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TIOTROPIUM 2.5 MICROGRAM SOLUTION FOR INHALATION

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Spiriva® Respimat®
2.5 microgram, Solution for Inhalation
tiotropium

PACKAGE LEAFLET INFORMATION FOR THE USER
Instructions for use________________________

PACKAGE LEAFLET:
INFORMATION FOR THE USER________________

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
Spiriva® Respimat®
warm water, stop using tiotropium bromide and
immediately consult your doctor for further advice.
2.5 microgram, Solution for Inhalation
If your breathing has got worse or if you experience rash,
tiotropium
swelling or itching directly after using your inhaler, stop
The name of your medicine is Spiriva Respimat 2.5
using it and tell your doctor immediately.
microgram, Solution for Inhalation but will be referred to as
Dry mouth which has been observed with anticholinergic
Spiriva Respimat throughout this leaflet.
treatment may in the long term be associated with dental
Read all of this leaflet carefully before you start
caries. Therefore, please remember to pay attention to
taking this medicine because it contains important
oral hygiene.
information for you.
Spiriva Respimat is indicated for the maintenance
- Keep this leaflet. You may need to read it again.
treatment of your chronic obstructive pulmonary disease.
- If you have any further questions, ask your doctor
It should not be used to treat a sudden attack of
or pharmacist.
breathlessness or wheezing.
- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
Make sure your prescriber knows if you have diseases of
their signs of illness are the same as yours.
the heart, in particular conditions affecting your heartbeat
- If you get any side effects, talk to your doctor or
(rhythm disorders). Rhythm disorders may include
pharmacist. This includes any possible side effects
irregular heartbeat, too slow heart beat (bradycardia), or
not listed in this leaflet.
too fast heartbeat (tachycardia). This is important to
decide if Spiriva Respimat is the right medicine for you to
What is in this leaflet
take.
1. What Spiriva Respimat is and what it is used for
Do not take Spiriva Respimat more frequently than once
2. What you need to know before you take Spiriva
daily.
Respimat
3. How to take Spiriva Respimat
You should also contact your doctor if you feel that your
4. Possible side effects
breathing is worsening.
5. How to store Spiriva Respimat
If you have cystic fibrosis, tell your doctor because Spiriva
6. Contents of the pack and other information
Respimat could make your cystic fibrosis symptoms worse.
1. What Spiriva Respimat is and what it is used for
Children and adolescents
Spiriva Respimat is not recommended for children and
Spiriva Respimat helps people who have chronic
adolescents under 18 years.
obstructive pulmonary disease (COPD) to breathe more
easily. COPD is a long-term lung disease that causes
Other medicines and Spiriva Respimat
shortness of breath and coughing. The term COPD is
Please tell your doctor or pharmacist if you are taking, or
associated with the conditions chronic bronchitis and
have recently taken, any other medicines, including
emphysema. As COPD is a long-term disease you should medicines obtained without a prescription.
take Spiriva Respimat every day and not only when you
In particular, please tell your doctor or pharmacist if you
have breathing problems or other symptoms of COPD.
are taking/have taken anticholinergic drugs, e.g.
Spiriva Respimat is a long-acting bronchodilator that helps ipratropium or oxitropium.
to open your airways and makes it easier to get air in and
out of the lungs. Regular use of Spiriva Respimat can also No interaction side effects have been reported when
Spiriva Respimat has been taken with other products
help you when you have ongoing shortness of breath
used to treat COPD such as reliever inhalers, e.g.
related to your disease, and will help to minimise the
salbutamol, methylxanthines, theophylline and/or inhaled
effects of the disease on your everyday life. Daily use of
or oral steroids, e.g. prednisolone.
Spiriva Respimat will also help to prevent any sudden,
short-term worsening of your COPD symptoms which may Pregnancy and breast-feeding
last for several days.
If you are pregnant or believe you are pregnant, or if you
For correct dosing of Spiriva Respimat please see section are breast-feeding, you should not use this medicine
unless specifically recommended by your doctor.
3. How to take Spiriva Respimat and the instructions for
use provided on the other side of the leaflet.
Ask your doctor for advice before taking this medicine.
2. What you need to know before you take Spiriva
Driving and using machines
Respimat
No studies on the effects and the ability to drive and use
machines have been performed. In case dizziness or
Please read the following questions carefully.
If you can answer any of these questions with ’Yes’ please blurred vision occurs the ability to drive and use machinery
may be influenced.
discuss this with your doctor before taking Spiriva
Respimat
3. How to take Spiriva Respimat
- are you allergic (hypersensitive) to tiotropium, atropine or
Always take this medicine exactly as your doctor has
similar drugs such as ipratropium or oxitropium?
told you. You should check with your doctor or pharmacist
- are you taking any other medicinal products containing
if you are not sure.
ipratropium or oxitropium?
- are you pregnant, do you think you are pregnant, or are Spiriva Respimat is for inhalation use only.
you breast-feeding?
The usual dose is: Spiriva Respimat is effective for 24
- are you suffering from blurred vision, eye pain and/or red hours so you will need to use Spiriva Respimat only
eyes, prostate problems or have difficulty passing urine? ONCE A DAY, if possible at the same time of the day.
- do you have any kidney problems?
Each time you use it take TWO PUFFS.
Do not use Spiriva Respimat
As COPD is a long-term disease take Spiriva Respimat
- if you are allergic (hypersensitive) to tiotropium, its active every day and not only when you experience breathing
ingredient or any of the other ingredients of this medicine problems. Do not take more than the recommended dose.
(listed in section 6)
Spiriva Respimat is not recommended for use in children
- if you are allergic (hypersensitive) to atropine or
and adolescents below 18 years due to lack of data on
substances related to it, e.g. ipratropium or oxitropium
safety and efficacy.
Warnings and precautions
Make sure that you know how to use your Spiriva
When taking Spiriva Respimat take care not to let any
Respimat inhaler properly. The instructions for use of the
spray enter your eyes. This may result in eye pain or
Spiriva Respimat inhaler are provided on the other side of
discomfort, blurred vision, seeing halos around lights or
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.
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:
affects 1 to 10 patients in 100
Uncommon:
affects 1 to 10 patients in 1,000
Rare:
affects 1 to 10 patients in 10,000
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.
Common:
- dry mouth: this is usually mild
Uncommon:
- dizziness
- headache
- irregular heart beat (atrial fibrillation, supraventricular
tachycardia)
- feeling your heartbeat (palpitations)
- faster heart beat (tachycardia)
- cough
- nosebleed (epistaxis)
- inflammation of the throat (pharyngitis)
- hoarseness (dysphonia)
- constipation
- fungal infections of the oral cavity and throat
(oropharyngeal candidiasis)
- difficulties swallowing (dysphagia)
- rash
- itching (pruritus)
- difficulties passing urine (urinary retention)
- painful urination (dysuria)
Rare:
- seeing halos around lights or coloured images in
association with red eyes (glaucoma)
- increase of the measured eye pressure
- blurred vision
- tightness of the chest, associated with coughing,
wheezing or breathlessness immediately after
inhalation (bronchospasm)
- inflammation of the larynx (laryngitis)
- heart burn (gastrooesophageal reflux disease)
- dental caries
- inflammation of the gums (gingivitis)
- inflammation of the tongue (glossitis)
- inflammation of the mouth (stomatitis)
- serious allergic reaction which causes swelling of
the mouth and face or throat (angioneurotic oedema)
- nettle rash (urticaria)
- infections or ulcerations of the skin
- dryness of the skin
- infections of the urinary tract
Not known:
- depletion of body water (dehydration)
- difficulty in sleeping (insomnia)
- inflammation in sinuses (sinusitis)

- blockage of intestines or absence of bowel
movements (intestinal obstruction, including ileus
paralytic)
- feeling sick (nausea)
- hypersensitivity, including immediate reactions
- severe allergic reaction (anaphylactic reaction)
- swelling of joint
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).
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in
this leaflet.
Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. How to store Spiriva Respimat
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which
is stated on the carton and on the inhaler label. 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.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What Spiriva Respimat contains
The active substance is tiotropium bromide. The
delivered dose is 2.5 microgram tiotropium per puff
(2 puffs comprise one medicinal dose) and is equivalent
to 3.124 microgram tiotropium bromide monohydrate.
The delivered dose is the dose which is available for the
patient after passing the mouthpiece.
The other ingredients are:
Benzalkonium chloride, disodium edetate, purified
water, and hydrochloric acid 3.6% for pH adjustment.
What Spiriva Respimat looks like and contents of
the pack
Spiriva Respimat 2.5 microgram is composed of one
cartridge with solution for inhalation and one Respimat
inhaler. The cartridge has to be inserted into the inhaler
before the first use.
Single pack: One cartridge with a clear colourless
solution for inhalation and one Respimat inhaler which
is plastic with a light green cap, light grey mouthpiece
and clear body. The cartridge has to be inserted into the
inhaler before the first use.
1 Respimat inhaler and 1 cartridge, providing 60 puffs
(30 medicinal doses)
Manufacturer
The manufacturer for Spiriva Respimat is:
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger
Straße 173, D-55216 Ingelheim am Rhein, Germany
Procured from within the EU and repackaged in the UK
by the Product Licence holder, CD Pharma Ltd, Unit 3,
Manor Point, Manor Way, Borehamwood, Herts
WD6 1EE.
Spiriva Respimat
PL No.: 20492/0443 POM
Date of preparation: 12th December 2013

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

Instructions for Use_______________________

Spiriva Respimat
2.5 microgram,
Solution for Inhalation
®

®

Daily use of your Spiriva Respimat
inhaler

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

When to get a new Spiriva Respimat
inhaler
Empty

tiotropium

The name of your medicine is Spiriva Respimat 2.5
microgram, solution for inhalation but will be referred to
as Spiriva Respimat inhaler throughout this leaflet.
How to use your Spiriva Respimat inhaler
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.

Full

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.

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).

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 red arrows on the label
until it clicks (half a turn).

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.

What if…
What if...

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

1) Inserting the cartridge

You will need to use this inhaler only ONCE A DAY.

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

Close the green cap until you use your Spiriva
Respimat inhaler again.
If Spiriva Respimat inhaler has not been used for more
3 Replace the clear base (G). Do not remove the clear base
than 7 days release one puff towards the ground. If Spiriva
6 Point the Spiriva Respimat inhaler towards the ground.
again.
Press the dose release button (D). Close the green cap (A). 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.
Repeat steps 4, 5 and 6 until a cloud is visible.
Then repeat steps 4, 5 and 6 three more times to
ensure the inhaler is prepared for use.
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 to do

a) The Spiriva
Respimat inhaler
can be used as it is.

b) The Spiriva
b) Prepare and use
Respimat inhaler is
your new Spiriva
locked after 60 puffs
Respimat inhaler.
(30 medicinal doses)

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

Spiriva Respimat inhaler and the Spiriva
Respimat cartridge

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

Reason

I can’t turn the base a) The Spiriva
easily.
Respimat inhaler
is already prepared
and ready to use.

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.

Safety catch

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.
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. At this
point, the base cannot be turned any further.
At the latest, three months after use the Spiriva Respimat
inhaler should be discarded even if not all medication
has been used.

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

While opening the
cap it was pulled too
hard.

The cap can easily be
attached again.

I can’t press the
The clear base has
dose release button. not been turned.

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

The clear base
springs back after I
have turned it.

The clear base was
not turned far enough.

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

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

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

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.

Tiotropium
2.5 microgram, Solution for Inhalation

PACKAGE LEAFLET:
INFORMATION FOR THE USER________________

PACKAGE LEAFLET INFORMATION FOR THE USER
Instructions for use________________________

tiotropium
The name of your medicine is Tiotropium 2.5
microgram, solution for inhalation but will be referred to as
Tiotropium throughout this leaflet.

tiotropium

Tiotropium
2.5 microgram, Solution for Inhalation

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

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 anticholinergic
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. It should
not be used to treat a sudden attack of breathlessness
or wheezing.
Make sure your prescriber knows if you have diseases of
the heart, in particular conditions affecting your heartbeat
(rhythm disorders). Rhythm disorders may include
irregular heartbeat, too slow heart beat (bradycardia), or
too fast heartbeat (tachycardia). This is important to
decide if Tiotropium 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, theophylline and/or inhaled or oral
steroids, e.g. prednisolone.
Pregnancy and breast-feeding
If you are pregnant or believe you are pregnant, or if you
are breast-feeding, you should not use this medicine
unless specifically recommended by your doctor.

1. What Tiotropium is and what it is used for
Tiotropium helps people who have chronic obstructive
pulmonary disease (COPD) to breathe more easily.
COPD is a long-term lung disease that causes shortness
of breath and coughing. The term COPD is associated
with the conditions chronic bronchitis and emphysema.
As COPD is a long-term disease you should take
Tiotropium every day and not only when you have
breathing problems or other symptoms of COPD.
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 ongoing 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.
Ask your doctor for advice before taking this medicine.
2. What you need to know before you take Tiotropium Driving and using machines
No studies on the effects and the ability to drive and use
Please read the following questions carefully.
If you can answer any of these questions with ’Yes’ please machines have been performed. In case dizziness or
blurred vision occurs the ability to drive and use machinery
discuss this with your doctor before taking Tiotropium
- are you allergic (hypersensitive) to tiotropium, atropine or may be influenced.
similar drugs such as ipratropium or oxitropium?
3. How to take Tiotropium
- are you taking any other medicinal products containing
Always take this medicine exactly as your doctor has
ipratropium or oxitropium?
- are you pregnant, do you think you are pregnant, or are told you. You should check with your doctor or pharmacist
if you are not sure.
you breast-feeding?
- are you suffering from blurred vision, eye pain and/or red Tiotropium is for inhalation use only.
eyes, prostate problems or have difficulty passing urine?
The usual dose is: Tiotropium is effective for 24 hours so
- do you have any kidney problems?
you will need to use Tiotropium only ONCE A DAY, if
Do not use Tiotropium
possible at the same time of the day. Each time you use it
- if you are allergic (hypersensitive) to tiotropium, its active take TWO PUFFS.
ingredient or any of the other ingredients of this medicine
As COPD is a long-term disease take Tiotropium every
(listed in section 6)
day and not only when you experience breathing problems.
- if you are allergic (hypersensitive) to atropine or
Do not take more than the recommended dose.
substances related to it, e.g. ipratropium or oxitropium
Tiotropium is not recommended for use in children
Warnings and precautions
and adolescents below 18 years due to lack of data on
When taking Tiotropium take care not to let any spray
enter your eyes. This may result in eye pain or discomfort, safety and efficacy.
blurred vision, seeing halos around lights or coloured
Make sure that you know how to use your Tiotropium
images in association with red eyes (i.e. narrow angle
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.
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:
affects 1 to 10 patients in 100
Uncommon:
affects 1 to 10 patients in 1,000
Rare:
affects 1 to 10 patients in 10,000
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.
Common:
- dry mouth: this is usually mild
Uncommon:
- dizziness
- headache
- irregular heart beat (atrial fibrillation, supraventricular
tachycardia)
- feeling your heartbeat (palpitations)
- faster heart beat (tachycardia)
- cough
- nosebleed (epistaxis)
- inflammation of the throat (pharyngitis)
- hoarseness (dysphonia)
- constipation
- fungal infections of the oral cavity and throat
(oropharyngeal candidiasis)
- difficulties swallowing (dysphagia)
- rash
- itching (pruritus)
- difficulties passing urine (urinary retention)
- painful urination (dysuria)
Rare:
- seeing halos around lights or coloured images in
association with red eyes (glaucoma)
- increase of the measured eye pressure
- blurred vision
- tightness of the chest, associated with coughing,
wheezing or breathlessness immediately after
inhalation (bronchospasm)
- inflammation of the larynx (laryngitis)
- heart burn (gastrooesophageal reflux disease)
- dental caries
- inflammation of the gums (gingivitis)
- inflammation of the tongue (glossitis)
- inflammation of the mouth (stomatitis)
- serious allergic reaction which causes swelling of
the mouth and face or throat (angioneurotic oedema)
- nettle rash (urticaria)
- infections or ulcerations of the skin
- dryness of the skin
- infections of the urinary tract
Not known:
- depletion of body water (dehydration)
- difficulty in sleeping (insomnia)
- inflammation in sinuses (sinusitis)

- blockage of intestines or absence of bowel
movements (intestinal obstruction, including ileus
paralytic)
- feeling sick (nausea)
- hypersensitivity, including immediate reactions
- severe allergic reaction (anaphylactic reaction)
- swelling of joint
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.
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).
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in
this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. How to store Tiotropium
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and on the inhaler label. 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.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What Tiotropium contains
The active substance is tiotropium bromide. The
delivered dose is 2.5 microgram tiotropium per puff
(2 puffs comprise one medicinal dose) and is equivalent
to 3.124 microgram tiotropium bromide monohydrate.
The delivered dose is the dose which is available for the
patient after passing the mouthpiece.
The other ingredients are:
Benzalkonium chloride, disodium edetate, purified
water, and hydrochloric acid 3.6% for pH adjustment.
What Tiotropium looks like and contents of
the pack
Tiotropium 2.5 microgram is composed of one cartridge
with solution for inhalation and one Respimat inhaler.
The cartridge has to be inserted into the inhaler before
the first use.
Single pack: One cartridge with a clear colourless
solution for inhalation and one Respimat inhaler which
is plastic with a light green cap, light grey mouthpiece
and clear body. The cartridge has to be inserted into the
inhaler before the first use.
1 Respimat inhaler and 1 cartridge, providing 60 puffs
(30 medicinal doses)
Manufacturer
The manufacturer for Tiotropium is:
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger
Straße 173, D-55216 Ingelheim am Rhein, Germany
Procured from within the EU and repackaged in the UK
by the Product Licence holder, CD Pharma Ltd, Unit 3,
Manor Point, Manor Way, Borehamwood, Herts
WD6 1EE.
Tiotropium 2.5 microgram, solution for inhalation
PL No.: 20492/0443
POM
Date of preparation: 12th December 2013

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

Instructions for Use_______________________

Tiotropium
2.5 microgram,
Solution for Inhalation

Daily use of your Tiotropium inhaler

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

When to get a new Tiotropium inhaler
Empty

tiotropium

The name of your medicine is Tiotropium 2.5
microgram, solution for inhalation but will be referred to
as Tiotropium inhaler throughout this leaflet.
How to use your Tiotropium inhaler
This leaflet explains how to use and care for your
Tiotropium inhaler. Please read and carefully follow
these instructions. See also section 3. How to take
Tiotropium on the other side of this leaflet.

Full

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

4 Hold the Tiotropium 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).

The Tiotropium inhaler contains 60 puffs (30 medicinal
doses). The dose indicator shows approximately how
much medication is left. When the pointer enters the
area of the scale, there is, approximately, medication
I Hold the Tiotropium inhaler upright, with the green cap (A) red7 days left (14 puffs). This is when you need to get a
for
closed, to avoid accidental release of dose. Turn the
base (G) in the direction of the red arrows on the label until new Tiotropium inhaler prescription.
it clicks (half a turn).
Once the dose indicator has reached the end of the red
scale (i.e. all 30 doses have been used), the Tiotropium
inhaler is empty and locks automatically. At this point,
the base cannot be turned any further.
At the latest, three months after use the Tiotropium
inhaler should be discarded even if not all medication
has been used.

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.

What if…
What if...
I can’t turn the base
easily

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

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 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.

Tiotropium inhaler and the Tiotropium Cartridge

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

1) Inserting the cartridge

Reason

a) The Tiotropium
a) The Tiotropium
inhaler is already
inhaler can be
prepared and ready used as it is
to use.
b) The Tiotropium
b) Prepare and
inhaler is locked
use your new
after 60 puffs (30
Tiotropium inhaler.
medicinal doses.

The cap is fully
pulled off and apart
from the inhaler

While opening the
cap it was pulled
too hard

Safety
catch

Close the green cap until you use your Tiotropium
inhaler again.
3 Replace the clear base (G). Do not remove the clear base
again.

6 Point the Tiotropium inhaler towards the ground. Press
the dose release button (D). Close the green cap (A).
Repeat steps 4, 5 and 6 until a cloud is visible.
Then repeat steps 4, 5 and 6 three more times to
ensure the inhaler is prepared for use.
Your Tiotropium inhaler is now ready to use.
These steps will not affect the number of doses available.
After preparation your Tiotropium inhaler will be able to
deliver your 60 puffs (30 medicinal doses).

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

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

The cap can easily be
attached again.

I can’t press the dose The clear base has
release button.
not been turned.

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

The clear base
springs back after
I have turned it.

The clear base was
not turned far
enough.

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

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

Either the dose
With the green cap
release button has
closed, turn the base
been pressed, or the unitl it clicks. (half a turn)
clear base has been
turned too far.

You will need to use this inhaler only ONCE A DAY.

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

What to do

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
inhaler.
If necessary, wipe the outside of your Tiotropium
inhaler with a damp cloth.
Further information
The Tiotropium inhaler must not be disassembled
after inserting the cartridge and replacing the clear base.
Do not touch the piercing element inside the base.

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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