SPIRIVA RESPIMAT 2.5MICROGRAM SOLUTION FOR INHALATION

Active substance: TIOTROPIUM BROMIDE MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Spiriva® Respimat®
2.5microgram,
Solution for Inhalation
(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
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
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?

Do not use Spiriva Respimat

Driving and using machines

− 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

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.

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 anti-cholinergic
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.

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 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.
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.
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.

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:
Uncommon:
Rare:
Not known:

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.

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 Frequency
COPD
Asthma
Common

Common

Uncommon Uncommon
Uncommon Uncommon
Not known Uncommon
Uncommon Not known

Uncommon Uncommon

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
Uncommon Not known
Uncommon Uncommon
Uncommon Not known
Uncommon Uncommon
Uncommon Uncommon
Rare
Uncommon

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 out of the sight and reach of children.

Uncommon Rare
Uncommon Uncommon

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.

Uncommon Not known
Uncommon Rare
Uncommon Rare
Uncommon Not known
Uncommon Not known
Rare
Not known

If your inhaler shows any signs of deterioration, 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
Rare

Not known

Rare
Rare

Not known
Not known

Rare

Not known

The active substance is tiotropium. The delivered dose is
2.5microgram tiotropium (as bromide monohydrate) per
puff (2 puffs comprise one medicinal dose).

Rare
Rare

Not known
Rare

The other ingredients are:
benzalkonium chloride, disodium edetate, purified
water, and hydrochloric acid 3.6% for pH adjustment.

Rare

Not known

Rare

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

What Spiriva Respimat contains

What Spiriva Respimat looks like and contents of
the pack
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 aluminium cylinder
containing a clear, colourless, solution for inhalation.
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® 2.5microgram, Solution for
inhalation, PL No: 18799/2376
POM
Leaflet date: 10.12.2014
®

Not known
Not known

Not known
Not known

Not known

Not known

®

Spiriva Respimat are registered trademarks of
Boehringer Ingelheim

Instructions for Use

Daily use of your Spiriva Respimat
inhaler

Spiriva® Respimat®
inhaler

When to get a new Spiriva Respimat
inhaler

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

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.
The Spiriva Respimat inhaler releases medication slowly
and gently, making it easy to inhale it into your lungs.

2a

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
4. Hold the Spiriva Respimat inhaler upright, with the
green cap (A) closed. Turn the base (G) in the
direction of the arrows on the label until it clicks
(half a turn).

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

2b

What if…

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

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

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

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

Air vent

II

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.

Spiriva Respimat inhaler and the Spiriva
Respimat cartridge

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.

1) Inserting the cartridge
The following steps 1– 6 are necessary before first
use:

III Repeat steps I and II so that you get the full dose.
You will need to use this inhaler only ONCE A DAY.

6

3
3. Replace the clear base (G). Do not remove the clear
base again.

6. 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.

2) To prepare the Spiriva Respimat
inhaler for first-time use
1. With the green cap (A) closed, press the safety catch
(E) while pulling off the clear base (G).

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.

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).

1

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.

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).

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.

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

b) Prepare and use
b) The Spiriva
your new Spiriva
Respimat inhaler
Respimat inhaler.
is locked after 60
puffs (30
medicinal doses).
The cap is fully
While opening the The cap can easily
pulled off and apart cap it was pulled
be attached again.
from the inhaler.
too hard.
I can’t press the
dose release
button.
The clear base
springs back after
I have turned it.

The clear base has Turn the clear base
not been turned.
until it clicks.
(half a turn)
The clear base was Prepare the Spiriva
not turned far
Respimat inhaler
enough.
for use by turning
the clear base until
it clicks. (half a
turn)
I can turn the clear Either the dose
With the green cap
base past the point release button has closed, turn the
where it clicks.
been pressed, or
base until it clicks.
the clear base has (half a turn)
been turned too far.

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.

Expand view ⇕

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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