Ulunar Breezhaler
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
24-02-2023
Valmisteyhteenveto
(SPC)
24-02-2023
Julkisesta arviointikertomuksesta
(PAR)
16-05-2014
Aktiivinen ainesosa:
Glycopyrronium bromide, indacaterol maleate
Saatavilla:
Novartis Europharm Limited
ATC-koodi:
R03AL04
INN (Kansainvälinen yleisnimi):
indacaterol, glycopyrronium bromide
Terapeuttinen ryhmä:
Drugs for obstructive airway diseases,
Terapeuttinen alue:
Pulmonary Disease, Chronic Obstructive
Käyttöaiheet:
Ulunar Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Tuoteyhteenveto:
Revision: 14
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2014-04-23
Pakkausseloste
39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE USER
ULUNAR 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 Ulunar Breezhaler is and what it is used for
2.
What you need to know before you use Ulunar Breezhaler
3.
How to use Ulunar Breezhaler
4.
Possible side effects
5.
How to store Ulunar Breezhaler
6.
Contents of the pack and other information
Instructions for use of Ulunar Breezhaler inhaler
1.
WHAT ULUNAR BREEZHALER IS AND WHAT IT IS USED FOR
WHAT ULUNAR BREEZHALER IS
This medicine contains two active substances called indacaterol and
glycopyrronium. These belong to
a group of medicines called bronchodilators.
WHAT ULUNAR 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 ULUNAR BREEZHALER
DO NOT USE ULUNAR 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 to your do
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ulunar 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
Ulunar 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 Ulunar
Breezhaler inhaler.
Ulunar 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 _
Ulunar Breezhaler can be used at the recommended dose in elderly
patients (75 years of age and
older).
3
_Renal impairment _
Ulunar Breezhaler can be used at the recommended dose in patients with
mild to moderate renal
impairment. In patients with severe renal impairment o
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