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STRIVERDI RESPIMAT 2.5 MICROGRAM INHALATION SOLUTION

Active substance(s): OLODATEROL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Striverdi® Respimat®
2.5 microgram, inhalation solution
olodaterol

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.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or pharmacist.
- 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 or
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. What you need to know before you take
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



olodaterol

Striverdi® Respimat®
2.5 microgram,
inhalation solution
309801-01

Striverdi® Respimat®
2.5 microgram,
inhalation solution
olodaterol

1. What Striverdi Respimat is and what it is
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. What you need to know before you take
Striverdi Respimat
Do not use Striverdi Respimat
- if you are allergic to olodaterol or any of the other
ingredients of this medicine (listed in section 6)

Warnings and precautions

Talk to your doctor or pharmacist before using
Striverdi Respimat if you:
- have asthma (you should not use this medicine for
the treatment of asthma)
- have diseases of the heart
- have high blood pressure
- have epilepsy
- have a specific thyroid gland problem called
thyrotoxicosis
- have an abnormal widening of an artery called
aneurysm
- have diabetes
- have severe liver problems as this medicine has
not been studied in this patient population
- have severe kidney problems as there is limited
experience with this medicine in this patient
population
- are due to have a planned surgery
During treatment with Striverdi Respimat
- Stop using the medicine and tell your doctor
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).
- If 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).
- If you experience any side effects affecting your
heart (increase in pulse rate, increase in blood
pressure and/or increase in symptoms like chest
pain), tell your doctor immediately (see section 4).

Mandatory in

File information

TD

Printfile

Issue date of TD:

17.12.2015

Yes

Yes

PPM SKU:

P030180

No

Yes

PPM SKU version: 

004

No

Yes

Issue date of artwork:

10.05.2016

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Print colors:

Black

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Yes

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Yes

Magenta

Yellow

Cyan
Mat. No. Pack. Site:

309801-01

Min. font size:

10pt

Legend case version:

V4.0 01/OCT/2012 (please do not change or remove it)

Technical information
a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

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Template name: TD-PI_710x274_90x35
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Only for BI-internal use, Template according to Drawing no.: SP-14-0090-001-B_Index_

MASS D:
MASS E:
MASS G:

0,35 mm
1,0 mm
0,65 mm

Example
Technical information
Control Code Type: Laetus mini

- If you experience muscle spasm, muscle weakness
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:
- certain medicines for breathing problems that are
similar to this medicine (ß-adrenergic agents). You
may be more likely to get side effects.
- medicines called beta blockers that are used for 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.
- medicines that lower the amount of potassium in
your blood. These include:
• steroids (e.g. prednisolone),
• diuretics (water tablets),
• medicines for breathing problems such as theophylline.
If you use these medicines together with this
medicine you may experience symptoms of muscle
spasm, muscle weakness or abnormal heart rhythm.
- medicines called tricyclic antidepressants or MAO
inhibitors (like selegiline or moclobemide), that are
used to treat neurological or psychiatric disorders
like Parkinson’s disease 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. How to take Striverdi Respimat
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.
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.

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



4. Possible side effects


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

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:

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

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.

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

- Nasopharyngitis (runny nose)
- Dizziness
- Rash
Rare (may affect up to 1 in 1,000 people):
- Arthralgia (joint pain)
- Hypertension
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
HPRA Pharmacovigilance
Earlsfort Terrace, IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.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.

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.


6. Contents of the pack and other information

What Striverdi Respimat contains

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.

The other ingredients are:
Benzalkonium chloride, disodium edetate, purified
water, and citric acid (anhydrous)
What Striverdi Respimat looks like and contents of the
pack

Striverdi Respimat 2.5 microgram is composed of one
cartridge with inhalation solution and one Respimat
inhaler. The cartridge has to be inserted into the inhaler
before the first use.

Single pack: 1 Respimat inhaler and 1 cartridge,

providing 60 puffs (30 medicinal doses)

Double pack: 2 single packages, each containing

1 Respimat inhaler and 1 cartridge,

providing 60 puffs (30 medicinal doses)
Triple pack: 3 single packages, each containing

1 Respimat inhaler and 1 cartridge,

providing 60 puffs (30 medicinal doses)

Eight pack:
8 single packages, each containing

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:
Austria, Liechtenstein: Striverdi Respimat
2,5 Mikrogramm - Lösung
zur Inhalation
Belgium, Luxembourg: Striverdi Respimat
2,5 microgrammes, solution
à inhaler
Bulgaria:
Стриверди Респимат

2,5 микрограма разтвор

за инхалация
Cyprus, Greece: Striverdi Respimat
Czech Republic: Striverdi Respimat
2,5 mikrogramů
Denmark: Striverdi Respimat
Estonia: Striverdi Respimat
Finland: Striverdi Respimat
2.5 mikrog inhalaationeste,
lious
France: Striverdi Respimat
2,5 microgrammes/dose,
solution à inhaler
Germany: Striverdi Respimat
2,5 Mikrogramm/Hub
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 įkvepiamasis
tirpalas
Netherlands: Striverdi Respimat
2,5 microgram,
inhalatieoplossing
Norway: Striverdi Respimat
Poland: Striverdi Respimat
Portugal: Striverdi Respimat
Romania: Striverdi Respimat
2,5 micrograme soluţie de
inhalat

Slovakia: Striverdi Respimat
Slovenia: Striverdi Respimat
2,5 mikrograma/vdih
raztopina za inhaliranje
Spain: Striverdi Respimat
2,5 microgramos solución
para inhalación
Sweden: Striverdi Respimat
2,5 mikrogram,
inhalationsvätska, lösning
This leaflet was last revised in 02/2016.

abcd
Striverdi Respimat

Instructions For Use

TWO
PUFFS
ONCE
DAILY

Boehringer Ingelheim Pharma GmbH & Co. KG
D-55216 Ingelheim, Germany

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 your Striverdi Respimat inhaler
performance. If necessary, wipe the outside of your
Striverdi Respimat inhaler with a damp cloth.

Striverdi Respimat (olodaterol). Read these Instructions
for Use before you start using Striverdi Respimat.

How to care for your Striverdi Respimat

Introduction

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

When to get a new Striverdi Respimat

1
2
3

Prepare for first use
Remove clear base
• Keep the cap closed.
• Press the safety catch while firmly
pulling off the clear base with your
other hand.



Insert cartridge
• Insert the narrow end of the cartridge
into the inhaler.
• Place the inhaler on a firm surface and
push down firmly until it clicks into
place.

Replace clear base
• Put the clear base back into place
until it clicks.

Daily use

TURN
• KEEP the cap closed.
• TURN the clear base in the direction of
the arrows on the label until it clicks
(half a turn).

• Your Striverdi Respimat inhaler contains 60
puffs (30 doses) if used as indicated (two puffs/
once daily).

• If Striverdi Respimat has not been
used for more than 7 days release one
puff towards the ground.

• When the dose indicator enters the red area of
the scale you need to get a new prescription;
there is approximately medication for 7 days
left (14 puffs).

4

Turn
• Keep the cap closed.
• Turn the clear base in the direction of
the arrows on the label until it clicks
(half a turn).

Open
• Open the cap until it snaps fully open.

5








Answers to Common Questions

Did you turn the clear base? If
not, turn the clear base in a
continuous movement until it
clicks (half a turn).

I cannot press the dose-release
button.

It is difficult to insert the
cartridge deep enough.

Did you turn the clear base
before you inserted the
cartridge? The dose indicator
counts each turn of the clear
base regardless whether a
cartridge has been inserted or
not.

PRESS

6

Did you accidentally turn the
clear base before inserting the
cartridge? Open the cap, press
the dose-release button, then
insert the cartridge.
Did you insert the cartridge
with the wide end first? Insert
the cartridge with the narrow
end first.

The dose indicator on the
Striverdi Respimat reaches
zero too soon.



OPEN

Did you use Striverdi Respimat
as indicated (two puffs/Once
daily)? Striverdi Respimat will
last 30 days if used at two puffs
once daily.

• OPEN the cap until it snaps fully open.

• The dose indicator shows approximately how
much medication is left.

• If Striverdi Respimat has not been used
for more than 21 days repeat steps 4 to
6 under ‘Prepare for first Use’ until a cloud is
visible. Then repeat steps 4 to 6 three more
times.
• Do not touch the piercing element inside
the clear base.

• Once the dose indicator reaches the end of the
red scale, your Striverdi Respimat locks
automatically – no more doses can be released.
At this point, the clear base cannot be turned
any further.
• Striverdi Respimat should be discarded three
months after you have prepared it for first use,
even if it has not been fully used or used at all.

Press
• Point the inhaler toward the ground.
• Press the dose-release button
• Close the cap.
• Repeat steps 4-6 until a cloud is visible.
• After a cloud is visible, repeat steps 4-6
three more times.
Your inhaler is now ready to use. These steps
will not affect the number of doses available.
After preparation your inhaler will be able to
deliver 60 puffs (30 doses).

• Breathe out slowly and fully.
• Close your lips around the mouthpiece

without covering the air vents. Point your
Inhaler to the back of your throat.
• While taking a slow, deep breath through

your mouth, PRESS the dose-release button
and continue to breathe in slowly for as
long as comfortable.
• Hold your breath for 10 seconds or for as

long as comfortable.
• Repeat TURN, OPEN, PRESS for a total of
2 puffs.
• Close the cap until you use your inhaler again.

Did you spray in the air often to
check whether the Striverdi
Respimat is working? Once you
have prepared Striverdi
Respimat, no test-spraying is
required if used daily.

Is the dose indicator on the
Striverdi Respimat pointing to
zero? The Striverdi Respimat
inhaler is locked after 60 puffs
(30 medicinal doses). Prepare
and use your new Striverdi
Respimat inhaler.

My Striverdi Respimat sprays
automatically.
Was the cap open when you
turned the clear base? Close the
cap, then turn the clear base.
Did you press the dose-release
button when turning the clear
base? Close the cap, so the
dose-release button is covered,
then turn the clear base.
Did you stop when turning the
clear base before it clicked?
Turn the clear base in a
continuous movement until it
clicks (half a turn).

I cannot turn the clear base.

Did you turn the clear base
already? If the clear base has
already been turned, follow
steps “OPEN” and “PRESS”
under “Daily Use” to get your
medicine.
Is the dose indicator on the
Striverdi Respimat pointing to
zero? The Striverdi Respimat
inhaler is locked after 60 puffs
(30 medicinal doses). Prepare
and use your new Striverdi
Respimat inhaler.
My Striverdi Respimat
doesn’t spray.
Did you insert a cartridge? If
not, insert a cartridge.
Did you repeat TURN, OPEN,
PRESS less than three times
after inserting the cartridge?
Repeat TURN, OPEN, PRESS
three times after inserting the
cartridge as shown in the steps
4 to 6 under “Prepare for first
Use”.
Is the dose indicator on the
Striverdi Respimat pointing to
0? If the dose indicator points
to 0, you have used up all your
medication and the inhaler is
locked.
Once your Striverdi Respimat is
assembled, do not remove the
clear base or the cartridge.
Always insert a new cartridge
into a NEW Striverdi Respimat®.

Did you insert the cartridge into
a used Striverdi Respimat?
Always insert a new cartridge
into a NEW Striverdi Respimat.

Expand view ⇕

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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