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TIOTROPIUM 2.5 MICROGRAM INHALATION SOLUTION

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

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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.

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.
In addition, in common with all inhaled medicines, some patients may
experience an unexpected tightness of the chest, coughing, wheezing or
breathlessness immediately after inhalation (bronchospasm).
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist.This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme (Tel: Freephone 0808 100
3352 or Website: www.mhra.gov.uk/yellowcard). By reporting side effects you
can help provide more information on the safety of this medicine.

Frequency
COPD

Frequency
Asthma

Common
Uncommon
Uncommon

Common
Uncommon

Difficulty in sleeping
(insomnia)

Rare

Uncommon

Irregular heart beat (atrial
fibrillation, supraventricular
tachycardia)

Rare

Not known

Feeling your heartbeat
(palpitations)

Rare

Uncommon

Faster heart beat (tachycardia)

Rare

Not known

Cough

Uncommon
Rare

Uncommon

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

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)
Painful urination (dysuria)

Uncommon

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

Manufacturer and Licence Holder
Manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, Binger
Strasse 173, D-55216 Ingelheim am Rhein, Germany and are procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
Spiriva ® Respimat ® is a registered trademark of Boehringer ingelheim
Pharma GmbH & Co. KG.

Side effect
Dry mouth: this is usually mild
Dizziness
Headache

Nosebleed (epistaxis)

Uncommon

Not known

Rare

Not known

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

Rare

Not known

Rare
Rare

Not known
Rare

Inflammation of the tongue
(glossitis)

Rare

Not known

Inflammation of the mouth
(stomatitis)

Not known

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

Rare

Nettle rash (urticaria)

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

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)
Severe allergic reaction
(anaphylactic reaction)

Not known
Not known

Not known
Not known

Page 2

How to store Spiriva Respimat

Keep out of the sight and reach of children.

Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Spiriva Respimat 2.5 mcg inhalation solution and will
be referred to as Spiriva Respimat throughout the rest of this leaflet.
What is in this leaflet
1 What Spiriva Respimat is and what it is used for

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).

3 How to take Spiriva Respimat
4 Possible side effects
5 How to store Spiriva Respimat

Rare

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 3.6% hydrochloric acid for pH adjustment.
What Spiriva Respimat looks like and contents of the pack
Spiriva Respimat is 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)

POM

PL 15184/1647 - Spiriva Respimat 2.5 microgram,
Inhalation Solution

Not known
Leaflet revision date: 30/06/16

Not known

Rare

Rare

Not known

6 Contents of the pack and other information

1

6

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

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.

2 What you need to know before you take Spiriva Respimat

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.

Ref:1647/300616/1/F

(tiotropium bromide)

Do not freeze.

Blurred vision

Swelling of joint

5

Spiriva ® Respimat ® 2.5 microgram, Inhalation Solution

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.

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 1

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

Prepare for first use
Remove clear base
1.

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

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).

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

Answers to Common Questions
It is difficult to insert the cartridge deep enough.
Did you accidentally turn the clear base before inserting the cartridge?
Open the cap, press the dose-release button, then insert the cartridge.
Did you 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.

Insert cartridge
2.

• Insert the narrow end of the cartridge into the inhaler.
• Place the inhaler on a firm surface and push down firmly until it clicks

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.

into place.

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

OPEN





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.



OPEN the cap until it snaps fully open.
I cannot press the dose-release button.
Did you turn the clear base?
If not, turn the clear base in a continuous movement until it clicks
(half a turn).

Replace clear base
3.



Put the clear base back into place until it clicks.

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.

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.

My Spiriva Respimat sprays automatically.
Was the cap open when you turned the clear base?
Close the cap, then turn the clear base.

When to get a new Spiriva Respimat
Turn
4.

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.

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

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.

Open







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).
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.
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.

5.



Open the cap until it snaps fully open.

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.
Press
6.

• 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.

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.

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).

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.

Page 2

Ref:1647/300616/1/B

Page 3

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

Frequency
COPD

Common
Uncommon

Difficulty in sleeping
(insomnia)

Rare

Uncommon

Irregular heart beat (atrial
fibrillation, supraventricular
tachycardia)

Rare

Not known

Feeling your heartbeat
(palpitations)

Rare

Uncommon

Faster heart beat (tachycardia)

Rare

Not known

Cough

Uncommon
Rare

Uncommon

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

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)
Painful urination (dysuria)

Uncommon

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 known

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)

Not known

Rare

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

Rare

Nettle rash (urticaria)

Rare

Headache

Nosebleed (epistaxis)

Not known

Tiotropium 2.5 microgram, Inhalation Solution
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Tiotropium 2.5 mcg, inhalation solution and will be
referred to as Tiotropium throughout the rest of this leaflet.

5

How to store Tiotropium
What is in this leaflet

Keep out of the sight and reach of children.

1 What Tiotropium is and what it is used for

Do not use Tiotropium 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 inhaler should be discarded at the latest 3 months after first use
(see Instructions for Use overleaf).
Do not freeze.

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

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

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

6

Contents of the pack and other information

What Tiotropium 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 3.6% hydrochloric acid for pH adjustment.
What Tiotropium looks like and contents of the pack
Tiotropium is 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 inhaler and 1 cartridge, providing 60 puffs
(30 medicinal doses)
Manufacturer and Licence Holder
Manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, Binger
Strasse 173, D-55216 Ingelheim am Rhein, Germany and are procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

2

3

PL 15184/1647 - Tiotropium 2.5 microgram,
Inhalation Solution

Leaflet revision date: 30/06/16

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

What Tiotropium is and what it is used for

Tiotropium 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
every day and not only when you have breathing problems or other
symptoms. When used to treat asthma you should use Tiotropium in addition
to so-called inhaled corticosteroids and long-acting ß2agonists.
Tiotropium 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 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 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 please see section 3. How to take
Tiotropium and the instructions for use provided on the other side of the
leaflet.

2

What you need to know before you take Tiotropium

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.


POM






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
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


Rare

Warnings and precautions
Talk to your doctor before taking Tiotropium.
Rare
Not known

Dryness of the skin
Hypersensitivity,
including immediate reactions

Rare
Not known

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)
Severe allergic reaction
(anaphylactic reaction)

Not known
Not known

Not known
Not known

Not known

Not known

Ref:1647/300616/2/F

(tiotropium bromide)



Rare

Page 2

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 via the Yellow Card Scheme (Tel: Freephone 0808 100
3352 or Website: www.mhra.gov.uk/yellowcard). By reporting side effects you
can help provide more information on the safety of this medicine.

Uncommon

Infections or ulcerations of the
skin

Swelling of joint

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).

Frequency
Asthma

Common
Uncommon
Uncommon

Dizziness

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

When taking Tiotropium 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 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 Tiotropium 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 Tiotropium 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 Tiotropium could make
your cystic fibrosis symptoms worse.
Children and adolescents
Tiotropium is not recommended for children and adolescents under 18 years.
Other medicines and Tiotropium
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 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

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 is for inhalation use only.
The recommended dose for adults is:
Tiotropium is effective for 24 hours so you will need to use Tiotropium 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 every day and
not only when you experience breathing problems. Do not take more than the
recommended dose.
Tiotropium 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 inhaler properly.
The instructions for use of the Tiotropium inhaler are provided on the other
side of this leaflet.
If you take more Tiotropium than you should
If you take more Tiotropium 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
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
Before you stop taking Tiotropium, you should talk to your doctor or your
pharmacist. If you stop taking Tiotropium 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 1

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

Prepare for first use
Remove clear base
1.




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

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).

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

Answers to Common Questions
It is difficult to insert the cartridge deep enough.
Did you accidentally turn the clear base before inserting the cartridge?
Open the cap, press the dose-release button, then insert the cartridge.
Did you insert the cartridge with the wide end first?
Insert the cartridge with the narrow end first.

The dose indicator on the Tiotropium reaches zero too soon.
Did you use Tiotropium as indicated (two puffs/Once daily)? Tiotropium
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.
Insert cartridge
2.

Did you spray in the air often to check whether the Tiotropium is
working?
Once you have prepared Tiotropium, no test-spraying is
required if used daily.

• 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.

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

I cannot press the dose-release button.

OPEN





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



OPEN the cap until it snaps fully open.

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

Replace clear base
3.



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

Put the clear base back into place until it clicks.

How to care for your Tiotropium

My Tiotropium sprays automatically.

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
inhaler performance. If necessary, wipe the outside of your Tiotropium inhaler
with a damp cloth.

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.

When to get a new Spiriva Respimat
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).

Turn
4.

• Keep the cap closed.
• Turn the clear base in the direction of the arrows on the label until it

I cannot turn the clear base.

clicks (half a turn).

PRESS







Open







Your Tiotropium inhaler contains 60 puffs (30 doses) if used as
indicated (two puffs/once daily).
The dose indicator shows approximately how much medication is left.
When the dose indicator enters the red area of the scale you need to get a
new prescription; there is approximately medication for 7 days left
(14 puffs).
Once the dose indicator reaches the end of the red scale, your Spiriva
Respimat locks automatically – no more doses can be released.
At this point, the clear base cannot be turned any further.
Tiotropium 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.

5.



Open the cap until it snaps fully open.

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 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 Tiotropium pointing to zero?
The Tiotropium inhaler is locked after 60 puffs (30 medicinal doses). Prepare
and use your new Tiotropium inhaler.
My Tiotropium 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 Tiotropium pointing to 0?
If the dose indicator points to 0, you have used up all your medication and
the inhaler is locked.
Once your Tiotropium is assembled, do not remove the clear base or the
cartridge. Always insert a new cartridge into a NEW Tiotropium.

Press
6.

• 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).

Page 2

Ref:1647/300616/1/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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