Skip to Content

SPIRIVA RESPIMAT 2.5 MICROGRAMS SOLUTION FOR INHALATION

Active substance: TIOTROPIUM BROMIDE MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
504023/PL1c

Package leaflet: information for the user

Spiriva Respimat
2.5 micrograms,
Solution for Inhalation
®

®

(tiotropium bromide)
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 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.

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 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.

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.

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.

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
COPD
Common

Frequency
Asthma
Common

Uncommon
Uncommon
Rare

Uncommon
Uncommon
Uncommon

Rare

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 or
pharmacist. 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.

Not known

5. How to store Spiriva Respimat
Keep out of the sight and reach of children.

Rare

Uncommon

Rare

Not known

Uncommon
Rare
Uncommon

Uncommon
Not known
Uncommon

Uncommon
Rare

Uncommon
Uncommon

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 freeze.
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.
6. Contents of the pack and other information
What Spiriva Respimat contains
The delivered dose is 2.5 micrograms tiotropium (as bromide
monohydrate) per puff (2 puffs comprise one medicinal dose).
One cartridge contains 4.0 ml providing 60 puffs (30 medicinal
doses).

Uncommon
Uncommon

Rare
Uncommon

Rare

Not known

Uncommon
Uncommon
Uncommon

Rare
Rare
Not known

Uncommon
Rare

Not known
Not known

What Spiriva Respimat looks like and contents of the pack
Spiriva Respimat 2.5 microgram 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.

Rare

Not known

Single pack:

Rare
Rare

Not known
Not known

Rare

Not known

Rare
Rare

Not known
Rare

Rare

Not known

Not known

Rare

Rare

Rare

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.

1 Respimat inhaler and 1 cartridge, providing
60 puffs (30 medicinal
doses)

Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd
and repackager Ginova UK Ltd, both at St James’ House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.
The manufacturer for Spiriva Respimat is:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173, D-55216 Ingelheim am Rhein
Germany
Spiriva Respimat 2.5 micrograms, Solution for Inhalation
PL No: 18067/0405
POM
®

®

Spiriva and Respimat are registered trademarks of Boehringer
Ingelheim Pharma GmbH & Co. KG
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

th

This leaflet was last approved on 25 January 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

Instructions for Use

When to get a new Spiriva Respimat
inhaler

Spiriva® Respimat®
Inhaler
How to use your Spiriva Respimat inhaler

Empty

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.
Full

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.

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).

6

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

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.

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

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).

Cap (A)
Mouthpiece (B)
Air vent (C)

Daily use of your Spiriva Respimat
inhaler

Dose release
button (D)

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

Cartridge (H)
Safety
catch (E)

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 locks automatically - no more doses can
be released. 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...

Clear
base (G)
Piercing
element (I)

3

Spiriva Respimat inhaler and the Spiriva Respimat
cartridge

Reason

What to do

I can’t turn the base
easily.

Dose indicator (F)

a) The Spiriva
Respimat inhaler
is already
prepared and
ready to use.

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

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

b) The Spiriva
Respimat inhaler
is locked after 60
puffs (30
medicinal doses).

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

b) Prepare and use
your new Spiriva
Respimat inhaler.

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

The following steps 1–6 are necessary before first use:
I

Safety
catch

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

The cap can easily
be attached again.

I can’t press the
dose release
button.

1) Inserting the cartridge

While opening the
cap it was pulled too
hard.
The clear base has
not been turned.

Turn the clear base
until it clicks. (half
a turn)

The clear base
springs back after
I have turned it.

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.

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
4

1

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.

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

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

Air vent
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.

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.

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.
III Repeat steps I and II so that you get the full dose.
5

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

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

504023/PL1c

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.

Hide