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SPIRIVA 18 MICROGRAM CAPSULES FOR INHALATION

Active substance(s): TIOTROPIUM BROMIDE / TIOTROPIUM BROMIDE MONOHYDRATE

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Blister handling

T05685

Spiriva® 18 microgram Capsules for Inhalation
(tiotropium bromide)

Patient Information Leaflet

Breathe out completely.
Important: Please avoid breathing into the
mouthpiece at any time.

Raise the HandiHaler® to your mouth and
close your lips tightly around the
mouthpiece. Keep your head in an upright
position and breathe in slowly and deeply
but at a rate sufficient to hear or feel the
capsule vibrate. Breathe until your lungs are
full; then hold your breath as long as
comfortable and at the same time take the
HandiHaler® out of your mouth. Resume
normal breathing. Repeat steps 6 and 7
once, in order to empty the capsule
completely.

Separate the blister strips by tearing along
the perforation.

You should also not use Spiriva 18
microgram
if
you
are
allergic
(hypersensitive) to atropine or substances
related to it, e.g. ipratropium or oxitropium.

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.

Warnings and precautions
- Talk to your doctor if you suffer from
narrow angle glaucoma, prostate
problems or have difficulty passing
urine.
- If you have problems with your kidneys,
please consult your doctor.
- Spiriva 18 microgram is indicated for
maintenance treatment of your chronic
obstructive pulmonary disease, it should
not be used to treat a sudden attack of
breathlessness or wheezing.
- Immediate allergic reactions such as
rash, swelling, itching, wheezing or
breathlessness
may
occur
after
administration
of
Spiriva
18
microgram. If this occurs, please consult
your doctor immediately.
- Inhaled medicines such as Spiriva 18
microgram may cause tightness of the
chest,
coughing,
wheezing
or
breathlessness
immediately
after
inhalation. If this occurs, please consult
your doctor immediately.
- Take care not to let the inhalation
powder enter your eye as this may result
in precipitation or worsening of
narrow-angle glaucoma, which is a
disease of the eyes. Eye pain or
discomfort, blurred vision, seeing halos
around lights or coloured images in
association with red eyes may be signs
of an acute attack of narrow-angle
glaucoma. Eye symptoms may be
accompanied by headache, nausea or
vomiting. You should stop using
tiotropium bromide and immediately
consult your doctor, preferably an eye
specialist, when signs and symptoms of
narrow-angle glaucoma appear.
- 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.
- 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 18 microgram
more frequently than once daily.

What is in this leaflet:
1. What Spiriva 18 microgram is and what
it is used for
2. What you need to know before you take
Spiriva 18 microgram
3. How to take Spiriva 18 microgram
4. Possible side effects
5. How to store Spiriva 18 microgram
6. Contents of the pack and other
information

Peel back foil (only immediately before use)
using the tab until one capsule is fully
visible.
In case a second capsule is exposed to air
inadvertently this capsule has to be
discarded.

1. What Spiriva 18 microgram is and
what it is used for
Spiriva 18 microgram helps people who
have chronic obstructive pulmonary disease
(COPD) to breathe more easily. COPD is a
chronic 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
chronic disease you should take Spiriva 18
microgram every day and not only when you
have breathing problems or other symptoms
of COPD.

Remove capsule.
Open the mouthpiece again. Tip out the
used capsule and dispose. Close the
mouthpiece and dust cap for storage of your
HandiHaler® device.

The name of your medicine is Spiriva® 18
microgram Capsules for Inhalation but will
be referred to as Spiriva 18 microgram
throughout the leaflet.

Spiriva 18 microgram 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 18
microgram can also help you when you have
on-going shortness of breath related to your
disease and will help you to minimise the
effects of the disease on your everyday life.
It also helps you to be active longer. Daily
use of Spiriva 18 microgram will also help to
prevent sudden, short-term worsening of
your COPD symptoms which may last for
several days. The effect of this medicine
lasts for 24 hours, so you only need to take
it once a day. For correct dosing of Spiriva
18 microgram please see section 3. How to
take Spiriva 18 microgram and the
instructions for use provided on the other
side of the leaflet.

Spiriva capsules contain only a small
amount of powder so that the capsule is only
partially filled.

Cleaning your HandiHaler®:

2. What you need to know before you
take Spiriva 18 microgram
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 18
microgram
- are you allergic to tiotropium, atropine or
similar drugs such as ipratropium or
oxitropium or to milk protein?
- 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 narrow angle
glaucoma, 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?

Clean the HandiHaler® once a month. Open
the dust cap and mouthpiece. Then open
the base by lifting the piercing button. Rinse
the complete inhaler with warm water to
remove any powder. Dry the HandiHaler®
thoroughly by tipping excess of water out on
a paper towel and air-dry afterwards, leaving
the dust cap, mouthpiece and base open. It
takes 24 hours to air dry, so clean it right
after you have used it and it will be ready for
your next dose. If needed the outside of the
mouthpiece may be cleaned with a moist but
not wet tissue.

Fold

Do not take Spiriva 18 microgram
You should not use Spiriva 18 microgram if
you are allergic (hypersensitive) to
tiotropium, its active ingredient or to lactose
monohydrate which contains milk protein.

Children and adolescents
Spiriva 18 microgram is not recommended
for children and adolescents under 18 years.
Other medicines and Spiriva 18
microgram
Please inform your doctor or pharmacist if
you are taking, or have recently taken, any
other medicines, even those not prescribed.
Please tell your doctor or pharmacist if you
are taking/have taken similar medicines for
your lung disease, such as ipratropium or
oxitropium.
No specific side effects have been reported
when Spiriva 18 microgram has been taken
together with other products used to treat
COPD such as reliever inhalers, e.g.
salbutamol,
methylxanthines,
e.g.
theophylline and/or oral and inhaled steroids
e.g. prednisolone.
Pregnancy and breast-feeding
If you are pregnant or believe you are
pregnant, or if you are breast-feeding,
consult with your doctor. You should not use
this
medicine
unless
specifically
recommended by your doctor.
Driving and using machines
The occurrence of dizziness, blurred vision,
or headache may influence the ability to
drive and use machinery.

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Page 2

3.

How to take Spiriva 18 microgram

Follow your doctor’s instructions about when
and how to take your medicine. If you are
unsure ask your doctor or pharmacist.
The recommended dose is to inhale the
contents of 1 capsule (18 micrograms of
tiotropium) once a day. Do not take more
than the recommended dose.
Spiriva 18 microgram is not recommended
for children and adolescents under 18 years.
You should try to take the capsule at the
same time every day. This is important
because Spiriva 18 microgram is effective
over 24 hours.
The capsules are only for inhalation and not
for oral intake. Do not swallow the capsules.
The HandiHaler device, which you should
put the Spiriva capsule into, makes holes in
the capsule and allows you to breathe in the
powder.
Make sure that you have a HandiHaler and
that you can use it properly. The instructions
for use of the HandiHaler are provided on
the other side of this leaflet.
Make sure that you do not blow into the
HandiHaler.
If you have any problems using the
HandiHaler, ask your doctor, nurse or
pharmacist to show you how it works.
You should clean your HandiHaler once a
month. Cleaning instructions for the
HandiHaler are provided on the other side of
this leaflet.
When taking Spiriva 18 microgram, take
care not to let any of the powder enter your
eyes. If any powder does get into your eyes
you may get blurred vision, eye pain and/or
red eyes, you should wash your eyes in
warm water immediately. Then talk to your
doctor immediately for further advice.
If you feel that your breathing is worsening,
you should tell your doctor as soon as
possible
If you take more Spiriva 18 microgram
than you should
If you inhale from more than 1 capsule of
Spiriva 18 microgram in a day, you should
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 18 microgram
If you forget to take a dose, take one 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 18 microgram
Before you stop taking Spiriva 18
microgram, you should talk to your doctor or
your pharmacist. If you stop taking Spiriva
18 microgram 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.

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.

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

5.

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.

How to store Spiriva 18 microgram

Do not use Spiriva 18 microgram after the
expiry date shown on the blister foil and
carton.
Keep out of the sight and reach of children.
Do not store above 25 °C. Do not freeze.
Once you have taken your first capsule of
Spiriva 18 microgram from the blister strip
you must continue to take the capsules for
the next 9 days, one capsule a day, from the
same strip.
If the capsules become discoloured or show
signs of any deterioration, you should 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.

Common:
- Dry mouth: this is usually mild
Uncommon:
- Dizziness
- Headache
- Taste disorders
- Blurred vision
- Irregular heart beat (atrial fibrillation)
- Sore throat (pharyngitis)
- Hoarseness (dysphonia)
- Cough
- Heart burn (gastrooesophageal reflux
disease)
- Constipation
- Fungal infections of the oral cavity and
throat (oropharyngeal candidiasis)
- Rash
- Difficulty
passing
urine
(urinary
retention)
- Painful urination (dysuria)

6.

Rare:
- Difficulty in sleeping (insomnia)
- Seeing halos around lights or coloured
images in association with red eyes
(glaucoma)
- Increase of the measured eye pressure
- Irregular heart beat (supraventricular
tachycardia)
- Faster heart beat (tachycardia)
- Feeling your heartbeat (palpitations)
- Tightness of the chest, associated with
coughing, wheezing or breathlessness
immediately
after
inhalation
(bronchospasm)
- Nosebleed (epistaxis)
- Inflammation of the larynx (laryngitis)
- Inflammation of the sinuses (sinusitis)
- Blockage of intestines or absence of
bowel movements (intestinal obstruction
including ileus paralytic)
- Inflammation of the gums (gingivitis)
- Inflammation of the tongue (glossitis)
- Difficulties swallowing (dysphagia)
- Inflammation of the mouth (stomatitis)
- Feeling sick (nausea)
- Allergic reactions (hypersensitivity),
including immediate reactions
- Serious allergic reaction which causes
swelling of the face or throat
(angioedema)
- Nettle rash (urticaria)
- Itching (pruritus)
- Infections of the urinary tract

The HandiHaler®
Dust cap
Mouthpiece
Base
Piercing button
Centre chamber

To release the dust cap press the piercing
button completely in and let go.

Contents of the pack and other
information

What Spiriva 18 microgram contains?
Each capsule contains 22.5 micrograms of
the active ingredient, tiotropium bromide
monohydrate equivalent to 18 micrograms
of tiotropium. The capsule also contains the
inactive ingredients lactose monohydrate.
What Spiriva 18 microgram looks like
and contents of the pack
The hard gelatin capsules contain powder,
which should be breathed in using the
HandiHaler® device.

Open the dust cap completely by pulling it
upwards.
Then open the mouthpiece by pulling it
upwards.

Spiriva 18 microgram is available in a packs
containing 30 capsules, 60 capsules or 30
capsules and 1 HandiHaler®.
The HandiHaler® is the device that must be
used with Spiriva 18 microgram capsules.
Manufacturer
Holder

and

Product

Licence

Manufactured by Boehringer Ingelheim
Pharma GmbH & Co. KG, Ingelheim am
Rhein, Germany. It is procured from within
the EU by the PL Holder: Swinghope Ltd,
Brandon House, Marlowe Way, Croydon
CR0 4XS UK and repackaged by Interport
Ltd, Brandon House, Marlowe Way,
Croydon CR0 4XS UK.
POM

Remove a Spiriva capsule from the blister
(only immediately before use, see blister
handling) and place it in the centre chamber
( ), as illustrated. It does not matter which
way the capsule is placed in the chamber.

PL No. 10380/0919

Leaflet revision date: 08/06/2015
Spiriva® and HandiHaler® are registered
trademarks of Boehringer Ingelheim
Pharma GmbH & Co. KG, Germany.

Not known:
- Depletion of body water (dehydration)
- Tooth decay (dental caries)
- Severe allergic reaction (anaphylactic
reaction)
- Infections or ulcerations of the skin
- Dryness of the skin
- Swelling of joints

Close the mouthpiece firmly until you hear a
click, leaving the dust cap open.

HandiHaler® Instructions for use
Dear Patient,
The HandiHaler® enables you to inhale the
medicine contained in the Spiriva® capsule that your physician has prescribed for your
breathing problems.

Serious side effects include allergic
reactions which cause swelling of the face or
throat
(angioedema)
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 18
microgram. 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 any of these occur,
please consult your doctor immediately.

Hold the HandiHaler® device with the
mouthpiece upwards and press the piercing
button completely in only once, and release.
This makes holes in the capsule and allows
the medication to be released when you
breathe in.
Remember to carefully follow your doctor’s
instructions for using Spiriva. The
HandiHaler® is especially designed for
Spiriva. You must not use it to take any other
medication. You can use your HandiHaler®
for up to one year to take your medication.

T05685

Fold

Spiriva 18 microgram contains lactose
monohydrate
When taken according to dosage
recommendations, one capsule once a day,
each dose supplies up to 5.5 mg lactose
monohydrate.

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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