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule
Transparent (uncoloured) capsules containing a white powder, with
“IDL 150” printed in black above
a black bar and company logo (
) printed in black below the black bar.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hirobriz Breezhaler is indicated for maintenance bronchodilator
treatment of airflow obstruction in
adult patients with chronic obstructive pulmonary disease (COPD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is the inhalation of the content of one 150
microgram capsule once a day,
using the Hirobriz Breezhaler inhaler. The dose should only be
increased on medical advice.
The inhalation of the content of one 300 microgram capsule once a day,
using the Hirobriz Breezhaler
inhaler has been shown to provide additional clinical benefit with
regard to breathlessness, particularly
for patients with severe COPD. The maximum dose is 300 microgram once
daily.
Hirobriz Breezhaler should be administered at the same time of the day
each day.
If a dose is missed the next dose should be taken at the usual time
the next day.
_Special populations _
_Elderly population_
Maximum plasma concentration and overall systemic exposure increase
with age but no dose
adjustment is required in elderly patients.
_Hepatic impairment _
No dose adjustment is required for patients with mild and moderate
hepatic impairment. There are no
data available for use of Hirobriz Breezhaler in patients with severe
hepatic impairment.
3
_Renal impair