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SPIRIVA 18 MICROGRAM INHALATION POWDER HARD CAPSULES

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

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If you take more Spiriva than you should

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

®

Spiriva 18 Microgram Inhalation Powder, Hard capsules
(tiotropium bromide)

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.

Your medicine is available using the name Spiriva 18 microgram Inhalation Powder, Hard Capsules but will be
referred to as Spiriva throughout 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 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 YOU NEED TO KNOW BEFORE YOU TAKE SPIRIVA

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 narrowangle 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 heartbeat 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.

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

Dry mouth: this is usually mild
















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. 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.

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.

5.

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.

3.

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

Uncommon:

You should not use Spiriva if you are allergic (hypersensitive) to tiotropium, its active ingredient, or to lactose
monohydrate which contains milk protein.



POSSIBLE SIDE EFFECTS

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



Do not take Spiriva



4.

Common:

WHAT SPIRIVA IS AND WHAT IT IS USED FOR

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 heartbeat or severe heart failure within the past year?




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

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.

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.



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.

Common:
Uncommon:
Rare:
Not known:

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.

2.

If you stop taking Spiriva

6.

HOW TO STORE SPIRIVA

Do not use Spiriva after the expiry date which is stated on the carton and the blister foil. The expiry date
refers to the last day of that month.
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.
Do not store above 25°C. Do not freeze.
Protect from direct sunlight and heat.
Keep out of the sight and reach of children.
If your doctor decides to stop treatment, return any left over capsules to your pharmacist. Only keep them
if your doctor tells you to.
If your capsules appear to be discoloured or show any other signs of deterioration, please return to your
pharmacist who will advise you.
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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Spiriva contains

HOW TO TAKE SPIRIVA

Each inhalation capsule contains 18 micrograms of tiotropium (as bromide monohydrate).

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

Each capsule also contains the inactive ingredient 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.

The capsules contain powder, which should be breathed in using the HandiHaler device.

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

The capsules are light green hard capsules, containing a white or yellowish white powder, printed in black with
‘TI 01’ on the cap and the manufacturer’s logo on the body. The HandiHaler device is light grey with ‘HandiHaler’
printed on the front. The HandiHaler device comprises of a dust cap, mouthpiece, piercing button and centre
chamber.

What Spiriva looks like and contents of the pack

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 is the device, which must be used with Spiriva.

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

Manufacturer

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.

Manufactured by: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.

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.

Your medicine is available in packs containing 30 capsules and 1 HandiHaler device.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0403

POM

Leaflet revision and issue date (Ref): 24.04.15
Spiriva® and HandiHaler® are registered trademarks of Boehringer Ingelheim Pharma GmbH & Co. KG.

Page 1 of 2

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.

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

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.

The
1.
2.
3.
4.
5.

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.

HandiHaler®
Dust cap
Mouth piece
Base
Piercing button
Centre chamber

Open the mouthpiece again. Tip out the used
capsule and dispose. Close the mouthpiece and
dust cap for storage of your HandiHaler® device.
To release the dust cap press the piercing button
completely in and let go.

Cleaning your HandiHaler®:
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.

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

Blister handling

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.

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

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

Remove capsule.
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.

Spiriva capsules contain only a small amount of
powder so that the capsule is only partially filled.

Leaflet revision and issue date (Ref): 24.04.15
Spiriva® and HandiHaler® are registered trademarks of Boehringer Ingelheim Pharma
GmbH & Co. KG.
Page 2 of 2

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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