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SPIRIVA RESPIMAT 2.5 MICROGRAM SOLUTION FOR INHALATION

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

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Spiriva® Respimat® 2.5 microgram, Solution for Inhalation
(tiotropium bromide)
Your medicine is known by the above name, but it will be referred to as
Spiriva Respimat throughout this Leaflet.
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.
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) 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 β2
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 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 or asthma. Do not use this medicine to treat a
sudden attack of breathlessness or wheezing. Your doctor should have given
you another inhaler (“rescue medication”) for this.
Please follow the instructions your doctor has given you.
If you have been prescribed Spiriva Respimat for your asthma it should be
added on to inhaled corticosteroids and long-acting ß2 agonists. Continue
taking the inhaled corticosteroids as prescribed by your doctor, even if you
feel better.
In case you have suffered from a myocardial infarction during the last 6
months or from any unstable or life threatening irregular heart beat or severe
heart failure within the past year, please, inform your doctor. This is important
to decide if Spiriva is the right medicine for you to take.
Do not take Spiriva Respimat more frequently than once daily.
You should also contact your doctor if you feel that your breathing is
worsening.
If you have cystic fibrosis, tell your doctor because Spiriva Respimat could
make your cystic fibrosis symptoms worse.
Children and adolescents
Spiriva Respimat is not recommended for children and adolescents under 18
years.
Other medicines and Spiriva Respimat
Please tell your doctor or pharmacist if you are taking, or have recently taken,
any other medicines, including medicines obtained without a prescription.
In particular, please tell your doctor or pharmacist if you are taking/have taken
anticholinergic drugs, e.g. ipratropium or oxitropium.
No interaction side effects have been reported when Spiriva Respimat has
been taken with other products used to treat COPD such as reliever inhalers
(e.g. salbutamol), methylxanthines (e.g. theophylline), antihistamines,
mucolytics (e.g. ambroxol), leukotriene modifiers (e.g. montelukast),
cromones, anti-IgE treatment (e.g. omalizumab) and/or inhaled or oral
steroids (e.g. budesonide, prednisolone).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this
medicine. You should not use this medicine unless specifically recommended
by your doctor.
Driving and using machines
No studies on the effects and the ability to drive and use machines have been
performed. In case dizziness or blurred vision occurs the ability to drive and
use machinery may be influenced.

3) How to take Spiriva Respimat
Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Spiriva Respimat is for inhalation use only.
The recommended dose for adults is:
Spiriva Respimat is effective for 24 hours so you will need to use Spiriva
Respimat only ONCE A DAY, if possible at the same time of the day. Each
time you use it take TWO PUFFS.
As COPD and asthma are long-term diseases take Spiriva Respimat every
day and not only when you experience breathing problems. Do not take more
than the recommended dose.
Spiriva Respimat is not recommended for use in children and adolescents
below 18 years due to lack of data on safety and efficacy.
Make sure that you know how to use your Spiriva Respimat inhaler properly.
The instructions for use of the Spiriva Respimat inhaler are provided on the
other side of this leaflet.

If you take more Spiriva Respimat than you should
If you take more Spiriva Respimat than two puffs in one day talk to your
doctor immediately. You may be at a higher risk of experiencing a side effect
such as dry mouth, constipation, difficulties passing urine, increased heart
beat or blurred vision.
If you forget to take Spiriva Respimat
If you forget to take your daily dose (TWO PUFFS ONCE A DAY), don’t
worry. Take it as soon as you remember but do not take two doses at the
same time or on the same day. Then take your next dose as usual.
If you stop taking Spiriva Respimat
Before you stop taking Spiriva Respimat, you should talk to your doctor or
your pharmacist. If you stop taking Spiriva Respimat the signs and symptoms
of COPD may worsen.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4) Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Evaluation of the side effects is based on the following frequencies:
Common:
may affect up to 1 in 10 people
Uncommon:
may affect up to 1 in 100 people
Rare:
may affect up to 1 in 1,000 people
Not known:
frequency cannot be estimated from the available data
The side effects described below have been experienced by people taking
this medicine and they are listed according to frequency as either common,
uncommon, rare or not known.
Side effect
Dry mouth: this is usually mild
Dizziness
Headache
Difficulty in sleeping (insomnia)
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)
Tightness of the chest, associated with
coughing, wheezing or breathlessness
immediately after inhalation (bronchospasm)
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)
Seeing halos around lights or coloured
images in association with red eyes
(glaucoma)
Increase of the measured eye pressure
Blurred vision
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
Hypersensitivity, including immediate
reactions
Infections of the urinary tract
Depletion of body water (dehydration)
Inflammation in sinuses (sinusitis)
Blockage of intestines or absence of bowel
movements (intestinal obstruction, including
ileus paralytic)
Feeling sick (nausea)
Severe allergic reaction (anaphylactic
reaction)
Swelling of joint

Frequency
COPD
Common
Uncommon
Uncommon
Rare
Rare

Frequency
Asthma
Common
Uncommon
Uncommon
Uncommon
Not known

Rare
Rare
Uncommon
Rare
Uncommon
Uncommon
Rare

Uncommon
Not known
Uncommon
Not known
Uncommon
Uncommon
Uncommon

Uncommon
Uncommon

Rare
Uncommon

Rare
Uncommon
Uncommon
Uncommon
Uncommon
Rare

Not known
Rare
Rare
Not known
Not known
Not known

Rare
Rare
Rare
Rare

Not known
Not known
Not known
Not known

Rare
Rare
Rare
Not known
Rare

Not known
Rare
Not known
Rare
Rare

Rare
Rare
Rare
Not known

Rare
Not known
Not known
Rare

Rare
Not known
Not known
Not known

Not known
Not known
Not known
Not known

Not known
Not known

Not known
Not known

Not known

Not known

Immediate allergic reactions such as rash, nettle rash (urticaria), swelling of
the mouth and face or sudden difficulties in breathing (angioneurotic oedema)
or other hypersensitivity reactions (such as sudden reduction of your blood
pressure or dizziness) may occur individually or as part of severe allergic
reaction (anaphylactic reaction) after administration of Spiriva Respimat. If
any of these occur, please consult your doctor immediately.
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, 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 all medicines out of the sight and reach of children.
• Do not use Spiriva Respimat after the expiry date which is stated on the
carton and on the inhaler label. The expiry date refers to the last day of the
month. Spiriva Respimat inhaler should be discarded at the latest 3 months
after first use (see Instructions for Use overleaf).
• Do not freeze.
• 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.

6) Contents of the pack and other information
What Spiriva Respimat contains
The active substance is tiotropium. 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 is composed of one cartridge and one Respimat inhaler.
Inhaler is plastic with a light green cap, light grey mouthpiece and clear body.
Cartridge with ring sealing and enclosed within an aluminium cylinder. The
cartridge has to be inserted into the inhaler before the first use.
Each single pack has 1 Respimat inhaler and 1 cartridge, providing 60 puffs
(30 medicinal doses)
PL 10383/1993 Spiriva Respimat 2.5 microgram, Solution for Inhalation POM
Who makes and repackages your medicine?
Your medicine is manufactured by Boehringer Ingelheim Pharma GmbH &
Co. KG Binger Strasse 173, D-55216 Ingelheim am Rhein Germany Procured
from within the EU and repackaged by Product Licence Holder Primecrown
Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 15.08.2016
Spiriva and Respimat are registered trademarks of Boehringer Ingelheim
Pharma GmbH & Co. KG, Germany.

Instructions For Use
Introduction
TWO PUFFS /ONCE DAILY
Spiriva Respimat (tiotropium bromide). Read these Instructions for Use before
you start using Spiriva Respimat.
You will need to use this inhaler only ONCE A DAY. Each time you use it take
TWO PUFFS.

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).

Open

OPEN the cap until it snaps
fully 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.

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.
When to get a new Spiriva Respimat

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.
Answers to Common Questions







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.

Prepare for first use
1. Remove clear base

Keep the cap closed.

Press the safety catch while
firmly pulling off the clear
base with your other hand.
2. Insert cartridge

Insert the narrow end of the
cartridge into the inhaler.

Place the inhaler on a firm
surface and push down firmly
until it clicks into place.
3. Replace clear base

Put the clear base back into
place until it clicks.

4. Turn

Keep the cap closed.

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

5. Open

Open the cap until it snaps
fully open.

6. Press

Point the inhaler toward the
ground.

Press the dose-release
button

Close the cap.

Repeat steps 4-6 until a
cloud is visible.

After a cloud is visible,
repeat steps 4-6 three more
times.
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).

It is difficult to insert
the cartridge deep
enough.

I cannot press the
dose-release button.

I cannot turn the clear
base.

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

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

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.

Did you insert the
cartridge with the
wide end first? Insert
the cartridge with the
narrow end first.

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

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

The dose indicator on
the Spiriva Respimat
reaches zero too
soon.

My Spiriva Respimat
sprays
automatically.

My Spiriva Respimat
doesn’t spray.

Did you use Spiriva
Respimat as
indicated (two
puffs/Once daily)?
Spiriva Respimat will
last 30 days if used at
two puffs once daily.

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

Did you insert a
cartridge? If not, insert
a cartridge.

Did you turn the clear
base before you
inserted the
cartridge? The dose
indicator counts each
turn of the clear base
regardless whether a
cartridge has been
inserted or not.

Did you press the
dose-release button
when turning the
clear base? Close the
cap, so the doserelease button is
covered, then turn the
clear base.

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”.

Did you spray in the
air often to check
whether the Spiriva
Respimat is working?
Once you have
prepared Spiriva
Respimat, no testspraying is required if
used daily.

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).

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.

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

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.

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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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