Xoterna Breezhaler
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
07-09-2021
Fachinformation
(SPC)
07-09-2021
Öffentlichen Beurteilungsberichts
(PAR)
04-10-2013
Wirkstoff:
indacaterol, Glycopyrronium bromide
Verfügbar ab:
Novartis Europharm Limited
ATC-Code:
R03AL04
INN (Internationale Bezeichnung):
indacaterol, glycopyrronium bromide
Therapiegruppe:
Adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids
Therapiebereich:
Pulmonary Disease, Chronic Obstructive
Anwendungsgebiete:
Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Produktbesonderheiten:
Revision: 16
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2013-09-18
Gebrauchsinformation
39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE USER
XOTERNA BREEZHALER 85 MICROGRAMS/43 MICROGRAMS INHALATION POWDER, HARD
CAPSULES
indacaterol/glycopyrronium
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
Instructions for use of Xoterna Breezhaler inhaler
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 muscles
in the lungs, making it easier for air to get in and out of the lungs.
If you use this medicine once a day, it will help to reduce the
effects of COPD on your everyday life.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE XOTERNA BREEZHALER
DO NOT USE XOTERNA BREEZHALER
-
if you are allergic to indacaterol or glycopyrronium or any of the
other ingredients of this
medicine (listed in section 6).
41
WARNINGS AND PRECAUTIONS
Talk
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 micrograms of indacaterol maleate equivalent
to 110 micrograms of
indacaterol and 63 micrograms of glycopyrronium bromide equivalent to
50 micrograms of
glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 110 micrograms of
indacaterol maleate equivalent to 85 micrograms of indacaterol and 54
micrograms of
glycopyrronium bromide equivalent to 43 micrograms 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 (inhalation powder).
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 should be taken as soon as possible on the same day.
Patients should be instructed not to
take more than one dose in a day.
Special populations
_Elderly population _
Xoterna Breezhaler can be used at the recommended dose in elderly
patients (75 years of age and
older).
3
_Renal impairment _
Xoterna Breezhaler can be used at the recommended dose in patients
with mild to moderate renal
impairment. In patients with severe renal impair
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