Onbrez Breezhaler 150microgram inhalation powder capsules with device

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indacaterol maleate

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

R03AC18

INN (International Name):

Indacaterol maleate

Dosage:

150microgram

Pharmaceutical form:

Inhalation powder

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010101; GTIN: 5010678915013

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ONBREZ
® BREEZHALER
® 150 MICROGRAM INHALATION POWDER, HARD CAPSULES
ONBREZ
® 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 Onbrez Breezhaler is and what it is used for
2.
What you need to know before you use Onbrez Breezhaler
3.
How to use Onbrez Breezhaler
4.
Possible side effects
5.
How to store Onbrez Breezhaler
6.
Contents of the pack and other information
1.
WHAT ONBREZ BREEZHALER IS AND WHAT IT IS USED FOR
WHAT ONBREZ BREEZHALER IS
Onbrez 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 ONBREZ BREEZHALER IS USED FOR
Onbrez 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 ONBREZ BREEZHALER
DO NOT USE ONBREZ 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 doctor or pharmacist before using Onbr

Summary of Product characteristics

OBJECT 1
ONBREZ BREEZHALER 300 MICROGRAM INHALATION
POWDER, HARD CAPSULES
Summary of Product Characteristics Updated 11-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Onbrez
®
Breezhaler
®
150 microgram inhalation powder, hard capsules
Onbrez
®
Breezhaler
®
300 microgram inhalation powder, hard capsules
2. Qualitative and quantitative composition
_ONBREZ BREEZHALER 150 MICROGRAM INHALATION POWDER, HARD CAPSULES: _
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.
_ONBREZ BREEZHALER 300 MICROGRAM INHALATION POWDER, HARD CAPSULES: _
Each capsule contains indacaterol maleate equivalent to 300 microgram
indacaterol.
The delivered dose leaving the mouthpiece of the inhaler is
indacaterol maleate equivalent to 240
microgram indacaterol.
Excipient with known effect:
Each capsule contains 24.6 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Inhalation powder, hard capsule
_ONBREZ BREEZHALER 150 MICROGRAM INHALATION POWDER, HARD CAPSULES: _
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.
_ONBREZ BREEZHALER 300 MICROGRAM INHALATION POWDER, HARD CAPSULES: _
Transparent (uncoloured) capsules containing a white powder, with "IDL
300" printed in blue above a
blue bar and company logo (
) printed in blue below the blue bar.
4. Clinical particulars
4.1 Therapeutic indications
Onbrez 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 Onbrez Breezhaler inhaler. Th