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TIOTROPIUM BROMIDE 2.5MCG SOLUTION FOR INHALATION

Active substance(s): TIOTROPIUM BROMIDE

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6 Point the Spiriva Respimat inhaler towards the ground. Press the dose
release button (D). Close the green cap (A).

Spiriva ® Respimat ® 2.5 mcg solution for inhalation

When to get a new Spiriva Respimat inhaler

(tiotropium bromide)

Repeat steps 4, 5 and 6 until a cloud is visible.

Patient Information Leaflet

Then repeat steps 4, 5 and 6 three more times to ensure the inhaler is
prepared for use.

Daily use of your Spiriva Respimat inhaler

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.

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

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.

Your Spiriva Respimat inhaler is now ready to use.
These steps will not affect the number of doses available. After preparation
your Spiriva Respimat inhaler will be able to deliver your 60 puffs (30
medicinal doses).

What is in this leaflet
1 What Spiriva Respimat is and what it is used for
The Spiriva 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
Spiriva Respimat inhaler prescription.

2

Once the dose indicator has reached the end of the red scale (i.e. all 30
doses have been used), the Spiriva Respimat inhaler is empty and locks
automatically - no mare doses can be released. At this point, the base cannot
be turned any further.

6

At the latest, three months after use the Spiriva Respimat inhaler should be
discarded even if not all medication has been used
What if...
What if...
I. Hold the Spiriva Respimat inhaler upright, with the green 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).

I can’t turn the base
easily.

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

Air vent

II Open the green 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 Spiriva Respimat inhaler to the back
of your throat.
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.

I can’t press the
dose release
button.

The clear base
springs back after
I have turned it.

Reason
a) The Spiriva
Respimat
inhaler is
already
prepared and
ready to use.
b) The Spiriva
Respimat
inhaler is
locked after
60 puffs
(30 medicinal
doses).

You will need to use this inhaler only ONCE A DAY.
I can turn the clear
base past the point
where it clicks.

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

What to do
a) The Spiriva
Respimat inhaler
can be used as
it is.
b) Prepare and
use your new
Spiriva
Respimat
inhaler.

While opening
The cap can
the cap it was
easily be
pulled too hard. attached again.

The clear base
has not been
turned.

The clear base
was not turned
far enough.

III Repeat steps I and II so that you get the full dose.

Close the green cap until you use your Spiriva Respimat inhaler again.

Ref:LTT0142/210715/1/F

Either the dose
release button
has been
pressed, or the
clear base has
been turned too
far.

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

Prepare the
Spiriva
Respimat
inhaler for
use by turning
the clear base
until it clicks.
(half a turn)
With the green
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 discolouration in
the mouthpiece does not affect the performance of your Spiriva Respimat
inhaler.
If necessary, wipe the outside of your Spiriva Respimat inhaler with a damp
cloth.
Further information
The Spiriva Respimat Inhaler must not be disassembled after inserting the
cartridge and replacing the clear base.
Do not touch the piercing element inside the base.
Boehringer Ingelheim Pharma GmbH & Co. KG D-55216 Ingelheim Germany.

3
4
5

1

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

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 ß2
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.

2

What you need to know before you take Spiriva Respimat

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








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.
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.
In case you have 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, please, inform your doctor. This is
important to decide if Spiriva is the right medicine for you to take.
Do not take Spiriva Respimat more frequently than once daily.
You should also contact your doctor if you feel that your breathing is
worsening.
If you have cystic fibrosis, tell your doctor because Spiriva Respimat could
make your cystic fibrosis symptoms worse.
Children and adolescents
Spiriva Respimat is not recommended for children and adolescents under 18
years.
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.
The recommended dose for adults is:
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.
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.

Page 4
Page 1

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
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
Side effect
Dry mouth: this is usually mild
Dizziness
Headache
Difficulty in sleeping
(insomnia)

Frequency
COPD
Common
Uncommon
Uncommon

Frequency
Asthma
Common
Uncommon
Uncommon

Rare

Uncommon

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).
Cap (A)

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 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).
Do not freeze.

Irregular heart beat (atrial
fibrillation, supraventricular
tachycardia)

Rare

Not known

Feeling your heartbeat
(palpitations)

Rare

Uncommon

Faster heart beat (tachycardia)
Cough
Nosebleed (epistaxis)
Inflammation of the throat
(pharyngitis)

Rare
Uncommon
Rare
Uncommon

Not known
Uncommon
Not Known
Uncommon

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

Uncommon

Uncommon

Rare

Uncommon

Uncommon

Rare

Fungal infections of the oral cavity
and throat (oropharyngeal
candidiasis)
Difficulties swallowing (dysphagia)
Rash
Itching (pruritus)
Difficulties passing urine (urinary
retention)
Painful urination (dysuria)

Uncommon

Uncommon

Rare
Uncommon
Uncommon
Uncommon

Not known
Rare
Rare
Not known

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 know

Inflammation of the larynx
(laryngitis)
Heart burn (gastrooesophageal
reflux disease)
Dental caries
Inflammation of the gums
(gingivitis)

Rare

Not known

Rare

Not Known

Rare
Rare

Not known
Rare

Inflammation of the tongue
(glossitis)

Rare

Inflammation of the mouth
(stomatitis)
Serious allergic reaction which
causes swelling of the mouth and
face or throat (angloneurotic
oedema)
Nettle rash (urticaria)

Not known

Rare

Rare

Rare

Rare

Rare

Infections or ulcerations of the
skin

Rare

Not known

Dryness of the skin
Hypersensitivity,
including immediate reactions

Rare
Not known

Not known
Rare

How to use your Spiriva Respimat Inhaler

Infections of the urinary tract
Depletion of body water
(dehydration)
Inflammation in sinuses (sinusitis)

Rare
Not known

Not known
Not known

This leaflet explains how to use and care for your Spiriva Respimat inhaler.
Please read and carefully follow these instructions. See also section 3.
How to take Spiriva Respimat on the other side of this leaflet.

Not known

Not known

Blockage of intestines or absence
of bowel movements (intestinal
obstruction, including ileus
paralytic)
Feeling sick (nausea)
Severe allergic reaction
(anaphylactic reaction)
Swelling of joint

Not known

Not known

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.

Air vent (C)
Dose release
button (D)
Cartridge (H)
Safety catch
(E)

Dose indicator (F)

Clear base (G)

Piercing
element (I)

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

Spiriva Respimat inhaler and the Spiriva Respimat cartridge

2) To prepare the Spiriva Respimat inhaler for first-time
use

1) Inserting the cartridge
The following steps 1–6 are necessary before first use:

If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.
Safety catch

6

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)

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

4. Hold the Spiriva Respimat inhaler upright, with the green cap (A) closed.
Turn the base (G) in the direction of the red arrows on the label until
it clicks (half a turn).

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

POM

PL 33723/0142 - Spiriva Respimat 250 microgram
solution for inhalation

Leaflet revision date: 21/07/15
Not known

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

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

Not known
Not known

Not known
Not known

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

Spiriva Respimat Inhaler

The Spiriva Respimat inhaler releases medication slowly and gently, making
it easy to inhale it into your lungs.
The Spiriva 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 Spiriva Respimat inhaler and
the Spiriva Respimat cartridge. Before the Spiriva Respimat inhaler is used
for the first time, the cartridge provided must be inserted.

Page 2

2. 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

Ref:LTT0142/210715/1/B

Page 3

6 Point the Tiotropium bromide inhaler towards the ground. Press the dose
release button (D). Close the green cap (A).

Tiotropium Bromide 2.5 mcg solution for inhalation

When to get a new Tiotropium bromide inhaler

Ref:LTT0142/210715/2/F

Repeat steps 4, 5 and 6 until a cloud is visible.

Patient Information Leaflet

Then repeat steps 4, 5 and 6 three more times to ensure the inhaler is
prepared for use.
Your Tiotropium bromide inhaler is now ready to use.
These steps will not affect the number of doses available. After preparation
your Tiotropium bromide inhaler will be able to deliver your 60 puffs (30
medicinal doses).

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

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.

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.

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.

Do not take Tiotropium bromide more frequently than once daily.

What is in this leaflet:
1 What Tiotropium bromide is and what it is used for
3 How to take Tiotropium bromide
4 Possible side effects
5 How to store Tiotropium bromide
6 Contents of the pack and other information

Once the dose indicator has reached the end of the red scale (i.e. all 30
doses have been used), the Tiotropium bromide inhaler locks
automatically - no mare doses can be released. At this point, the base cannot
be turned any further.

What if...
I. Hold the Tiotropium bromide inhaler upright, with the green 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).

What if...

I can’t turn the base
easily.

Air vent

II Open the green 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 Tiotropium bromide inhaler to the
back of your throat.

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

I can’t press the
dose release
button.

Reason
a) The
Tiotropium
Bromide at
inhaler is
already
prepared and
ready to use.
b) The
Tiotropium
Bromide
inhaler is
locked after
60 puffs
(30 medicinal
doses).
While opening
the cap it was
pulled too hard.

III Repeat steps I and II so that you get the full dose.

The clear base
was not turned
far enough.

You will need to use this inhaler only ONCE A DAY.
Close the green cap until you use your Tiotropium Bromide inhaler
again.
If Tiotropium Bromide inhaler has not been used for more than 7 days
release one puff towards the ground. If Tiotropium Bromide inhaler has 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.

I can turn the clear
base past the point
where it clicks.

a) The
Tiotropium
Bromide inhaler
can be used as
it is.
b) Prepare and
use your new
Tiotropium
Bromide
inhaler.

The cap can
easily be
attached again.

Turn the clear
The clear base base until it
has not been
clicks.
turned.
(half a turn)

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.
The clear base
springs back after
I have turned it.

What to do

Either the dose
release button
has been
pressed, or the
clear base has
been turned too
far.

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

With the green
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 discolouration in
the mouthpiece does not affect the performance of your Tiotropium bromide
inhaler.
If necessary, wipe the outside of your Tiotropium bromide inhaler with a
damp cloth.
Further information
The Tiotropium bromide Inhaler must not be disassembled after inserting the
cartridge and replacing the clear base.

1

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
long-acting 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.

If you have cystic fibrosis, tell your doctor because Tiotropium bromide could
make your cystic fibrosis symptoms worse.
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.
2 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.

Do not touch the piercing element inside the base.
Boehringer Ingelheim Pharma GmbH & Co. KG D-55216 Ingelheim Germany.

You should also contact your doctor if you feel that your breathing is
worsening.

2 What you need to know before you take Tiotropium bromide

The Tiotropium bromide 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
Tiotropium bromide inhaler prescription.

At the latest, three months after use the Tiotropium bromide inhaler should
be discarded even if not all medication has been used

In case you have 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, please, inform your doctor. This is
important to decide if Tiotropium bromide is the right medicine for you to take.

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.

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 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 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.

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.

Page 4

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.
Please follow the instructions your doctor has given you.

Page 1

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
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.
Side effect

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).
Cap (A)

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 Tiotropium bromide

Frequency
COPD
Common
Uncommon
Uncommon

Frequency
Asthma
Common
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)
Cough
Nosebleed (epistaxis)
Inflammation of the throat
(pharyngitis)

Rare
Uncommon
Rare
Uncommon

Not known
Uncommon
Not Known
Uncommon

Hoarseness
Uncommon
(dysphonia)
Tightness of the chest, associated Rare
with coughing, wheezing or
breathlessness immediately after
inhalation (bronchospasm)
Constipation
Uncommon

Uncommon

Fungal infections of the oral cavity
and throat (oropharyngeal
candidiasis)
Difficulties swallowing (dysphagia)
Rash
Itching (pruritus)
Difficulties passing urine (urinary
retention)
Painful urination (dysuria)

Uncommon

Uncommon

Rare
Uncommon
Uncommon
Uncommon

Not known
Rare
Rare
Not known

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 know

Inflammation of the larynx
(laryngitis)
Heart burn (gastrooesophageal
reflux disease)
Dental caries
Inflammation of the gums
(gingivitis)

Rare

Not known

Rare

Not Known

Rare
Rare

Not known
Rare

Inflammation of the tongue
(glossitis)

Rare

Not known

Inflammation of the mouth
(stomatitis)
Serious allergic reaction which
causes swelling of the mouth and
face or throat (angloneurotic
oedema)
Nettle rash (urticaria)

Not known

Rare

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

Rare

Rare

Instructions for Use

Rare

Rare

Tiotropium bromide Inhaler

Infections or ulcerations of the
skin

Rare

Not known

How to use your Tiotropium bromide Inhaler

Dryness of the skin
Hypersensitivity,
including immediate reactions

Rare
Not known

Not known
Rare

This leaflet explains how to use and care for your Tiotropium bromide inhaler.
Please read and carefully follow these instructions. See also section 3.
How to take Tiotropium bromide on the other side of this leaflet.

Infections of the urinary tract
Depletion of body water
(dehydration)
Inflammation in sinuses (sinusitis)

Rare
Not known

Not known
Not known

Not known

Not known

Blockage of intestines or absence
of bowel movements (intestinal
obstruction, including
ileus paralytic)
Feeling sick (nausea)
Severe allergic reaction
(anaphylactic reaction)
Swelling of joint

Not known

Not known

Dry mouth: this is usually mild
Dizziness
Headache

Not known

Uncommon

Rare

Not known
Not known

Not known
Not known

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
Tiotropiurm bromide. If any of these occur, please consult your doctor
immediately.

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).

Air vent (C)
Dose release
button (D)
Cartridge (H)
Safety catch
(E)

Dose indicator (F)

Clear base (G)

Piercing
element (I)

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

Do not freeze.

Tiotropium bromide inhaler and the Tiotropium bromide cartridge

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.

1) Inserting the cartridge

If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.

The following steps 1–6 are necessary before first use:

6

Contents of the pack and other information

2) To prepare the Tiotropium bromide inhaler for
first-time use

Safety catch

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)

4. Hold the Tiotropium bromide inhaler upright, with the green cap (A) closed.
Turn the base (G) in the direction of the red arrows on the label until
it clicks (half a turn).
1 With the green cap (A) closed, press the safety catch
(E) while pulling off the clear base (G).

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.
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

PL 33723/0142 - Tiotropium bromide 250 microgram
solution for inhalation

Leaflet revision date: 21/07/15

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

The Tiotropium bromide inhaler releases medication slowly and gently,
making it easy to inhale it into your lungs.
The Tiotropium bromide 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 Tiotropium bromide inhaler and
the Tiotropium bromide cartridge. Before the Tiotropium bromide inhaler is
used for the first time, the cartridge provided must be inserted.

2. 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

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Ref:LTT0142/210715/2/B

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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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