SPIRIVA RESPIMAT 2.5 MICROGRAMS SOLUTION FOR INHALATION

Active substance: TIOTROPIUM BROMIDE MONOHYDRATE

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500000/PL1a

Package leaflet: information for the user

Spiriva Respimat
2.5 micrograms,
Solution for Inhalation
®

®

(tiotropium bromide)
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 Spiriva Respimat is and what it is used for
2. What you need to know before you take Spiriva
Respimat
3. How to take Spiriva Respimat
4. Possible side effects
5. How to store Spiriva Respimat
6. Contents of the pack and other information
1. What Spiriva Respimat is and what it is used for
Spiriva Respimat 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 Spiriva Respimat every day and not only when you
have breathing problems or other symptoms of COPD.
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 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 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?
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
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 anticholinergic 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. 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 Spiriva Respimat is the right
medicine for you to take.

4. Possible side effects

6. Contents of the pack and other information

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

What Spiriva Respimat contains
The delivered dose is 2.5 micrograms tiotropium (as
bromide monohydrate) per puff (2 puffs comprise one
medicinal dose). One cartridge contains 4.0 ml providing 60
puffs (30 medicinal doses).

Do not take Spiriva Respimat more frequently than once
daily.

Common:
Uncommon:
Rare:
Not known:

You should also contact your doctor if you feel that your
breathing is worsening.
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, 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.
Ask your doctor for advice before taking this medicine.
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 usual dose 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 is a long-term disease 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.

Evaluation of the side effects is based on the following
frequencies:
affects 1 to 10 patients in 100
affects 1 to 10 patients in 1,000
affects 1 to 10 patients in 10,000
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
- 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 may occur after administration
of Spiriva Respimat. If this occurs, 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.
5. How to store Spiriva Respimat
Keep 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.

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:

1 Respimat inhaler and 1 cartridge,
providing 60 puffs (30 medicinal
doses)

Product Licence Holder
Procured from within the EU. Product Licence Holder
Ginova Ltd and repackager Ginova UK Ltd, both at St
James’ House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
The manufacturer for Spiriva Respimat is:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173, D-55216 Ingelheim am Rhein
Germany
Spiriva Respimat 2.5 micrograms, Solution for
Inhalation
PL No: 18067/0405
POM
®
®
Spiriva and Respimat are registered trademarks of
Boehringer Ingelheim Pharma GmbH & Co. KG

This leaflet was last approved on 21st January 2013.
To request a copy of this leaflet in Braille, large print or
audio please call 01622 693000.

Instructions for Use

When to get a new Spiriva Respimat
inhaler

Spiriva® Respimat®
Inhaler
How to use your Spiriva Respimat inhaler

Empty

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.

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).

6

The cartridge will not be flush with the inhaler, you will
still see the silver ring of the lower end of the cartridge.

Point the Spiriva Respimat 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.

Do not remove the cartridge once it has been inserted
into the inhaler.

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).

Cap (A)
Mouthpiece (B)
Air vent (C)

Daily use of your Spiriva Respimat
inhaler

Dose release
button (D)

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.

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

Cartridge (H)
Safety
catch (E)

Reason

What to do

I can’t turn the base
easily.

a) The Spiriva
Respimat inhaler
is already prepared
and ready to use.

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

b) The Spiriva
Respimat inhaler is
locked after
60 puffs
(30 medicinal
doses).

b) Prepare and use
your new Spiriva
Respimat inhaler.

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 dose
release button.

The clear base has
not been turned.

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

The clear base
springs back after
I have turned it.

Dose indicator (F)

What if...

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)

Clear
base (G)
Piercing
element (I)

3

Spiriva Respimat inhaler and the Spiriva Respimat
cartridge

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

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:
I

Safety
catch

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).

How to care for your inhaler

4

1

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.

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).

If necessary, wipe the outside of your Spiriva Respimat
inhaler with a damp cloth.

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

Air vent
Further information
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.

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
Binger Strasse 173, D-55216 Ingelheim am Rhein
Germany

III Repeat steps I and II so that you get the full dose.
5

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

You will need to use this inhaler only ONCE A DAY.
Close the green cap until you use your Spiriva Respimat
inhaler again.
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.

500000/PL1a

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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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