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SPIRIVA 18MICROGRAM INHALATION POWDER HARD CAPSULE

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

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Package leaflet: Information for the user
®

SPIRIVA 18 microgram
INHALATION POWDER, HARD
CAPSULES
(tiotropium bromide monohydrate)
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.
The name of your medicine is SPIRIVA 18 microgram
INHALATION POWDER, HARD CAPSULES but will be
referred to as Spiriva throughout this leaflet.
What is in this leaflet:
1. What Spiriva is and what it is used for
2. What you need to know before you take Spiriva
3. How to take Spiriva
4. Possible side effects
5. How to store Spiriva
6. Contents of the pack and other information
1. What Spiriva is and what it is used for
Spiriva 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 every day and
not only when you have breathing problems or other
symptoms of COPD.
Spiriva 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 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 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 please see
section 3.’How to take Spiriva’ and the instructions for use
provided on the other side of the leaflet.
2. What you need to know before you take Spiriva
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
-

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 lifethreatening irregular heart beat or severe heart failure
within the past year?

Do not take Spiriva
You should not use Spiriva if you are allergic
(hypersensitive) to tiotropium, its active ingredient or to
lactose monohydrate which contains milk protein.
You should also not use Spiriva 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 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. If this occurs, please consult
your doctor immediately.
- Inhaled medicines such as Spiriva 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.
- In case you have suffered from a myocardial infarction
during the last 6 months or from any unstable or lifethreatening 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 more frequently than once daily.
Children and adolescents
Spiriva is not recommended for children and adolescents
under 18 years.
Other medicines and Spiriva
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 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.

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

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.

3. How to take Spiriva

Common:
- Dry mouth: this is usually mild

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 (18micrograms of tiotropium) once a day.
Do not take more than the recommended dose.
Spiriva 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 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, 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 than you should
If you inhale from more than 1 capsule of Spiriva
18microgram 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
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
Before you stop taking Spiriva, you should talk to your
doctor or your pharmacist. If you stop taking Spiriva the
signs and symptoms of COPD may worsen.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Evaluation of the side effects is based on the following
frequencies:
Common:
Uncommon:
Rare:
Not known:

may affect up to 1 in 10 people
may affect up to 1 in 100 people
may affect up to 1 in 1,000 people
frequency cannot be estimated from the
available data

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.

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)

5. How to store Spiriva

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 heart beat (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

KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.

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. 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.

Spiriva 18 microgram inhalation powder, hard capsule
should be stored below 25°C.
Do not use after the expiry date printed on the carton or
blister label. The expiry date refers to the last day of that
month.
Do not place in the sun or on radiators. Do not freeze.
Once you have taken your first capsule from your blister
strip you must continue to take the capsules for the next 9
days, one capsule a day, from the same strip.
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.

If your doctor tells you to stop using the medicine, please
take it back to the pharmacist for safe disposal. Only
keep the medicine if your doctor tells you to.
If the capsules become discoloured or show any other
signs of deterioration, you should seek the advice of your
pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Spiriva contains
Each capsule contains 18 micrograms of the active
ingredient tiotropium (as the bromide monohydrate).
Spiriva also contains the following:
Lactose monohydrate
What Spiriva looks like and contents of the pack
Spiriva is a light-green gelatin capsule that contains a
white powder for inhalation and is marked ‘TI 01’ on the
cap with a logo on the body for use in a grey
circular plastic HandiHaler® device.
Spiriva is available in the following packs:
A pack contains 30 capsules.
A pack containing 30 capsules and a Handihaler.
Manufactured by: Boehringer Ingelheim Pharma KG,
D-55216 Ingelheim am Rhein, Germany.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
SPIRIVA® 18 microgram INHALATION POWDER, HARD
CAPSULES
PL No: 18799/2635
Leaflet date: 03.09.2015
See overleaf for instructions on how to use
HandiHaler.

POM

Blister handling

®

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.

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.

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

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.

Open the dust cap completely 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.

Then open the mouthpiece by pulling it upwards.

In case a second capsule is exposed to air inadvertently this
capsule has to be discarded.

Cleaning your HandiHaler:

The HandiHaler






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.

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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