SPIRIVA RESPIMAT 2.5MICROGRAM SOLUTION FOR INHALATION
Active substance(s): TIOTROPIUM BROMIDE / TIOTROPIUM BROMIDE MONOHYDRATE / TIOTROPIUM BROMIDE / TIOTROPIUM BROMIDE MONOHYDRATE / TIOTROPIUM BROMIDE / TIOTROPIUM BROMIDE MONOHYDRATE
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
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.
The name of your medicine is Spiriva Respimat
2.5microgram, Solution for Inhalation but will be
referred to as Spiriva Respimat throughout 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
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
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
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
2. What you need to know before you take
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
are you allergic (hypersensitive) to tiotropium,
atropine or similar drugs such as ipratropium or
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
do you have any kidney problems?
have you suffered from a myocardial infarction
during the last 6 months or from any unstable or lifethreatening 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
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
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
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 Respimat is the
right medicine for you to take.
Do not take Spiriva Respimat more frequently than
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
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 anti-cholinergic 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
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
may affect up to 1 in 10 people
may affect up to 1 in 100 people
may affect up to 1 in 1,000 people
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.
Dry mouth: this is usually Common
Difficulty in sleeping
Irregular heart beat
Feeling your heart beat
Faster heart beat
Inflammation of the throat Uncommon
Hoarseness (dysphonia) Uncommon
Tightness of the chest,
associated with coughing,
Fungal infections of the
oral cavity and throat
Difficulties passing urine
Painful urination (dysuria)
Seeing halos around
lights or coloured images
in association with red
Increase of the measured
Inflammation of the larynx
Inflammation of the gums
Inflammation of the
Inflammation of the mouth
Serious allergic reaction
which causes swelling of
the mouth and face or
Nettle rash (urticaria)
Infections or ulcerations of
Dryness of the skin
Infections of the urinary
Depletion of body water
Inflammation in sinuses
Blockage of intestines or
absence of bowel
including ileus paralytic)
Feeling sick (nausea)
Severe allergic reaction
Swelling of joint
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:
By reporting side effects, you can help provide more
information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use the 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.
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).
5. How to store Spiriva Respimat
Spiriva Respimat inhaler should be discarded at the
latest 3 months after first use (see Instructions for Use
Do not freeze.
If your inhaler shows any signs of damage, seek the
advice of your pharmacist
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
What Spiriva Respimat contains
The active substance is tiotropium. The delivered dose
is 2.5microgram tiotropium (as bromide monohydrate)
(2 puffs comprise one medical dose).
The other ingredients are: benzalkonium chloride,
disodium edetate, purified water, and hydrochloric acid
3.6% for pH adjustment.
What Spiriva Respimat looks like and contents of
Spiriva Respimat includes one Respimat Inhaler and
one cartridge. Inhaler is made of plastic with a light
green cap, light grey mouth piece and clear body,
cartridge with ring sealing and enclosed within an
aluminum cylinder containing a clear, colourless,
solution for Inhalation.
The cartridge has to be inserted into the inhaler before
the first use.
1 Respimat inhaler and
1 cartridge, providing 60 puffs (30
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 the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Spiriva Respimat 2.5microgram, Solution for
Inhalation; PL 18799/2376
Leaflet date: 20.06.2016
Spiriva and Respimat are registered trademark of
Boehringer and Ingelheim.
Instructions for Use
Spiriva® Respimat® 2.5microgram, solution for Inhalation
Instructions For Use
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.
Prepare for first use
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 discolouration 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.
Remove clear base
Keep the cap closed.
Press the safety catch while firmly pulling off the
clear base with your other hand.
When to get a new Spiriva Respimat
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.
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.
Insert the narrow end of the cartridge into the
Place the inhaler on a firm surface and push down
firmly until it clicks into place.
Replace clear base
Put the clear base back into place until it clicks.
Keep the cap closed.
Turn the clear base in the direction of the arrows
on the label until it clicks (half a turn).
Open the cap until it snaps fully open.
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
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).
Keep the cap closed.
TURN the clear base in the direction of the
arrows on the label until it clicks (half a turn).
OPEN the cap until it snaps fully open.
Answers to Common Questions
It is difficult to insert the
cartridge deep enough.
I cannot press the doserelease button.
I cannot turn the clear
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 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.
The dose indicator on the
Spiriva Respimat reaches zero
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
My Spiriva Respimat sprays
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 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 dose-release
button is covered, then turn the clear
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.
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).
Did you insert the cartridge into a
used Spiriva Respimat? Always insert a
new cartridge into a NEW Spiriva
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
My Spiriva Respimat
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
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
Once your Spiriva Respimat is
assembled, do not remove the
clear base or the cartridge. Always
insert a new cartridge into a NEW
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
Hold your breath for 10 seconds or for as long as
Repeat TURN, OPEN, PRESS for a total of 2 puffs.
Close the cap until you use your inhaler again.
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.