Skip to Content

STRIVERDI RESPIMAT 2.5 MICROGRAM SOLUTION FOR INHALATION

Active substance(s): OLODATEROL HYDROCHLORIDE / OLODATEROL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Striverdi® Respimat®
2.5 microgram, inhalation solution
(olodaterol hydrochloride)
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.
This medicine is available as the above name but will be referred as Striverdi
Respimat throughout the following leaflet.
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

If you regularly take certain medicines called short-acting β-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
(β-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.

1. What Striverdi Respimat is and what it is used for
Pregnancy, breast-feeding and fertility
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 longterm 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 longacting 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

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.

Do not use Striverdi Respimat
 if you are allergic to olodaterol or any of the other ingredients of this
medicine (listed in section 6)

Dosage

Warnings and precautions

The recommended dose is:

Talk to your doctor or pharmacist before using Striverdi Respimat if you:

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.

 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).
 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).

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.

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 longacting β-adrenergic agonists, like salmeterol or formoterol.

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

Repackaged by O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts
WD24 4PR.

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
5. How to store Striverdi Respimat
 Keep 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.
 If your inhaler fails to work properly or shows any signs of deterioration you
should ask your doctor or pharmacist for advice.
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 (2 puffs comprise one medicinal dose).
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 is composed of one inhaler and one aluminium cylindrical
cartridge containing a clear colourless solution for inhalation. A plastic cap is
present on both ends of the inhaler: a yellow cap covering the mouth piece;
and a transparent cap where the cartridge is to be inserted. The inhaler has
an indicator on the side showing the number of doses left. 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).
PL: 27777/0020

POM

Striverdi Respimat is manufactured by Boehringer Ingelheim Pharma GmbH &
Co. KG, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany.
Procured from within the EU by the Product Licence holder: Vital Supplies
(UK) Ltd., 6 Enterprise Court, Witham, Essex CM8 3YS.

Leaflet revision and issue date (Ref.): 05.09.2016.
The trademarks STRIVERDI® and RESPIMAT® are registered trademarks of
Boehringer Ingelheim Pharma GmbH & Co. KG.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

Striverdi® Respimat®
Instructions For Use

TWO PUFFS
ONCE DAILY

Prepare for first use

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

1

Remove clear base
 Keep the cap closed.
 Press the safety catch while firmly pulling
off the clear base with your other hand.

2

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.

3

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

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

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

4

How to care for your Striverdi Respimat
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.

5

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.

When to get a new Striverdi Respimat

6

 Your Striverdi Respimat inhaler contains 60 puffs (30 doses) if used as indicated (two puffs/ once daily).
 The dose indicator shows approximately how much medication is left.
 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).
 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).

Daily use

Answers to Common Questions

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

It is difficult to insert the
cartridge deep enough.

I cannot press the dose-release
button.

I cannot turn the clear base.

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

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.

Did you insert the cartridge with
the wide end first? Insert the
cartridge with the narrow end first.

OPEN
 OPEN the cap until it snaps fully open.

PRESS
 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.

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.

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

My Striverdi Respimat sprays
automatically.

My Striverdi Respimat doesn’t
spray.

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

Was the cap open when you
turned the clear base? Close the
cap, then turn the clear base.

Did you insert a cartridge? If not,
insert a cartridge.

Did you press the dose-release
button when turning the clear
base? Close the cap, so the doserelease button is covered, then turn
the clear base.

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.

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).

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

PL: 27777/0020

POM

Leaflet revision and issue date (Ref.): 05.09.2016.

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.

Expand Transcript

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.

Hide