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SPIOLTO RESPIMAT 2.5 MICROGRAM/2.5 MICROGRAM INHALATION SOLUTION

Active substance(s): OLODATEROL HYDROCHLORIDE / TIOTROPIUM BROMIDE MONOHYDRATE

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1. What Spiolto Respimat is and what it is
used for

PACKAGE LEAFLET: INFORMATION FOR THE USER

Spiolto® Respimat®
2.5 microgram/2.5 microgram,
inhalation solution
tiotropium/olodaterol

What Spiolto Respimat is

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 Spiolto Respimat is and what it is used for
2. What you need to know before you take Spiolto
Respimat
3. How to take Spiolto Respimat
4. Possible side effects
5. How to store Spiolto Respimat
6. Contents of the pack and other information








Spiolto Respimat contains two active substances
called tiotropium and olodaterol. These belong to
a group of medicines called long-acting
bronchodilators. Tiotropium belongs to the subgroup
of anticholinergics; olodaterol belongs to the
subgroup of long acting beta2 agonists.

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
conditions chronic bronchitis and emphysema.











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.

2. What you need to know before you take
Spiolto Respimat

Spiolto® Respimat®
2.5 microgram/2.5 microgram,
inhalation solution
tiotropium/olodaterol
Spiolto® Respimat®
2.5 microgram/2.5 microgram,
inhalation solution
tiotropium/olodaterol

309838-01



TD

Printfile

Issue date of TD:

17.12.2015

Yes

Yes

PPM SKU:

P033604

No

Yes

PPM SKU version: 

003

No

Yes

Issue date of artwork:

22.04.2016

No

Yes

Print colors:

Black

No

Yes

No

Yes

Cyan

Magenta

Yellow
Mat. No. Pack. Site:

309838-01

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

Technical colors
BI-Diecut-Legendcase

Free area

Gluepoints

Additional Requirements of Packaging site
Template name: TD-PI_710x274_90x35
Index: a
Only for BI-internal use, Template according to Drawing no.: SP-14-0090-001-B_Index_

– 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).

MASS D:
MASS E:
MASS G:

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

Example
Technical information
Control Code Type: Laetus mini

– 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 Spiolto Respimat

– medicines that lower the amount of potassium in
your blood. These include:
– If your breathing has got worse or if you experience
– steroids (e.g. prednisolone),
rash, swelling or itching directly after using your
– diuretics (water tablets),
inhaler, stop using it and tell your doctor immediately – medicines for breathing problems such as
(see section 4).
theophylline.
If you use these medicines together with Spiolto
– If you experience any side effects affecting your heart Respimat you may experience symptoms of muscle
(increase in pulse rate, increase in blood pressure
spasm, muscle weakness or abnormal heart rhythm.
and/or increase in symptoms like chest pain), tell
your doctor immediately (see section 4).
– medicines called tricyclic antidepressants or
monoamine oxidase (MAO) inhibitors (like selegiline
– If you experience muscle spasm, muscle weakness or or moclobemide), that are used to treat neurological
abnormal heart rhythm, consult your doctor as these or psychiatric disorders like Parkinson´s disease or
may be related to low blood levels of potassium (see depression; the use of these drugs will increase the
section 4).
likelihood that you get side effects affecting your heart.
When taking Spiolto Respimat take care not to let any
spray enter your eyes. This may result in eye pain or
discomfort, blurred vision, seeing halos around lights
or coloured images in association with red eyes (i.e.
narrow angle glaucoma). Eye symptoms may be
accompanied by headache, nausea or vomiting. Wash
your eyes in warm water, stop using Spiolto Respimat
and immediately consult your doctor for further advice.
Spiolto 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 Spiolto Respimat
– if you are allergic to tiotropium or olodaterol or any
Do not use Spiolto Respimat together with certain
of the other ingredients of this medicine (listed in
medicines containing long-acting β-adrenergic
section 6)
– if you are allergic to atropine or substances related agonists, like salmeterol or formoterol.
to it, e.g. ipratropium or oxitropium
If you regularly take certain medicines called shortacting β-adrenergic agents, like salbutamol, continue
Warnings and precautions
to use these only to relieve acute symptoms like
breathlessness.
Talk to your doctor or pharmacist before using
Spiolto Respimat
Dry mouth which has been observed with anti – if you have asthma (you should not use Spiolto
cholinergic treatment may in the long term be
Respimat for the treatment of asthma).
associated with dental caries. Therefore, please
– if you have diseases of the heart.
remember to pay attention to oral hygiene.
– if you have high blood pressure.
– if you have epilepsy.
Do not take Spiolto Respimat more frequently than
– if you have a specific thyroid gland problem called
once daily.
thyrotoxicosis.
– if you have an abnormal widening of an artery
Children and adolescents
called aneurysm.
Spiolto Respimat should not be given to children or
– if you have diabetes.
adolescents (below the age of 18 years).
– if you have severe hepatic impairment.
– if you have renal impairment.
Other medicines and Spiolto Respimat
– in case of a planned surgery.
Please tell your doctor or pharmacist if you are taking,
– if you have an eye problem called narrow-angle
or have recently taken any other medicines.
glaucoma.
– if you have prostate problems or have difficulty
In particular, please tell your doctor if you are using:
passing urine.
– any medicines that may be similar to Spiolto
Respimat (contain similar active substances, such as
anticholinergic drugs or β-adrenergic agents). You
may be more likely to get side effects.

Mandatory in

File information

During treatment with Spiolto Respimat

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. You should not use this medicine unless
specifically recommended by your doctor.
Driving and using machines
No studies on the effects on the ability to drive and
use machines have been performed. If you feel dizzy or
if blurred vision occurs while taking Spiolto Respimat,
do not drive or use any tools or machines.

3. How to take Spiolto Respimat
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
Spiolto Respimat is for inhalation use only.
Dosage
The recommended dose is: Spiolto Respimat is
effective for 24 hours so you will need to use Spiolto
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 Spiolto 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 Spiolto Respimat in the
paediatric population (under 18 years).
Make sure that you know how to use your Spiolto
Respimat inhaler properly. The instructions for use of
the Spiolto Respimat inhaler are provided on the other
side of this leaflet.

If you take more Spiolto Respimat than you should
You may be at a higher risk of experiencing a side
effect such as dry mouth, constipation, difficulties
passing urine, blurred vision, chest pain, high or low
blood pressure, faster or irregular heartbeat or feeling
of heart beat, dizziness, nervousness, difficulty in
sleeping, anxiety, headache, shaking, 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 Spiolto 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 Spiolto Respimat
Before you stop taking Spiolto Respimat, you should talk
to your doctor or your pharmacist. If you stop taking Spiolto
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.
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 (such as sudden
reduction of your blood pressure or dizziness) may
occur individually or as part of severe allergic reaction
(anaphylactic reaction) after administration of Spiolto
Respimat. If any of these occur, please stop using this
medicine and consult your doctor immediately.
The side effects described below have been
experienced by people taking this medicine and they
are listed according to frequency.
Common (may affect up to 1 in 10 people)
– dry mouth
Uncommon (may affect up to 1 in 100 people)
– dizziness
– difficulty in sleeping (insomnia)
– headache
– hypertension
– irregular heart beat (atrial fibrillation)
– feeling your heartbeat (palpitations)
– faster heart beat (tachycardia)
– cough
– constipation
Rare (may affect up to 1 in 1,000 people)
– nasopharyngitis
– sore throat (pharyngitis)
– inflammation of the larynx (laryngitis)
– inflammation of the gums (gingivitis)
– hoarseness (dysphonia)
– nosebleed (epistaxis)

– fungal infections of the oral cavity and throat
(oropharyngeal candidiasis)
– blurred vision
– rapid heartbeat (supraventricular tachycardia)
– feeling sick (nausea)
– joint pain (arthralgia)
– back pain
– difficulties passing urine (urinary retention)
– painful urination (dysuria)
– hypersensitivity, including immediate reactions
– serious allergic reaction which causes swelling of the
mouth and face or throat (angioneurotic oedema)
– itching (pruritus)
– nettle rash (urticaria)
Not known (frequency cannot be estimated from the
available data)
– seeing halos around lights or coloured images in
association with red eyes (glaucoma)
– increase of the measured eye pressure
– tightness of the chest, associated with coughing,
wheezing or breathlessness immediately after
inhalation (bronchospasm)
– inflammation of the tongue (glossitis)
– dental caries
– inflammation in sinuses (sinusitis)
– inflammation of the mouth (stomatitis)
– difficulties swallowing (dysphagia)
– heart burn (gastrooesophageal reflux disease)
– blockage of intestines or absence of bowel movements
(intestinal obstruction, including ileus paralytic)
– rash
– severe allergic reaction (anaphylactic reaction)
– dryness of the skin
– infections or ulcerations of the skin
– depletion of body water (dehydration)
– infections of the urinary tract
– swelling of joint
You may also experience side effects which are known
to occur with certain medicines for breathing problems
similar to Spiolto Respimat (beta-adrenergic agents).
These may be irregular heartbeat, chest pain, low
blood pressure, shaking, nervousness, 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).

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
Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Spiolto Respimat
Keep this medicine out of the sight and reach of children.
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.
Do not freeze.
Spiolto 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 Spiolto Respimat contains
The active substances are tiotropium and olodaterol.
The delivered dose is 2.5 microgram tiotropium (as
bromide monohydrate) and 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 hydrochloric acid for pH adjustment.
What Spiolto Respimat looks like and contents of the
pack

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).

Spiolto Respimat 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.

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.

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)

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder for Spiolto
Respimat is:
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
The manufacturer for Spiolto 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: Spiolto Respimat 2,5 Mikrogramm/

2,5 Mikrogramm – Lösung zur

Inhalation
Belgium, Luxembourg: Spiolto Respimat 2,5 microgrammes/

2,5 microgrammes/inhalation,

solution à inhaler
Bulgaria:
Spiolto Respimat Спиолто Респимат
Spiolto Respimat
Cyprus, Greece:
Croatia:
Spiolto Respimat 2,5 mikrograma/

2,5 mikrograma, otopina inhalata
Spiolto Respimat 2,5 mikrogramů/
Czech Republic:

2,5 mikrogramů
Denmark:
Spiolto Respimat
Estonia:
Spiolto Respimat
France:
Spiolto Respimat 2,5 microgrammes/
2,5 microgrammes/dose,


solution à inhaler
Germany:
Spiolto Respimat 2,5 Mikrogramm/

2,5 Mikrogramm pro Hub,

Lösung zur Inhalation
Spiolto Respimat 2,5 mikrogramm/
Hungary:

2,5 mikrogramm inhalációs oldat
Spiolto Respimat
Iceland:
Ireland, Malta, UK: Spiolto Respimat
Italy:
Spiolto Respimat 2,5 microgrammi/

2,5 microgrammi, soluzione per

inalazione
Latvia:
Spiolto Respimat 2,5 mikrogrami/
2,5 mikrogrami šķīdums inhalācijām

Spiolto Respimat 2,5 mikrogramo/
Lithuania:

2,5 mikrogramo/išpurškime

įkvepiamasis tirpalas
Netherlands:
Spiolto Respimat 2,5 microgram/
2,5 microgram, inhalatieoplossing

Spiolto Respimat
Norway:
Spiolto Respimat
Poland:
Spiolto Respimat
Portugal:
Romania:
Spiolto Respimat 2,5 micrograme/
2,5 micrograme soluţie de inhalat

Spiolto Respimat
Slovakia:
Slovenia:
Spiolto Respimat 2,5 mikrogramov/

2,5 mikrogramov/vdih raztopina za

inhaliranje
Spiolto Respimat 2,5 microgramos/
Spain:

2,5 microgramos solución para

inhalación
Sweden:
Spiolto Respimat

This leaflet was last revised in 04/2016.

abcd
Spiolto® Respimat®

Instructions For Use
Introduction
Spiolto Respimat (tiotropium and olodaterol). Read
these Instructions for Use before you start using Spiolto
Respimat.
You will need to use this inhaler only ONCE
A DAY. Each time you use it take TWO PUFFS.

TWO
PUFFS
ONCE
DAILY

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

How to care for your Spiolto 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 Spiolto Respimat inhaler
performance. If necessary, wipe the outside of your
Spiolto Respimat inhaler with a damp cloth.
When to get a new Spiolto Respimat

1

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.

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

4

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

3

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.

2

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).

• If Spiolto 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.

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

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

5

Open
• Open the cap until it snaps fully open.

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).

Did you accidentally turn the
clear base before inserting the
cartridge? Open the cap, press
the dose-release button, then
insert the cartridge.

I cannot press the dose-release
button.

It is difficult to insert the
cartridge deep enough.

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

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

OPEN

Did you use Spiolto Respimat
as indicated (two puffs/once
daily)? Spiolto 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.
• 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).

• Do not touch the piercing element inside
the clear base.

• Once the dose indicator reaches the end of the
red scale, your Spiolto Respimat locks
automatically – no more doses can be released.
At this point, the clear base cannot be turned
any further.
• Spiolto 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.

6

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).

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
• 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 Spiolto
Respimat is working? Once you
have prepared Spiolto
Respimat, no test-spraying is
required if used daily.

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

My Spiolto 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
Spiolto Respimat pointing to
zero? The Spiolto Respimat
inhaler is locked after 60 puffs
(30 medicinal doses). Prepare
and use your new Spiolto
Respimat inhaler.
My Spiolto 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
Spiolto 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 Spiolto Respimat is
assembled, do not remove the
clear base or the cartridge.
Always insert a new cartridge
into a NEW Spiolto Respimat.

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