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SPIRIVA 18 MICROGRAMS INHALATION POWDER HARD CAPSULES

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Spiriva 18 microgram Inhalation Powder, Hard Capsules
(tiotropium bromide monohydrate)
Your medicine is known by the above name but will be referred to as Spiriva 18 microgram
throughout the following.
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 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
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?
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.
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.
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.
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.
Spiriva 18 microgram contains lactose monohydrate
When taken according to dosage recommendations, one capsule once a day, each dose
supplies up to 5.5mg lactose monohydrate.

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 18 microgram 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.
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.
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, 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.
5. HOW TO STORE SPIRIVA 18 MICROGRAM
Keep out of the sight and reach of children.
Do not use Spiriva 18 microgram after the expiry date shown on the blister foil and carton. The
expiry date refers to the last day of that month.
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.
Do not store above 25 °C. Do not freeze.
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.
Only keep the medicine if your doctor tells you to.
If the medicine becomes discoloured or show signs of any deterioration, you should seek the
advice of your pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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.

Breathe out completely.

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.

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

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

What Spiriva 18 microgram contains
Each capsule contains 18 micrograms of the active ingredient tiotropium (as bromide
monohydrate).
The capsule also contains the inactive ingredient lactose monohydrate.
What Spiriva 18 microgram looks like and contents of the pack
Your medicine is a light green, hard gelatin capsule, containing a white or yellowish powder,
with the product code (TI 01) and company logo printed on the capsule.
This product is available in a pack containing 30 capsules and one Handihaler device.
Spiriva 18 microgram is manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG,
Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany and are procured from within the
EU by Product Licence holder: Caseview (PL) Limited, 20 Alliance Court, Alliance Road,
London W3 0RB and repackaged by OPD Laboratories Ltd, Watford, Herts WD24 4PR.
PL 13826/1464

POM
Spiriva 18 microgram Inhalation Powder, Hard Capsules
Leaflet revision date (ref) 18/02/2015

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
HandiHaler Instructions for use
Dear Patient,
The HandiHaler enables you to inhale the medicine contained in the Spiriva 18 microgram
capsule - that your physician has prescribed for your breathing problems.

Cleaning your HandiHaler:

Remember to carefully follow your
doctor’s instructions for using Spiriva
18 microgram. The HandiHaler is
especially designed for Spiriva 18
microgram. You must not use it to take
any other medication. You can use your
HandiHaler for up to one year to take
your medication.

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

The HandiHaler
1

Dust cap

2

Mouthpiece

3

Base

4

Piercing button

5

Centre chamber

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

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.
Blister handling

Separate the blister strips by tearing
along the perforation.

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.

Remove capsule.

Remove a Spiriva 18 microgram capsule from
the blister (only immediately before use, see
blister handling) and place it in the centre
chamber ( 5 ), as illustrated. It does not
matter which way the capsule is placed in the
chamber.

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

Spiriva 18 microgram capsules contain only a small amount of powder so that the capsule is
only partially filled.
‘Spiriva’ and ‘HandiHaler’ are registered trademarks of Boehringer Ingelheim Pharma GmbH &
Co. KG.

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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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