Xoterna Breezhaler 85 micrograms/43 micrograms, inhalation powder hard capsules

Country: European Union

Language: English

Source: myHealthbox

Active ingredient:

Indacaterol, Glycopyrronium

Available from:

Novartis Europharm Limited

ATC code:

R03AL04

INN (International Name):

Indacaterol, Glycopyrronium

Dosage:

85 micrograms/43 micrograms

Pharmaceutical form:

Inhalation powder, hard capsule

Administration route:

Inhalation use

Units in package:

6x1, 12x1, 30x1 capsules + 1 inhaler. Multiple packs available.

Prescription type:

Subject to medical prescription

Manufactured by:

Novartis Pharm GmbH

Therapeutic group:

Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics

Therapeutic area:

Pulmonary Disease, Chronic Obstructive

Therapeutic indications:

Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)

Authorization status:

Authorized

Authorization date:

2013-09-19

Patient Information leaflet

 
36 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

XOTERNA BREEZHALER 85 MICROGRAMS/43 MICROGRAMS INHALATION POWDER,
HARD CAPSULES 
Indacaterol/glycopyrronium 

This medicine is subject to additional monitoring.
This will allow quick identification of new 
safety information. You can help by reporting any side effects
you may get. See the end of section 4 
for how to report side effects. 

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 any further questions, ask your doctor,
pharmacist or nurse. 
- 
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,
pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET 

1. 
What Xoterna Breezhaler is and what it is used for 
2. 
What you need to know before you use Xoterna Breezhaler 
3. 
How to use Xoterna Breezhaler 
4. 
Possible side effects 
5. 
How to store Xoterna Breezhaler 
6. 
Contents of the pack and other information 

1. 
WHAT XOTERNA BREEZHALER IS AND WHAT IT IS USED FOR 

WHAT XOTERNA BREEZHALER IS 
This medicine contains two active
substances called indacaterol and glycopyrronium. These belong to 
a group of medicines called bronchodilators. 

WHAT XOTERNA BREEZHALER IS USED FOR 
This medicine 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
blocks the tightening of these muscle

Summary of Product characteristics

 
2 
This medicinal product is subject to additional monitoring. This
will allow quick identification of 
new safety information. Healthcare professionals are asked to
report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 

1. 
NAME OF THE MEDICINAL PRODUCT 

Xoterna Breezhaler 85 micrograms/43 micrograms,
inhalation powder hard capsules 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each capsule contains 143 µg of indacaterol maleate
equivalent to 110 µg of indacaterol and 63 µg of 
glycopyrronium bromide equivalent to 50 µg of glycopyrronium. 

Each delivered dose (the dose that leaves the
mouthpiece of the inhaler) contains 110 µg of indacaterol  
maleate
equivalent to 85 µg of indacaterol and 54 µg of glycopyrronium bromide
equivalent to 43 µg 
of glycopyrronium. 

Excipient(s) with known effect: 
Each capsule contains 23.5 mg lactose (as monohydrate). 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Inhalation powder, hard capsule 

Capsules with transparent yellow cap and
natural transparent body containing a white to almost white 
powder, with the product code “IGP110.50” printed in blue
under two blue bars on the body and the 
company logo ( ) printed in black on the cap. 

4. 
CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 

Xoterna Breezhaler is
indicated as a maintenance bronchodilator treatment to relieve
symptoms 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 capsule once daily using the Xoterna 
Breezhaler inhaler. 

Xoterna Breezhaler is recommended to be administered at the same
time of the day each day. If a dose 
is missed, it s