Riltrava Aerosphere

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Budesonide, formoterol fumarate dihydrate, Glycopyrronium bromide

Available from:

AstraZeneca AB

ATC code:

R03AL11

INN (International Name):

formoterol fumarate dihydrate, glycopyrronium, budesonide

Therapeutic group:

Drugs for obstructive airway diseases,

Therapeutic area:

Pulmonary Disease, Chronic Obstructive

Therapeutic indications:

Riltrava Aerosphere is indicated as a 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 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).

Product summary:

Revision: 3

Authorization status:

Authorised

Authorization date:

2022-01-06

Patient Information leaflet

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RILTRAVA AEROSPHERE 5 MICROGRAMS/7.2 MICROGRAMS/160 MICROGRAMS,
PRESSURISED INHALATION,
SUSPENSION
formoterol fumarate dihydrate/glycopyrronium/budesonide
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 Riltrava Aerosphere is and what it is used for
2.
What you need to know before you use Riltrava Aerosphere
3.
How to use Riltrava Aerosphere
4.
Possible side effects
5.
How to store Riltrava Aerosphere
6.
Contents of the pack and other information
Instructions for use
1.
WHAT RILTRAVA AEROSPHERE IS AND WHAT IT IS USED FOR
Riltrava Aerosphere contains three active substances: formoterol
fumarate dihydrate, glycopyrronium,
and budesonide.

Formoterol fumarate dihydrate and glycopyrronium belong to a group of
medicines called
‘bronchodilators’. They work in different ways to prevent
tightening of the muscles around
the airways, making it easier for air to get in and out of the lungs.

Budesonide belongs to a group of medicines called
‘corticosteroids’. These work by reducing
inflammation in your lungs.
Riltrava Aerosphere is an inhaler that is used for adults with a lung
disease called ‘chronic obstructive
pulmonary disease’ (or ‘COPD’), a long-term disease of the
airways in the lungs.
Riltrava Aerosphere is used to make breathing easier and improve
symptoms of COPD such as
shortness of breath, wheezing and cough. Riltrava Aerosphere can also
prevent flare-ups
(exacerbations) of COPD.
Riltrava Aerosphe

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Riltrava Aerosphere 5 micrograms/7.2 micrograms/160 micrograms
pressurised inhalation,
suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single actuation (delivered dose, ex-actuator) contains 5
micrograms of formoterol fumarate
dihydrate, glycopyrronium bromide 9 micrograms, equivalent to 7.2
micrograms of glycopyrronium,
and budesonide 160 micrograms.
This corresponds to a metered dose of 5.3 micrograms of formoterol
fumarate dihydrate,
glycopyrronium bromide 9.6 micrograms, equivalent to 7.7 micrograms of
glycopyrronium, and
budesonide 170 micrograms.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
White suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Riltrava Aerosphere is indicated as a 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 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 and maximum dose is two inhalations twice daily (two
inhalations in the morning
and two inhalations in the evening).
If a dose is missed, it should be taken as soon as possible and the
next dose should be taken at the
usual time. A double dose should not be taken to make up for a
forgotten dose.
Special populations
_Elderly_
No dose adjustments are required in elderly patients (see section
5.2).
_Renal impairment_
This medicinal product can be used at the recommended dose in patients
with mild to moderate renal
impairment. It can also be used at the recommended dose in patients
with severe renal impairment or
3
end-stage renal disease requiring dialysis, only if the expected
benefit outweighs the potential risk
(see