Tovanor Breezhaler
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
09-11-2021
Produktets egenskaber
(SPC)
09-11-2021
Offentlige vurderingsrapport
(PAR)
09-07-2018
Aktiv bestanddel:
Glycopyrronium bromide
Tilgængelig fra:
Novartis Europharm Limited
ATC-kode:
R03BB06
INN (International Name):
glycopyrronium bromide
Terapeutisk gruppe:
Drugs for obstructive airway diseases,
Terapeutisk område:
Pulmonary Disease, Chronic Obstructive
Terapeutiske indikationer:
Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Produkt oversigt:
Revision: 15
Autorisation status:
Authorised
Autorisation dato:
2012-09-28
Indlægsseddel
32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOVANOR BREEZHALER 44 MICROGRAMS INHALATION POWDER, HARD CAPSULES
glycopyrronium
(as glycopyrronium bromide)
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 Tovanor Breezhaler is and what it is used for
2.
What you need to know before you use Tovanor Breezhaler
3.
How to use Tovanor Breezhaler
4.
Possible side effects
5.
How to store Tovanor Breezhaler
6.
Contents of the pack and other information
1.
WHAT TOVANOR BREEZHALER IS AND WHAT IT IS USED FOR
WHAT TOVANOR BREEZHALER IS
This medicine contains an active substance called glycopyrronium
bromide. This belongs to a group of
medicines called bronchodilators.
WHAT TOVANOR 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 TOVANOR BREEZHALER
DO NOT USE TOVANOR BREEZHALER
-
if you are allergic to glycopyrronium bromide or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Tovanor Breezhaler, if any of the
follow
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tovanor Breezhaler
44 micrograms inhalation powder, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 63 micrograms of glycopyrronium bromide
equivalent to 50 micrograms of
glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 55 micrograms of
glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium.
Excipient(s) with known effect:
Each capsule contains 23.6 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Transparent orange capsules containing a white powder, with the
product code “GPL50” printed in
black above and the company logo (
) printed in black below a black bar.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tovanor 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 Tovanor
Breezhaler inhaler.
Tovanor Breezhaler is recommended to be administered, at the same time
of the day each day. If a
dose is missed, the next dose should be taken as soon as possible.
Patients should be instructed not to
take more than one dose in a day.
Special populations
_Elderly population _
Tovanor Breezhaler can be used at the recommended dose in elderly
patients (75 years of age and
older) (see section 4.8).
_ _
_Renal impairment _
Tovanor Breezhaler can be used at the recommended dose in patients
with mild to moderate renal
impairment. In patients with severe renal impairment or end-stage
renal disease requiring dialysis
Tovanor Breezhaler should be used only if the expected benefit
outweighs the potential risk since the
systemic exposure to glycopyrronium may be increased in this
population (see sections
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