STRIVERDI RESPIMAT 2.5 MICROGRAM SOLUTION FOR INHALATION

Active substance: OLODATEROL HYDROCHLORIDE

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06/09/2013
Package leaflet: Information for the user
Striverdi Respimat 2.5 microgram, solution for inhalation
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

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 Striverdi Respimat 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 Striverdi 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.

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)

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Warnings and precautions
Talk to your doctor or pharmacist before using Striverdi Respimat
-

if you have asthma (you should not use Striverdi Respimat for the treatment of asthma).
if you have diseases of the heart.
if you have high blood pressure.
if you have epilepsy.
if you have a specific thyroid gland problem called thyrotoxicosis.
if you have an abnormal widening of an artery called aneurysm.
if you have diabetes.
if you have severe hepatic impairment, as Striverdi Respimat has not been studied in this patient
population.
if you have severe renal impairment, as there is limited experience with Striverdi Respimat in this
patient population.
in case of 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).

-

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 short-acting ß-adrenergic agents, like salbutamol,
continue to use these only to relieve acute symptoms like breathlessness.
Children and adolescents
Striverdi Respimat 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:

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-

certain medicines for breathing problems that are similar to Striverdi Respimat (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 Striverdi Respimat

-

medicines that lower the amount of potassium in your blood. These include:
o steroids (e.g. prednisolone),
o diuretics (water tablets),
o medicines for breathing problems such as theophylline.
If you use these medicines together with Striverdi Respimat 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 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 Striverdi Respimat, 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 Striverdi Respimat 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 Striverdi Respimat 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 Striverdi Respimat 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.

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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.
Evaluation of the side effects is based on the following frequencies:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

may affect more than 1 in 10 people
may affect up to 1 in 10 people
may affect up to 1 in 100 people
may affect up to 1 in 1,000 people
may affect up to 1 in 10,000 people
frequency cannot be estimated from the available data

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:
- Nasopharyngitis (runny nose)
- Dizziness
- Rash
Rare:
- Arthralgia (joint pain)
- Hypertension
You may also experience side effects which are known to occur with certain medicines for breathing
problems similar to Striverdi Respimat (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

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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).
Immediate allergic reactions such as rash, nettle rash (urticaria), swelling of the mouth and face or
sudden difficulties in breathing (angioneurotic oedema) or other hypersensitivity reactions may occur
after administration of Striverdi Respimat. If this occurs, stop using Striverdi Respimat and consult
your doctor immediately.
In addition, in common with all inhaled medicines, some patients may experience an unexpected
tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation
(bronchospasm).
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
Reports may be made by following the links to the online reporting option accessible from the IMB
homepage, or by completing the downloadable report form also accessible from the IMB website,
which may be completed manually and submitted to the IMB via freepost, to the following address:
FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrrace
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.

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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 solution for inhalation 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

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Germany
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria, Liechtenstein:
Belgium, Luxembourg:
Bulgaria:
Cyprus, Greece:
Czech Republic:
Denmark:
Estonia:
Finland:
France:
Germany:
inhalation
Hungary:
Iceland:
Ireland, Malta, UK:
Italy:
Latvia:
Lithuania:
Netherlands:
Norway:
Poland:
Portugal:
Romania:
Slovakia:
Slovenia:
Spain:
Sweden:
This leaflet was last revised in
09/2013

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Instructions for Use
Striverdi Respimat inhaler
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.
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.

Striverdi Respimat inhaler and the Striverdi Respimat cartridge
1) Inserting the cartridge
The following steps 1-6 are necessary before first use:
1

1

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

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2

2a

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.

2b

3

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

3
2) To prepare the Striverdi Respimat inhaler for first-time use
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).

5

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

4

5

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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.

6

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).

Daily use of your Striverdi Respimat inhaler
You will need to use this inhaler ONLY ONCE A DAY.
Each time you use it take TWO PUFFS.
I

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

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.

I

II

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

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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.

When to get a new Striverdi Respimat inhaler
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...

Reason

What to do

I can’t turn the base
easily.

a) The Striverdi Respimat inhaler is
already prepared and ready to use.

a) The Striverdi Respimat
inhaler can be used as it is.

b) The Striverdi Respimat inhaler is locked
after 60 puffs (30 medicinal doses).

b) Prepare and use your new
Striverdi Respimat inhaler.

The cap is fully
pulled of and apart
from the inhaler.

While opening the cap it was pulled too
hard.

The cap can easily be attached
again.

I can’t press the dose
release button.

The clear base has not been turned.

Turn the clear base until it
clicks. (half a turn)

The clear base
springs back after I
have turned it.

The clear base was not turned far enough.

Prepare the Striverdi Respimat
inhaler for use by turning the
clear base until it clicks.
(half a turn)

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.

With the yellow cap closed,
turn the base until it clicks.
(half a turn)

How to care for your inhaler
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.

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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.

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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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