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TIOTROPIUM 18 MICROGRAM INHALATION POWDER HARD CAPSULE

Active substance(s): TIOTROPIUM

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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 Capsule
Tiotropium 18 Microgram Inhalation Powder, Hard Capsule
Spiriva® 18 Microgram Inhalation Powder, Hard Capsule and
Handihaler® Device
Tiotropium 18 Microgram Inhalation Powder, Hard Capsule and
Handihaler® Device
(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.

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.

Your medicine is available using the above names but will be referred to as Spiriva throughout this
leaflet.

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

4.

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.

Evaluation of the side effects is based on the following frequencies:
Common:
Uncommon:
Rare:
Not known:

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.

Common:

















WHAT SPIRIVA IS AND WHAT IT IS USED FOR

WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPIRIVA

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 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.

Children and adolescents

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






























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.



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.

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.




Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines,
even those not prescribed.

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

Not known:

5.

Other medicines and Spiriva

6.

HOW TO STORE SPIRIVA

Keep out of the sight and reach of children.
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.
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 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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Spiriva contains

Driving and using machines

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

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

The capsule also contains the inactive ingredient Lactose monohydrate.

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.

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:

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?




Dry mouth: this is usually mild

Uncommon:

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, 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 please see
section 3. How to take Spiriva and the instructions for use provided on the other side of the leaflet.



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.

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.

POSSIBLE SIDE EFFECTS

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

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

What Spiriva looks like and contents of the pack

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 is not recommended for children and adolescents under 18 years.

The capsules are light green hard capsules, containing a white or yellowish white powder, with
‘TI 01’ and company logo printed on the capsules.
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.
The HandiHaler is the device, which must be used with Spiriva.
Your medicine is available in packs of 60 capsules, 30 capsules or 30 capsules with a Handihaler
device.

You should try to take the capsule at the same time every day. This is important because Spiriva is
effective over 24 hours.

Manufacturer

The manufacturer of Spiriva is:
Boehringer Ingelheim Pharma GmbH & Co. KG, 55216 Ingelheim am Rhein, Germany.
Or
Boehringer Ingelheim Pharma KG, 55216 Ingelheim am Rhein, Germany.

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.

Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.

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.

Product Licence holder: BR Lewis Pharmaceuticals Ltd, Kirk Sandall, Doncaster, DN3 1QR.

Make sure that you do not blow into the HandiHaler.

PL No: 08929/0135

If you have any problems using the HandiHaler, ask your doctor, nurse or pharmacist to show you how
it works.

POM

Leaflet revision and issue date (Ref): 10.03.16

You should clean your HandiHaler once a month. Cleaning instructions for the HandiHaler are provided
on the other side of this leaflet.

Spiriva® and HandiHaler® are registered trademarks of Boehringer Ingelheim Pharma GmbH &
Co. KG.

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.

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.

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.

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.

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

The
1.
2.
3.
4.
5.

HandiHaler®
Dust cap
Mouthpiece
Base
Piercing button
Centre chamber
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.

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

Blister handling

Separate the blister strips by tearing along the
perforation.

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

Peel back foil (only immediately before use) using
the tab until one capsule is fully visible.

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.

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

Remove capsule.

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

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

Leaflet revision and issue date (Ref): 10.03.16
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® and HandiHaler® are registered trademarks of Boehringer Ingelheim Pharma
GmbH & Co. KG.

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

Page 2 of 2

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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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