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SPIRIVA 18 MICROGRAM INHALATION POWDER HARD CAPSULE

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

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Assessed against UK PIL dated August 2005

Final Draft

By austino at 4:29 pm, 1/9/07

LANDMARK PHARMA LTD
PROPOSED TEXT: PATIENT INFORMATION LEAFLET
PL (PI) 21828/0137
Page 1 of 3
term COPD is associated with the conditions
chronic bronchitis and emphysema.

Spiriva® 18 microgram Inhalation
Powder, Hard Capsules
(tiotropium)
PATIENT INFORMATION LEAFLET
This medicine is available using the above name
but will be referred to as SPIRIVA INHALATION
POWDER throughout the following leaflet.
Please read this leaflet carefully.
This leaflet applies only to SPIRIVA INHALATION
POWDER. If you have any questions, or are unsure
about anything, ask your doctor or pharmacist
(chemist). Remember, SPIRIVA INHALATION
POWDER is only for you; do not give it to anyone
else, even if their symptoms are similar to yours.
What is in your Medicine?
The name of your medicine is SPIRIVA
INHALATION POWDER.
Each capsule contains 18 micrograms of the active
ingredient tiotropium (as bromide monohydrate).
The capsule also contains the inactive ingredient
lactose monohydrate. The capsules are light green
hard capsules, containing a white powder, with ‘TI
01’ and company logo printed on the capsule.
The capsules contain powder which should be
breathed in using the HANDIHALER device.
The product is available in the following packs:
A pack containing 30 capsules.
Manufacturer:
Your medicine is manufactured by Boehringer
Ingelheim Pharma, GmbH & Co. KG, Ingelheim am
Rhein, Germany.
Your medicine is procured from within the EU and
repackaged on behalf of the Parallel Import Product
Licence holder: Landmark Pharma Ltd., 7 Regents
Drive, Prudhoe, Northumberland, NE42 6PX.
POM

PL No: 21828/0137

What is SPIRIVA INHALATION POWDER?
SPIRIVA INHALATION POWDER is a medicine
containing the active ingredient tiotropium.
Tiotropium belongs to a group of medicines called
bronchodilators. Bronchodilators help to improve
your breathing by opening up your airways.
How SPIRIVA INHALATION POWDER helps you
SPIRIVA INHALATION POWDER helps people
who have chronic obstructive pulmonary disease
(COPD) to breathe more easily. SPIRIVA
INHALATION POWDER should be taken regularly
once a day as directed by your doctor. You should
not take it only when you have an attack and you
should not take extra doses.
Chronic obstructive pulmonary disease (COPD) is a
lung disease that causes shortness of breath and
cough. It is nearly always caused by smoking. The

Before you take SPIRIVA INHALATION POWDER
Do not take SPIRIVA INHALATION POWDER if:
− you are under 18 years of age
− you are allergic to tiotropium, atropine or similar
drugs such as ipratropium or oxitropium or if you
are allergic to lactose
− you are taking any other medicinal products
containing ipratropium or oxitropium. Ask your
doctor for advice.
− you are pregnant, think you are pregnant or if you
are breast-feeding. Ask your doctor for advice.
Take special care with SPIRIVA INHALATION
POWDER if:
− you suffer from narrow angle glaucoma, prostate
problems or have difficulty passing urine
− you have problems with your kidneys
Pregnancy
You should not use this medicine if you are
pregnant or think that you may be pregnant.
Breast-feeding
This product is not generally recommended for
breast-feeding mothers. Ask your doctor for advice.
Driving and using machines
Taking this product should not affect your ability to
drive or use machines. However, if you do
experience any side effects do not drive or operate
machines and talk to your doctor.
Further important information about the product
Each capsule contains approximately 5 mg of
lactose. When taken according to dosage
recommendations, one capsule once a day, each
dose supplies up to 5 mg lactose. This product is
unsuitable for people with lactose insufficiency,
galactosaemia or glucose/galactose malabsorption
syndrome.
Taking other medicines
Please inform your doctor or pharmacist if you are
taking, or have recently taken, any other medicines,
even those not prescribed. In particular please tell
your doctor or pharmacist if you are taking/have
taken anticholinergic drugs for example ipratropium,
oxitropium.
No interaction side effects have been reported
when SPIRIVA INHALATION POWDER has been
taken with other products used to treat COPD such
as
reliever
inhalers
e.g.
salbutamol,
methylxanthines e.g. theophylline and/or oral
inhaled steroids e.g. prednisolone.
How to take SPIRIVA INHALATION POWDER
Follow your doctor'
s instructions about when and
how to take your medicine. If you are unsure ask
your doctor or pharmacist.

Original Application Date: 06/12/05
Date of Amendment/Printing: 14/11/2006

Name: LANDMARK PHARMA LTD

Signed:

LANDMARK PHARMA LTD
PROPOSED TEXT: PATIENT INFORMATION LEAFLET
PL (PI) 21828/0137
Page 2 of 3
The recommended dose is one 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
INHALATION POWDER is effective over 24 hours.
Do not give to children under 18 years of age.
Do not swallow the capsules.
The HANDIHALER device, which you should put
the SPIRIVA INHALATION POWDER 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 in a separate
leaflet.

Other common side effects, experienced in between
1% to 2% of patients in one year studies, are
constipation, inflammation of the sinuses (sinusitis),
sore throat (pharyngitis), nosebleeds and throat
infection e.g. moniliasis. Another common side
effect is cough.
Rarely, SPIRIVA INHALATION POWDER may
make it difficult for you to pass urine (especially if
you already have problems passing urine).
Rarely, SPIRIVA INHALATION POWDER may also
cause your heart to beat faster or with an irregular
beat.
Rarely, some patients have had allergic reactions to
SPIRIVA INHALATION POWDER such as rash,
urticaria (nettle rash), itching, swelling of the mouth
and face or sudden difficulties in breathing.

Make sure that you do not blow into the
HANDIHALER.

In addition, in common with all inhaled medicines,
some patients may experience an unexpected
tightness of the chest and cough immediately after
inhaling SPIRIVA INHALATION POWDER.

If you have any problems using the HANDIHALER,
ask your doctor, nurse or pharmacist to show you
how it works.

Some people taking SPIRIVA INHALATION
POWDER have also experienced feeling sick
(nausea), hoarseness, dizziness and headache.

You should clean your HANDIHALER once a
month.

Eye problems, such as blurred vision or eye pain,
can occur if SPIRIVA INHALATION POWDER
accidentally gets into your eyes. If this occurs wash
your eyes in warm water immediately and then talk
to your doctor immediately for further advice.

When taking SPIRIVA INHALATION POWDER
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.
What to do if an overdose is taken:
If you take more SPIRIVA INHALATION POWDER
than you should - talk to your doctor immediately.
What to do if you miss a dose:
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 your breathing gets worse straight after using your
inhaler, stop using it immediately and tell your
doctor straight away.
If you feel that your breathing is worsening, you
should tell your doctor as soon as possible.
Possible side effects
All medicines can sometimes cause side effects.
The most common side effect with SPIRIVA
INHALATION POWDER is dry mouth. This is
usually mild and often stops on continuing
treatment.

If you have any of these side effects and they
become troublesome or do not go away after a
short while talk to your doctor.
Storage:
Do not use SPIRIVA INHALATION POWDER after
the expiry date shown on the blister foil and carton.
Do not store above 25 °C. Do not place in the sun
or on radiators etc.
Do not freeze.
Once you have taken your first capsule of SPIRIVA
INHALATION POWDER from the blister strip you
must continue to take the capsules for the next 9
days, one capsule a day, from the same strip.
KEEP ALL MEDICINES OUT OF THE REACH
AND SIGHT OF CHILDREN.
Further information
For further information on COPD, join the Open Air
Patient Club.
Free membership of this club entitles you to
complimentary Open Air newsletters which are for
anyone concerned with long-standing breathing
problems. Not just for patients, but for carers too,
they hope to inform, educate, support and entertain
all those who read them. The information provided
is designed to complement that given by your
doctor, practice nurse or pharmacist.

Original Application Date: 06/12/05
Date of Amendment/Printing: 14/11/2006

Name: LANDMARK PHARMA LTD

Signed:

LANDMARK PHARMA LTD
PROPOSED TEXT: PATIENT INFORMATION LEAFLET
PL (PI) 21828/0137
Page 3 of 3
To join the club, send your name and address
(please print) to:
Open Air
Freepost
PO Box 70
Bracknell
Berkshire
RG12 4GR
United Kingdom
®

®

SPIRIVA and HANDIHALER are trademarks of
Boehringer Ingelheim Pharma GmbH & Co. KG,
Germany
Leaflet revision date: 14 November 2006
Ref: SPI0137-PILv1

Original Application Date: 06/12/05
Date of Amendment/Printing: 14/11/2006

Name: LANDMARK PHARMA LTD

Signed:

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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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