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SPIRIVA 18MCG INHALATION POWDER HARD CAPSULES

Active substance(s): TIOTROPIUM BROMIDE MONOHYDRATE

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SPIRIVA® 18 MICROGRAM INHALATION POWDER,
HARD CAPSULES
Patient Information Leaflet
(Tiotropium)
Read all of this leaflet carefully before you start taking this medicine
because it contains important information.
• 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 18 microgram throughout the
remainder of this leaflet.
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, 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 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 one 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:
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)
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
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not store above 25°C. Do not freeze.
Do not use Spiriva 18 microgram 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.
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
Each capsule contains 18 micrograms of the active ingredient tiotropium (as
bromide monohydrate). During inhalation, 10 micrograms tiotropium are
delivered from the mouthpiece of the Handihaler. The other ingredient is
lactose monohydrate.
What Spiriva 18 microgram looks like and contents of the pack
The capsules are green, hard gelatin capsules printed ‘TI 01’ on one half and
company logo on the other half. To be used in the grey coloured egg shaped
Handihaler® device. During inhalation 10 micrograms tiotropium are
delivered from the mouth piece of the Handihaler.
The product is available in pack sizes of 30 capsules and 1 HANDIHALER.
The HandiHaler® is the device that must be used with SPIRIVA
POM

PL No: 20774/0949

This product is manufactured by Boehringer Ingelheim Pharma GmbH & Co.
KG, 55216 Ingelheim am Rhein, Germany.
Procured from within the EU. Product Licence holder: Quadrant
Pharmaceuticals Ltd. Lynstock House, Lynstock Way, Lostock, Bolton
BL6 4SA. Repackaged by Maxearn Ltd, Bolton. BL6 4SA
th

Leaflet revision and date of issue: 11 August 2015
Spiriva and HandiHaler are registered trademarks of Boehringer Ingelheim
Pharma GmbH& Co. KG.
PP6/0949/V2

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.

Remove a Spiriva capsule from the blister (only immediately before use, see
blister handling) and place it in the centre chamber (r), as illustrated. It
does not matter which way the capsule is placed in the chamber.

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.

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.

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

Separate the blister strips by tearing along the perforation.

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

Cleaning your HandiHaler®:

®

o Mouthpiece
p Base
q Piercing button
r Centre chamber

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.
Remove capsule.
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.

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

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

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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