Spiolto Respimat Inhalation Solution 2.5mcg2.5mcg per actuation

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

TIOTROPIUM BROMIDE MONOHYDRATE; olodaterol hydrochloride

MAH:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN:

TIOTROPIUM BROMIDE MONOHYDRATE; olodaterol hydrochloride

units_in_package:

1units Units; 1 respimat pro inhaler and 1 cartridge containing 4ml inhalation solution providing 60 puffs (30 medicinal doses) Units; 1 cartridge (refill) containing 4ml inhalation solution providing 60 puffs (30 medicinal doses) Units

manufactured_by:

Boehringer Ingelheim Pharma GmbH & Co.KG

PIL

SPIOLTO
RESPIMAT
INHALATION SOLUTION
Tiotropium/olodaterol (2.5 microgram/ 2.5 microgram per actuation)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What SPIOLTO RESPIMAT is used
for
2.
How SPIOLTO RESPIMAT works
3.
Before
you
use
SPIOLTO
RESPIMAT
4.
How to use SPIOLTO RESPIMAT
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of SPIOLTO
RESPIMAT
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT SPIOLTO RESPIMAT IS USED
FOR
SPIOLTO
RESPIMAT
helps
adult
patients
who
have
chronic
obstructive
pulmonary
disease
(COPD)
to
breathe
more easily. COPD is a long-term lung
disease that causes shortness of breath and
coughing. The term COPD is associated
with the condition’s chronic bronchitis
and emphysema.
HOW SPIOLTO RESPIMAT WORKS
SPIOLTO
RESPIMAT
helps
to
open
your airways and make it easier to get air
in and out of the lungs. Regular use of
SPIOLTO RESPIMAT can also help you
when
you
have
on-going
shortness
of
breath related to your disease, and will
help to minimise the effects of the disease
on your everyday life. As COPD is a long-
term disease you should take SPIOLTO
RESPIMAT every day and not only when
you
have
breathing
problems
or
other
symptoms of COPD.
BEFORE YOU USE SPIOLTO RESPIMAT
-
_When you must not use it _
Do not use SPIOLTO RESPIMAT
•
if you are allergic to tiotropium or
olodaterol
or
any
of
the
other
ingredients of this medicine (listed in
Product Description)
•
if
you
are
allergic
to
atropine
or
substances
related
to
it,
e.g.
ipratropium or oxitropium
SPIOLTO RESPIMAT should not be
given to children or adolescents (below
the age of 18 years).
If you are pregnant or breast-feeding,
think
you
may
be
pregnant
or
are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine. You should not use this
medicine
unless
specifically
recommended by your doctor.
This
medicine
contains
0.0011
mg
benzalkonium
chloride
in
each
actuation.
Benzalkonium
chloride
m

SPC

Abcd
1.
NAME OF THE MEDICINAL PRODUCT
SPIOLTO
®
RESPIMAT
®
Inhalation Solution 2.5 microgram/2.5 microgram per actuation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The delivered dose is 2.5 microgram tiotropium and 2.5 microgram
olodaterol per puff (2 puffs
comprise one medicinal dose) and is equivalent to 3.124 microgram
tiotropium bromide monohydrate
and 2.736 microgram olodaterol hydrochloride.
(INN = tiotropium bromide) (INN = olodaterol)
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation solution
Clear, colourless, inhalation solution
3.1
PRODUCT DESCRIPTION
SPIOLTO RESPIMAT Inhalation Solution is composed of an aqueous,
multidose solution of
tiotropium bromide monohydrate and olodaterol hydrochloride for oral
inhalation, delivered by a
RESPIMAT inhaler, which provides an aerosolized mist of appropriate
particle size for delivery to
the lung. Each actuation delivers 2. 5 μg of tiotropium and 2.5 μg
of olodaterol from the mouthpiece.
One dose consists of two actuations.
SPIOLTO RESPIMAT Inhalation Solution is a clear, colourless solution
of tiotropium bromide
monohydrate and olodaterol hydrochloride contained in a cartridge. The
solution is filled in a plastic
container which is crimped into an aluminium cylinder to form the
cartridge.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SPIOLTO RESPIMAT 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 medicinal product is intended for inhalation use only. The
cartridge can only be inserted and
used in the Respimat inhaler.
Two puffs from the Respimat inhaler comprise one medicinal dose.
Adults
The recommended dose for adults is 5 microgram tiotropium and 5
microgram olodaterol given as two
puffs from the Respimat inhaler once daily at the same time of the day
(see Instructions for