Rolufta Ellipta (previously Rolufta)

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

umeclidinium bromide

Saadav alates:

GlaxoSmithKline Trading Services Limited

ATC kood:

R03BB07

INN (Rahvusvaheline Nimetus):

umeclidinium

Terapeutiline rühm:

Drugs for obstructive airway diseases,

Terapeutiline ala:

Pulmonary Disease, Chronic Obstructive

Näidustused:

Rolufta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).,

Toote kokkuvõte:

Revision: 11

Volitamisolek:

Authorised

Loa andmise kuupäev:

2017-03-20

Infovoldik

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROLUFTA ELLIPTA 55 MICROGRAMS INHALATION POWDER, PRE-DISPENSED
umeclidinium
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Rolufta Ellipta is and what it is used for
2.
What you need to know before you use Rolufta Ellipta
3.
How to use Rolufta Ellipta
4.
Possible side effects
5.
How to store Rolufta Ellipta
6.
Contents of the pack and other information
Step-by-step instructions for use
1.
WHAT ROLUFTA ELLIPTA IS AND WHAT IT IS USED FOR
WHAT ROLUFTA ELLIPTA IS
Rolufta Ellipta contains the active substance umeclidinium (as
bromide), which belongs to a group of
medicines called bronchodilators.
WHAT ROLUFTA ELLIPTA IS USED FOR
This medicine is used to treat chronic obstructive pulmonary disease (
COPD
) in adults. COPD is a
long-term condition in which the airways and air-sacs in the lungs
gradually become blocked or
damaged, leading to breathing difficulties that slowly get worse.
Difficulties in breathing is added to
by tightening of the muscles around the airways, which narrows the
airways and so restricts the flow
of air.
This medicine blocks the tightening of these muscles, making it easier
for air to get in and out of the
lungs. When used regularly, it can help control your breathing
di

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See section
4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 55 micrograms
umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
This corresponds to a pre-
dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2
micrograms umeclidinium
bromide.
Excipient with known effect
Each delivered dose contains approximately 12.5 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed (inhalation powder)
White powder in a grey inhaler (Ellipta) with a light green mouthpiece
cover and a dose counter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rolufta Ellipta 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 one inhalation once daily.
It should be administered each day at the same time of the day to
maintain bronchodilation. The
maximum dose is one inhalation once daily. If a dose is missed the
next dose should be inhaled at the
usual time the next day.
Special populations
_Elderly _
_ _
No dose adjustment is required in patients 65 years of age or older
(see section 5.2).
_Renal impairment _
_ _
No dose adjustment is required in patients with renal impairment (see
section 5.2).
3
_Hepatic impairment _
_ _
No dose adjustment is required in patients with mild or moderate
hepatic impairment. Umeclidinium
has not been studied in patients with severe hepatic impairment and
should be used with c