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TIOPTROPIUM 18 MICROGRAM INHALATION POWDER HARD CAPSULES

Active substance(s): TIOTROPIUM BROMIDE MONOHYDRATE

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Spiriva® 18 microgram Inhalation Powder Hard Capsules/
Tiotropium 18 microgram Inhalation Powder Hard Capsules
(Tiotropium bromide)
The above product is known as either of the above names but will be referred
to as Spiriva 18 microgram throughout this:
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.
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 capsule into, makes
holes in the capsule and allows you to breath 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 your 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:
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
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 (gastrooesophagel 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 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.

3. Base
4. Piercing button
5. Centre chamber
1) To release the dust cap press the piercing button
completely in and let go

2) Open the dust cap completely by pulling it
upwards. Then open the mouthpiece by pulling it
upwards (Fig. 2)

3) Remove a Spiriva 18 microgram 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.

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

5) 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.

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

5) How to store Spiriva 18 microgram
• Keep all medicines out of the sight and reach of children.
• Do not use Spiriva 18 microgram after the expiry date (which is the last day
of that month) printed on the carton or blister strip.
• Once you have taken your first capsule from the blister strip you must
continue to take the capsules for the next 9 days, one capsule a day, from
the same strip. Discard unused capsules nine days after opening the blister
strip. Discard the HandiHaler device 12 months after first use.
• Do not store above 25°C. Do not freeze.
• Medicines should not be disposed of via wastewater or household waste.
• If your doctor tells you to stop taking the capsules, ask your pharmacist how
to dispose of medicines no longer required. These measures will help to
protect the environment.
• If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.

6) Contents of the pack and other 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.
Each capsule also contains lactose monohydrate.
What Spiriva 18 microgram looks like and contents of the pack
Each light green hard gelatine capsule containing white or yellowish white
powder is marked with a Company Logo and ‘T1 01’, is to be used with the
light grey Handihaler® device which has a white plastic mouthpiece, and a
chamber for the capsule. You must use a HANDIHALER device with Spiriva
18 Microgram Inhalation Powder Hard Capsules.

7) 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 step 6
and 7 once, in order to empty the capsule
completely.
8) Open the mouthpiece again. Tip out the used
capsule and dispose. Close the mouthpiece and
dust cap for storage of your HandiHaler® device.

Cleaning your HandiHaler®:
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.

Spiriva 18 Microgram Inhalation Powder Hard Capsules are available in packs
containing blister strips of 30 capsules and a Handihaler device.

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.

PL 10383/1336 Spiriva® 18 microgram Inhalation Powder Hard Capsules/
Tiotropium 18 microgram Inhalation Powder Hard Capsules
POM

Blister handling:
A) Separate the blister strips by tearing along the
perforation.

Who makes and repackages your medicine?
Your medicine is manufactured by Boehringer Ingelheim Pharma KG,
Ingelheim, Germany. Procured from within the EU and repackaged by
Product Licence Holder Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue
Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 20.07.2015

B) 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

Spiriva and HandiHaler are registered trademarks of Boehringer Ingelheim
Pharma GmbH & Co. KG
HandiHaler® Instructions for use:
Dear Patient,
The HandiHaler® enables you to inhale the medicine
contained in the Spiriva 18 microgram - that your
physician has prescribed for your breathing problems.
Remember to carefully follow your doctor’s instructions
for using Spiriva 18 microgram.
The HandiHaler® is especially designed for Spiriva 18
microgram capsule. You must not use it to take any
other medication. You can use your HandiHaler® for up to one year to take
your medication.
The HandiHaler®
1. Dust cap
2. Mouthpiece

C) Remove capsule.
Spiriva 18 microgram contain only a small amount of
powder so that the capsule is only partially filled.

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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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