Incruse Ellipta 55microgramsdose dry powder inhaler

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Umeclidinium bromide

Available from:

GlaxoSmithKline UK Ltd

ATC code:

R03BB07

INN (International Name):

Umeclidinium bromide

Dosage:

65microgram/1dose

Pharmaceutical form:

Inhalation powder

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010200; GTIN: 5000123114399

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
INCRUSE 55 MICROGRAMS INHALATION POWDER, PRE-DISPENSED
umeclidinium (umeclidinium bromide)
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 Incruse is and what it is used for
2.
What you need to know before you use Incruse
3.
How to use Incruse
4.
Possible side effects
5.
How to store Incruse
6.
Contents of the pack and other information
Step-by-step instructions for use
1.
WHAT INCRUSE IS AND WHAT IT IS USED FOR
WHAT INCRUSE IS
Incruse contains an active substance called umeclidinium bromide,
which belongs to a group of medicines
called
_bronchodilators_
.
WHAT INCRUSE 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 difficulties
and reduce the effects of COPD on your
everyday life.
INC

Summary of Product characteristics

OBJECT 1
INCRUSE 55 MICROGRAMS INHALATION POWDER, PRE-
DISPENSED
Summary of Product Characteristics Updated 20-Jul-2017 |
GlaxoSmithKline UK
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
Incruse 55 micrograms inhalation powder, pre-dispensed
2. Qualitative and quantitative composition
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece of the inhaler) 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 (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 grey inhaler (Ellipta) with a light green mouthpiece
cover and a dose counter.
4. Clinical particulars
4.1 Therapeutic indications
Incruse 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
_Adults _
The recommended dose is one inhalation of umeclidinium bromide once
daily.
Incruse should be administered once daily at the same time of the day
each day to maintain
bronchodilation. The maximum dose is one inhalation of umeclidinium
bromide once daily.
_Special populations _
Elderly patients
No dosage adjustment is required in patients over 65 years (see
section 5.2).
Renal impairment
No dosage adjustment is required in patients with renal impairment
(see section 5.2).
Hepatic impairment
No dosage adjustment is required in patients with mild or moderate
hepatic impairment. Incruse has not
been studied in pa