Skip to Content

SPIRIVA RESPIMAT 2.5 MICROGRAMS INHALATION SOLUTION

Active substance(s): TIOTROPIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
Page 1

Page 4

T06613

Spiriva® Respimat® 2.5 micrograms, inhalation solution
(tiotropium bromide)

Patient Information Leaflet
Your medicine is called Spiriva Respimat 2.5
micrograms, inhalation solution, but will be
referred to as Spiriva Respimat throughout the
following Patient Information Leaflet.
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?

Fold

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
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.
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.

Page 3

Page 2

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:
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

Frequency
COPD

Dry mouth:

Common

Common

Dizziness

Uncommon

Uncommon

Headache

Uncommon

Uncommon

Difficulty in
sleeping
(insomnia)

Rare

Uncommon

this is usually

Frequency
Asthma

mild

Irregular
Rare
heart beat
(atrial
fibrillation,
supraventricular
tachycardia)

Not known

Feeling your
heartbeat
(palpitations)

Rare

Uncommon

Faster heart
beat
(tachycardia)

Rare

Not known

Cough

Uncommon

Uncommon

Nosebleed
(epistaxis)

Rare

Not known

Inflammation of
the throat
(pharyngitis)

Uncommon Uncommon

Hoarseness

Uncommon

(dysphonia)

Tightness of the Rare
chest, associated
with coughing,
wheezing or
breathlessness
immediately after
inhalation
(bronchospasm)
Constipation

Inflammation in Not known
sinuses

Uncommon

Uncommon Rare

Fungal infections Uncommon Uncommon
of the oral cavity
and throat
(oropharyngeal
candidiasis)
Difficulties
swallowing
(dysphagia)

Rare

Rash

Uncommon Rare

Itching (pruritus)

Uncommon

Not known

Difficulties
Uncommon Not known
passing urine
(urinary retention)

Increase of the
measured eye
pressure

Rare

Not known

Blurred vision

Rare

Not known

Inflammation of
the larynx
(laryngitis)

Rare

Not known

Heart burn
(gastrooesophageal reflux
disease)

Rare

Not known

Dental caries

Rare

Not known

Inflammation of
the gums
(gingivitis)

Rare

Rare

Inflammation of
the tongue
(glossitis)

Rare

Not known

Inflammation of
the mouth
(stomatitis)

Not known

Rare

Not known

Serious allergic
Rare
reaction which
causes swelling
of the mouth and
face or throat
(angioneurotic
oedema)

Rare

Nettle rash
(urticaria)

Rare

Rare

Infections or
Rare
ulcerations of the
skin

Not known

Dryness of the
skin

Rare

Not known

Hypersensitivity,
including
immediate
reactions

Not known

Rare

Infections of the
urinary tract

Rare

Not known

Depletion of body Not known
water
(dehydration)

Not known

Not known

Feeling sick
(nausea)

Not known

Not known

Severe allergic Not known
reaction
(anaphylactic
reaction)

Not known

Swelling of
joint

Not known

This product is manufactured by Boehringer
Ingelheim Pharma GmbH & Co. KG, Binger
Strasse 173 D-55216 Ingelheim am Rhein,
Germany. It is procured from within the EU by
the Product Licence Holder: Swinghope Limited,
Brandon House, Marlowe Way, Croydon,
CR0 4XS UK.
POM
PL No: 10380/1583
Leaflet revision date: 10/05/2016

Not known

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

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).

Painful urination Uncommon Not known
(dysuria)
Rare

Blockage of
intestines or
absence of
bowel
movements
(intestinal
obstruction,
including
ileus paralytic)

Manufacturer and Product Licence Holder

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.

Rare

Seeing halos
around lights or
coloured images
in association
with red eyes
(glaucoma)

Not known

(sinusitis)

Uncommon

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 via: 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 this medicine out of the sight and
reach of children.
− 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.
− If the medicine becomes discoloured or
shows any other signs of deterioration, you
should seek the advice of your pharmacist
who will tell you what to do.
− 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
− Each delivered dose is 2.5 microgram
tiotropium (as bromide monohydrate) per
puff (2 puffs comprise one medicinal dose).
− 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.
What Spiriva Respimat looks like and
contents of the pack
Spiriva Respimat 2.5 microgram is a clear
colourless solution, in a plastic grey cartridge
with green cap and metal canister. The cartridge
is held in the metal canister. 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)

Not known
T06613
Fold

3. How to take Spiriva Respimat

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