Anoro Ellipta (previously Anoro)

Šalis: Europos Sąjunga

kalba: anglų

Šaltinis: EMA (European Medicines Agency)

Veiklioji medžiaga:

umeclidinium bromide, vilanterol trifenatate

Prieinama:

GlaxoSmithKline (Ireland) Limited

ATC kodas:

R03AL03

INN (Tarptautinis Pavadinimas):

umeclidinium bromide, vilanterol

Farmakoterapinė grupė:

Drugs for obstructive airway diseases,

Gydymo sritis:

Pulmonary Disease, Chronic Obstructive

Terapinės indikacijos:

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

Produkto santrauka:

Revision: 18

Autorizacija statusas:

Authorised

Leidimo data:

2014-05-08

Pakuotės lapelis

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANORO ELLIPTA 55 MICROGRAMS/22 MICROGRAMS INHALATION POWDER,
PRE-DISPENSED
umeclidinium/vilanterol
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 ANORO ELLIPTA is and what it is used for
2.
What you need to know before you use ANORO ELLIPTA
3.
How to use ANORO ELLIPTA
4.
Possible side effects
5.
How to store ANORO ELLIPTA
6.
Contents of the pack and other information
Step-by-step instructions
1.
WHAT ANORO ELLIPTA IS AND WHAT IT IS USED FOR
WHAT ANORO ELLIPTA IS
ANORO ELLIPTA contains two active substances umeclidinium bromide and
vilanterol. These belong to a
group of medicines called bronchodilators.
WHAT ANORO ELLIPTA IS USED FOR
ANORO ELLIPTA is used to treat chronic obstructive pulmonary disease (
COPD
) in adults. COPD is a
long-term condition characterised by breathing difficulties that
slowly get worse.
In COPD the muscles around the airways tighten. This medicine blocks
the tightening of these muscles in the
lungs, making it easier for air to get in and out of the lungs. When
used regularly, it can help to control your
breathing difficulties and reduce the effects of COPD on your everyday
life.
ANORO ELLIPTA SHOULD NOT BE USED TO RELIEVE A SUDDEN ATTACK OF
BREATHLESSNESS OR WHEEZING

Prekės savybės

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
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder,
pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 65 micrograms
umeclidinium bromide equivalent to 55 micrograms of umeclidinium and
22 micrograms of vilanterol (as
trifenatate). This corresponds to a pre-dispensed dose of 74.2
micrograms umeclidinium bromide equivalent
to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as
trifenatate).
Excipient with known effect
Each delivered dose contains approximately 24 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed (inhalation powder)
White powder in a light grey inhaler (ELLIPTA) with a red mouthpiece
cover and a dose counter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ANORO 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 and maximum dose is one inhalation once daily.
ANORO ELLIPTA should be administered at the same time of the day each
day to maintain bronchodilation.
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. The use of ANORO
ELLIPTA has not been