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SPIRIVA RESPIMAT 2.5MCG SOLUTION FOR INHALATION

Active substance(s): TIOTROPIUM BROMIDE / TIOTROPIUM BROMIDE / TIOTROPIUM BROMIDE

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Spiriva ® Respimat ® 2.5 mcg solution for inhalation

Answers To Common Question

Daily Use

Ref:LTT0142/251016/1/F

(tiotropium bromide)
It is difficult to insert the cartridge deep enough.

TURN




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

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

Arrows
Did you insert the cartridge with the wide end first? Insert the cartridge
with the narrow end first.
The dose indicator on the Spiriva Respimat reaches zero too soon.
Did you use Spiriva Respimat as indicated (two puffs/Once daily)?
Spiriva Respimat will last 30 days if used at two puffs once daily.
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 spray in the air often to check whether the Spiriva Respimat is
working? Once you have prepared Spiriva Respimat, no test-spraying is
required if used daily.

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.

In case you have suffered from a myocardial infarction during the last 6
months or fromany unstable or life threatening irregular heart beat or severe
heart failure within the past year, please, inform your doctor. This is important
to decide if Spiriva is the right medicine for you to take.

Your medicine is called Spiriva Respimat 2.5 mcg solution for inhalation and
will be referred to as Spiriva Respimat throughout the rest of this leaflet.

If you have cystic fibrosis, tell your doctor because Spiriva Respimat could
make your cystic fibrosis symptoms worse.

What is in this leaflet

Children and adolescents
Spiriva Respimat is not recommended for children and adolescents under 18
years.

1 What Spiriva Respimat is and what it is used for
2
3

OPEN



Patient Information Leaflet

CAP

OPEN the cap untill it
snaps fully open

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

4
5

I cannot press the dose-release button.

6

What you need to know before you take Spiriva Respimat
How to take Spiriva Respimat
Possible side effects
How to store Spiriva Respimat
Contents of the pack and other information

Did you turn the clear base? If not, turn the clear base in a continuous
movement until it clicks (half a turn).
Is the dose indicator on the Spiriva Respimat pointing to zero? The
Spiriva Respimat inhaler is locked after 60 puffs (30 medicinal doses).
Prepare and use your new Spiriva Respimat inhaler.
My Spiriva 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.

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 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.

AIR VENT

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

My Spiriva 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 Spiriva 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 Spiriva Respimat is assembled, do not remove the clear base or
the cartridge. Always insert a new cartridge into a NEW Spiriva Respimat.

1

What Spiriva Respimat is and what it is used for

Spiriva Respimat helps people who have chronic obstructive pulmonary
disease (COPD) or asthma 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. Asthma
is a long-term disease characterised by airway inflammation and narrowing of
the airways. As COPD and asthma are long-term diseases you should take
Spiriva Respimat every day and not only when you have breathing problems
or other symptoms. When used to treat asthma you should use Spiriva
Respimat in addition to so-called inhaled corticosteroids and long-acting ß 2
agonists.
Spiriva Respimat is a long-acting bronchodilator that helps to open your
airways and makes it easier to get air in and out of the lungs. Regular use of
Spiriva 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. Daily use of Spiriva Respimat will also help to
prevent any sudden, short-term worsening of your COPD symptoms which
may last for several days.
For correct dosing of Spiriva Respimat please see section 3. How to take
Spiriva Respimat and the instructions for use provided on the other side of
the leaflet.

Do not take Spiriva Respimat more frequently than once daily.
You should also contact your doctor if you feel that your breathing is
worsening.

Other medicines and Spiriva Respimat
Please tell your doctor or pharmacist if you are taking, or have recently
taken, any other medicines, including medicines obtained without a
prescription.
In particular, please tell your doctor or pharmacist if you are taking/have
taken anticholinergic drugs, e.g. ipratropium or oxitropium.
No interaction side effects have been reported when Spiriva Respimat has
been taken with other products used to treat COPD such as reliever inhalers
(e.g. salbutamol), methylxanthines (e.g. theophylline), antihistamines,
mucolytics (e.g. ambroxol), leukotriene modifiers (e.g. montelukast),
cromones, anti-IgE treatment (e.g. omalizumab) and/or inhaled or oral
steroids (e.g. budesonide, prednisolone).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor 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 and the ability to drive and use machines have
been performed. In case dizziness or blurred vision occurs the ability to drive
and use machinery may be influenced.

3

How to take Spiriva Respimat

Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Spiriva Respimat is for inhalation use only.

2

What you need to know before you take Spiriva Respimat

The recommended dose for adults is:

Please read the following questions carefully.
If you can answer any of these questions with ‘Yes’ please discuss this with
your doctor before taking Spiriva Respimat

Spiriva Respimat is effective for 24 hours so you will need to use Spiriva
Respimat only ONCE A DAY, if possible at the same time of the day. Each
time you use it take TWO PUFFS.



As COPD and asthma are long-term diseases take Spiriva Respimat every
day and not only when you experience breathing problems. Do not take more
than the recommended dose.







are you allergic (hypersensitive) to tiotropium, atropine or similar drugs
such as ipratropium or oxitropium?
are you taking any other medicinal products containing ipratropium or
oxitropium?
are you pregnant, do you think you are pregnant, or are you
breast-feeding?
are you suffering from blurred vision, eye pain and/or red eyes, prostate
problems or have difficulty passing urine?
do you have any kidney problems?
have you suffered from a myocardial infarction during the last 6 months or
from any unstable or life threatening irregular heart beat or severe heart
failure within the past year?

Do not use Spiriva Respimat
• if you are allergic (hypersensitive) to tiotropium, its active ingredient or any
of the other ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to atropine or substances related to it,
e.g. ipratropium or oxitropium
Warnings and precautions
Talk to your doctor before taking Spiriva Respimat.
When taking Spiriva 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 tiotropium bromide and
immediately consult your doctor for further advice.

Spiriva Respimat is not recommended for use in children and adolescents
below 18 years due to lack of data on safety and efficacy.
Make sure that you know how to use your Spiriva Respimat inhaler properly.
The instructions for use of the Spiriva Respimat inhaler are provided on the
other side of this leaflet.
If you take more Spiriva Respimat than you should
If you take more Spiriva Respimat than two puffs in one day talk to your
doctor immediately. You may be at a higher risk of experiencing a side effect
such as dry mouth, constipation, difficulties passing urine, increased heart
beat or blurred vision.
If you forget to take Spiriva Respimat
If you forget to take your daily dose (TWO PUFFS ONCE A DAY), don’t
worry. Take it as soon as you remember but do not take two doses at the
same time or on the same day. Then take your next dose as usual.
If you stop taking Spiriva Respimat
Before you stop taking Spiriva Respimat, you should talk to your doctor or
your pharmacist. If you stop taking Spiriva 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.

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.
Dry mouth which has been observed with anti-cholinergic treatment may in
the long term be associated with dental caries. Therefore, please remember
to pay attention to oral hygiene.
Spiriva Respimat is indicated for the maintenance treatment of your chronic
obstructive pulmonary disease or asthma. Do not use this medicine to treat a
sudden attack of breathlessness or wheezing. Your doctor should have given
you another inhaler (“rescue medication”) for this.
Please follow the instructions your doctor has given you.
If you have been prescribed Spiriva Respimat for your asthma it should be
added on to inhaled corticosteroids and long-acting ß2 agonists. Continue
taking the inhaled corticosteroids as prescribed by your doctor, even if you
feel better.

Page 4

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:

Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data

Page 1

The side effects described below have been experienced by people
taking this medicine and they are listed according to frequency as either
common, uncommon, rare or not known

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).

Introduction

Prepare for first use

Introduction
Side effect

Frequency
COPD

Frequency
Asthma

Dry mouth: this is usually mild

Common

Common

Dizziness

Uncommon

Uncommon

Headache

Uncommon

Uncommon

Difficulty in sleeping
(insomnia)

Rare

Uncommon

Irregular heart beat (atrial
fibrillation, supraventricular
tachycardia)

Rare

Feeling your heartbeat
(palpitations)

Rare

Uncommon

Faster heart beat (tachycardia)

Rare

Not known

Cough

Uncommon

Uncommon

Nosebleed (epistaxis)

Rare

Not Known

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

Spiriva Respimat (tiotropium bromide). Read these Instructions for Use
before you start using Spiriva Respimat.

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

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

SAFETY CATCH

CAP
MOUTHPIECE

CLEAR BASE

AIR VENT
Not known

5

DOSE
RELEASE
BUTTON

How to store Spiriva Respimat

Keep out of the sight and reach of children.
Do not use Spiriva Respimat after the expiry date which is stated on the
carton and on the inhaler label. The expiry date refers to the last day of the
month. Spiriva Respimat inhaler should be discarded at the latest 3 months
after first use (see Instructions for Use overleaf).

SAFTEY
CATCH

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.

Do not freeze.
Inflammation of the throat
(pharyngitis)

Uncommon

Uncommon

Hoarseness (dysphonia)

Uncommon

Uncommon

Tightness of the chest, associated
with coughing, wheezing or
breathlessness immediately after
inhalation (bronchospasm)

Rare

Uncommon

CLEAR BASE
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.

6
Constipation

Uncommon

Rare

Fungal infections of the oral
cavity and throat (oropharyngeal
candidiasis)

Uncommon

Uncommon

Difficulties swallowing (dysphagia)

Rare

Not known

Rash

Uncommon

Rare

Itching (pruritus)

Uncommon

Rare

Difficulties passing urine (urinary
retention)

Uncommon

Not known

Painful urination (dysuria)

Uncommon

Not known

Seeing halos around lights or
coloured images in association
with red eyes (glaucoma)

Rare

Not known

Increase of the measured eye
pressure

Rare

Not known

Blurred vision

Rare

Not known

Contents of the pack and other information

What Spiriva Respimat contains:
The active substance is tiotropium. The delivered dose is 2.5 micrograms
tiotropium (as bromide monohydrate) per puff (2 puffs comprise one
medicinal dose).
The other ingredients are: Benzalkonium chloride, disodium edetate, purified
water, and hydrochloric acid 3.6% for pH adjustment.
What Spiriva Respimat looks like and contents of the pack
The Cardboard carton contains 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 green 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.
Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs
(30 medicinal doses)
Manufacturer and Licence Holder
This medicine is manufactured by Boehringer Ingelheim Pharma GmbH &
Co. KG, Binger Strasse 173,D-55216 Ingelheim am Rhein, Germany and is
procured from within the EU. Product Licence Holder: LTT Pharma Limited,
Unit 18 Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.

Inflammation of the larynx
(laryngitis)

Rare

Not known

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

Heart burn (gastrooesophageal
reflux disease)

Rare

Not Known

Spiriva ® Respimat ® is a registered trademark of Boehringer ingelheim
Pharma GmbH & Co. KG.

Dental caries

Rare

Not known

POM

Inflammation of the gums
(gingivitis)

Rare

Rare

Inflammation of the tongue
(glossitis)

Rare

Not known

Inflammation of the mouth
(stomatitis)

Not known

Rare

Serious allergic reaction which
causes swelling of the mouth and
face or throat (angloneurotic
oedema)

Rare

Nettle rash (urticaria)

PL 33723/0142 - Spiriva Respimat 2.5 microgram
solution for inhalation

PIERCING
ELEMENT



CARTRIDGE

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



If Spiriva 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.

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

DOSE
INDICATOR

EMPTY

CLEAR BASE

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).

FULL
ARROWS

Your Spiriva 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).

Rare



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

Rare

Rare



Spiriva 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.

Infections or ulcerations of the
skin

Rare

Not known

Dryness of the skin

Rare

Not known

Hypersensitivity,
including immediate reactions

Not known

Rare

Infections of the urinary tract

Rare

Not known

Depletion of body water
(dehydration)

Not known

Not known

Inflammation in sinuses (sinusitis)

Not known

Not known

Blockage of intestines or absence
of bowel movements (intestinal
obstruction, including ileus
paralytic)

Not known

Not known

Feeling sick (nausea)

Not known

Not known

Severe allergic reaction
(anaphylactic reaction)

Not known

Not known

Swelling of joint

Not known

Not known

Leaflet revision date: 25/10/16

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
Spiriva Respimat. If any of these occur, please consult your doctor
immediately.

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

When to get a new Spiriva Respimat



Blind or partially sighted? Is this leaflet hard to see
or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

“CLICK”

5 Open
• Open the cap until it snaps fully open
Cap

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

DOSE
RELEASE
BUTTON

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).

Page 2

Ref:LTT0142/251016/1/B

Page 3

It is difficult to insert the cartridge deep enough.

TURN




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

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

Arrows
Did you insert the cartridge with the wide end first? Insert the cartridge
with the narrow end first.
The dose indicator on the Spiriva Respimat reaches zero too soon.
Did you use Spiriva Respimat as indicated (two puffs/Once daily)?
Spiriva Respimat will last 30 days if used at two puffs once daily.
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 spray in the air often to check whether the Spiriva Respimat is
working? Once you have prepared Spiriva Respimat, no test-spraying is
required if used daily.

OPEN



CAP

OPEN the cap untill it
snaps fully open





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.

AIR VENT

Your medicine is called Tiotropium Bromide 2.5 mcg solution for inhalation
and will be referred to as Tiotropium Bromide throughout the rest of this
leaflet.

If you have cystic fibrosis, tell your doctor because Tiotropium Bromide could
make your cystic fibrosis symptoms worse.

What is in this leaflet
1 What Tiotropium Bromide is and what it is used for
2

5

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

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.

In case you have suffered from a myocardial infarction during the last 6
months or fromany unstable or life threatening irregular heart beat or severe
heart failure within the past year, please, inform your doctor. This is important
to decide if Spiriva is the right medicine for you to take.

I cannot press the dose-release button.

My Spiriva Respimat sprays automatically.

PRESS

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.

3

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

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

4
6

1

What you need to know before you take Tiotropium Bromide
How to take Tiotropium Bromide
Possible side effects
How to store Tiotropium Bromide
Contents of the pack and other information

What Tiotropium Bromide is and what it is used for

Tiotropium Bromide helps people who have chronic obstructive pulmonary
disease (COPD) or asthma 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. Asthma
is a long-term disease characterised by airway inflammation and narrowing of
the airways. As COPD and asthma are long-term diseases you should take
Tiotropium Bromide every day and not only when you have breathing problems or other symptoms. When used to treat asthma you should use
Tiotropium Bromide in addition to so-called inhaled corticosteroids and longacting ß2
agonists.
Tiotropium Bromide is a long-acting bronchodilator that helps to open your
airways and makes it easier to get air in and out of the lungs. Regular use of
Tiotropium Bromide 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. Daily use of Tiotropium Bromide will also help
to prevent any sudden, short-term worsening of your COPD symptoms which
may last for several days.
For correct dosing of Tiotropium Bromide please see section 3. How to take
Tiotropium Bromide and the instructions for use provided on the other side of
the leaflet.

My Spiriva Respimat doesn’t spray
2
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 Spiriva 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 Spiriva Respimat is assembled, do not remove the clear base or
the cartridge. Always insert a new cartridge into a NEW Spiriva Respimat.

Ref:LTT0142/251016/2/F

Patient Information Leaflet

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

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




Tiotropium Bromide 2.5 mcg solution for inhalation

Answers To Common Question

Daily Use

What you need to know before you take Tiotropium
Bromide

Please read the following questions carefully.
If you can answer any of these questions with ‘Yes’ please discuss this with
your doctor before taking Tiotropium Bromide








are you allergic (hypersensitive) to tiotropium, atropine or similar drugs
such as ipratropium or oxitropium?
are you taking any other medicinal products containing ipratropium or
oxitropium?
are you pregnant, do you think you are pregnant, or are you
breast-feeding?
are you suffering from blurred vision, eye pain and/or red eyes, prostate
problems or have difficulty passing urine?
do you have any kidney problems?
have you suffered from a myocardial infarction during the last 6 months or
from any unstable or life threatening irregular heart beat or severe heart
failure within the past year?

Do not use Tiotropium Bromide
• if you are allergic (hypersensitive) to tiotropium, its active ingredient or any
of the other ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to atropine or substances related to it,
e.g. ipratropium or oxitropium
Warnings and precautions
Talk to your doctor before taking Tiotropium Bromide.
When taking Tiotropium Bromide 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 tiotropium bromide and
immediately consult your doctor for further advice.
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.
Dry mouth which has been observed with anti-cholinergic treatment may in
the long term be associated with dental caries. Therefore, please remember
to pay attention to oral hygiene.
Tiotropium Bromide is indicated for the maintenance treatment of your chronic obstructive pulmonary disease or asthma. Do not use this medicine to treat
a
sudden attack of breathlessness or wheezing. Your doctor should have given
you another inhaler (“rescue medication”) for this.

Do not take Tiotropium Bromide more frequently than once daily.
You should also contact your doctor if you feel that your breathing is
worsening.

Children and adolescents
Tiotropium Bromide is not recommended for children and adolescents under
18 years.
Other medicines and Tiotropium Bromide
Please tell your doctor or pharmacist if you are taking, or have recently
taken, any other medicines, including medicines obtained without a
prescription.
In particular, please tell your doctor or pharmacist if you are taking/have
taken anticholinergic drugs, e.g. ipratropium or oxitropium.
No interaction side effects have been reported when Tiotropium Bromide has
been taken with other products used to treat COPD such as reliever inhalers
(e.g. salbutamol), methylxanthines (e.g. theophylline), antihistamines,
mucolytics (e.g. ambroxol), leukotriene modifiers (e.g. montelukast),
cromones, anti-IgE treatment (e.g. omalizumab) and/or inhaled or oral
steroids (e.g. budesonide, prednisolone).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor 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 and the ability to drive and use machines have
been performed. In case dizziness or blurred vision occurs the ability to drive
and use machinery may be influenced.

3

How to take Tiotropium Bromide

Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Tiotropium Bromide is for inhalation use only.
The recommended dose for adults is:
Tiotropium Bromide is effective for 24 hours so you will need to use
Tiotropium Bromide only ONCE A DAY, if possible at the same time of the
day. Each time you use it take TWO PUFFS.
As COPD and asthma are long-term diseases take Tiotropium Bromide every
day and not only when you experience breathing problems. Do not take more
than the recommended dose.
Tiotropium Bromide is not recommended for use in children and adolescents
below 18 years due to lack of data on safety and efficacy.
Make sure that you know how to use your Tiotropium Bromide inhaler properly.
The instructions for use of the Tiotropium Bromide inhaler are provided on
the other side of this leaflet.
If you take more Tiotropium Bromide than you should
If you take more Tiotropium Bromide than two puffs in one day talk to your
doctor immediately. You may be at a higher risk of experiencing a side effect
such as dry mouth, constipation, difficulties passing urine, increased heart
beat or blurred vision.
If you forget to take Tiotropium Bromide
If you forget to take your daily dose (TWO PUFFS ONCE A DAY), don’t
worry. Take it as soon as you remember but do not take two doses at the
same time or on the same day. Then take your next dose as usual.
If you stop taking Tiotropium Bromide
Before you stop taking Tiotropium Bromide, you should talk to your doctor or
your pharmacist. If you stop taking Tiotropium Bromide 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:

Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data

Please follow the instructions your doctor has given you.

Page 4

If you have been prescribed Tiotropium Bromide for your asthma it should be
added on to inhaled corticosteroids and long-acting ß2 agonists. Continue
taking the inhaled corticosteroids as prescribed by your doctor, even if you
feel better.

Page 1

The side effects described below have been experienced by people
taking this medicine and they are listed according to frequency as either
common, uncommon, rare or not known

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).

Introduction

Prepare for first use

Introduction
Side effect

Frequency
COPD

Frequency
Asthma

Dry mouth: this is usually mild

Common

Common

Dizziness

Uncommon

Uncommon

Headache

Uncommon

Uncommon

Difficulty in sleeping
(insomnia)

Rare

Uncommon

Irregular heart beat (atrial
fibrillation, supraventricular
tachycardia)

Rare

Feeling your heartbeat
(palpitations)

Rare

Uncommon

Faster heart beat (tachycardia)

Rare

Not known

Cough

Uncommon

Uncommon

Nosebleed (epistaxis)

Rare

Not Known

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

Tiotropium Bromide (tiotropium bromide). Read these Instructions for Use
before you start using Tiotropium Bromide.

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

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

SAFETY CATCH

CAP
MOUTHPIECE

CLEAR BASE

AIR VENT
Not known

5

DOSE
RELEASE
BUTTON

How to store Tiotropium Bromide

Keep out of the sight and reach of children.
Do not use Tiotropium Bromide after the expiry date which is stated on the
carton and on the inhaler label. The expiry date refers to the last day of the
month. Tiotropium Bromide inhaler should be discarded at the latest 3
months after first use (see Instructions for Use overleaf).

SAFTEY
CATCH

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.

Do not freeze.
Inflammation of the throat
(pharyngitis)

Uncommon

Uncommon

Hoarseness (dysphonia)

Uncommon

Uncommon

Tightness of the chest, associated
with coughing, wheezing or
breathlessness immediately after
inhalation (bronchospasm)

Rare

Uncommon

CLEAR BASE
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.

6
Constipation

Uncommon

Rare

Fungal infections of the oral
cavity and throat (oropharyngeal
candidiasis)

Uncommon

Uncommon

Difficulties swallowing (dysphagia)

Rare

Not known

Rash

Uncommon

Rare

Itching (pruritus)

Uncommon

Rare

Difficulties passing urine (urinary
retention)

Uncommon

Not known

Painful urination (dysuria)

Uncommon

Not known

Seeing halos around lights or
coloured images in association
with red eyes (glaucoma)

Rare

Not known

Increase of the measured eye
pressure

Rare

Not known

Blurred vision

Rare

Not known

Inflammation of the larynx
(laryngitis)

Rare

Not known

Heart burn (gastrooesophageal
reflux disease)

Rare

Not Known

Dental caries

Rare

Not known

Inflammation of the gums
(gingivitis)

Rare

Rare

Inflammation of the tongue
(glossitis)

Rare

Not known

Inflammation of the mouth
(stomatitis)

Not known

Rare

Serious allergic reaction which
causes swelling of the mouth and
face or throat (angloneurotic
oedema)

Rare

Nettle rash (urticaria)

Contents of the pack and other information

What Tiotropium Bromide contains:
The active substance is tiotropium. The delivered dose is 2.5 micrograms
tiotropium (as bromide monohydrate) per puff (2 puffs comprise one
medicinal dose).
The other ingredients are: Benzalkonium chloride, disodium edetate, purified
water, and hydrochloric acid 3.6% for pH adjustment.
What Tiotropium Bromide looks like and contents of the pack
The Cardboard carton contains 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 green 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.
Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs
(30 medicinal doses)
Manufacturer and Licence Holder
This medicine is manufactured by Boehringer Ingelheim Pharma GmbH &
Co. KG, Binger Strasse 173,D-55216 Ingelheim am Rhein, Germany and is
procured from within the EU. Product Licence Holder: LTT Pharma Limited,
Unit 18 Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.

PIERCING
ELEMENT



If Tiotropium Bromide has not been used for more than 7 days release one
puff towards the ground.



If Tiotropium Bromide 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.

How to care for your Tiotropium Bromide
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 Tiotropium Bromide inhaler
performance. If necessary, wipe the outside of your Tiotropium Bromide
inhaler with a damp cloth.

DOSE
INDICATOR

EMPTY

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

CLEAR BASE

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).

FULL
ARROWS

PL 33723/0142 - Tiotropium Bromide 2.5 microgram
solution for inhalation

Leaflet revision date: 25/10/16



Your Tiotropium Bromide 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).

Rare



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

Rare

Rare



Tiotropium Bromide 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.

Infections or ulcerations of the
skin

Rare

Not known

Dryness of the skin

Rare

Not known

Hypersensitivity,
including immediate reactions

Not known

Rare

Infections of the urinary tract

Rare

Not known

Depletion of body water
(dehydration)

Not known

Not known

Inflammation in sinuses (sinusitis)

Not known

Not known

Blockage of intestines or absence
of bowel movements (intestinal
obstruction, including ileus
paralytic)

Not known

Not known

Feeling sick (nausea)

Not known

Not known

Severe allergic reaction
(anaphylactic reaction)

Not known

Not known

Swelling of joint

Not known

Not known

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
Tiotropium Bromide. If any of these occur, please consult your doctor
immediately.

“CLICK”

When to get a new Tiotropium Bromide

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

POM

CARTRIDGE

Blind or partially sighted? Is this leaflet hard to see
or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

5 Open
• Open the cap until it snaps fully open
Cap

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

DOSE
RELEASE
BUTTON

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).

Page 2

Ref:LTT0142/251016/1/B

Page 3

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.

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