STRIVERDI RESPIMAT 2.5 MICROGRAM SOLUTION FOR INHALATION

Active substance: OLODATEROL HYDROCHLORIDE

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Package leaflet: Information for the user

Striverdi® Respimat®
2.5 microgram,
solution for inhalation
olodaterol

abcd


2.5 microgram,
solution for inhalation
olodaterol

2.5 microgram,
solution for inhalation
olodaterol

abcd

304394-01

Striverdi® Respimat®
Striverdi® Respimat®

abcd

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
taking this medicine because it contains important
information for you.
–  eep this leaflet. You may need to read it again.
K
–  f you have any further questions, ask your doctor
I
or pharmacist.
–  his medicine has been prescribed for you only.
T
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
–  f you get any side effects, talk to your doctor or
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pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Striverdi Respimat is and what it is used for
2.  hat you need to know before you take
W
Striverdi Respimat
3. How to take Striverdi Respimat
4. Possible side effects
5. How to store Striverdi Respimat
6. Contents of the pack and other information

1.  hat Striverdi Respimat is and what it is
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used for
Striverdi Respimat helps people 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 conditions chronic
bronchitis and emphysema. As COPD is a long-term
disease you should take this medicine every day and
not only when you have breathing problems or other
symptoms of COPD.
Striverdi Respimat contains the active substance
olodaterol which is a long-acting bronchodilator
(long acting beta 2 agonist) that helps to open your
airways and makes it easier to get air in and out of
the lungs. Regular use of this medicine 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.

2.  hat you need to know before you take
W
Striverdi Respimat
Do not use Striverdi Respimat
– f you are allergic to olodaterol or any of the other
i
ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before using
Striverdi Respimat if you:
–  ave asthma (you should not use this medicine for
h
the treatment of asthma)
–  ave diseases of the heart
h
–  ave high blood pressure
h
–  ave epilepsy
h
–  ave a specific thyroid gland problem called
h
thyrotoxicosis
–  ave an abnormal widening of an artery called
h
aneurysm
–  ave diabetes
h
–  ave severe liver problems as this medicine has not
h
been studied in this patient population
–  ave severe kidney problems as there is limited
h
experience with this medicine in this patient
population
–  re due to have a planned surgery
a
During treatment with Striverdi Respimat
–  top using the medicine and tell your doctor
S
immediately if you get tightness of the chest,
coughing, wheezing or breathlessness immediately
after using the medicine. These may be signs of
a condition called bronchospasm (see section 4).
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–  f your breathing has got worse or if you experience
rash, swelling or itching directly after using your
inhaler, stop using it and tell your doctor
immediately (see section 4).
–  f you experience any side effects affecting your
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heart (increase in pulse rate, increase in blood
pressure and/or increase in symptoms like chest
pain), tell your doctor immediately (see section 4).

–  f you experience muscle spasm, muscle weakness
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or abnormal heart rhythm, consult your doctor as
these may be related to low blood levels of
potassium (see section 4).
Striverdi Respimat is indicated for the maintenance
treatment of your chronic obstructive pulmonary
disease. It should not be used to treat a sudden
attack of breathlessness or wheezing.
Do not use Striverdi Respimat together with certain
medicines containing long-acting ß-adrenergic
agonists, like salmeterol or formoterol.
If you regularly take certain medicines called shortacting ß-adrenergic agents, like salbutamol, continue
to use these only to relieve acute symptoms like
breathlessness.
Children and adolescents
this medicine should not be given to children or
adolescents (below the age of 18 years).
Other medicines and Striverdi Respimat
Please tell your doctor or pharmacist if you are taking,
or have recently taken any other medicines.
In particular, please tell your doctor if you are using:
–  ertain medicines for breathing problems that are
c
similar to this medicine (ß-adrenergic agents). You
may be more likely to get side effects.
–  edicines called beta blockers that are used for
m
high blood pressure or other heart problems (such
as propranolol), or for the eye problem called
glaucoma (such as timolol). This may result in loss
of the effect of this medicine.
–  edicines that lower the amount of potassium in
m
your blood. These include:
 teroids (e.g. prednisolone),
s
 iuretics (water tablets),
d
 edicines for breathing problems such as
m
theophylline.
If you use these medicines together with
this medicine you may experience
symptoms of muscle spasm, muscle
weakness or abnormal heart rhythm.
–  edicines called tricyclic antidepressants or MAO
m
inhibitors (like selegiline or moclobemide), that are
used to treat neurological or psychiatric disorders
like Parkinson’s disease or depression; the use of
these drugs will increase the likelihood that you get
side effects affecting your heart.





Pregnancy, breast-feeding and fertility
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.
Driving and using machines
No studies on the effects on the ability to drive and
use machines have been performed.
If you feel dizzy while taking this medicine, do not
drive or use any tools or machines.

3.  ow to take Striverdi Respimat
H
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
Striverdi Respimat is for inhalation use only.
Dosage
The recommended dose is:
Striverdi Respimat is effective for 24 hours so you will
need to use this medicine only ONCE A DAY, if
possible at the same time of the day. Each time you
use it take TWO PUFFS.
As COPD is a long-term disease take this medicine
every day and not only when you experience
breathing problems. Do not take more than the
recommended dose.
Use in children and adolescents
There is no relevant use of this medicine in the
paediatric population (under 18 years).
Make sure that you know how to use your Striverdi
Respimat inhaler properly. The instructions for use
of the Striverdi Respimat inhaler are provided on
the other side of this leaflet.
If you take more Striverdi Respimat than you should
You may be at a higher risk of experiencing a side
effect such as chest pain, high or low blood pressure,
faster or irregular heartbeat or feeling of heart beat,
dizziness, nervousness, difficulty in sleeping, anxiety,
headache, shaking, dry mouth, muscle cramps,
nausea, fatigue, malaise, low blood levels of
potassium (which may cause symptoms of muscle
spasm, muscle weakness or abnormal heart rhythm),
high blood sugar, or too much acid in your blood
(which may cause symptoms of nausea, vomiting,
weakness, muscle cramps and more rapid breathing).

If you forget to take Striverdi Respimat
If you forget to inhale a dose, inhale just one dose at
the usual time the next day.
Do not take a double dose to make up for a forgotten
dose.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

If you stop using Striverdi Respimat
Before you stop taking Striverdi Respimat, you should
talk to your doctor or your pharmacist. If you stop
taking Striverdi Respimat the signs and symptoms of
COPD may worsen.

6.  ontents of the pack and other
C
information
What Striverdi Respimat contains

4. Possible side effects

The active substance is olodaterol. The delivered
dose is 2.5 microgram olodaterol (as hydrochloride)
per puff.
The delivered dose is the dose which is available for
the patient after passing the mouthpiece.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

The other ingredients are:
Benzalkonium chloride, disodium edetate, purified
water, and citric acid (anhydrous)

Stop taking this medicine and tell your doctor straight
away if you notice any of the following serious side
effects - you may need urgent medical treatment:

What Striverdi Respimat looks like and contents
of the pack

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

–  mmediate allergic reactions such as rash, nettle
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rash (urticaria), swelling of the mouth and face or
sudden difficulties in breathing (angioneurotic
oedema)
–  nexpected tightness of the chest, coughing or
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wheezing or breathlessness immediately after
inhalation (bronchospasm)

Striverdi Respimat 2.5 microgram is composed of
one cartridge with solution for inhalation and one
Respimat inhaler. The cartridge has to be inserted
into the inhaler before the first use.
Single pack:  Respimat inhaler and 1 cartridge,
1
providing 60 puffs (30 medicinal
doses)

The side effects described below have been
experienced by people taking this medicine and they
are listed according to frequency as either uncommon
or rare.

Double pack:  single packages, each containing
2
1 Respimat inhaler and 1 cartridge,
providing 60 puffs (30 medicinal
doses)

Uncommon (may affect up to 1 in 100 people):

Triple pack:  single packages, each containing
3
1 Respimat inhaler and 1 cartridge,
providing 60 puffs (30 medicinal
doses)

–  asopharyngitis (runny nose)
N
–  izziness
D
–  ash
R
Rare (may affect up to 1 in 1,000 people)
–  rthralgia (joint pain)
A
–  ypertension
H
You may also experience side effects which are known
to occur with certain medicines for breathing problems
similar to this medicine (beta-adrenergic agents).
These may be faster or irregular heartbeat or feeling
of heart beat, chest pain, high or low blood pressure,
shaking, headache, nervousness, difficulty in sleeping,
dizziness, dry mouth, nausea, muscle cramps, fatigue,
malaise, low blood levels of potassium (which may
cause symptoms of muscle spasm, muscle weakness
or abnormal heart rhythm), high blood sugar, or too
much acid in your blood (which may cause symptoms
of nausea, vomiting, weakness, muscle cramps and
more rapid breathing).
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly (see details below). By reporting side
effects you can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store Striverdi Respimat
Keep this medicine out of the sight and reach of
children.
Do not freeze.
Do not use this medicine after the expiry date which
is stated on the carton and on the inhaler label after
EXP. The expiry date refers to the last day of the
month. Striverdi Respimat inhaler should be
discarded at the latest 3 months after first use.

Eight pack:  single packages, each containing
8
1 Respimat inhaler and 1 cartridge,
providing 60 puffs (30 medicinal
doses)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder for
Striverdi Respimat is:
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
The manufacturer for Striverdi Respimat is:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
Striverdi Respimat
Austria, Liechtenstein: 
2,5 Mikrogramm - Lösung
zur Inhalation
Striverdi Respimat
Belgium, Luxembourg: 
2,5 microgrammes, solution
pour inhalation
Striverdi Respimat
Bulgaria: 
Стриверди Респимат
Striverdi Respimat
Cyprus, Greece: 
Czech Republic: 
Striverdi Respimat
2,5 mikrogramů
Denmark: 
Striverdi Respimat
Striverdi Respimat
Estonia: 
Striverdi Respimat
Finland: 
2.5 mikrog inhalaationeste,
lious
France: 
Striverdi Respimat
2,5 microgrammes/dose,
solution pour inhalation
Germany: 
Striverdi Respimat
2,5 Mikrogramm/Sprühstoß
Lösung zur Inhalation
Hungary: 
Striverdi Respimat
2,5 mikrogram inhalációs
oldat
Iceland: 
Striverdi Respimat
Ireland, Malta, UK: 
Striverdi Respimat
Italy: 
Striverdi Respimat
2,5 microgrammi, soluzione
per inalazione
Latvia: 
Striverdi Respimat
2,5 mikrogrami šķīdums
inhalācijām
Lithuania: 
Striverdi Respimat
2,5 mikrogramo/išpurškime
inhaliacinis tirpalas
Netherlands: 
Striverdi Respimat
2,5 microgram, oplossing
voor inhalatie
Norway: 
Striverdi
Poland: 
Striverdi Respimat



Portugal:
Romania:

Striverdi Respimat
Striverdi Respimat
2,5 micrograme soluţie de
inhalat
Striverdi Respimat
Striverdi Respimat
2,5 mikrograma/vdih
raztopina za inhaliranje
Striverdi Respimat
2,5 microgramos solución
para inhalación
Striverdi Respimat
2,5 mikrogram,
inhalationsvätska, lösning

Slovakia:
Slovenia:
Spain:
Sweden:

Daily use of your Striverdi Respimat inhaler

2a

I
2b

Striverdi® Respimat®
inhaler

abcd

How to use your Striverdi Respimat inhaler
This leaflet explains how to use and care for your
Striverdi Respimat inhaler. Please read and carefully
follow these instructions. See also section 3. How to
take Striverdi Respimat on the other side of this
leaflet.

2 Take the cartridge (H) out of the box. Push the
narrow end of the cartridge into the inhaler until it
clicks into place. The cartridge should be pushed
firmly against a firm surface to ensure that it has
gone all the way in (2b).
The cartridge will not be flush with the inhaler,
you will still see the silver ring of the lower end of
the cartridge.
Do not remove the cartridge once it has been
inserted into the inhaler.

The Striverdi Respimat inhaler releases medication
slowly and gently, making it easy to inhale it into
your lungs.
The Striverdi Respimat inhaler enables you to inhale
the medicine contained in a cartridge. The full
cartridge provides 60 puffs (30 medicinal doses). You
will need to use this inhaler only ONCE A DAY, if
possible at the same time of the day. Each time you
use it take TWO PUFFS. There is enough medicine for
30 days when it is used according to the directions
for use. In the box you will find the Striverdi
Respimat inhaler and the Striverdi Respimat
cartridge. Before the Striverdi Respimat inhaler is
used for the first time, the cartridge provided must
be inserted.

3

3 Replace the clear base (G).
Do not remove the clear base again.

Hold the Striverdi Respimat inhaler upright, with
the yellow cap (A) closed, to avoid accidental
release of dose. Turn the base (G) in the direction
of the black arrows on the label until it clicks (half
a turn).

II

Air vent

II Open the yellow cap (A) until it snaps fully open.
Breathe out slowly and fully, and then close your
lips around the end of the mouthpiece without
covering the air vents (C). Point your Striverdi
Respimat inhaler to the back of your throat.
While taking in a slow, deep breath through your
mouth, press the dose release button (D) and
continue to breathe in slowly for as long as you
can. Hold your breath for 10 seconds or for as long
as comfortable.
III Repeat steps I and II so that you get the full dose.
Close the yellow cap until you use your Striverdi
Respimat inhaler again.
If Striverdi Respimat inhaler has not been used for
more than 7 days release one puff towards the
ground. If Striverdi Respimat inhaler has not been
used for more than 21 days repeat steps 4 to 6 until
a cloud is visible. Then repeat steps 4 to 6 three more
times.

Mouthpiece (B)
Air vent (C)

4
Cartridge (H)

Safety catch (E)
Dose indicator (F)

4 Hold the Striverdi Respimat inhaler upright, with
the yellow cap (A) closed. Turn the base (G) in the
direction of the black arrows on the label until it
clicks (half a turn).

When to get a new Striverdi Respimat
inhaler

Empty

Clear base (G)
Piercing
element (I)

Full

Striverdi Respimat inhaler and the
Striverdi Respimat cartridge

1) Inserting the cartridge
The following steps 1– 6 are necessary before first use:

5

5 Open the yellow cap (A) until it snaps fully open.

Safety catch

6
1

1 With the yellow cap (A) closed, press the safety
catch (E) while pulling off the clear base (G).

I can turn the
clear base past
the point where
it clicks.

Either the dose
release button
has been
pressed, or the
clear base has
been turned too
far.

6 Point the Striverdi Respimat inhaler
towards the ground.
Press the dose release button (D).
Close the yellow cap (A).
Repeat steps 4, 5 and 6 until a cloud is visible.
Then repeat steps 4, 5 and 6 three more times
to ensure the inhaler is prepared for use.
Your Striverdi Respimat inhaler is now
ready to use.
These steps will not affect the number of doses
available. After preparation your Striverdi
Respimat inhaler will be able to deliver your
60 puffs (30 medicinal doses).

What to do
Turn the clear
base until it
clicks. (half
a turn)
Prepare the
Striverdi
Respimat
inhaler for use
by turning the
clear base until
it clicks.
(half a turn)
With the yellow
cap closed, turn
the base until it
clicks. (half
a turn)

How to care for your inhaler

You will need to use this inhaler only ONCE A DAY.

2) To prepare the Striverdi Respimat inhaler
for first-time use

Cap (A)

Dose release
button (D)

The clear base
was not turned
far enough.

I

This leaflet was last revised in 04/2014.

Instructions for Use

Reason
The clear base
has not been
turned.

The clear base
springs back
after I have
turned it.

You will need to use this inhaler ONLY ONCE A DAY.
Each time you use it take TWO PUFFS.

What if...
I can’t press the
dose release
button.

The Striverdi Respimat inhaler contains 60 puffs
(30 medicinal doses). The dose indicator shows
approximately how much medication is left. When
the pointer enters the red area of the scale, there is,
approximately, medication for 7 days left (14 puffs).
This is when you need to get a new Striverdi Respimat
inhaler prescription.
Once the dose indicator has reached the end of the
red scale (i.e. all 30 doses have been used), the
Striverdi Respimat inhaler is empty and locks
automatically. At this point, the base cannot be
turned any further.
At the latest, three months after use the Striverdi
Respimat inhaler should be discarded even if not all
medication has been used.

What if….
What if...
I can’t turn the
base easily.

Reason
What to do
a) The Striverdi a) The Striverdi
Respimat
Respimat
inhaler is
inhaler can
already
be used as
prepared and
it is.
ready to use.

b) The Striverdi
Respimat
inhaler is
locked after
60 puffs
(30 medicinal
doses).
While opening
The cap is fully
pulled of and apart the cap it was
from the inhaler. pulled too hard.

b) Prepare and
use your new
Striverdi
Respimat
inhaler.
The cap can
easily be
attached again.

Clean the mouthpiece including the metal part
inside the mouthpiece with a damp cloth or tissue
only, at least once a week.
Any minor discoloration in the mouthpiece does not
affect the performance of your StriverdiRespimat
inhaler.
If necessary, wipe the outside of your Striverdi
Respimat inhaler with a damp cloth.

Further Information
The Striverdi Respimat inhaler must not be
disassembled after inserting the cartridge and
replacing the clear base.
Do not touch the piercing element inside the base.
Boehringer Ingelheim Pharma GmbH & Co. KG
D-55216 Ingelheim
Germany

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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