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SPIRIVA 18MCG INHALATION POWDER HARD CAPSULE

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 monohydrate)
Your medicine is known by the above name but will be referred to as Spiriva 18 microgram
throughout the following.
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, shortterm 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.
Driving and using machines
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.

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.
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 18 microgram 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 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:
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:
■ 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, 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.
5. How to store Spiriva 18 microgram










Do not use Spiriva 18 microgram after the expiry date shown on the blister foil and carton.
The expiry date refers to the last day of that month.
Keep out of the sight and reach of children.
Do not store above 25°C. Do not place in the sun or on radiators etc. Do not freeze.
After first opening the blister strip, use within 9 days.
Once you have taken your first capsule of Spiriva 18 microgram from the blister strip you must
continue to take the capsules for the next 9 days, one capsule a day, from the same strip.
Only keep the medicine if your doctor tells you to.
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 the medicine becomes discoloured or show signs of any deterioration, you should
seek the advice of your pharmacist.

6. Contents of the pack and other information
What Spiriva 18 microgram contains
Each capsule contains Tiotropium Bromide Monohydrate 22.5mcg equivalent to Tiotropium
18mcg as the active ingredient.
The capsule also contains the inactive ingredients lactose monohydrate, gelatin and black
printing ink. The capsules are hard gelatin capsules.
What Spiriva 18 microgram looks like and contents of the pack
The light green gelatin capsules are marked ‘TI 01’ on the cap and company logo on the
body in black ink containing powder for inhalation, which should be breathed in using the
light grey HandiHaler device.
The product is available in the following packs:
1. A Combopack containing 30 capsules and 1 HandiHaler
The HandiHaler is the device that must be used with Spiriva 18 microgram.
2. A Refill pack containing 30 or 60 capsules only.
POM
PL NO: 15814/0760
Manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein,
Germany and is procured from within the EU and repackaged by the Product Licence
holder O.P.D. Laboratories Ltd, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref): 19.02.2015.
Spiriva and HandiHaler are registered Trade Marks of Boehringer Ingelheim Pharma GmbH
& Co. KG.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
HandiHaler Instructions for use
Dear Patient,
The HandiHaler enables you to inhale the medicine contained in the Spiriva 18 microgram
capsule - that your physician has prescribed for your breathing problems.

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.

Breathe out completely.

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.

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

Cleaning your HandiHaler:

Remember to carefully follow your
doctor’s instructions for using Spiriva
18 microgram. The HandiHaler is
especially designed for Spiriva 18
microgram. 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.

Remove a Spiriva 18 microgram
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.

The HandiHaler
Dust cap
1
Mouthpiece
2
Base
3
Piercing button
4
Centre chamber
5

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

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

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.

Close the mouthpiece firmly until you
hear a click, leaving the dust cap open.
Remove capsule.
Spiriva 18 microgram 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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