Trydonis

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium

MAH:

Chiesi Farmaceutici S.p.A.

ATC_code:

R03AL09

INN:

beclometasone, formoterol, glycopyrronium bromide

therapeutic_group:

Drugs for obstructive airway diseases,

therapeutic_area:

Pulmonary Disease, Chronic Obstructive

therapeutic_indication:

Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptoms control and prevention of exacerbations see section 5.1).

leaflet_short:

Revision: 5

authorization_status:

Authorised

authorization_date:

2018-04-26

PIL

63
B. PACKAGE LEAFLET
64
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRYDONIS 87 MICROGRAMS/5 MICROGRAMS/9 MICROGRAMS PRESSURISED
INHALATION, SOLUTION
beclometasone dipropionate/formoterol fumarate
dihydrate/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 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 Trydonis is and what it is used for
2.
What you need to know before you use Trydonis
3.
How to use Trydonis
4.
Possible side effects
5.
How to store Trydonis
6.
Contents of the pack and other information
1.
WHAT TRYDONIS IS AND WHAT IT IS USED FOR
Trydonis is a medicine to help breathing that contains the three
active substances:
•
beclometasone dipropionate,
•
formoterol fumarate dihydrate and
•
glycopyrronium.
Beclometasone dipropionate belongs to a group of medicines called
corticosteroids which act to
reduce the swelling and irritation in your lungs.
Formoterol and glycopyrronium are medicines called long-acting
bronchodilators. They act in
different ways to relax the muscles in your airways, helping to open
the airways wider and allowing
you to breathe more easily.
Regular treatment with these three active substances helps to relieve
and prevent symptoms such as
shortness of breath, wheezing and cough in adult patients with chronic
obstructive pulmonary disease
(COPD). Trydonis can reduce exacerbations (flare-ups) of COPD symptoms
.
COPD is a serious long-
term disease in which the airways become blocked and air sacs inside
the lungs become damaged,
leading to difficulty breathing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE T

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Trydonis 87 micrograms/5 micrograms/9 micrograms pressurised
inhalation, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose leaving the mouthpiece) contains 87
micrograms of beclometasone
dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9
micrograms of glycopyrronium (as
11 micrograms glycopyrronium bromide).
Each metered dose (the dose leaving the valve) contains 100 micrograms
of beclometasone
dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10
micrograms of glycopyrronium
(as 12.5 micrograms glycopyrronium bromide).
Excipient with known effect
Trydonis contains 8.856 mg ethanol per actuation.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, solution (pressurised inhalation)
Colourless to yellowish liquid solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Maintenance treatment in adult patients with moderate to severe
chronic obstructive pulmonary
disease (COPD) who are not adequately treated by a combination of an
inhaled corticosteroid and a
long-acting beta2-agonist or a combination of a long-acting
beta2-agonist and a long-acting
muscarinic antagonist (for effects on symptoms control and prevention
of exacerbations see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is two inhalations twice daily.
The maximum dose is two inhalations twice daily.
Special populations
_ _
_Elderly _
No dose adjustment is required in elderly patients (65 years of age
and older).
_ _
_Renal impairment _
Trydonis can be used at the recommended dose in patients with mild
(glomerular filtration rate [GFR]
≥50 to <80 mL/min/1.73 m
2
) to moderate (GFR ≥30 to <50 mL/min/1.73 m
2
) renal impairment. Use in
patients with severe (GFR <30 mL/min/1.73 m
2
) renal impairment or end-stage renal (GFR
<15 mL/min/1.73 m
2
) disease requiring dialysis, especially if associated with
significant body weight