SPIRIVA RESPIMAT 2.5MICROGRAM SOLUTION FOR INHALATION

Active substance: TIOTROPIUM BROMIDE MONOHYDRATE

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III.

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

S1673 LEAFLET Spiriva Resp 20130822

PACKAGE LEAFLET: INFORMATION FOR THE USER

You will need to use this inhaler only ONCE A DAY.

SPIRIVA RESPIMAT 2.5microgram,
SOLUTION FOR INHALATION
(tiotropium bromide)

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.
When to get a new Spiriva Respimat inhaler

Your medicine is known as Spiriva Respimat 2.5microgram,
Solution for Inhalation but will be referred to as Spiriva Respimat
throughout the following leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.


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.


Point the Spiriva Respimat inhaler towards the ground. Press
the dose release button (D). Close the green cap (A).

If you have any further questions, ask your doctor or
pharmacist.



6

Keep this leaflet. You may need to read it again.



If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.

Repeat steps 4, 5 and 6 until a cloud is visible.

What is in this leaflet

Then repeat steps 4, 5 and 6 three more times to ensure the
inhaler is prepared for use.

1. What Spiriva Respimat is and what it is used for

Your Spiriva Respimat inhaler is now ready to use.

3. How to take Spiriva Respimat

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).
Daily use of your Spiriva Respimat inhaler
You will need to use this inhaler only ONCE A DAY. Each time
you use it take TWO PUFFS.

2. What you need to know before you take Spiriva Respimat

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...
What if...

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.

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 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.

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).

The cap is fully
pulled off and apart
from the inhaler.

The clear base
springs back after I
have turned it.

I.

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)

How to care for your inhaler

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.

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.
S1673 LEAFLET Spiriva Resp 20130822

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.

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.
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,
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 breastfeeding, 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:

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.

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.

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.

2

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

5. How to store Spiriva Respimat
4. Possible side effects




Do not freeze.



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 remove the cartridge once it has been inserted into the
inhaler.

Keep out of the sight and reach of children.

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

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).

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.

Evaluation of the side effects is based on the following frequencies:
Common:

affects 1 to 10 patients in 100

Uncommon:

affects 1 to 10 patients in 1,000

Rare:

affects 1 to 10 patients in 10,000

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.
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

6. Contents of the pack and other information
What Spiriva Respimat contains




Spiriva Respimat inhaler and the Spiriva Respimat cartridge
1) Inserting the cartridge

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 following steps 1–6 are necessary before first use:

3

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

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

2) To prepare the Spiriva Respimat inhaler for first-time use

What Spiriva Respimat looks like and contents of the pack
Spiriva Respimat 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.
Spiriva Respimat is available as a single pack containing 1
Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal
doses).
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

1

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

Manufacturer
This product is manufactured by Boehringer Ingelheim Pharma
Gmbh & Co. KG, Binger Strasse 173, D-55216 Ingelheim am
Rhein, Germany.
POM

4

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).

5

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

PL No: 19488/1673

Leaflet revision date: 22 August 2013
Spiriva and Respimat are registered trademarks of Boehringer
Ingelheim.
S1673 LEAFLET Spiriva Resp 20130822

SPIRIVA RESPIMAT INHALER
How to use your Spiriva Respimat inhaler

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.

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.
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.

S1673 LEAFLET Spiriva Resp 20130822

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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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