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TIOTROPIUM 18 MICROGRAM INHALATION POWDER HARD CAPSULES

Active substance(s): TIOTROPIUM BROMIDE MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE
USER
SPIRIVA® 18 MICROGRAM INHALATION POWDER
HARD CAPSULES
(tiotropium bromide)

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

The name of your medicine is SPIRIVA 18 microgram
Inhalation Powder Hard Capsules but will be referred
to as SPIRIVA 18 microgram throughout the
remainder of this leaflet.

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.
- 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.
In this leaflet:
1. What Spiriva 18 microgram is and what it is
used for
2. 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
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.
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.
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?

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 narrowangle glaucoma appear.
- 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.
- 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.

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.

4. Possible side effects

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.

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

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.
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 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 and 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 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
product, ask your doctor.

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

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.
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)
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
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

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.
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.
5. How to store Spiriva 18 microgram
 KEEP OUT OF SIGHT AND REACH OF

CHILDREN
 Do not use after the expiry date printed on the

blister label or carton label.
 Once you have taken your first capsule of

SPIRIVA from the blister strip you must continue
to take the capsules for the next 9 days, one
capsule a day, from the same strip
 Do not store above 25°C.
 Do not freeze.
 Do not place in the sun or on radiators etc.
6. Further information
What SPIRIVA 18 microgram contains
Each capsule contains 18 micrograms of the active
ingredient tiotropium (as bromide monohydrate).
During inhalation, 10 micrograms tiotropium are
delivered from the mouthpiece of the handihaler.
The other ingredient is lactose monohydrate. The
capsules are hard gelatin capsules.
What SPIRIVA 18 microgram looks like and the
contents of the pack
SPIRIVA 18 microgram, inhalation powder, hard
capsule is a light green hard capsule, containing a
white or yellowish-white powder with TIO1 and
company logo printed on the capsule. HandiHaler® is
a grey oval shaped plastic device with a green lever
with an inner cream mouthpiece.
SPIRIVA 18 microgram comes in packs of 30 or 60
capsules.
Your pack may include a HandiHaler® device that
must be used with SPIRIVA 18 microgram.
Manufacturer
This product is manufactured by: Boehringer
Ingelheim Pharma GmbH & Co. KG., D-55216
Ingelheim am Rhein, Germany. Procured from within
the EU. Parallel Import Product Licence Holder:
G Pharma Ltd, Salford M50 2PU.

Revision Date: 13/05/2015
PL 16369/1302
POM

‘SPIRIVA’ and ‘HandiHaler’ are registered
trademarks of Boehringer Ingelheim Pharma GmbH.

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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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