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SPIRIVA COMBOPACK

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

SPIRIVA® COMBOPACK
(tiotropium bromide)

Read all of this leaflet carefully before you
start taking this medicine.
- 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
- If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
Your medicine is known by any of the above names but
will be referred to as SPIRIVA 18 microgram

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. Further information
1. WHAT SPIRIVA 18 MICROGRAM IS AND
WHAT IT IS USED FOR

(tiotropium bromide)

SPIRIVA® COMBOPACK
PACKAGE LEAFLET:
INFORMATION FOR THE USER
PACKAGE LEAFLET:
INFORMATION FOR THE USER

SPIRIVA® COMBOPACK
(tiotropium bromide)

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. 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?

Do not take SPIRIVA 18 microgram
You should not use SPIRIVA 18 microgram if
you are allergic (hypersensitive) to tiotropium 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
You should not use SPIRIVA 18 microgram if
you are under 18 years of age.
Take special care with SPIRIVA 18
microgram
- If you suffer from narrow angle glaucoma,
prostate problems or have difficulty passing
urine
- If you have problems with your kidneys
- 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
anticholinergic treatment, may in the long
term be associated with dental caries.
Therefore, please remember to pay attention
to oral hygiene.
- Do not take SPIRIVA 18 microgram more
frequently than once daily.
Taking other medicines
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.

Important information about some of the
ingredients of SPIRIVA 18 microgram
When taken according to dosage
recommendations, one capsule once a day,
each dose supplies up to 5.5 mg 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.
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.
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,
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 product, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, SPIRIVA 18 microgram can
cause side effects, although not everybody gets
them.

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

5. HOW TO STORE SPIRIVA 18 microgram

Common:
Uncommon:
Rare:
Not known:

Do not use SPIRIVA 18 microgram after the
expiry date which is stated on the carton and the
blister foil. The expiry date refers to the last day
of that month.

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 any of the side effects gets serious or, if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

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. Use within 9 days of
opening the blister strip.
Do not store above 25°C. Do not freeze.
If your doctor tells you to stop taking the
medicine, please take it back to the
pharmacist for safe disposal. Only keep it if your
doctor tells you to.
If the medicine becomes discoloured or shows
any other signs of deterioration, you
should seek the advice of your pharmacist who
will advise you what to do.
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.
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
What SPIRIVA 18 microgram looks like and
contents of the pack
SPIRIVA 18 microgram, inhalation powder, hard
capsule comes as light green hard gelatin
capsules, containing a white powder printed
TI 01 on the cap and the company logo printed
on the body.
The HandiHaler® is grey with ‘HandiHaler®’
printed on the dust cap and ‘Boehringer
Ingelheim’ and the company logo printed on the
base. The device also consists of a
mouthpiece, green piercing button and see
through centre chamber. This device must
be used with Spiriva.
The product is available in the following pack:
A pack containing 30 capsules and 1 HandiHaler
Manufacturer
The manufacturer for SPIRIVA 18 microgram
and the HandiHaler device is:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
Procured from within the EU. Product Licence
holder and repackaged by: S.C.A.C Ltd., Unit 2A,
Bandeath Industrial Estate, Throsk, Stirling, FK7
7NP, United Kingdom
PL: 30984/0152

POM

This medicinal product is authorised in the
member States of the EEA under the
tradename SPIRIVA 18 microgram.
This leaflet was last approved in 20.03.2013.
Spiriva® and HandiHaler® are registered
trademarks of Boehringer Ingelheim Pharma
GmbH & Co KG.

HandiHaler® Instructions for use

Blister handling

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

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

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

Open the dust cap completely by pulling it
upwards.

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

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.

Separate the blister strips by tearing along the
perforation.

HandiHaler®
Then open the mouthpiece by pulling it upwards.

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 your HandiHaler® device.

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®:

HandiHaler®

The HandiHaler®

Œ

Ž



Dust cap
Mouthpiece
Base
Piercing button
Centre chamber

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

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

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.

Remove capsule.
SPIRIVA capsules contain only a small amount
of powder so that the capsule is only partially
filled.
Manufacturer of the HandiHaler® device:
Boehringer Ingelheim
Pharma GmbH & Co. KG
D-55216 Ingelheim am Rhein
Germany

+ Expand Transcript

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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