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SPIRIVA 18 MICROGRAM CAPSULES

Active substance(s): TIOTROPIUM

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PACKAGE LEAFLET: INFORMATION FOR THE
USER
SPIRIVA® 18 MICROGRAM CAPSULES
(tiotropium bromide)
The name of your medicine is Spiriva 18 microgram
Inhalation Powder Hard Capsules but will be referred
to as Spiriva 18 microgram throughout the
remainder of 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. 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
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.

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.

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

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

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.

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

3. How to take Spiriva 18 microgram

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

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 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.

4. Possible side effects

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

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)
- 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 of side effects
If you get any side effects, talk to your doctor or
pharmacist.
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.
5. How to store Spiriva 18 microgram
 KEEP OUT OF SIGHT AND REACH OF

CHILDREN
 Do not use after the expiry date printed on the

blister label or carton label.
 Once you have taken your first capsule of

SPIRIVA 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 store above 25°C.
 Do not freeze.
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.
The other ingredient is lactose monohydrate. .
What SPIRIVA 18 microgram looks like and the
contents of the pack
SPIRIVA 18 microgram, inhalation powder, hard
capsule is a light green capsule with TIO1 and
company logo printed on the capsule.
SPIRIVA 18 microgram comes in packs of 30
capsules.
Your pack may include a HandiHaler® device that
must be used with SPIRIVA 18 microgram.
A pack containing 1 HandiHaler device is available.
Manufacturer
This product is manufactured by: Boehringer
Ingelheim Pharma GmbH & Co. KG., Binger Strasse
173, 55216 Ingelheim am Rhein, Germany.
Procured from within the EU and repackaged by the
Product Licence Holder: G Pharma Ltd,
Salford M50 2PU.
POM

Revision Date: 13/12/2016
PL 16369/1710
‘SPIRIVA’ and ‘HandiHaler’ are registered
trademarks of Boehringer Ingelheim Pharma GmbH.

+ 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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