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TIOTROPIUM 18MICROGRAMS INHALATION CAPSULES

Active substance(s): TIOTROPIUM BROMIDE MONOHYDRATE

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Cleaning your HandiHaler ®:

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.

S261 LEAFLET Spiriva 20150325

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

Warnings and precautions

PACKAGE LEAFLET: INFORMATION FOR THE USER



SPIRIVA 18 micrograms INHALATION CAPSULES
(tiotropium bromide)

Talk to your doctor if you suffer from narrow angle glaucoma,
prostate problems or have difficulty passing urine.



Your medicine is known with the above name but will be referred to
as Spiriva 18 microgram throughout the following patient
information leaflet.

If you have problems with your kidneys, please consult your
doctor.



Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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.



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

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

1. What Spiriva 18 microgram is and what it is used for

Separate the blister strips by tearing along the perforation.

®

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.
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.

Open the mouthpiece again. Tip out the used capsule and dispose.
Close the mouthpiece and dust cap for storage of your HandiHaler®
device.
Remove capsule.
Spiriva capsules contain only a small amount of powder so that the
capsule is only partially filled.

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.

Spiriva 18 microgram is not recommended for children and
adolescents under 18 years.

2. What you need to know before you take Spiriva 18
microgram

Pregnancy and breast-feeding

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

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.
If you are pregnant or believe you are pregnant, or if you are breastfeeding, consult with your doctor. You should not use this medicine
unless specifically recommended by your doctor.
Driving and using machines



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?

3. How to take Spiriva 18 microgram



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?

Follow your doctor’s instructions about when and how to take your
medicine. If you are unsure ask your doctor or pharmacist.

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

S261 LEAFLET Spiriva 20150325

Children and adolescents

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 5.5 mg lactose monohydrate.

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.

Rare:


Difficulty in sleeping (insomnia)

The HandiHaler device, which you should put the Spiriva capsule
into, makes holes in the capsule and allows you to breathe in the
powder.



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)

Make sure that you do not blow into the HandiHaler.



Feeling your heartbeat (palpitations)

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



Tightness of the chest, associated with coughing, wheezing or
breathlessness immediately after inhalation (bronchospasm)

You should clean your HandiHaler once a month. Cleaning
instructions for the HandiHaler are provided on the other side of this
leaflet.



Nosebleed (epistaxis)



Inflammation of the larynx (laryngitis)

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.



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)

If you take more Spiriva 18 microgram than you should



Inflammation of the mouth (stomatitis)

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.



Feeling sick (nausea)



Allergic reactions (hypersensitivity), including immediate
reactions

Product Licence holder



Serious allergic reaction which causes swelling of the face or
throat (angioedema)



Nettle rash (urticaria)

The product is procured from within the EU and repackaged by the
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



Itching (pruritus)



Infections of the urinary tract

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.

If you feel that your breathing is worsening, you should tell your
doctor as soon as possible

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

Depletion of body water (dehydration)



Tooth decay (dental caries)

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



Severe allergic reaction (anaphylactic reaction)



Infections or ulcerations of the skin



Dryness of the skin

4. Possible side effects



Swelling of joints

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

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.

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:

1. Dust Cap
2. Mouthpiece
3. Base

6. Contents of the pack and other information
What Spiriva 18 microgram contains


Each hard 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.



Spiriva 18 microgram also contain the following: lactose
monohydrate.

4. Piercing button
5. Centre chamber

What Spiriva 18 microgram looks like and contents of the pack


Spiriva 18 microgram is a light green hard capsule marked ‘TI
01’ with a company logo in black ink containing a white powder.
The HandiHaler is the device that must be used with Spiriva
Capsules.



The HandiHaler is light grey and comprises a dust cap,
mouthpiece, a sea-green piercing button and a centre chamber.



Spiriva 18 microgram is available as blister packs containing 30
capsules and 1 HandiHaler.

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

This product is manufactured by Boehringer Ingelheim Pharma
GmbH & Co. KG, 55216 Ingelheim am Rhein, Germany.

Not known:


Common:

The HandiHaler®

Manufacturer

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.

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

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.

POM

PL No: 19488/0261
Open the dust cap completely by pulling it upwards.

Leaflet revision date: 25 March 2015

Then open the mouthpiece by pulling it upwards.

Spiriva and Handihaler are registered trade marks of Boehringer
Ingelheim Pharma GmbH & Co KG, Germany.
®

HandiHaler Instructions for use
Dear Patient,
®

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

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.

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



Dizziness



Headache



Taste disorders



5. How to store Spiriva 18 microgram

Blurred vision





KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Irregular heart beat (atrial fibrillation)





Spiriva 18 microgram should not be stored above 25°C.

Sore throat (pharyngitis)





Do not freeze.

Hoarseness (dysphonia)





Cough



Heart burn (gastrooesophageal reflux disease)

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.



Constipation



Fungal infections of the oral cavity and throat
(oropharyngeal candidiasis)



Rash



Difficulty passing urine (urinary retention)



Painful urination (dysuria)



Do not use Spiriva 18 microgram after the expiry date which is
stated on the label and carton. The expiry date refers to the last
day of the month.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

S261 LEAFLET Spiriva 20150325

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.
Close the mouthpiece firmly until you hear a click, leaving the dust
cap open.
S261 LEAFLET Spiriva 20150325

Cleaning your HandiHaler ®:

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.

S246 LEAFLET Tiotropium 20150325

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

Warnings and precautions

PACKAGE LEAFLET: INFORMATION FOR THE USER



TIOTROPIUM 18 micrograms INHALATION CAPSULES
(tiotropium bromide)

Talk to your doctor if you suffer from narrow angle glaucoma,
prostate problems or have difficulty passing urine.



Your medicine is known with the above name but will be referred to
as Tiotropium Capsules throughout the following patient information
leaflet.

If you have problems with your kidneys, please consult your
doctor.



Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Tiotropium Capsules 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
Tiotropium Capsules. If this occurs, please consult your doctor
immediately.



Inhaled medicines such as Tiotropium 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.



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 Tiotropium Capsules more frequently than once
daily.



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 Tiotropium Capsules is and what it is used for
2. What you need to know before you take Tiotropium Capsules
3. How to take Tiotropium Capsules
4. Possible side effects
5. How to store Tiotropium Capsules
6. Contents of the pack and other information

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

1. What Tiotropium Capsules is and what it is used for

Separate the blister strips by tearing along the perforation.

Tiotropium 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
Tiotropium Capsules every day and not only when you have
breathing problems or other symptoms of COPD.
Tiotropium Capsules 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 Tiotropium 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
Tiotropium 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 Tiotropium
Capsules please see section 3. How to take Tiotropium Capsules
and the instructions for use provided on the other side of the leaflet.

®

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.
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.

Open the mouthpiece again. Tip out the used capsule and dispose.
Close the mouthpiece and dust cap for storage of your HandiHaler®
device.
Remove capsule.
Spiriva capsules contain only a small amount of powder so that the
capsule is only partially filled.

2. What you need to know before you take Tiotropium
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 Tiotropium Capsules

Tiotropium Capsules is not recommended for children and
adolescents under 18 years.
Other medicines and Tiotropium 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 Tiotropium
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.
Pregnancy and breast-feeding
If you are pregnant or believe you are pregnant, or if you are breastfeeding, 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.



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?

Follow your doctor’s instructions about when and how to take your
medicine. If you are unsure ask your doctor or pharmacist.



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?

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.

Do not take Tiotropium Capsules
You should not use Tiotropium Capsules if you are allergic
(hypersensitive) to tiotropium, its active ingredient or to lactose
monohydrate which contains milk protein.
You should also not use Tiotropium Capsules if you are allergic
(hypersensitive) to atropine or substances related to it, e.g.
ipratropium or oxitropium

S261 LEAFLET Tiotropium 20150325

Children and adolescents

Tiotropium Capsules contains lactose monohydrate
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 Tiotropium Capsules

Tiotropium Capsules 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 Tiotropium Capsules is effective over 24
hours.
The capsules are only for inhalation and not for oral intake. Do not
swallow the capsules.



Seeing halos around lights or coloured images in association
with red eyes (glaucoma)

6. Contents of the pack and other information

The HandiHaler®



Increase of the measured eye pressure

What Tiotropium Capsules contain

1. Dust Cap

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.



2. Mouthpiece

Irregular heart beat (supraventricular tachycardia)





Faster heart beat (tachycardia)

Make sure that you do not blow into the HandiHaler.



Feeling your heartbeat (palpitations)

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



Tightness of the chest, associated with coughing, wheezing or
breathlessness immediately after inhalation (bronchospasm)

You should clean your HandiHaler once a month. Cleaning
instructions for the HandiHaler are provided on the other side of this
leaflet.



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

The product is procured from within the EU and repackaged by the
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



Serious allergic reaction which causes swelling of the face or
throat (angioedema)

Manufacturer



Nettle rash (urticaria)



Itching (pruritus)



Infections of the urinary tract

The HandiHaler device, which you should put the Spiriva capsule
into, makes holes in the capsule and allows you to breathe in the
powder.

When taking Tiotropium 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 Tiotropium Capsules than you should
If you inhale from more than 1 capsule of Tiotropium Capsules 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 Tiotropium 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.



Each hard 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.
Tiotropium Capsules also contain the following: lactose
monohydrate.



Tiotropium Capsules are light green hard capsules marked ‘TI
01’ with a company logo in black ink containing a white powder.
The HandiHaler is the device that must be used with Tiotropium
Capsules.



The HandiHaler is light grey and comprises a dust cap,
mouthpiece, a sea-green piercing button and a centre chamber.



Tiotropium is available as blister packs containing 30 capsules
and 1 HandiHaler.

Product Licence holder

POM



Depletion of body water (dehydration)



Tooth decay (dental caries)



Severe allergic reaction (anaphylactic reaction)

HandiHaler ® Instructions for use



Infections or ulcerations of the skin

Dear Patient,



Dryness of the skin

4. Possible side effects



Swelling of joints

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

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 Tiotropium
Capsules. 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.

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:

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.



Headache



Taste disorders

5. How to store Tiotropium Capsules



Blurred vision



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Irregular heart beat (atrial fibrillation)



Tiotropium Capsules should not be stored above 25°C.



Sore throat (pharyngitis)



Do not freeze.



Hoarseness (dysphonia)





Cough



Heart burn (gastrooesophageal reflux disease)

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.



Constipation





Fungal infections of the oral cavity and throat
(oropharyngeal candidiasis)

Do not use Tiotropium Capsules after the expiry date which is
stated on the label and carton. The expiry date refers to the last
day of the month.



Rash



Difficulty passing urine (urinary retention)

Difficulty in sleeping (insomnia)

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

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

Dizziness



Leaflet revision date: 25 March 2015

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



 Painful urination (dysuria)
Rare:

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

PL No: 19488/0261

Not known:

Common:

5. Centre chamber

This product is manufactured by Boehringer Ingelheim Pharma
GmbH & Co. KG, 55216 Ingelheim am Rhein, Germany.

Before you stop taking Tiotropium Capsules, you should talk to your
doctor or your pharmacist. If you stop taking Tiotropium Capsules
the signs and symptoms of COPD may worsen.

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

4. Piercing button

What Tiotropium Capsules look like and contents of the pack

If you stop taking Tiotropium Capsules

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

3. Base



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell 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.
S261 LEAFLET Tiotropium 20150325

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.

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.

Close the mouthpiece firmly until you hear a click, leaving the dust
cap open.
S261 LEAFLET Tiotropium 20150325

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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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