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SPIRIVA RESPIMAT INHALER

Active substance(s): TIOTROPIUM / TIOTROPIUM BROMIDE

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Package leaflet: Information for the user

Spiriva® Respimat®
Inhaler
(tiotropium)
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.
The name of your medicine is Spiriva Respimat Inhaler
but will be referred to as Spiriva Respimat
2.5microgram, Solution for Inhalation 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
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 ß2
agonists.
Spiriva Respimat is a long-acting bronchodilator that
helps to open your airways and makes it easier to get
air in and out of the lungs. Regular use of Spiriva
Respimat can also help you when you have on-going
shortness of breath related to your disease, and will
help to minimise the effects of the disease on your
everyday life. Daily use of Spiriva Respimat will also
help to prevent any sudden, short-term worsening of
your COPD symptoms which may last for several days.
For correct dosing of Spiriva Respimat please see
section 3. ‘How to take Spiriva Respimat’ and the
instructions for use provided on the other side of the
leaflet.

2. What you need to know before you take
Spiriva Respimat
Please read the following questions carefully. If you
can answer any of these questions with ‘Yes’ please
discuss this with your doctor before taking Spiriva
Respimat.
are you allergic (hypersensitive) to tiotropium,
atropine or similar drugs such as ipratropium or
oxitropium?
are you taking any other medicinal products
containing ipratropium or oxitropium?
are you pregnant, do you think you are pregnant, or
are you breast-feeding?
are you suffering from blurred vision, eye pain and/
or red eyes, prostate problems or have difficulty
passing urine?
do you have any kidney problems?
have you suffered from a myocardial infarction
during the last 6 months or from any unstable or life
threatening irregular heart beat or severe heart
failure within the past year?
Do not use Spiriva Respimat
if you are allergic (hypersensitive) to tiotropium, its
active ingredient or any of the other ingredients of
this medicine (listed in section 6)
if you are allergic (hypersensitive) to atropine or
substances related to it, e.g. ipratropium or
oxitropium
Warnings and precautions
Talk to your doctor before taking Spiriva Respimat.
When taking Spiriva Respimat take care not to let any
spray enter your eyes. This may result in eye pain or
discomfort, blurred vision, seeing halos around lights or
coloured images in association with red eyes (i.e.
narrow angle glaucoma). Eye symptoms may be
accompanied by headache, nausea or vomiting. Wash
your eyes in warm water, stop using tiotropium bromide
and immediately consult your doctor for further advice.
If your breathing has got worse or if you experience
rash, swelling or itching directly after using your inhaler,
stop using it and tell your doctor immediately.
Dry mouth which has been observed with 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 Respimat 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
Frequency
Frequency
COPD
Asthma
Dry mouth: this is usually Common
Common
mild
Dizziness
Uncommon
Uncommon
Headache
Uncommon
Uncommon
Difficulty in sleeping
Rare
Uncommon
(insomnia)
Irregular heart beat
Rare
Not known
(atrial fibrillation,
supraventricular
tachycardia)
Feeling your heart beat
Rare
Uncommon
(palpitations)
Faster heart beat
Rare
Not known
(tachycardia)
Cough
Uncommon
Uncommon
Nosebleed (epistaxis)
Rare
Not known
Inflammation of the throat Uncommon
Uncommon
(pharyngitis)
Hoarseness (dysphonia) Uncommon
Uncommon
Tightness of the chest,
Rare
Uncommon
associated with coughing,
wheezing or
breathlessness
immediately after
inhalation
(bronchospasm)
Constipation
Uncommon
Rare

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)
Heartburn
(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

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.

Uncommon

Uncommon

Rare

Not known

Uncommon
Uncommon
Uncommon

Rare
Rare
Not known

Uncommon
Rare

Not known
Not known

Keep out of the sight and reach of children.

Rare

Not known

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.

Rare
Rare

Not known
Not known

Rare

Not known

Rare
Rare

Not known
Rare

Rare

Not known

Not known

Rare

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).

5. How to store Spiriva Respimat

Spiriva Respimat inhaler should be discarded at the
latest 3 months after first use (see Instructions for Use
overleaf).
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
information
What Spiriva Respimat contains
The active substance is tiotropium. The delivered dose
is 2.5microgram tiotropium (as tiotropium bromide
monohydrate).
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 made of 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.
Single Pack:
1 Respimat inhaler and
1 cartridge, providing 60 puffs (30
medicinal doses)
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 Inhaler;
Leaflet date: 05.05.2016

PL 18799/2404
POM

Spiriva and Respimat are registered trademark of
Boehringer and Ingelheim.

Instructions for Use

Spiriva® Respimat® Inhaler
Instructions For Use
Introduction
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 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.

1

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

2
3
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.

4
5

6

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.

Replace clear base
Put the clear base back into place until it clicks.

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.

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).

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.

Answers to Common Questions
It is difficult to insert the
cartridge deep enough.

I cannot press the doserelease button.

I cannot turn the clear
base.

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.

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.

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
base.

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 Respimat.

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

My Spiriva Respimat
doesn’t spray.
Did you insert a cartridge?
If not, insert a cartridge.
Did you repeat TURN, OPEN,
PRESS less than three times
after inserting the cartridge?
Repeat TURN, OPEN, PRESS
three times after inserting the
cartridge as shown in the steps 4
to 6 under ‘Prepare for first
Use’.
Is the dose indicator on the
Spiriva Respimat pointing to 0?
If the dose indicator points to 0,
you have used up all your
medication and the inhaler is
locked.
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.

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.

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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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