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TIOTROPIUM 18MICROGRAM INHALATION POWDER HARD CAPSULES

Active substance(s): TIOTROPIUM BROMIDE MONOHYDRATE

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Version No: 3
Date: 27.08.2013
Ref.:

SPI 18

Not Approved

26.08.2013 [0054]
Leaflet Name: SPIRIVA 18 MICROGRAM INH. POWDER

Approved

Leaflet Date:

Size: 540 x 325 mm

Folded to: 90 x 82 mm

No. Colours: 1/1

Colour: Black

Paper: Offset white 50 g/m2
Fonts

ITC Officina Sans std
Size: 10,6 pt.

Date and Signed

Diseño realizado a escala: 100%

Front
Back

PACKAGE LEAFLET:
INFORMATION FOR THE USER

- are you suffering from narrow angle glaucoma,
prostate problems or have difficulty passing urine?
- do you have any kidney problems?

Spiriva®
18 microgram,
inhalation powder,
hard capsules

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

(tiotropium bromide)

Your medicine will be referred to as Spiriva Capsules
throughout this 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.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

(tiotropium bromide)

1. WHAT SPIRIVA CAPSULES ARE AND WHAT THEY
ARE USED FOR
Spiriva Capsules 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 Capsules every day
and not only when you have breathing problems or
other symptoms of COPD.
Spiriva Capsules are a long-acting broncholidator
that helps to open your airways and makes it easier
to get air in and out of the lungs. Regular use of
Spiriva Capsules 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 Capsules 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 Capsules please see section 3 ‘How
to take Spiriva Capsules’ and the instructions for use
provided on the other side of the leaflet.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SPIRIVA CAPSULES
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 Capsules.
- 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 are breast-feeding?

4. POSSIBLE SIDE EFFECTS

3. HOW TO TAKE SPIRIVA CAPSULES

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

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.

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 Capsules are 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 Capsules.
If this occurs, please consult your doctor
immediately.
- Inhaled medicines such as Spiriva Capsules 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.
- Do not take Spiriva Capsules more frequently than
once daily.
Children and adolescents
Spiriva Capsules are not recommended for children
and adolescents under 18 years.
Other medicines and Spiriva Capsules
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 Capsules 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.

Spiriva Capsules are 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
Capsules are 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 Capsules, 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 Capsules than you should
If you inhale from more than 1 capsule of Spiriva 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 Capsules
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 Capsules
Before you stop taking Spiriva Capsules, you should
talk to your doctor or your pharmacist. If you stop
taking Spiriva Capsules the signs and symptoms of
COPD may worsen.

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.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Driving and using machines
The occurrence of dizziness, blurred vision, or
headache may influence the ability to drive and use
machinery.

540 mm

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

Common:
Uncommon:
Rare:
Not known:

affects 1 to 10 patients in 100
affects 1 to 10 patients in 1,000
affects 1 to 10 patients in 10,000
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)
- 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 tightness of the chest, associated with coughing,
wheezing or breathlessness immediately after
inhalation (bronchospasm). If this occurs, please
consult your doctor immediately.

If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.

5. HOW TO STORE SPIRIVA CAPSULES










Keep this medicine out of the sight and reach of
children.
Do not store above 25 °C. Do not freeze.
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.
Do not use this medicine after the expiry date
which is stated on the carton and blister foil. The
expiry date refers to the last day of that month.
If your capsules or Handihaler show 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.
Ask your pharmacist how to throw away medicines
you no longer use. These measures will help to
protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Spiriva Capsules contains
Each inhalation capsule contains 18 micrograms
tiotropium (as bromide monohydrate).
The capsules also contain lactose monohydrate.
What Spiriva Capsules looks like and the contents
of the pack
Each light green hard capsule containing a white
powder is marked ‘T1 01’ on the cap and the
Boehringer logo on the body in black printing ink,
is to be used with the grey/green plastic inhaler
device.
The capsules contain powder which should be
breathed in using the HandiHaler® device.
Spiriva Capsules are available in packs containing
blister strips of 30 capsules with a HandiHaler®
device.
The HandiHaler® is the device that must be used
with Spiriva Capsules.
Who manufactured your medicine
Spiriva Capsules are manufactured by Boehringer
Ingelheim Pharma GmbH & Co KG, Binger Strasse
173, D-55216 Ingelheim am Rhein, Germany.
Procured from within the EU and repackaged by
Product Licence Holder Boticalia Ltd., 27 Acton
Park, The Vale, London W3 7QE.
PL 23038/0054
Date: 26.08.2013

POM
Ref: SPI 18

Spiriva is a registered trademark of Boeringher Ingelheim

325 mm

Spiriva®
18 microgram,
inhalation powder,
hard capsules

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

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

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

Version No: 3
Date: 27.08.2013
Ref.:

SPI 18

Not Approved

26.08.2013 [0054]
Leaflet Name: SPIRIVA 18 MICROGRAM INH. POWDER
Leaflet Date:

Size: 540 x 325 mm

Folded to: 90 x 82 mm

No. Colours: 1/1

Colour: Black

Paper: Offset white 50 g/m2
ITC Officina Sans std
Size: 10,6 pt.

Fonts

Approved

Date and Signed

Diseño realizado a escala: 100%

Front
Back

HandiHaler® Instructions for use

Dear Patient
The HandiHaler® enables you to inhale the
medicine contained in the Spiriva Capsules - that
your physician has prescribed for your breathing
problems.

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

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

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.

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

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.

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

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.

Cleaning your HandiHaler®:

The HandiHaler®
1

Dust cap

2

Mouthpiece

3

Base

4

Piercing button

5

Centre chamber

Remove a Spiriva 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.

Breathe out completely.

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

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

540 mm

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

325 mm

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

Blister handling

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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