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SPIRIVA 18 MICROGRAM INHALATION CAPSULES

Active substance(s): TIOTROPIUM BROMIDE MONOHYDRATE

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PACKAGE LEAFLET
INFORMATION FOR THE USER

Spiriva ®
18 microgram
Inhalation Powder,
Hard Capsule
(tiotropium bromide)
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.
Your medicine is called Spiriva 18 microgram inhalation
powder, hard capsule 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 life threatening
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.
- Spriva 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
narrowangle 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 more frequently than once daily.

3. How to take Spiriva
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 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

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

If you take more Spiriva than you should
If you inhale from more than 1 capsule of Spiriva 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.

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.

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.

Please tell your doctor or pharmacist if you are taking/have
taken similar medicines for your lung disease, such as
ipratropium or oxitropium.

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.

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.

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

4. Possible side effects
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 5.5 mg
lactose monohydrate.

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

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)

Reporting of side effects
If you get any side effects, talk to your doctor, 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
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not freeze.
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 use after the expiry date shown on the carton or
blister strip. If your doctor tells you to stop taking this
medicine, return any unused medicine to your pharmacist
(chemist) for safe disposal. Only keep this medicine if your
doctor tells you to. If your medicine become discoloured or
show any other signs of deterioration, consult your
pharmacist (chemist) 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.

6. Contents of the pack and other information
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

What Spiriva contains
Each capsule contains 18 micrograms of the active
ingredient tiotropium (as bromide monohydrate).
The capsules also contain the inactive ingredient lactose
monohydrate.
What Spiriva looks like and contents of the pack
Your medicine are light green hard capsules which contain
white powder, printed ‘TI 01’ and the company logo in black
ink. The powder in the capsules should be inhaled using the
HandiHaler device.
The pack contains either 30 capsules and 1 handihaler or
30 capsules.
The handihaler is the device that must be used with Spiriva.
Manufacturer and Licence Holder
Spiriva is manufactured by Boehringer Ingelheim
International GmbH, Binger Strasse 173, D-55216 Ingelheim
am Rhein, Germany and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.

POM PL Number: 15184/1098
SPIRIVA and HandiHaler are registered trademarks of
Boehringer Ingelheim Pharma GmbH & Co. KG.
Leaflet revision date: 13/04/16

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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414
for help.

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.

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

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.

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.

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.

Open the mouthpiece again. Tip out the used
capsule and dispose. Close the mouthpiece and
dust cap for storage of your HandiHaler ® device.

Separate the blister strips by tearing along the
perforation.

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® :

The HandiHaler ®
1 Dust Cap
2 Mouthpiece
3 Base
4 Piercing button
5 Centre 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 view ⇕

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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